chapter 1 — definitions of terms in the general rules · web viewchapter 2 —...

DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018

Consultation for:Categorisation Guidelines (Draft) Consultation finishes 31 May 2018 National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

NICNAS contact detailsWebsite: www.nicnas.gov.au

email: [email protected]

Freecall: 1800 638 528

Phone: + 61 2 8577 8800

http://www.nicnas.gov.au/


BLANK PAGE


Table of ContentsChapter 1 — Definitions of terms in the General Rules................14

Chemical identity holder.................................................................14

Known hazard classification............................................................14

Low concern following migration to food.........................................15

Not persistent................................................................................16

Chapter 2 — Internationally-assessed introductions...................18

Is the human health risk higher in Australia?...................................18

How relevant are the overseas assessments compared to your introduction?....................................................................................................................... 18

Is the environment risk higher in Australia?.....................................19

How relevant are the overseas assessment compared to your introduction?19

Chapter 3 — Hazard bands........................................................21

Working out hazard bands that don't apply.....................................21

Hazard characteristics in the highest hazard bands..........................22

Hazard characteristics band C human health................................................23

Hazard characteristics band D environment..................................................23

Specified lists and existing information.........................................................23

Human health hazard band C lists.................................................................24

Environment hazard band lists.......................................................................25

Hazard information for known environment degradation products....26

Demonstrating the absence of a hazard characteristic.....................26

Use of in silico information.............................................................................27

How to use ‘read-across information’............................................................31

How to work out if the read-across information is appropriate to fill an information gap..............................................................................................31


Things to consider if you use a category approach........................................32

Conflicting study results and hierarchy of information......................32

Draft, deleted and equivalent test guidelines..................................33

Chapter 4 — Human health risk by exposure bands....................34

Human health exposure band 1.......................................................35

Work out hazard characteristics.....................................................................35

Hazard band C characteristics.................................................................36

Hazard band C: carcinogenicity.....................................................................36

Hazard band C: mutagenicity or genotoxicity................................................37

Hazard band C: reproductive toxicity.............................................................38

Hazard band C: developmental toxicity.........................................................39

Hazard band C: adverse effects mediated by an endocrine mode of action. .39




Human health exposure band 2 — low risk.......................................43

Definitions hazard band C..............................................................................44







Human health exposure band 2 — very low risk...............................50

Hazard band C characteristics.................................................................51







Hazard band B hazard characteristics....................................................56

Hazard band B: acute toxicity (fatal or toxic).................................................57

Hazard band B: specific target organ toxicity after a single exposure (significant toxicity).......................................................................................59

Hazard band B: specific target organ toxicity after repeated exposure.........60

Hazard band B: skin corrosion.......................................................................62

Hazard band B: eye damage..........................................................................64

Hazard band B: skin sensitisation..................................................................65

Hazard band B: respiratory sensitisation.......................................................67

Hazard band B: respiratory corrosion.............................................................68

Hazard band B: high molecular weight polymer that is water absorbing.......69

Hazard band B: high molecular weight polymer that is reactive....................69

Hazard band B: high molecular weight polymer that contains certain chemical elements........................................................................................................70

Hazard band A hazard characteristics....................................................70

Hazard band A: acute toxicity (harmful)........................................................71

Hazard band A: specific target organ toxicity after a single exposure (harmful or transient effects).......................................................................................73

Hazard band A: skin irritation.........................................................................74

Hazard band A: eye irritation.........................................................................75

Hazard band A: aspiration hazard..................................................................77

Hazard band A: high molecular weight polymer that has lung overloading potential.........................................................................................................77

Hazard band A: high molecular weight polymer with other potential hazards....................................................................................................................... 77





Human health exposure band 3 — low risk.......................................81

Hazard band C hazard characteristics....................................................81






Hazard band B hazard characteristics....................................................87

Hazard band B: acute toxicity (fatal or toxic).................................................88

Hazard band B: specific target organ toxicity after a single exposure (significant toxicity).......................................................................................90

Hazard band B: specific target organ toxicity after repeated exposure.........90

Hazard band B: skin corrosion.......................................................................93

Hazard band B: eye damage..........................................................................95

Hazard band B: skin sensitisation..................................................................96

Hazard band B: respiratory sensitisation.......................................................98

Hazard band B: respiratory corrosion.............................................................99

Hazard band B: high molecular weight polymer that is water absorbing.....100

Hazard band B: high molecular weight polymer that is reactive..................100

Hazard band B: high molecular weight polymer that contains certain chemical elements......................................................................................................101

Human health hazard band C lists...............................................................101

Human health exposure band 3 — very low risk..............................102

Hazard band C hazard characteristics..................................................103


Hazard band C: carcinogenicity...................................................................104

Hazard band C: mutagenicity or genotoxicity..............................................104

Hazard band C: reproductive toxicity...........................................................106

Hazard band C: developmental toxicity.......................................................107

Hazard band C: adverse effects mediated by an endocrine mode of action 108

Hazard band B hazard characteristics..................................................109

Hazard band B: acute toxicity (fatal or toxic)...............................................110

Hazard band B: specific target organ toxicity after a single exposure (significant toxicity).....................................................................................112

Hazard band B: specific target organ toxicity after repeated exposure.......113

Hazard band B: skin corrosion.....................................................................115

Hazard band B: eye damage........................................................................117

Hazard band B: skin sensitisation................................................................118

Hazard band B: respiratory sensitisation.....................................................120

Hazard band B: respiratory corrosion...........................................................121

Hazard band B: high molecular weight polymer that is water absorbing.....122

Hazard band B: high molecular weight polymer that is reactive..................122

Hazard band B: high molecular weight polymer that contains certain chemical elements......................................................................................................123

Hazard band A hazard characteristics..................................................123

Hazard band A: acute toxicity (harmful)......................................................124

Hazard band A: specific target organ toxicity after a single exposure (harmful or transient effects).....................................................................................126

Hazard band A: skin irritation.......................................................................126

Hazard band A: eye irritation.......................................................................128

Hazard band A: aspiration hazard................................................................129

Hazard band A: high molecular weight polymer that has lung overloading potential.......................................................................................................129


Hazard band A: high molecular weight polymer with other potential hazards..................................................................................................................... 130

Human health hazard band C lists...............................................................130

Chapter 5 — Environment risk by exposure band......................132

Determining the environment categorisation volume.....................133

Environment exposure band 1.......................................................144

Work out hazard characteristics...................................................................144

Environment exposure band 1 — low risk.......................................145

Hazard band D characteristics...............................................................146

Hazard band D: persistent, bioaccumulative and toxic................................146

Hazard band D: ozone depleting chemicals.................................................148

Hazard band D: synthetic greenhouse gas..................................................148

Hazard band D: contains arsenic, cadmium, lead or mercury......................148

Hazard band D: adverse effects mediated by an endocrine mode of action 148

Environment hazard band lists.....................................................................150

Environment exposure band 1 — very low risk................................151

Hazard band D hazard characteristics..................................................152







Hazard band C: very toxic to any aquatic life..............................................156

Hazard band C: persistent and bioaccumulative..........................................157






Hazard band D characteristics...............................................................161


















Hazard band B: toxic to any aquatic life......................................................179


























Hazard band B characteristics...............................................................209



Hazard band A: harmful to any aquatic life..................................................212

Hazard band A: has bioaccumulation potential............................................214

Hazard band A: industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradability.........................................................215

Hazard band A: contains aluminium, chromium, copper, nickel, silver, selenium or zinc...........................................................................................216


Hazard band A: polymers that have an overall cationic charge at pH 4 to 9..................................................................................................................... 216

Hazard band A: polymers that are not stable...............................................216































Hazard band A: harmful to any aquatic life..................................................251

Hazard band A: has bioaccumulation potential............................................253

Hazard band A: industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradability.........................................................254

Hazard band A: contains aluminium, chromium, copper, nickel, silver, selenium or zinc...........................................................................................254

Hazard band A: polymers that have an overall cationic charge at pH 4 to 9..................................................................................................................... 255

Hazard band A: polymers that are not stable...............................................255


Chapter 6 — Specified classes of introduction..........................258

About specified classes of introductions........................................258

Human health hazard bands for specified classes of introductions. .259

Working out the indicative human health risk..............................................259

Introducing a UV filter – exposure band 3....................................................260

Introducing a chemical with an end use in an article with food contact – exposure band 3..........................................................................................260

Introducing a chemical for an end use in a personal vaporiser – exposure bands 2 and 3..............................................................................................262

Introducing a chemical for an end use in tattoo ink – exposure bands 2 and 3..................................................................................................................... 262

Introducing a polyhalogenated organic chemical – exposure band 3..........263

Environment hazard bands for specified classes of introductions....263

Working out the indicative environment risk...............................................263


Introducing a highly branched organic chemical – exposure bands 2, 3 and 4..................................................................................................................... 264

Introducing a chemical for an end use as a biocide - exposure bands 2, 3 and 4................................................................................................................... 264

Terms relating to record keeping for specified introductions of industrial chemicals......................................................................265

Chapter 7 — Polymers of low concern......................................267

The polymer is stable...................................................................267

Chapter 8 — Equivalent test guidelines....................................268

Human health hazard characteristics.............................................269

Acute toxicity (fatal or toxic) and specific target organ toxicity after a single exposure......................................................................................................269

Specific target organ toxicity after repeated exposure................................269

Skin corrosion..............................................................................................270

Skin irritation...............................................................................................271

Serious eye damage....................................................................................271

Eye irritation................................................................................................272

Skin sensitisation.........................................................................................272

Carcinogenicity............................................................................................273

Mutagenicity................................................................................................274

Genotoxicity.................................................................................................274

Reproductive and developmental toxicity....................................................275

Chemicals with adverse effects known to be mediated by an endocrine mode of action.......................................................................................................275

Environment hazard characteristics...............................................276

Acute aquatic toxicity (Very toxic or toxic)..................................................276

Bioaccumulation..........................................................................................277

Persistence...................................................................................................277


Chapter 1 — Definitions of terms in the General RulesYou must refer to this chapter of the Categorisation Guidelines for the meaning of some terms used in the General Rules. For other definitions, please refer to our Glossary.

Relevant General Rule: section 5Section 5 of the General Rules contains a list of terms used in the General Rules and their meanings. For some of these terms you must refer to these guidelines to see the meanings. This chapter sets out these terms and their meanings.

Chemical identity holderChemical identity holder means a person who has knowledge of the identity of the industrial chemical, including its proper name and Chemical Abstracts Service Registry Number (CAS number), if assigned.

Known hazard classificationKnown hazard classification, for an industrial chemical, means hazard information that the introducer is aware of in the form of one of the following:

A hazard class and category arising from classification under the ‘Globally Harmonized System of Classification and Labelling of Chemicals’ (the GHS) published by the United Nations.

A hazard class and category found in the Safe Work Australia Hazardous Chemical Information System (HCIS)(previously known as Hazardous Substances Information System).

or

A non-GHS hazard statement, assigned under the classification criteria in ‘Guidance on the Classification of Hazardous Chemicals under the WHS Regulations’ published by Safe Work Australia.

Chapter 1 – draft Categorisation Guidelines of 288www.nicnas.gov.au Freecall: 1800 638 528 phone: + 61 2 8577 8800


https://www.safeworkaustralia.gov.au/system/files/documents/1702/classification_hazardous_chemicals.pdf

https://www.safeworkaustralia.gov.au/system/files/documents/1702/classification_hazardous_chemicals.pdf

http://hsis.safeworkaustralia.gov.au/

http://hsis.safeworkaustralia.gov.au/

https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e0.html

https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e0.html

https://www.nicnas.gov.au/reforms/Rules-Guidelines/draft-categorisation-guidelines-main/Categorisation-guidelines/defined-terms


Except that it does not include any of the following hazard classes:

flammable gases, category 2

acute toxicity-oral, category 5

acute toxicity-dermal, category 5

acute toxicity-inhalation, category 5

skin corrosion/irritation, category 3

serious eye damage/eye irritation, category 2B

aspiration hazard, category 2

Low concern following migration to foodLow concern following migration to food, in relation to the introduction of an industrial chemical that has an end use in an article with food contact, means:

The industrial chemical has an estimated dietary exposure value less than the threshold of toxicological concern (TTC) for the industrial chemical based on its structural class categorisation according to Cramer [1].

or The end use of the industrial chemical, concentration at the end use and

dietary concentration associated with the end use, as applicable, are consistent with one of the following:

o The listing of the industrial chemical under Annexes I or II to Regulation (EC) No 10/2011 or Annex I to Regulation (EC) No 1935/2004 and any applicable restrictions.

o An adopted opinion on the industrial chemical by the European Food Safety Authority.

o Use of the industrial chemical authorised under the United States Food and Drug Administration (US FDA) regulations, 21 CFR.170-199.

or

The industrial chemical is a permitted flavouring substance as defined by Standard 1.1.2 of the Food Standards Australia New Zealand Act 1991,



https://www.legislation.gov.au/Details/F2017C00715


with the dietary concentration associated with the end use of the industrial chemical less than that associated with use as a flavouring substance.

or

The extent of migration was below the level of detection in a migration study conducted under conditions that simulated:

o The food types that will be contacted at end use.

o The food contact conditions that are relevant for the end use.

or

The No Observed Adverse Effect Level (NOAEL) in an in vivo study on the industrial chemical or a suitable analogue conducted following The Organisation for Economic Co-operation and Development (OECD) test guidelines :

o OECD test guideline 407 was ≥1000 mg/kg bw/day

o OECD test guideline 408 or 409 was ≥300 mg/kg bw/day

Not persistentNot persistent, in relation to an industrial chemical that is a gas, means that:

An in silico model of the industrial chemical conducted using EPI SuiteTM results in an in-domain prediction for the half-life in air of less than 2 days.

or

A study or estimation conducted on the industrial chemical according to a method described in the OECD 1993[2]monograph results in a half-life in air of less than 2 days.

Not persistent, in relation to an industrial chemical that is a polyhalogenated organic chemical, means that:

A study conducted on the industrial chemical following OECD test guideline 301 results in one of the following:

o The pass levels being reached within the specified time period such that the industrial chemical is considered to be ready biodegradable.



http://www.oecd-ilibrary.org/content/book/9789264070349-en





http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm




o The pass levels being reached within the duration of the test, but not within the specified time period for the industrial chemical to be considered ready biodegradable.

or

A study conducted on the industrial chemical following OECD test guideline 308 or 309 results in a half-life in water of less than 2 months.

or

A study conducted on the industrial chemical following OECD test guideline 308 results in a half-life in sediment of less than 6 months.

Footnotes[1] Cramer (Cramer GM, Ford RA, Hall RL, Estimation of toxic hazard--a decision tree approach. Food Cosmet Toxicol. 1978 Jun; 16(3):255-76.)[2] The rate of photochemical transformation of gaseous organic compounds in air under tropospheric conditions. Environment Monograph No 61, OECD/GD(92)172, Paris 1993







Chapter 2 — Internationally-assessed introductionsHow to determine whether the risks to human health or the environment from the introduction or use of your chemical are higher in Australia compared to those identified in another country.

Relevant General Rule: sections 6(1)(e) and 6(2)(e)These General Rules require that you use the Categorisation Guidelines to determine whether the risks to human health or the environment from the introduction or use of your chemical are higher in Australia compared to the findings of a risk assessment conducted in an overseas jurisdiction.

Is the human health risk higher in Australia?To work out if the human health risk is higher in Australia you must check differences and similarities of the risk assessment assumptions used by an international assessment body compared to Australian risk assessment assumptions.

How relevant are the overseas assessments compared to your introduction?

Are there any Australian risk assessment assumptions excluded from the international assessment report?

Are international risk assessment assumptions used in a different way to their use in Australia?

Are there any international risk assessment assumptions that are not used in (or appropriate for) Australia?

If the assumptions are different, you need to consider if this affects the risk to human health.




The Australian human health risk assessment assumptions you should consider include:

human body weight

default absorption into the human body, in the absence of study information

factors used to estimate exposure

risk mitigation measures

acceptable margin of exposure values

methodologies for skin sensitisation risk assessment

If you have access to the full international report from the overseas jurisdiction you should consider the information in the overseas report regarding the risk assessment assumptions used.

If you don’t have access to the full international report, you should consider whether any of the information available suggests the risk to human health could be higher in Australia than was assessed or evaluated in the overseas jurisdiction. To establish this you should consider publicly available information on risk assessment assumptions and factors generally used by the international assessment body.

Is the environment risk higher in Australia?To work out if the environment risk is higher in Australia you must check differences and similarities of the risk assessment assumptions used by an international body compared to Australian risk assessment assumptions.

How relevant are the overseas assessment compared to your introduction?

Are there any Australian risk assessment assumptions excluded from the international assessment report?

Are the international risk assessment assumptions used in a different way to their use in Australia?




Are there any international risk assessment assumptions that are not used in (or appropriate for) Australia?

If the assumptions are different, you need to consider if this affects the risk to the environment.

The Australian environment risk assessment assumptions you should consider include:

Australian PBT criteria (persistence, bioaccumulation and toxicity)

factors used to estimate exposure

size of the Australian population

receiving water capacity

efficiency of sewage treatment plant (STP) removal

predicted Environmental Concentration (PEC) calculation

predicted No Effect Concentration (PNEC) calculation

risk quotient (RQ) calculation

waste disposal methods

If you have access to a full international report, from an overseas jurisdiction, you should consider the risk assessment assumptions information used in the report.

If you don’t have access to the full international report, you should consider whether any of the information available suggests the risk to environment could be higher in Australia than that assessed or evaluated in the overseas jurisdiction. To establish this you should consider publicly available information on risk assessment assumptions and factors generally used by the international assessment body.




Chapter 3 — Hazard bandsThis general information on hazard bands will help you work out indicative human health risk, indicative environment risk and specified classes of introduction.

Content- Hazard bands

Working out hazard bands that don't apply Hazard characteristics in the highest hazard bands Hazard information for known environment degradation products Demonstrating the absence of a hazard characteristic Conflicting study results and hierarchy of information Draft, deleted and equivalent test guidelines

Working out hazard bands that don't applyYou are in Chapter 3 of the Categorisation Guidelines

Relevant General Rule: sections 23 and 27If your introduction is not internationally-assessed for human health or the environment you must determine the indicative risk for your introduction. To do this, you work out which human health or environment hazard bands do not apply to your introduction based on the hazard characteristics of the industrial chemical.

Chapters 3-6 of these Categorisation Guidelines detail how to determine the industrial chemical hazard characteristics for human health and environment. They will help you evaluate indicative risk and tell you the types of records you must keep to support the hazard characterisation.




This chapter provides general information to help you meet the requirements of Chapter 4 (indicative human health risk), Chapter 5 (indicative environment risk) and Chapter 6 (specified classes of introductions), as follows:

hazard characteristics in the highest hazard bands

consideration of known hazard information for known environment degradation

options to demonstrate the absence of a hazard characteristic

conflicting study results and hierarchy of information

draft, deleted and equivalent test guidelines

Note: The definitions of many of the hazard characteristics are broader than the definitions or classification criteria under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Our hazard criteria are used for the purposes of categorisation. They identify which chemical introductions do not require an assessment by us as part of the introduction process. Because of this they have been set to take into account uncertainty in identifying the hazard characteristics. If there is enough uncertainty for a particular characteristic, the indicative risk cannot be considered low or very low.

When working out the indicative risk to human health and the environment, the presence of a hazard characteristic may be based on information that you know. In this context, 'know' means that you are aware, or ought reasonably to be aware having regard to:

your abilities, experience, qualifications and other attributes

the nature of the circumstances

If you are unable to (or choose not to) demonstrate the absence of a particular hazard characteristic, the industrial chemical is considered as having that characteristic for categorisation purposes. This is to determine indicative risk for regulatory purposes only and is due to the uncertainty of the chemical’s health or environmental effect(s).



https://www.safeworkaustralia.gov.au/doc/globally-harmonised-system-classification-and-labelling-chemicals-ghs-information-sheet



Hazard characteristics in the highest hazard bandsYou are in Chapter 3 of the Categorisation Guidelines

Relevant General Rule: sections 25 and 29The human health indicative risk for your industrial chemical cannot be low or very low if it has any of the hazard characteristics found in hazard band C (section 25 of the General Rules).

Similarly, the environment indicative risk for your industrial chemical cannot be low or very low if it has any of the hazard characteristics found in hazard band D (section 30 of the General Rules).

Contents

List of hazard characteristics band C human health List of hazard characteristics band D environmentSpecified lists for hazard band C human health and hazard band D environment

Hazard characteristics band C human healthThese hazard characteristics for band C human health are:

carcinogenicity

mutagenicity

genotoxicity

reproductive toxicity

developmental toxicity

adverse effects mediated by an endocrine mode of action

Hazard characteristics band D environmentThe hazard characteristics in band D environment are:

persistent, bioaccumulative and toxic (PBT)

ozone depleting chemicals




synthetic greenhouse gas

contains arsenic, cadmium, lead or mercury


Specified lists and existing informationFor many industrial chemicals, the studies to allow the characterisation of hazard characteristics in the highest hazard bands for human health (C) and/or environment (D) may not be available. These studies are often expensive, time-consuming to generate and rely on extensive animal testing.

Unless otherwise identified in Chapter 4 (indicative human health risk), Chapter 5 (indicative environment risk) or Chapter 6 (specified classes of introductions), the characterisation of these hazard characteristics is based on existing information and on whether the industrial chemical is found on specified lists.

If your industrial chemical is on a specified list, but you have conflicting results from a study, then there is sufficient uncertainty for that hazard characteristic for us to do an assessment of the chemical before introduction.

If your industrial chemical is an ester or a salt, you also need to check if the chemical of which it is an ester or salt is on the specified lists, based on it having a human health hazard band C and/or environment hazard band D hazard characteristic. If it is, then to determine the indicative risk, your chemical is also considered to have these characteristics.

Human health hazard band C listsHuman health hazard band C will apply if your industrial chemical (or the chemical of which it is an ester or salt) is identified on any of the following lists as having one or more of the hazard characteristics in hazard band C:

Safe Work Australia’s Hazardous Chemical Information System (HCIS)

European Chemicals Agency (ECHA) Harmonised Classification and Labelling of Hazardous Substances (Annex VI to the CLP Regulation) — list of substances classified for CMR and PBT

European Union Substances of Very High Concern (EU SVHC) — list of carcinogenic, mutagenic, reproductive toxic substances, substances with endocrine disrupting potential, PBT and vPvB substance



https://echa.europa.eu/candidate-list-table

https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp

http://hcis.safeworkaustralia.gov.au/


United States National Toxicology Program (US NTP) Report on Carcinogens — list of carcinogenic substances

International Agency for Research on Cancer (IARC) Monographs — list of carcinogens

European Commission Endocrine Disruptors Strategy — list of Category 1 substances with evidence of endocrine disrupting activity

Environment and Climate Change Canada Toxic Substances List (Schedule 1) — inorganic and organic chemicals with known health and/or environmental concerns

Chemical Substances Control Law of Japan (CSCL) Class I and II Specified Chemical Substances and CSCL Monitoring Chemical Substances as identified under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. — organic chemicals with known health and/or environmental concerns

Environment hazard band listsEnvironment hazard band C or D will apply if your industrial chemical (or the chemical of which it is an ester or salt) is identified on any of the following lists as having one or more of the hazard characteristics in hazard band C or D:


European Union Substances of Very High Concern (EU SVHC) — list of carcinogenic, mutagenic, reproductive toxic substances, substances with endocrine disrupting potential, PBT and vPvB substances


Stockholm Convention on Persistent Organic Pollutants (Annexes A, B and C) — Persistent Organic Pollutants (POPs) with known health and/or environmental concerns

Montreal Protocol on Substances that Deplete the Ozone Layer Handbook (Annexes A, B, C, E and F) — chemicals linked to the depletion of the ozone layer



https://unep.ch/ozone/publications/handbooks/mp_handbook_2006.pdf

https://unep.ch/ozone/publications/handbooks/mp_handbook_2006.pdf

http://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx

http://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx

http://chm.pops.int/Home/tabid/2121/Default.aspx

http://ec.europa.eu/environment/chemicals/endocrine/strategy/index_en.htm



https://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling

https://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling

http://www.nite.go.jp/en/chem/kasinn/lists.html


http://www.nite.go.jp/en/chem/chrip/chrip_search/sltLst

https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-registry/substances-list/toxic.html


http://ec.europa.eu/environment/chemicals/endocrine/strategy/substances_en.htm

http://monographs.iarc.fr/

https://ntp.niehs.nih.gov/pubhealth/roc/index-1.html



Kyoto Protocol , Synthetic Greenhouse Gases under Annex A — organic chemicals that contribute to the greenhouse effect

Minamata Convention on Mercury mercury and its compounds, those having known health and/or environmental concerns

International Convention on the Control of Harmful Anti-fouling Systems on Ships (Annex 1) — organotins, those being hazardous to marine life

European Chemicals Agency (ECHA) List of substances included in Annex XIV of REACH and the Candidate List of substances of very high concern for Authorisation — inorganic and organic chemicals with known health and/or environmental concerns

Chemical Substances Control Law of Japan (CSCL), CSCL Class I and II Specified Chemical Substances and CSCL Monitoring Chemical Substances as identified under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. — organic chemicals with known health and/or environmental concerns.

Hazard information for known environment degradation productsYou are in Chapter 3 of the Categorisation Guidelines

You must consider the hazard information on the degradants when determining the environment hazard bands that do not apply to your introduction, if:

You know the degradants of the industrial chemical in the environment.

These degradants are known (or reasonably anticipated) to be of higher hazard (ecotoxicity, persistence, or bioaccumulation) than the industrial chemical.







https://echa.europa.eu/information-on-chemicals

http://www.imo.org/en/about/conventions/listofconventions/pages/international-convention-on-the-control-of-harmful-anti-fouling-systems-on-ships-(afs).aspx

http://www.imo.org/en/about/conventions/listofconventions/pages/international-convention-on-the-control-of-harmful-anti-fouling-systems-on-ships-(afs).aspx

http://www.mercuryconvention.org/

http://unfccc.int/kyoto_protocol/items/2830.php


Demonstrating the absence of a hazard characteristicYou are in chapter 3 of the Categorisation Guidelines

Content

Use of in silico information

How to use 'read-across information'

Chapter 4 (human health), Chapter 5 (environment) and Chapter 6 (specified classes of introduction) in these Categorisation Guidelines give possible options to help you exclude your industrial chemical from hazard bands, based on their hazard characteristics.

These options can include:

in silico

in chemico

in vitro, and/or

in vivo methods

You can also use read-across information in some circumstances.

To choose the most appropriate option you must consider the:

nature of the industrial chemical

availability of existing information that meets the requirements identified in Chapters 4-6

suitability of any read-across information

applicability of the different prediction and testing options for your chemical

We provide details on the use of in silico and ‘read-across information’ in the next sections of these Categorisation Guidelines.

Use of in silico informationWe have provided in silico options you can use to demonstrate the absence of a hazard characteristic.




In some situations the in silico prediction is sufficient on its own. In other instances, the prediction needs additional information (e.g. an in vitro study).

We provide a list of the programs/models available to predict the relevant hazard characteristics.

Tables 1 and 2 provide an overview for which human health and environment hazard characteristics have in silico options, and which in silico models are appropriate.

Table 1 - In silico options for human health hazard characteristics


Acute toxicity

Skin irritation / Skin corrosion

Eye damage / Eye irritation

Skin sensitisation

Respiratory sensitisation

Mutagenicity / Genotoxicity

OECD QSAR Toolbox

Yes Yes Yes Yes - Yes

VEGA QSAR

- - - Yes - Yes

Danish EPA QSAR Database

Yes Yes - Yes Yes Yes

T.E.S.T. Yes - - - - Yes





ToxTree - - Yes Yes Yes Yes

Derek Nexus

- - Yes Yes Yes Yes

Sarah Nexus

- - - - - Yes

OASIS-TIMES

Yes - Yes Yes - Yes

Chemtunes

- Yes - Yes - -

Case ULTRA

Yes Yes Yes - - Yes

ADMET Predictor

Yes - - Yes - Yes

TOPKAT Yes Yes Yes Yes - Yes

ACD Percepta

Yes Yes Yes - - Yes

Hazard Expert

- - - - - Yes





Table 2 - In silico options for environment hazard characteristics

Table 2 - In silico options for environment hazard characteristics

Acute aquatic toxicity

Chronic aquatic toxicity

Persistence (as a function of half-life)

Bioaccumulation (as a function of Log Kow)

ECOSAR Yes Yes - -

EPI Suite - - Yes -

KOWWIN - - - Yes

In silico information can’t be used for all categorisations. In silico modelling is not suitable to predict the hazard characteristics of:

UVCB substances

polymers

surfactants

nanomaterials

In silico modelling is also not suitable to predict the environmental hazard characteristics of:

inorganic chemicals

organometallic chemicals

You need to consider the following before choosing an in silico model or program to demonstrate the absence of a hazard characteristic:

the nature of the industrial chemical




the suitability of the program/model for the (relevant) hazard characteristics

you must follow each program/model’s guidance and documentation

To work out the indicative risk, we will only accept in silico predictions to establish an absence of a hazard characteristic when ALL the following apply:

You have used a program/model suitable for the hazard characteristic, according to the requirements explained in Chapters 4-6 of these Categorisation Guidelines.

The prediction must be for the industrial chemical itself. You can’t use in silico information on analogue chemicals to work out the indicative risk.

The industrial chemical is within the applicability domain (AD) of the in silico model used.

You must be able to demonstrate you have followed the program guidelines, instructions and parameters to get your prediction (you should retain a report generated by the program).

If the industrial chemical that you are introducing is not appropriate for use in in silico models or the abovementioned requirements cannot be fulfilled, you must demonstrate the absence of a hazard characteristic via other means (using an alternative option outlined in Chapters 4-6). This may include results obtained from a suitable in vitro and/or in vivo study on the industrial chemical (or use of read across information, where appropriate).

How to use ‘read-across information’Read-across information can be useful when you do not have enough information on your chemical to work out the absence of a hazard characteristic.

You can use a read-across approach to fill information gaps.

A read-across approach predicts the hazard characteristics of a chemical (target chemical) by using information from one or more other chemicals (source chemical/s).

There are two read-across techniques:

Analogue approach – you use a single chemical as the source chemical (this single chemical is then known as the ‘analogue chemical’).




Category approach – you use a group of chemicals as the source chemicals.

How to work out if the read-across information is appropriate to fill an information gapYou must consider the suitability of the source chemical/s for each of the hazard characteristics you are trying to predict, and then justify and document your choice. To do this you will need to look at the source chemical’s areas of similarity to your chemical:

Similar structure

o Does the source chemical/s contain most, if not all, of the same structural features as your (target) chemical?

o Are the relevant substructures for the hazard characteristic for which there is a data gap similar?

Similar physical-chemical properties

o Does the source chemical/s have similar physical-chemical properties to your chemical? This may influence bioavailability and environmental fate.

Similar metabolism/degradation

o Is metabolism/degradation important for the hazard characteristic you are predicting?

o If so, does the source chemical/s produce similar breakdown products (metabolites or degradants) to your chemical?

Similar mode of action

o Do you know the relevant mode of action for the hazard characteristic you are predicting?

o If so, does the source chemical/s have a similar mode of action to your chemical?

Similar reactivity/stability




o Does the source chemical/s have similar reactivity/stability to your chemical?

Not all of these will be relevant for every read-across justification. Regardless, you will still need to consider them all and document even if an area is not relevant.

UVCB substances (chemical substances of Unknown or Variable Composition, complex reaction products and Biological materials) may need more justification to account for complexity of the composition and its impacts on the predictions of hazard characteristics.

Things to consider if you use a category approachYou still need to look at 'similarity' (as described above). You may also need to consider that the chemical’s properties may not be very similar. Rather, they may follow a regular trend, which allows you to predict the hazard characteristic for your chemical.

Conflicting study results and hierarchy of informationYou are in chapter 3 of the Categorisation Guidelines

When you have multiple sources of information for a hazard characteristic, you need to consider the quality and reliability of each study/prediction.

When information has similar quality and reliability you must weigh the information based on the type of data, including:

The weight given in the Globally Harmonized System of classification and labelling (GHS), where the GHS defines it for that hazard characteristic.

Reflected in the definitions of the hazard characteristics in Chapter 4 (human health) and Chapter 5 (environment).

Otherwise apply this hierarchy:






o In vivo > in vitro > in chemico > in silico on the industrial chemical.

o Results derived from studies on the industrial chemical > results derived from read across information.

Draft, deleted and equivalent test guidelinesYou are in Chapter 3 of the Categorisation Guidelines

Chapter 4 (indicative human health risk), Chapter 5 (indicative environment risk) and Chapter 6 (specified classes of introductions)of our guidelines refer to Organisation for Economic Cooperation and Development (OECD) test guidelines.

We will update our Categorisation Guidelines to reflect any changes in OECD standards and other approved test protocols.

As well as the most current OECD test guidelines, other studies will be accepted if they are done under:

any adopted OECD guidelines, even if the version identified in Chapters 4-6 uses a draft version

a deleted guideline if the study was done before the guideline was deleted

an equivalent test guideline (see Chapter 8)




Chapter 4 — Human health risk by exposure bandsUse the information here to work out which human health hazard bands do not apply to your introduction. You do this based on the hazard characteristics of the chemical. You need to know the exposure band before you start.

You must know your exposure band before you can work out your introduction's indicative human health risk. We have set information out in this chapter by exposure bands.

Contents – chapter 4

Human health exposure band 1

In this exposure band, the indicative human health risk for your introduction is very low if your chemical does not have any human health band C hazard characteristics. Read more here.


In this exposure band, the indicative human health risk for your introduction is low if your chemical does not have any human health band C hazard characteristics and very low if your chemical does not have any human health band C, B and A hazard characteristics. Read more here.


In this exposure band, the indicative human health risk for your introduction is low if your chemical does not have any human health band C and B hazard characteristics and very low if your chemical does not have any human health band C, B and A hazard characteristics. Read more here.




Human health exposure band 1You are in Chapter 4 of the Categorisation Guidelines

The following information is to work out your introduction's indicative human health risk for human health exposure band 1.

Before you start

Ensure you have read and understood our hazard characteristics general information in Chapter 3 — Hazard bands.

Relevant General Rule: section 26 indicative human health riskThe indicative human health risk for your introduction is very low when the:

human health exposure band is 1, and

your chemical does not have any human health band C hazard characteristics

If the indicative human health risk for your introduction is not very low, then it is medium to high.

Indicative human health risk is defined in our Glossary

Work out hazard characteristicsYou must always start at the highest band and work through the hazard characteristics of your industrial chemical.

If you determine that your chemical has a hazard characteristic, then the hazard band relevant to that characteristic applies. If a hazard band applies then you have the information necessary to determine the indicative human health risk for the introduction and you don't need to consider the remaining hazard characteristics in that hazard band (or lower hazard bands).

However, please note that you might need information on these other hazard characteristics to meet other obligations such as:




applications requirements (for Assessed introductions under AICIS) or

classification requirements (to meet your WHS obligations under other regulators)


Hazard band C characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band C for human health. If any of these definitions apply to your chemical, it is not a very low risk introduction.

This page has definitions for:

carcinogenicity

mutagenicity or genotoxicity




Hazard band C: carcinogenicityThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Carcinogenicity, to determine the indicative human health risk, means:

the chemical is a known, presumed or suspected human carcinogen, as described in chapter 3.6 of the GHS, with the chemical classified as follows:

o carcinogenicity (category 1 or 2)

or




the chemical (or the chemical of which it is an ester or salt) is on any of the lists identified in the hazard band C lists (chapter 3 of these guidelines), based on its carcinogenicity

or

an in vivo study on the chemical:

o conducted following OECD test guideline 408, 409, 411, 413, 451, 452 or 453 results in carcinogenic effects

Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines) based on carcinogenicity.

Hazard band C: mutagenicity or genotoxicityThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Mutagenicity or genotoxicity, to determine the indicative human health risk, means:

the chemical is known to induce or may induce mutations in the germ cells of humans, as described in chapter 3.5 of the GHS, with the chemical classified as follows:

o mutagenicity (category 1 or 2) or

the chemical (or the chemical of which it is an ester or salt) is on any of the lists identified in the hazard band C lists (chapter 3 of these guidelines), based on its mutagenicity or genotoxicity, or


o conducted following OECD test guideline 474, 475, 478, 485, 486, 488 or 489 results in mutagenic or genotoxic effects, or

an in vitro study on the chemical:

o conducted following OECD test guideline 471, 473, 476, 487 or 490 results in the prediction of mutagenic or genotoxic effects, and




o the results of the study have not been negated based on a weight of evidence determination involving studies conducted on the chemical for mutagenicity or genotoxicity in vivo, or

an in silico model of the chemical:

o conducted using OECD QSAR Toolbox, Danish QSAR database, VEGA QSAR. ToxTree, TOPKAT, Derek Nexus, Sarah Nexus, Case Ultra, OASIS TIMES, Chemtunes, ADMET Predictor, T.E.S.T. or Hazard Expert results in the presence of alerting groups or an in-domain prediction of mutagenicity or genotoxicity, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted on the chemical for mutagenicity or genotoxicity in vitro or in vivo.

Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on mutagenicity or genotoxicity.

Hazard band C: reproductive toxicityThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Reproductive toxicity, to determine the indicative human health risk, means:

the chemical is known, presumed or suspected to produce adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS, with the chemical classified as follows:

o toxic to reproduction (category 1 or 2) or

the chemical (or the chemical of which it is an ester or salt) is on any of the lists identified in the hazard band C lists (chapter 3 of these guidelines), based on its reproductive toxicity, or


o conducted following OECD test guideline 408, 409, 411, 413, 414, 415, 416, 421, 422, 443, 451, 452 or 453 results in adverse effects




on sexual function and fertility, as described in chapter 3.7 of the GHS.

Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on reproductive toxicity.

Hazard band C: developmental toxicityThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Developmental toxicity, to determine the indicative human health risk, means:

the chemical is known, presumed or suspected to produce adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS, with the chemical classified as follows:


o effects on or via lactation, or

the chemical (or the chemical of which it is an ester or salt) is on any of the lists identified in the hazard band C lists (chapter 3 of these guidelines), based on its developmental toxicity, or


o conducted following OECD test guideline 414, 415, 416, 421, 422, 426 or 443 results in adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS.

Otherwise, to work out if it is very low risk, you need to show the definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines) based on developmental toxicity.




Hazard band C: adverse effects mediated by an endocrine mode of actionThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Adverse effects mediated by an endocrine mode of action, to determine the indicative human health risk, means:

The chemical meets all of the following:

o It shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or lifespan of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in the susceptibility to other influences.

o It has an endocrine activity, which is the capacity to alter the function(s) of the endocrine system.

o The adverse effect is a consequence of the endocrine activity.

or

The chemical (or the chemical of which it is an ester or salt) is on any of the lists identified in the hazard band C lists (chapter 3 of these guidelines), based on its known adverse health effects mediated by an endocrine mode of action.

If your chemical has existing information that would allow you to determine if this definition applies, then you should consider the information in a weight of evidence analysis:

as described in EU guidance for identifying endocrine disruptors[1] and

taking into account the guidance provided in OECD GD 150[2].

The indicative human health risk for your introduction is not very low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.




Where you have no existing information available

To work out that the indicative human health risk is very low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines) based on its known adverse effects mediated by an endocrine mode of action.









Chemical Substances Control Law of Japan (CSCL) Class I and II Specified Chemical Substances and CSCL Monitoring Chemical Substances as identified under the Act on the Evaluation of Chemical Substances and
















Regulation of Their Manufacture, etc. — organic chemicals with known health and/or environmental concerns

Footnotes[1] Guidance for the identification of endocrine disruptors in the context of 39 Regulations (EU) No 528/2012 and (EC) No 1107/2009, currently a 2017 consultation draft. Accessed here.

[2] ENV/JM/MONO(2012)22, OECD Series on Testing and Assessment, No. 150 - Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption. Accessed here.



http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2012)22&doclanguage=en

https://comments.echa.europa.eu/comments_cms/ED_Guidance%20for%20public%20consultation_20171207.pdf


Human health exposure band 2You are reading Chapter 4 of the Categorisation GuidelinesThe following information is to work out your introduction's indicative human health risk for human health exposure band 2.

Relevant General Rule(s): section 25 human health hazard band, section 26 indicative human health riskThe indicative human health risk for your chemical is low when:

the human health exposure band is 2 and your industrial chemical does not have any human health hazard band C

characteristics (see link below)

The indicative human health risk for your chemical is very low when:

the human health exposure band is 2 and your industrial chemical does not have any human health hazard band C,

B and A characteristics (see link below)

If the indicative human health risk for your introduction is neither low or very low, then it is medium to high.





applications requirements (for Assessed introductions under AICIS) or classification requirements (to meet your WHS obligations under other

regulators).




https://www.nicnas.gov.au/reforms/Rules-Guidelines/draft-categorisation-guidelines-main/Categorisation-guidelines/defined-terms#indicativehh


Summary: Human health exposure band 2

How to determine indicative human health risk is lowIf any of these hazard band C definitions apply to your chemical, the indicative human health risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

How to determine indicative human health risk is very lowIf any of these human health hazard band C, B and A definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

Human health exposure band 2 — low riskYou are in Chapter 4 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): sections 25 human health hazard band, section 26 indicative human health risk, section 31 information required to demonstrate categorisationThe indicative human health risk for your chemical is low when:

the human health exposure band is 2 and

your industrial chemical does not have any human health hazard band C characteristics (defined below)


We have also summarised information about working out hazard characteristics at the start of exposure band 2.




Definitions hazard band CThe following definitions apply to chemicals that do fall into hazard band C for human health. If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not low risk. If your introduction is a specified class of introduction, additional requirements apply —refer Chapter 6 specified classes of introductions.

carcinogenicity





Hazard band C: carcinogenicityThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.




or


or



Otherwise, to work out that it is low risk, you need to show that this definition doesn't apply by confirming that your chemical (or a chemical of which is an




ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines) based on carcinogenicity.

Hazard band C: mutagenicity or genotoxicityThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.
















Otherwise, to work out if it is low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on mutagenicity or genotoxicity.

Hazard band C: reproductive toxicityThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.






o conducted following OECD test guideline 408, 409, 411, 413, 414, 415, 416, 421, 422, 443, 451, 452 or 453 results in adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS.

Otherwise, to work out that it is low risk, you need to show that this definition doesn't apply by confirming that your chemical (or a chemical of which is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines) based on reproductive toxicity.




Hazard band C: developmental toxicityThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.








Otherwise, to work out if it is low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on developmental toxicity.

Hazard band C: adverse effects mediated by an endocrine mode of actionThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.









or


The indicative human health risk for your introduction is not low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.


To work out that the indicative human health risk is low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on its known adverse effects mediated by an endocrine mode of action.







Human health exposure band 2 — very low riskYou are in Chapter 4 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): section 25 human health hazard band, section 26 indicative human health risk, section 31 information required to demonstrate categorisationThe indicative human health risk for your introduction is very low when:

the human health exposure band is 2, and

your industrial chemical does not have any human health band C, B or A hazard characteristics (defined below).


You need to work out if the industrial chemical you are introducing has any of the hazard characteristics in:

Hazard band C (start here)

Hazard band B

Hazard band A

For specific hazard characteristics, go to each hazard band





Hazard band C characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band C for human health. If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introductions.

carcinogenicity





Note: the definitions and information requirements below are the same as in our section: 'Human health exposure band 2 – low risk (Definitions hazard band C)' except that there are different requirements for 'mutagenicity or genotoxicity.

Hazard band C: carcinogenicityThe indicative human health risk for your introduction is not very low risk if you know that the following definition applies to your chemical.




or





or



Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on carcinogenicity.

Hazard band C: mutagenicity or genotoxicityThe indicative human health risk for your introduction is not very low risk if you know that the following definition applies to your chemical.
















Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on mutagenicity or genotoxicity and one of items 1-4 must apply:

1. You can assume the ‘mutagenicity or genotoxicity’ definition does not apply to your chemical if it is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion.

2. You have an in domain in silico prediction (using Danish QSAR database, VEGA QSAR. ToxTree, TOPKAT, Derek Nexus, Sarah Nexus, Case Ultra, OASIS TIMES, Chemtunes, ADMET Predictor, T.E.S.T. or Hazard Expert) or information on the absence of alerting groups using OECD QSAR Toolbox which does not indicate mutagenic or genotoxic effects, and at least one of the following:

an in vitro test result on your chemical or from suitable read-across information for mutagenicity or genotoxicity, conducted following OECD test guideline 471, 473, 476, 487 or 490, which does not indicate mutagenic or genotoxic effects, or

an in vivo test result on your chemical or from suitable read-across information for mutagenicity or genotoxicity, conducted following OECD test guideline 474, 475, 486, 488 or 489, which does not indicate mutagenic or genotoxic effects.

3. You have test results which do not indicate mutagenic or genotoxic effects from both:

a study on the chemical or from suitable read-across information that addresses point mutations in microbial systems. This could be in vitro (conducted following OECD test guideline 471 or 476) or in vivo (conducted following OECD test guideline 486, 488 or 489)




a study on the chemical or from suitable read-across information, that addresses chromosome damage in mammalian cells. This could be in vitro (conducted following OECD test guideline 473, 487 or 490) or in vivo (conducted following OECD test guideline 474 or 475).

4. The chemical is a high molecular weight polymer and you have an in vitro test result on the chemical or from suitable read-across information for mutagenicity, conducted following OECD test guideline 471, which does not indicate mutagenic effects.

Hazard band C: reproductive toxicityThe indicative human health risk for your introduction is not very low risk if you know that the following definition applies to your chemical.







Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on reproductive toxicity.




Hazard band C: developmental toxicityThe indicative human health risk for your introduction is not very low risk if you know that the following definition applies to your chemical.








Otherwise, to work out if it is very low risk, you need to show that this definition doesn't apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown below and in Chapter 3 of these Categorisation Guidelines), based on developmental toxicity.

Hazard band C: adverse effects mediated by an endocrine mode of actionThe indicative human health risk for your introduction is not very low risk if you know that the following definition applies to your chemical.









or





The indicative human health risk for your introduction is not very low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.


To work out that the indicative human health risk is very low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified in the hazard band C lists (shown in chapter 3 of these guidelines), based on its known adverse effects mediated by an endocrine mode of action.




Hazard band B hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band B for human health.

If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introductions.

acute toxicity (fatal or toxic)

specific target organ toxicity after single exposure (significant toxicity)

specific target organ toxicity after repeated exposure

skin corrosion

eye damage

skin sensitisation

respiratory sensitisation

respiratory corrosion

high molecular weight polymer that is water absorbing

high molecular weight polymer that reactive

high molecular weight polymer that contains certain elements

Hazard band B: acute toxicity (fatal or toxic)Note: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below apply — refer to Chapter 6 specified classes of introductions.

The indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Acute toxicity (fatal or toxic), to determine the indicative human health risk , means:




the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as follows:

o acute toxicity (category 1 or 2 or 3) or


o conducted following OECD test guidelines 420, 423, 425 or deleted 401 results in an experimental acute oral LD50 value of ≤300 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in an experimental acute dermal LD50 value of ≤1,000 mg/kg bw, or

o conducted following OECD test guidelines 403, 436 or draft 433 results in an experimental acute inhalation LC50 (4 h) value of ≤2,500 ppmV (for gases) or ≤10 mg/L (for vapours) or ≤1 mg/L (for dusts/mists), or

o in humans or in animals (conducted following OECD test guideline 405) results in overt signs of systemic toxicity or mortality, which is likely to be attributed to absorption of the chemical through the mucous membranes of the eye, with the chemical classified with the non-GHS hazard statement – AUH070, or


o conducted following OECD test guideline 129, results in a predicted acute oral toxicity LD50 value of ≤300 mg/kg bw, and

o the results of the study have not been negated based on a weight of evidence determination involving studies conducted on the chemical for acute toxicity in vivo, or


o conducted using OECD QSAR Toolbox, Danish QSAR database, HazardExpert, TOPKAT, OASIS TIMES, CASE Ultra, T.E.S.T., Derek Nexus, ACD/Percepta or ADMET Predictor results in the presence of alerting groups or an in-domain acute oral toxicity LD50 prediction of ≤300 mg/kg bw, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted on the chemical for acute toxicity in vitro or in vivo.




Otherwise, to determine the indicative human health risk, one of items 1-3 applies:

1. you can assume the ‘acute toxicity (fatal or toxic)’ definition does apply to your chemical if:

o the chemical is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5)), together with high buffering capacity (if relevant).

2. you can assume the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical:

o if the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1,000 g/mol, or <2% by mass of molecules with molecular weight <500 g/mol

o via the oral route if a NOAEL ≥1,000 mg/kg bw/day was demonstrated in an oral subacute toxicity study on the chemical or from suitable read-across information

3. to determine that the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

o in vivo test result on the chemical or from suitable read-across information for acute oral toxicity (LD50), conducted following OECD test guideline 420 or 423 or 425 or deleted 401 of >300 mg/kg bw, or

o in vivo test result on the chemical or from suitable read-across information for acute dermal toxicity (LD50), conducted following OECD test guideline 402 or draft 434 of >1,000 mg/kg bw, or

o in vivo test result on the chemical or from suitable read-across information for acute inhalation toxicity (LC50), conducted following OECD test guideline 403 or 436 or draft 433 of >2,500 ppmV (for gases) or >10 mg/L (for vapours) or >1 mg/L (for dusts/mists/fumes).




Hazard band B: specific target organ toxicity after a single exposure (significant toxicity)The indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Specific target organ toxicity after a single exposure (significant toxicity), to determine the indicative human health risk, means:

the chemical is known or presumed to produce significant toxicity in humans, as described in chapter 3.8 of the GHS, with the chemical classified as follows:

o specific target organ toxicity (category 1) or


o conducted following OECD test guidelines 420, 423, 425 or deleted 401 results in significant severe toxic effects of relevance to human health (such as respiratory corrosion), as discussed in chapter 3.8 of the GHS, at ≤300 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in significant severe toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at ≤1,000 mg/kg bw, or

o conducted following OECD test guidelines 403, 436 or draft 433 results in significant severe toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at ≤2,500 ppmV (for gases, 4h) or ≤10 mg/L (for vapours, 4h) or ≤1 mg/L (for dusts/mists, 4h).

Hazard band B: specific target organ toxicity after repeated exposureNote: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below apply — refer to Chapter 6 specified classes of introductions.





Specific target organ toxicity after repeated exposure, to determine the indicative human health risk, means:

the chemical is known to exhibit significant severe toxicity or be potentially harmful to human health following repeated exposure, as described in chapter 3.9 of the GHS, with the chemical classified as follows:

o specific target organ toxicity – repeated exposure (category 1 or 2) or


o conducted following OECD test guideline 407 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) value of <300 mg/kg bw/day, or

o conducted following OECD test guidelines 408 or 409 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) of <100 mg/kg bw/day, or

o conducted following OECD test guideline 410 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) value of <600 mg/kg bw/day, or

o conducted following OECD test guideline 411 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) of <200 mg/kg bw/day, or

o conducted following OECD test guideline 412 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of <750 ppmV/6 h/day (for gases) or <3 mg/L/6 h/day (for vapours) or <0.6 mg/L (for dusts/mists), or

o conducted following OECD test guideline 413 results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of <250 ppmV/6 h/day (for gases) or <1 mg/L/6 h/day (for vapours) or <0.2 mg/L (for dusts/mists).





1. You can assume the ‘specific target organ toxicity after repeated exposure’ definition does apply to your chemical if:

the chemical is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5)), together with high buffering capacity (if relevant).

2. You can assume the ‘specific target organ toxicity after repeated exposure’ definition does not apply to your chemical if:

the chemical is a high molecular weight polymer, unless it is known to be corrosive or severely irritating

the chemical is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical.

3. To determine that the ‘specific target organ toxicity after repeated exposure’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

in vivo study conducted following OECD test guideline 407 on the chemical or suitable analogue, in which the NOAEL is ≥ 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

in vivo study conducted following OECD test guideline 408 or 409 on the chemical or suitable analogue, in which the NOAEL is ≥100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

in vivo study conducted following OECD test guideline 410 on the chemical or suitable analogue, in which the NOAEL is ≥600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or





in vivo study conducted following OECD test guideline 412 on the chemical or suitable analogue, in which the NOAEC is ≥750 ppmV/6 h/day (for gases) or ≥3 mg/L/6 h/day (for vapours) or ≥0.6 mg/L/6 h/day (for dusts/mists), or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

in vivo study conducted following OECD test guideline 413 on the chemical or suitable analogue, in which the NOAEC is ≥250 ppmV/6 h/day (for gases) or ≥1 mg/L/6 h/day (for vapours) or ≥0.2 mg/L/6 h/day (for dusts/mists) or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.

Hazard band B: skin corrosionThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Skin corrosion, to determine the indicative human health risk, means:

the chemical is known to produce irreversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as follows:

o skin corrosion (category 1) or


o conducted following OECD test guideline 404 results in destruction of skin tissue, as described in chapter 3.2 of the GHS, or


o conducted following OECD test guideline 430 or 431 or 435 results in the prediction of skin corrosion effects, and

o the results of the study have not been negated based on a weight of evidence determination involving studies conducted on the chemical for skin corrosion in vivo, or


o conducted using OECD QSAR Toolbox, Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS Times, Case Ultra, Chemtunes or




ACD/Percepta results in the presence of alerting groups or an in-domain prediction of skin corrosion, and



1. you can assume the ‘skin corrosion’ definition does apply to your chemical if:

o it is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant), or

o it is spontaneously flammable in air at room temperature

2. you can assume the ‘skin corrosion’ definition does not apply to your chemical if:

o the chemical is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride

epoxide

sulfonic acid

amine

3. to determine that the ‘skin corrosion’ definition does not apply to your chemical, you need one of the following:

o an in domain in silico prediction (using Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS Times, Case Ultra, Chemtunes or ACD/Percepta) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical is not corrosive, or

o an in vitro test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 430, 431 or 435, with a non-corrosive prediction, or




o an in vitro test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 439, with a non-irritant prediction, or

o an in vivo test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 404, which does not indicate destruction of skin tissue, as described in chapter 3.2 of the GHS.

Hazard band B: eye damageThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Eye damage, to determine the indicative human health risk, means:

the chemical is known to produce serious eye damage, as described in chapter 3.3 of the GHS, with the chemical classified as follows:

o eye damage (category 1) or

an in vivo study on the chemical conducted following:

o conducted following OECD test guideline 405 results in effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS, or


o conducted following OECD test guideline 437, 438, 460 or 491 results in the prediction of serious eye damage effects, and

o the results of the study have not been negated based on a weight of evidence determination involving studies conducted on the chemical for eye damage in vivo, or


o conducted using OECD QSAR Toolbox, ToxTree, OASIS TIMES, TOPKAT, Derek Nexus, Case Ultra, ACD/Labs Percepta, PaDEL-DDPredictor or BfR Decision results in the presence of alerting groups or an in-domain prediction of serious eye damage, and




o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted on the chemical for eye damage in vitro or in vivo.


1. you can assume the ‘eye damage’ definition does apply to your chemical if:

o the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant), or

2. you can assume the ‘eye damage’ definition does not apply to your chemical if

o it is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride

epoxide

sulfonic acid

amine

3. to determine that the ‘eye damage’ definition does not apply to your chemical, you need one of the following:

o an in vitro test result on the chemical or from suitable read-across information for eye damage, conducted following OECD test guideline 437, 438, 460 or 491, which predicts the chemical would not induce serious eye damage, or

o an in vivo test result on the chemical or from suitable read-across information for eye damage, conducted following OECD test guideline 405, which does not indicate effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS.

Hazard band B: skin sensitisationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.




Skin sensitisation, to determine the indicative human health risk, means:

the chemical is known to cause an allergic response following skin contact, as described in chapter 3.4 of the GHS, with the chemical classified as follows:

o skin sensitisation (category 1), or

human testing or epidemiological studies on the chemical result in evidence of an allergic response, as described in chapter 3.4 of the GHS, or


o conducted following OECD test guideline 406, 429, 442A or 442B, results in the induction of an allergic response, as described in chapter 3.4 of the GHS, or


o conducted following OECD test guideline TG 442D or 442E, results in the prediction of skin sensitisation effects, and

o the results of the study have not been negated based on a weight of evidence determination involving studies conducted on the chemical for skin sensitisation in vivo, or

an in chemico study on the chemical:

o conducted following OECD test guideline TG 442C, results in the prediction of skin sensitisation effects, and


an in silico model of the chemical and its metabolite/s (if any):

o conducted using OECD QSAR Toolbox, ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database, results in the presence of alerting groups or an in-domain prediction of skin sensitisation for either or both the chemical and its metabolite/s, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted on the chemical for skin sensitisation in vivo.





1. you can assume the ‘skin sensitisation’ definition does not apply if the chemical is a high molecular weight polymer that:

o contains only low concern functional groups, or

o the only high concern functional groups are:

unsubstituted positions ortho and para to phenolic hydroxyl groups

partially-hydrolysed acrylamides, or

has a combined functional group equivalent weight of ≥ 1000 g/mol.

2. the chemical is corrosive or severely irritating to skin (GHS Category 1). You do not need to work out the skin sensitisation potential because:

o the test may not be able to be conducted,

o if the chemical is corrosive then hazard band B will already be applying to the introduction.

3. To determine that the ‘skin sensitisation’ definition does not apply to your chemical, you need one of the following:

A combination of:

o An in domain in silico prediction (using ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical and its metabolite/s (if any) does not cause skin sensitisation, and

o An in chemico test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442C, with a non-sensitising prediction, and

o An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442D, with a non-sensitising prediction, and




o An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442E, with a non-sensitising prediction, or

An in vivo test result on the chemical or from suitable read-across information, conducted following OECD test guideline 406, 429, 442A or 442B, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS.

Hazard band B: respiratory sensitisationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Respiratory sensitisation, to determine the indicative human health risk, means:

the chemical is known or presumed to produce hypersensitivity of the airways in humans, as described in chapter 3.4 of the GHS, with the chemical classified as follows:

o respiratory sensitisation (category 1), or

the chemical is named:

o on the EU SVHC authorisation list for respiratory sensitisers (acc. Art. 57(f)), or

o in the Danish EPA (Q)SAR Database as a predicted respiratory sensitiser, or

an in vivo or in vitro study on the chemical:

o indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, or


o conducted using OECD QSAR Toolbox results in the presence of alerting groups for respiratory sensitisation for the chemical and/or its metabolites, and

o the alerting group has not been negated based on a weight of evidence determination involving studies conducted on the chemical for respiratory sensitisation in vitro or in vivo.




If your chemical is an enzyme the chemical must be assumed to induce respiratory sensitisation, unless proven otherwise.

Enzyme means a protein that is capable of catalysing a chemical reaction.

Hazard band B: respiratory corrosionThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Respiratory corrosion, to determine the indicative human health risk, means:

the chemical is known to cause destruction of the respiratory tract tissue, as described in chapter 3.1 of the GHS, with the chemical classified as follows (non-GHS hazard statement):

o corrosive to the respiratory tract (AUH071), or


o conducted following OECD test guideline 403, 412, 413, draft-433 or 436 results in destruction of the respiratory tract, as described in chapter 3.1 of the GHS.

Hazard band B: high molecular weight polymer that is water absorbingThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer that is water absorbing, to determine the indicative human health risk, means a polymer that:

has a number average molecular weight that is ≥10,000 g/mol, and

is capable of absorbing its own weight, or more, in water, and

is in particulate form, and

contains particles with a particle size <10 micrometres (microns)

You can assume the ‘high molecular weight polymer that is water absorbing’ definition applies to your chemical if:




it forms a gel in water that does not dissolve upon the addition of further water, or

it is a cross-linked polymer containing hydrophilic monomers such as acrylic acid (and its salts) and acrylamide.

Hazard band B: high molecular weight polymer that is reactiveThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer that is reactive, to determine the indicative human health risk, means a polymer that:

has a number average molecular weight that is ≥1,000 g/mol and <10,000 g/mol, and

has moderate and/or high concern reactive functional groups, and

has ≥5% by mass of molecules with molecular weight <1,000 g/mol, or ≥2% by mass of molecules with molecular weight <500 g/mol, and

has combined functional group equivalent weight <1,000 g/mol (moderate concern reactive functional groups only), or combined functional group equivalent weight < 5,000 g/mol (high concern and moderate concern reactive functional groups).

Hazard band B: high molecular weight polymer that contains certain chemical elementsThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer that contains certain chemical elements, to determine the indicative human health risk, means a polymer that has a number average molecular weight that is ≥1,000 g/mol and <10,000 g/mol, and any of the following apply:




does not contain as an integral part of its composition (other than as an impurity) at least 2 of the chemical elements set out in Schedule 1, Clause 6 of the Rules, or

contains as an integral part of its composition (other than as an impurity) chemical elements other than those set out in Schedule 1, Clause 7 of the Rules, or

contains as an integral part of its composition (other than as an impurity), 0.2% or more (by weight) of any combination of the chemical elements set out in Schedule 1, paragraph 7(s) of the Rules

Hazard band A hazard characteristicsYou have to show that your industrial chemical does not have human health band A hazard characteristics:

acute toxicity (harmful)

specific target organ toxicity after a single exposure (harmful or transient effects)

skin irritation

eye irritation

aspiration hazard

high molecular weight polymer that has lung overloading potential

high molecular weight polymer with other potential hazards

The following definitions apply to chemicals that do fall into human health hazard band A. If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk.

Hazard band A: acute toxicity (harmful)Note: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to the below for the ‘acute toxicity (harmful)’ hazard characteristic apply, as outlined in Chapter 6 specified classes of introduction.





Acute toxicity (harmful), to determine the indicative human health risk, means:


o acute toxicity (category 4) or


o conducted following OECD test guidelines 420 or 423 or 425 or deleted 401 results in an experimental acute oral LD50 value of >300 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in an experimental acute dermal LD50 value of >1,000 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 403 or 436 or draft 433 results in an experimental acute inhalation LC50 (4 h) value of >2500 but ≤20,000 ppmV (for gases) or >10 but ≤20 mg/L (for vapours) or >1 but ≤5 mg/L (for dusts/mists/fumes), or


o conducted following OECD test guideline 129, results in a predicted acute toxicity LD50 value of >300 but ≤2,000 mg/kg bw, and



o conducted using OECD QSAR Toolbox, Danish QSAR database, HazardExpert, TOPKAT, OASIS TIMES, CASE Ultra, T.E.S.T., Derek Nexus, ACD/Percepta or ADMET Predictor results in the presence of alerting groups or an in-domain acute toxicity LD50 prediction of >300 but ≤2,000 mg/kg bw and





Otherwise, to determine the indicative human health risk, one of items 1 or 2 applies:

1. you can assume the ‘acute toxicity (harmful)’ definition does not apply to your chemical:

o if the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1,000 g/mol, or <2% by mass of molecules with molecular weight <500 g/mol


2. to determine that the ‘acute toxicity (harmful)’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

o a combination of:

an in domain in silico prediction (using OECD QSAR Toolbox, Danish QSAR database, HazardExpert, TOPKAT, OASIS TIMES, CASE Ultra, T.E.S.T., Derek Nexus, ACD/Percepta or ADMET Predictor) for acute toxicity (LD50) of the chemical of >2,000 mg/kg bw, and

an in vitro test result on the chemical or from suitable read-across information for acute toxicity (LD50), conducted following OECD test guideline 129, of >2,000 mg/kg bw, or

o in vivo test result on the chemical or from suitable read-across information for acute oral toxicity (LD50), conducted following OECD test guideline 420 or 423 or 425 or deleted 401 of >2,000 mg/kg bw, or


o in vivo test result on the chemical or from suitable read-across information for acute inhalation toxicity (LC50), conducted following OECD test guideline 403 or 436 or draft 433 of >2,500 ppmV (for




gases) or >10 mg/L (for vapours) or >5 mg/L (for dusts/mists/fumes).

Hazard band A: specific target organ toxicity after a single exposure (harmful or transient effects)The indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Specific target organ toxicity after a single exposure (harmful or transient effects), to determine the indicative human health risk, means:

the chemical is known or presumed to be harmful to humans or to cause transient target organ effects, as described in chapter 3.8 of the GHS, with the chemical classified as follows:

o specific target organ toxicity (category 2 or 3) or


o conducted following OECD test guidelines 420, 423, 425 or deleted 401 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >300 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >1,000 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 403, 436 or draft 433 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >2,500 but ≤20,000 ppmV (for gases, 4h) or >10 but ≤20 mg/L (for vapours, 4h) or >1 but ≤5 mg/L (for dusts/mists, 4h).

Hazard band A: skin irritationNote: If your chemical is introduced for an end use in tattoo ink , additional requirements to the below for the ‘skin irritation’ hazard characteristic apply, as outlined in chapter 6 specified classes of introduction.





Skin irritation, to determine the indicative human health risk, means:

the chemical is known to produce reversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as follows:

o skin irritation (category 2) or


o conducted following OECD test guideline 404 results in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS, or

in vitro studies on the chemical:

o conducted following OECD test guideline 439 results in the prediction of skin irritation effects, when combined with the results of an in vitro study on the chemical, conducted following OECD test guideline 430,431 or 435, which predicts the chemical would not be corrosive, and

o the results of the studies have not been negated based on a weight of evidence determination involving studies conducted for skin irritation in vivo, or


o conducted using OECD QSAR Toolbox, Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS TIMES, Case Ultra, Chemtunes or ACD/Percepta results in the presence of alerting groups or an in-domain prediction of skin irritation, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted for skin irritation in vitro or in vivo.





1. you can assume the ‘skin irritation’ definition does not apply to your chemical if:

o the chemical is not irritating to the skin in a study conducted following OECD test guidelines 402 or draft 434 results, when tested at 2,000 mg/kg bw.

2. to determine that the ‘skin irritation’ definition does not apply to your chemical, you need one of the following:

o an in domain in silico prediction (using Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS TIMES, Case Ultra, Chemtunes or ACD/Percepta) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical is not irritating to skin, or

o an in vitro test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 439, with a non-irritant prediction

o an in vivo test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 404, which does not indicate skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS.

Hazard band A: eye irritationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Eye irritation, to determine the indicative human health risk, means:

the chemical is known to produce changes in the eye, as described in chapter 3.3 of the GHS, with the chemical classified as follows:

o eye irritation (category 2A) or


o conducted following OECD test guideline 405 results in changes in the eye, as described for eye irritation in chapter 3.3 of the GHS, and




o the changes in the eye are not fully reversible within 7 days or persist for longer than 21 days, or


o conducted following OECD test guideline 492 results in the prediction of eye irritation effects, when combined with the results of an in vitro study on the chemical, conducted following OECD test guideline 437, 438, 460 or 491, which predicts the chemical would not induce serious eye damage, and

o the results of the studies have not been negated based on a weight of evidence determination involving studies conducted for eye damage in vivo, or


o conducted using OECD QSAR Toolbox, ToxTree, OASIS TIMES, TOPKAT, Derek Nexus, Case Ultra, ACD/Labs Percepta, PaDEL-DDPredictor or BfR Decision results in the presence of alerting groups or an in-domain prediction of eye irritation, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted for eye damage in vitro and/or in vivo.


1. an in domain in silico prediction (using ToxTree, OASIS TIMES, TOPKAT, Derek Nexus, Case Ultra, ACD/Labs Percepta, PaDEL-DDPredictor or BfR Decision) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical is not irritating to eyes, or

2. an in vitro test result on the chemical or from suitable read-across information for eye irritation, conducted following OECD test guideline 437, 438, 491 or 492 with a non-irritant prediction

3. an in vivo test result on the chemical or from suitable read-across information for eye irritation, conducted following OECD test guideline 405, which either:




o does not indicate changes in the eye, as described for eye irritation (category 2A) in chapter 3.3 of the GHS, or

o where there are changes in the eye, as described for eye irritation (category 2A) in chapter 3.3 of the GHS, these changes are fully reversible within 7 days.

Hazard band A: aspiration hazardThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Aspiration hazard, to determine the indicative human health risk, means:

the chemical is known or presumed to cause aspiration toxicity, as described in chapter 3.10 of the GHS, with the chemical classified as follows:

o may be fatal if swallowed and enters airways (category 1) or

the chemical is a hydrocarbon that has a kinematic viscosity ≤ 20.5 mm2/s, measured at 40°C.

You can assume the ‘aspiration hazard’ definition applies to your chemical if it is a hydrocarbon with at least 3 carbon atoms but less than 13 , unless it has a kinematic viscosity ≤ 20.5 mm2/s, measured at 40°C.

Hazard band A: high molecular weight polymer that has lung overloading potentialThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer that has lung overloading potential, to determine the indicative human health risk, means a polymer that:

has a number average molecular weight that is >70,000 g/mol, and

has a solubility in water of < 0.1 mg/L, and

becomes aerosolised during end use.




Hazard band A: high molecular weight polymer with other potential hazardsThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer with other potential hazards, to determine the indicative human health risk, means a polymer that:

has a number average molecular weight that is greater than or equal to 1,000 g/mol, and

is not a polymer of low concern (within the definition of Schedule 1 of the Rules)






















Human health exposure band 3You are reading chapter 4 of the Categorisation Guidelines

The following information is to work out if your introduction's indicative human health risk for human health exposure band 3.

Relevant section of the Rule(s): section 25 human health hazard band, section 26 indicative human health riskThe indicative human health risk for your chemical is low when:


your industrial chemical does not have any human health hazard band C or B characteristics (see link below)

The indicative human health risk for your chemical is very low when:












your industrial chemical does not have any human health hazard band C, B and A characteristics (see link below)

If the indicative human health risk for your introduction is neither low or very low, then it is medium to high.





applications requirements (for Assessed introductions under AICIS) or

classification requirements (to meet your WHS obligations under other regulators).

Ensure you have read and understood our hazard characteristics general information in Chapter 3 — Hazard bands

Summary: Human health exposure band 3

How to determine indicative human health risk is low

If any of these hazard band C and B definitions apply to your chemical, the indicative human health risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

How to determine indicative human health risk is very low




If any of these hazard band C, B and A definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.




Human health exposure band 3 — low riskYou are in Chapter 4 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): section 25 human health hazard band, section 26 indicative human health risk, section 31 information required to demonstrate categorisationThe indicative human health risk for your introduction is low when:


your industrial chemical does not have any human health hazard band C and B characteristics (defined below).



Hazard band C hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band C for human health. If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not low risk. If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.

carcinogenicity








Hazard band C: carcinogenicityNote: If your chemical is a UV filter, additional requirements to those set out below for the carcinogenicity hazard characteristic apply — refer to chapter 6 on specified classes of introduction.

The indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.




or


or



Otherwise, to work out that it is low risk, you need to show that this definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on carcinogenicity.




Hazard band C: mutagenicity or genotoxicityNote: If your chemical is a UV filter, additional requirements to those set out below for the ‘mutagenicity or genotoxicity’ hazard characteristic apply — refer to Chapter 6 on specified classes of introduction.

















Otherwise, to work out that it is low risk, you need to show that this definition does not apply by:

Confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on mutagenicity or genotoxicity and one of items 1-3 must apply:

1. You can assume the ‘mutagenicity or genotoxicity’ definition does not apply to your chemical if it is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS) Database as a Type 1 Conclusion.

2. You have test results which do not indicate mutagenic or genotoxic effects from both:

o A study on the chemical or from suitable read-across information that addresses point mutations in microbial systems. This could be in vitro (conducted following OECD test guideline 471 or 476) or in vivo (conducted following OECD test guideline 486, 488 or 489).

o A study on the chemical or from suitable read-across information, that addresses chromosome damage in mammalian cells. This could be in vitro (conducted following OECD test guideline 473, 487 or 490) or in vivo (conducted following OECD test guideline 474 or 475).

3. The chemical is a high molecular weight polymer.

Hazard band C: reproductive toxicityNote: If your chemical is a polyhalogenated organic chemical, additional requirements to those set out below for the ‘reproductive toxicity’ hazard characteristic apply — refer to Chapter 6 on specified classes of introduction.











Otherwise, to work out that it is low risk, you need to show that this definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on reproductive toxicity

Hazard band C: developmental toxicityNote: If your chemical is a polyhalogenated organic chemical or a monohalogenated organic chemical, additional requirements to those set out below for the ‘developmental toxicity’ hazard characteristic apply — refer to Chapter 6 on specified classes of introduction.















Otherwise, to work out that it is low risk, you need to show that this definition does not apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on developmental toxicity.

Hazard band C: adverse effects mediated by an endocrine mode of actionThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.









or





The indicative human health risk for your introduction is not low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.


To determine that the indicative human health risk is low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition does not apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on its known adverse effects mediated by an endocrine mode of action.


If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not low risk. If your introduction is a specified class




of introduction, additional requirements — refer Chapter 6 specified classes of introduction.


specific target organ toxicity after a single exposure (significant toxicity)


skin corrosion

eye damage

skin sensitisation




high molecular weight polymer that is reactive

high molecular weight polymer that contains certain chemical elements

Hazard band B: acute toxicity (fatal or toxic)Note: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below for the ‘acute toxicity (fatal or toxic)’ hazard characteristic apply — refer to Chapter 6 on specified classes of introduction.


Acute toxicity (fatal or toxic), to determine the indicative human health risk, means:









o conducted following OECD test guidelines 403, 436 or draft 433 results in an experimental acute inhalation LC50 (4 h) value of ≤2,500 ppmV (for gases) or ≤10 mg/L (for vapours) or ≤1 mg/L (for dusts/mists), or









1. You can assume the ‘acute toxicity (fatal or toxic)’ definition does apply to your chemical if:




o It is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant).

2. You can assume the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical:

o If the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1,000 g/mol, or <2% by mass of molecules with molecular weight <500 g/mol, or

o Via the oral route if a NOAEL ≥1,000 mg/kg bw/day was demonstrated in an oral subacute toxicity study on the chemical or from suitable read-across information.

3. To determine that the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

o In vivo test result on the chemical or from suitable read-across information for acute oral toxicity (LD50), conducted following OECD test guideline 420 or 423 or 425 or deleted 401 of >300 mg/kg bw, or

o In vivo test result on the chemical or from suitable read-across information for acute dermal toxicity (LD50), conducted following OECD test guideline 402 or draft 434 of >1,000 mg/kg bw, or

o In vivo test result on the chemical or from suitable read-across information for acute inhalation toxicity (LC50), conducted following OECD test guideline 403 or 436 or draft 433 of >2,500 ppmV (for gases) or >10 mg/L (for vapours) or >1 mg/L (for dusts/mists/fumes).

Hazard band B: specific target organ toxicity after a single exposure (significant toxicity)The indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.











Hazard band B: specific target organ toxicity after repeated exposureNote: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below for the ‘specific target organ toxicity after repeated exposure’ hazard characteristic apply — refer to Chapter 6 of the Categorisation Guidelines on specified classes of introduction.















Otherwise, if your introduction is for:

An end use in cosmetics, tattoo ink or personal vaporisers and the total introduction volume of the chemical in a registration year is >1,000 kg, or

An end use other than in cosmetics, tattoo ink or personal vaporisers and the total introduction volume of the chemical in a registration year is >10,000 kg,

To determine the indicative human health risk, one of items 1-3 applies:





o It is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5)), together with high buffering capacity (if relevant).


o It is a high molecular weight polymer, unless it is known to be corrosive or severely irritating, or

o It is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical.


o In vivo study conducted following OECD test guideline 407 on the chemical or suitable analogue, in which the NOAEL is ≥ 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 408 or 409 on the chemical or suitable analogue, in which the NOAEL is ≥100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 410 on the chemical or suitable analogue, in which the NOAEL is ≥600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 411 on the chemical or suitable analogue, in which the NOAEL is ≥200 mg/kg




bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 412 on the chemical or suitable analogue, in which the NOAEC is ≥750 ppmV/6 h/day (for gases) or ≥3 mg/L/6 h/day (for vapours) or ≥0.6 mg/L/6 h/day (for dusts/mists), or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 413 on the chemical or suitable analogue, in which the NOAEC is ≥250 ppmV/6 h/day (for gases) or ≥1 mg/L/6 h/day (for vapours) or ≥0.2 mg/L/6 h/day (for dusts/mists)or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.

Hazard band B: skin corrosionThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.













o conducted using OECD QSAR Toolbox, Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS Times, Case Ultra, Chemtunes or ACD/Percepta results in the presence of alerting groups or an in-domain prediction of skin corrosion, and



1. You can assume the ‘skin corrosion’ definition does apply to your chemical if:

o It is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant), or

o It is is spontaneously flammable in air at room temperature

2. You can assume the ‘skin corrosion’ definition does not apply to your chemical if:

o The chemical is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride

epoxide

sulfonic acid

amine

3. To determine that the ‘skin corrosion’ definition does not apply to your chemical, you need one of the following:

o An in vitro test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 430, 431 or 435, with a non-corrosive prediction, or




o An in vitro test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 439, with a non-irritant prediction, or

o An in vivo test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 404, which does not indicate destruction of skin tissue, as described in chapter 3.2 of the GHS.

Hazard band B: eye damageThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.
















1. You can assume the ‘eye damage’ definition does apply to your chemical if:

o It is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant).

2. You can assume the ‘eye damage’ definition does not apply to your chemical if:

o It is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride

epoxide

sulfonic acid

amine

3. To determine that the ‘eye damage’ definition does not apply to your chemical, you need one of the following:

o An in domain in silico prediction (using ToxTree, OASIS TIMES, TOPKAT, Derek Nexus, Case Ultra, ACD/Labs Percepta, PaDEL-DDPredictor or BfR Decision) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical does not cause serious eye damage, or

o An in vitro test result on the chemical or from suitable read-across information for eye damage which predicts the chemical would not induce serious eye damage. This must be conducted following OECD test guideline 437, 438, 460 or 491, or

o An in vivo test result on the chemical or from suitable read-across information for eye damage which does not indicate effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS. This must be conducted following OECD test guideline 405.




Hazard band B: skin sensitisationThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.














o conducted using OECD QSAR Toolbox, ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database, results in the presence




of alerting groups or an in-domain prediction of skin sensitisation for either or both the chemical and its metabolite/s, and



1. You can assume the ‘skin sensitisation’ definition does not apply to your chemical if:

o The chemical is a high molecular weight polymer.

2. The chemical is corrosive or severely irritating to skin (GHS Category 1). You do not need to work out the skin sensitisation potential because:

o The test may not be able to be conducted.

o If the chemical is corrosive then hazard band B will already be applying to the introduction.


o A combination of:

An in domain in silico prediction (using ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical and its metabolite/s (if any) does not cause skin sensitisation, and

An in chemico test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442C, with a non-sensitising prediction, and

An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442D, with a non-sensitising prediction, and

An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442E, with a non-sensitising prediction, or




o An in vivo test result on the chemical or from suitable read-across information, conducted following OECD test guideline 406, 429, 442A or 442B, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS.

Hazard band B: respiratory sensitisationThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.

















Hazard band B: respiratory corrosionThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.






Hazard band B: high molecular weight polymer that is water absorbingThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.












Hazard band B: high molecular weight polymer that is reactiveThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.






Hazard band B: high molecular weight polymer that contains certain chemical elementsThe indicative human health risk for your introduction is not low risk, if you know that the following definition applies to your chemical.









Human health exposure band 3 — very low riskYou are in Chapter 4 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): section 25 human health hazard band, section 26 indicative human health risk, section 31 information required to demonstrate categorisationIndicative human health risk is defined in our Glossary

Work out if the industrial chemical you are introducing has any of the hazard characteristics in:

hazard band C (start here)

hazard band B

hazard band A

For specific hazard characteristics, go to each hazard band (using the above links).







Hazard band C hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band C for human health.

If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.

carcinogenicity





Note: These definitions and information requirements below are the same as in our above section: Human health exposure band 3 – low risk (Definitions hazard band C), except that there are different requirements for mutagenicity or genotoxicity if your chemical is a polymer.

Hazard band C: carcinogenicityNote: If your chemical is a UV filter, additional requirements to those set out below for the ‘carcinogenicity' hazard characteristic apply — refer to Chapter 6 specified classes of introduction.


If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.







or


or



Otherwise, to work out that it is very low risk, you need to show that this definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on carcinogenicity.

Hazard band C: mutagenicity or genotoxicityNote: If your chemical is a UV filter, additional requirements to those set out below for the ‘mutagenicity or genotoxicity’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.

















Otherwise, to determine that it’s very low risk, you need to show that this definition doesn’t apply by:

confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on mutagenicity or genotoxicity, and

one of items 1-3 must apply:

1. you can assume the ‘mutagenicity or genotoxicity’ definition does not apply to your chemical if it is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion.




2. you have test results which do not indicate mutagenic or genotoxic effects from both:

o a study on the chemical or from suitable read-across information that addresses point mutations in microbial systems. This could be in vitro (conducted following OECD test guideline 471 or 476) or in vivo (conducted following OECD test guideline 486, 488 or 489)

o a study on the chemical or from suitable read-across information, that addresses chromosome damage in mammalian cells. This could be in vitro (conducted following OECD test guideline 473, 487 or 490) or in vivo (conducted following OECD test guideline 474 or 475).

3. the chemical is a high molecular weight polymer and you have an in vitro test result on the chemical or from suitable read-across information for mutagenicity, conducted following OECD test guideline 471, which does not indicate mutagenic effects.

Hazard band C: reproductive toxicityNote: If your chemical is a polyhalogenated organic chemical , additional requirements to those set out below for the ‘reproductive toxicity’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.







o conducted following OECD test guideline 408, 409, 411, 413, 414, 415, 416, 421, 422, 443, 451, 452 or 453 results in adverse effects




on sexual function and fertility, as described in chapter 3.7 of the GHS.

Otherwise, to work out that it is very low risk, you need to show that this definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on reproductive toxicity.

Hazard band C: developmental toxicityNote: If your chemical is a polyhalogenated organic chemical, additional requirements to those set out below for the ‘developmental toxicity’ hazard characteristic apply — refer Chapter 6 specified classes of introduction.









Otherwise, to work out that it is very low risk, you need to show that this definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band




C lists (Chapter 3 of these Categorisation Guidelines), based on developmental toxicity.

Hazard band C: adverse effects mediated by an endocrine mode of actionThe indicative human health risk for your introduction is not very low risk, if you know that that the following definition applies to your chemical.






or





The indicative human health risk for your introduction is not very low risk, if, based on this analysis, the ‘adverse health effects mediated by an endocrine mode of action’ definition applies to your chemical.





Otherwise, to work out that the indicative human health risk is very low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition does not apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on any of the lists identified on the hazard band C lists (Chapter 3 of these Categorisation Guidelines), based on its known adverse effects mediated by an endocrine mode of action.


If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a specified class of introduction, additional requirements apply — refer to Chapter 6 specified classes of introduction.

This section on working out if the indicative risk is very low has definitions on:


specific target organ toxicity after a single exposure (significant toxicity)


skin corrosion

eye damage

skin sensitisation




high molecular weight polymer that is reactive




high molecular weight polymer that contains certain chemical elements

The definitions and information requirements below are the same as in our section ‘how to work out if the indicative risk is low’, except that there are different requirements for:

‘specific target organ toxicity after repeated exposure’

‘acute toxicity (fatal or toxic)’ if your chemical is a polymer‘

skin sensitisation’ if your chemical is a polymer

Hazard band B: acute toxicity (fatal or toxic)Note: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below for the ‘acute toxicity (fatal or toxic)’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.


Acute toxicity (fatal or toxic), to determine the indicative human health risk , means:






o conducted following OECD test guidelines 403, 436 or draft 433 results in an experimental acute inhalation LC50 (4 h) value of




≤2,500 ppmV (for gases) or ≤10 mg/L (for vapours) or ≤1 mg/L (for dusts/mists), or









1. you can assume the ‘acute toxicity (fatal or toxic)’ definition does apply to your chemical if:

the chemical is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5)), together with high buffering capacity (if relevant).

2. you can assume the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical:




if the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1,000 g/mol, or <2% by mass of molecules with molecular weight <500 g/mol, or

via the oral route if a NOAEL ≥1,000 mg/kg bw/day was demonstrated in an oral subacute toxicity study on the chemical or from suitable read-across information

3. to determine that the ‘acute toxicity (fatal or toxic)’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

in vivo test result on the chemical or from suitable read-across information for acute oral toxicity (LD50), conducted following OECD test guideline 420 or 423 or 425 or deleted 401 of >300 mg/kg bw, or

in vivo test result on the chemical or from suitable read-across information for acute dermal toxicity (LD50), conducted following OECD test guideline 402 or draft 434 of >1,000 mg/kg bw,

or in vivo test result on the chemical or from suitable read-across information for acute inhalation toxicity (LC50), conducted following OECD test guideline 403 or 436 or draft 433 of >2,500 ppmV (for gases) or >10 mg/L (for vapours) or >1 mg/L (for dusts/mists/fumes).

Hazard band B: specific target organ toxicity after a single exposure (significant toxicity)The indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.











Hazard band B: specific target organ toxicity after repeated exposureNote: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below for the ‘specific target organ toxicity after repeated exposure’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.
















1. you can assume the ‘specific target organ toxicity after repeated exposure’ definition does apply to your chemical if:

o it is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5)), together with high buffering capacity (if relevant).

2. you can assume the ‘specific target organ toxicity after repeated exposure’ definition does not apply to your chemical if:it is a high molecular weight polymer, unless it is known to be corrosive or severely irritating, or the chemical is included in the GRAS for FDA Inventory Notice (GRAS




Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical.

3. to determine that the ‘specific target organ toxicity after repeated exposure’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):

in vivo study conducted following OECD test guideline 407 on the chemical or suitable analogue, in which the NOAEL is ≥ 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

in vivo study conducted following OECD test guideline 408 or 409 on the chemical or suitable analogue, in which the NOAEL is ≥100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or



in vivo study conducted following OECD test guideline 412 on the chemical or suitable analogue, in which the NOAEC is ≥750 ppmV/6 h/day (for gases) or ≥3 mg/L/6 h/day (for vapours) or ≥0.6 mg/L/6 h/day (for dusts/mists), or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

in vivo study conducted following OECD test guideline 413 on the chemical or suitable analogue, in which the NOAEC is ≥250 ppmV/6 h/day (for gases) or ≥1 mg/L/6 h/day (for vapours) or ≥0.2 mg/L/6 h/day (for dusts/mists)or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.




Hazard band B: skin corrosionThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.










o conducted using OECD QSAR Toolbox, Danish QSAR database, Derek Nexus, ToxTree, TOPKAT, OASIS Times, Case Ultra, Chemtunes or ACD/Percepta results in the presence of alerting groups or an in-domain prediction of skin corrosion, and



1. you can assume the ‘skin corrosion’ definition does apply to your chemical if:




o it is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant), or

o it is spontaneously flammable in air at room temperature

2. you can assume the ‘skin corrosion’ definition does not apply to your chemical if:

o it is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride

epoxide

sulfonic acid

amine

3. to determine that the ‘skin corrosion’ definition does not apply to your chemical, you need one of the following:

o an in vitro test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 430, 431 or 435, with a non-corrosive prediction, or

o an in vitro test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 439, with a non-irritant predictionan

o an in vivo test result on the chemical or from suitable read-across information for skin corrosion, conducted following OECD test guideline 404, which does not indicate destruction of skin tissue, as described in chapter 3.2 of the GHS.

Hazard band B: eye damageThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.
















1. you can assume the ‘eye damage’ definition does apply to your chemical if:

o the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), together with high buffering capacity (if relevant), or

2. you can assume the ‘eye damage’ definition does not apply to your chemical if:

o is a high molecular weight polymer, other than a polymer that contains any of the following reactive functional groups, with a combined functional group equivalent weight of < 1000 g/mol:

anhydride




epoxide

sulfonic acid

amine

3. to determine that the ‘eye damage’ definition does not apply to your chemical, you need one of the following:

o an in vitro test result on the chemical or from suitable read-across information for eye damage, conducted following OECD test guideline 437, 438, 460 or 491, which predicts the chemical would not induce serious eye damage, or

o an in vivo test result on the chemical or from suitable read-across information for eye damage, conducted following OECD test guideline 405, which does not indicate effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS.

Hazard band B: skin sensitisationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

















o conducted using OECD QSAR Toolbox, ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database, results in the presence of alerting groups or an in-domain prediction of skin sensitisation for either or both the chemical and its metabolite/s, and



1. you can assume the ‘skin sensitisation’ definition does not apply if the chemical is a high molecular weight polymer that:

o contains only low concern functional groups, or

o the only high concern functional groups are:

unsubstituted positions ortho and para to phenolic hydroxyl groups

partially-hydrolysed acrylamides, or

has a combined functional group equivalent weight of ≥ 1000 g/mol.

2. the chemical is corrosive or severely irritating to skin (GHS Category 1). You do not need to work out the skin sensitisation potential because:

o the test may not be able to be conducted,




o if the chemical is corrosive then hazard band B will already be applying to the introduction.


o A combination of:

An in domain in silico prediction (using ToxTree, Derek Nexus, OASIS TIMES, HazardExpert, TOPKAT, CASE Ultra, VEGA QSAR, Tox21, ACD/Percepta or the Danish QSAR database) or information on the absence of alerting groups using OECD QSAR Toolbox indicating that the chemical and its metabolite/s (if any) does not cause skin sensitisation, and

An in chemico test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442C, with a non-sensitising prediction, and

An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442D, with a non-sensitising prediction, and

An in vitro test result on the chemical or from suitable read-across information, conducted following OECD test guideline 442E, with a non-sensitising prediction, or

o An in vivo test result on the chemical or from suitable read-across information, conducted following OECD test guideline 406, 429, 442A or 442B, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS.

Hazard band B: respiratory sensitisationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

















Hazard band B: respiratory corrosionThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.









Hazard band B: high molecular weight polymer that is water absorbingThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.









If your chemical is known or can be assumed to be a high molecular weight polymer that is water absorbing, the indicative human health risk for your introduction is not very low risk.

Hazard band B: high molecular weight polymer that is reactiveThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.









Hazard band B: high molecular weight polymer that contains certain chemical elementsThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.








Hazard band A hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band A for human health.

If any of these definitions apply to your chemical, the indicative human health risk for your introduction is not very low risk. If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.

Hazard band A: acute toxicity (harmful)Note: If your chemical is introduced for an end use in a personal vaporiser, additional requirements to those set out below for the ‘acute toxicity (harmful)’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.


Acute toxicity (harmful), to determine the indicative human health risk, means:

the chemical is known to exhibit acute toxicity effects, as described in the GHS, with the chemical classified as follows:

o acute toxicity (category 4) or


o conducted following OECD test guidelines 420 or 423 or 425 or deleted 401 results in an experimental acute oral LD50 value of >300 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in an experimental acute dermal LD50 value of >1,000 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 403 or 436 or draft 433 results in an experimental acute inhalation LC50 (4 h) value of




>2500 but ≤20,000 ppmV (for gases) or >10 but ≤20 mg/L (for vapours) or >1 but ≤5 mg/L (for dusts/mists/fumes), or


o conducted following OECD test guideline 129, results in a predicted acute toxicity LD50 value of >300 but ≤2,000 mg/kg bw, and



o conducted using OECD QSAR Toolbox, Danish QSAR database, HazardExpert, TOPKAT, OASIS TIMES, CASE Ultra, T.E.S.T., Derek Nexus, ACD/Percepta or ADMET Predictor results in the presence of alerting groups or an in-domain acute toxicity LD50 prediction of >300 but ≤2,000 mg/kg bw and



1. you can assume the ‘acute toxicity (harmful)’ definition does not apply to your chemical:

o if the chemical is a high molecular weight polymer that has <5% by mass of molecules with molecular weight <1,000 g/mol, or <2% by mass of molecules with molecular weight <500 g/mol, or


2. to determine that the ‘acute toxicity (harmful)’ definition does not apply to your chemical, you need one of the following, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available):




o in vivo test result on the chemical or from suitable read-across information for acute oral toxicity (LD50), conducted following OECD test guideline 420 or 423 or 425 or deleted 401 of >2,000 mg/kg bw, or


o in vivo test result on the chemical or from suitable read-across information for acute inhalation toxicity (LC50), conducted following OECD test guideline 403 or 436 or draft 433 of >2,500 ppmV (for gases) or >10 mg/L (for vapours) or >5 mg/L (for dusts/mists/fumes).

Hazard band A: specific target organ toxicity after a single exposure (harmful or transient effects)The indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Specific target organ toxicity after a single exposure (harmful or transient effects), to determine the indicative human health risk, means:

the chemical is known or presumed to be harmful to humans or to cause transient target organ effects, as described in chapter 3.8 of the GHS, with the chemical classified as follows:

o specific target organ toxicity (category 2 or 3) or


o conducted following OECD test guidelines 420, 423, 425 or deleted 401 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >300 but ≤2,000 mg/kg bw, or

o conducted following OECD test guidelines 402 or draft 434 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >1,000 but ≤2,000 mg/kg bw, or




o conducted following OECD test guidelines 403, 436 or draft 433 results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at >2,500 but ≤20,000 ppmV (for gases, 4h) or >10 but ≤20 mg/L (for vapours, 4h) or >1 but ≤5 mg/L (for dusts/mists, 4h).

Hazard band A: skin irritationNote: If your chemical is introduced for an end use in tattoo ink, additional requirements to the below for the ‘skin irritation’ hazard characteristic apply — refer to Chapter 6 specified classes of introduction.

Skin irritation, to determine the indicative human health risk, means:

the chemical is known to produce reversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as follows:

o skin irritation (category 2) or


o conducted following OECD test guideline 404 results in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS, or


o conducted following OECD test guideline 439 results in the prediction of skin irritation effects, when combined with the results of an in vitro study on the chemical, conducted following OECD test guideline 430,431 or 435, which predicts the chemical would not be corrosive, and

o the results of the studies have not been negated based on a weight of evidence determination involving studies conducted for skin irritation in vivo, or


o conducted using OECD QSAR Toolbox, ToxTree, Derek Nexus, TOPKAT, OASIS TIMES, Case Ultra, Danish QSAR database, Chemtunes or ACD/Percepta results in the presence of alerting groups or an in-domain prediction of skin irritation, and




o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted for skin irritation in vitro or in vivo.


1. you can assume the ‘skin irritation’ definition does not apply to your chemical if:

o the chemical is not irritating to the skin in a study conducted following OECD test guidelines 402 or draft 434 results, when tested at 2,000 mg/kg bw.

2. to determine that your chemical does not have the skin irritation hazard characteristic, you need one of the following:

o an in vitro test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 439, with a non-irritant prediction

o an in vivo test result on the chemical or from suitable read-across information for skin irritation, conducted following OECD test guideline 404, which does not indicate skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS.

Hazard band A: eye irritationThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Eye irritation, to determine the indicative human health risk, means:

the chemical is known to produce changes in the eye, as described in chapter 3.3 of the GHS, with the chemical classified as follows:

o eye irritation (category 2A) or


o conducted following OECD test guideline 405 results in changes in the eye, as described for eye irritation in chapter 3.3 of the GHS, and




o the changes in the eye are not fully reversible within 7 days or persist for longer than 21 days, or


o conducted following OECD test guideline 492 results in the prediction of eye irritation effects, when combined with the results of an in vitro study on the chemical, conducted following OECD test guideline 437, 438, 460 or 491, which predicts the chemical would not induce serious eye damage, and

o o the results of the studies have not been negated based on a weight of evidence determination involving studies conducted for eye damage in vivo, or


o conducted using OECD QSAR Toolbox, ToxTree, TOPKAT, OACSIS TIMES, Derek Nexus, Case Ultra, ACD/Labs Percepta, PaDEL-DDPredictor or BfR Decision results in the presence of alerting groups or an in-domain prediction of eye irritation, and

o the alerting group or prediction has not been negated based on a weight of evidence determination involving studies conducted for eye damage in vitro or in vivo.

Otherwise, to determine that the ‘eye irritation’ definition does not apply to your chemical, you need one of the following:

an in vitro test result on the chemical or from suitable read-across information for eye irritation, conducted following OECD test guideline 437, 438, 491 or 492 with a non-irritant prediction, or

an in vivo test result on the chemical or from suitable read-across information for eye irritation, conducted following OECD test guideline 405, which either:

o does not indicate changes in the eye, as described for eye irritation (category 2A) in chapter 3.3 of the GHS, or

o where there are changes in the eye, as described for eye irritation (category 2A) in chapter 3.3 of the GHS, these changes are fully reversible within 7 days.




Hazard band A: aspiration hazardThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Aspiration hazard, to determine the indicative human health risk, means:

the chemical is known or presumed to cause aspiration toxicity, as described in chapter 3.10 of the GHS, with the chemical classified as follows:

o may be fatal if swallowed and enters airways (category 1) or

the chemical is a hydrocarbon that has a kinematic viscosity ≤ 20.5 mm2/s, measured at 40°C.

You can assume the chemical meets the ‘aspiration hazard’ definition if it is a hydrocarbon with at least 3 carbon atoms but less than 13 , unless it has a kinematic viscosity ≤ 20.5 mm2/s, measured at 40°C.

Hazard band A: high molecular weight polymer that has lung overloading potentialThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer that has lung overloading potential, to determine the indicative human health risk, means a polymer that:

has a number average molecular weight that is >70,000 g/mol, and

has a solubility in water of < 0.1 mg/L, and

becomes aerosolised during end use.

Hazard band A: high molecular weight polymer with other potential hazardsThe indicative human health risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

High molecular weight polymer with other potential hazards, to determine the indicative human health risk, means a polymer that:




has a number average molecular weight that is greater than or equal to 1,000 g/mol, and

is not a polymer of low concern (within the definition of Schedule 1 of the General Rules)

























Chapter 5 — Environment risk by exposure bandYou must know your exposure band before you can work out your introduction's indicative environment risk. We have set information out in this chapter by exposure bands.

Contents - chapter 5

Determining the environment categorisation volume

You work out the environment categorisation volume by multiplying the total introduction volume by the default reduction factor relevant for the intended end use.

Environment exposure band 1

In this exposure band, the indicative environment risk is low if your chemical does not have any environment band D hazard characteristics, and very low if your chemical does not have any environment band D and C hazard characteristics.


In this exposure band, the indicative environment risk is low if your chemical does not have any environment band D hazard characteristics, and very low if your chemical does not have any environment band D, C and B hazard characteristics.


In this exposure band, the indicative environment risk is low if your chemical does not have any environment band D and C hazard characteristics, and very low if your chemical does not have any environment band D, C, B and A hazard characteristics.


In this exposure band, the indicative environment risk is low if your chemical does not have any environment band D, C and B hazard characteristics, and very




low if your chemical does not have any environment band D, C, B and A hazard characteristics.

Determining the environment categorisation volumeYou are reading Chapter 5 of the Categorisation Guidelines

Relevant section of the Rules: section 5 definitionsYou work out the environment categorisation volume by multiplying the total introduction volume by the default reduction factor relevant for the intended end use. The total introduction volume is the total volume of the industrial chemical that you will introduce in a registration year.

[Environment categorisation volume] = total introduction volume x reduction factor

If the industrial chemical you are introducing has multiple end uses then there are two options for determining the environment categorisation volume:

The simplest approach is to allocate the total introduction volume to the end use that has the highest reduction factor, and use the equation above.

If you know the introduction volume to be allocated to each use scenario, you can calculate a separate environment categorisation volume for each end use, and then you can add these together to get a total environment categorisation volume, using the equation:

o ECV = (IV x RF)1 + (IV x RF)2 + … + (IV x RF)n].

The environment categorisation volume will be the same or lower than the total introduction volume.

The reduction factors you need to calculate your introduction’s environment categorisation volume are set out in the table below.

These reduction factors are default values largely based on how much industrial chemical expected to be released across all parts of the environment:

as a result of the end use of the industrial chemical

associated disposal




They take into account the uncertainty associated with particular end uses.

Reduction factors apply to groups of chemicals and are a screening tool for the purposes of categorisation of industrial chemicals. The reduction factors in the table below are reasonable worst-case scenarios that take into account release throughout the whole lifecycle of an industrial chemical. We based this on approaches established by the European Chemicals Agency (ECHA) and the OECD. For industrial chemicals that we later assess, we conduct a more refined environmental exposure assessment that considers chemical-specific information. We have aligned our end uses and their descriptions as much as possible with OECD harmonised terminology.

For some end uses the reduction factor is 1, which means the environment categorisation volume is equal to the total introduction volume. These are end uses where we can’t confidently predict that the volume of industrial chemical released to the environment will always be lower than the volume introduced into Australia.

Table: The reduction factor you need to use, depending on end use

If your introduction's end use is... The reduction factor you need to use is

Adhesive and sealants 0.05

Apparel and footwear care products 0.05

Arts, crafts and hobby materials 0.05

Explosive materials 0.05

Fuel, oil, fuel oil additives and related products 0.05

Lubricants and greases 0.05

Personal care products - limited environmental release 0.05

Tattoo ink 0.05

Paints and coatings 0.05

Plastic and polymer industry 0.05

Chemicals used in construction not covered by other end uses

0.2




If your introduction's end use is... The reduction factor you need to use is

Fabric, textile and leather products not covered by other end uses

0.4

Electronic industry 0.5

Ink, toner and colourant products 0.8

Air care products 1

Anti-freeze and de-icing products 1

Automotive care products 1

Cleaning and furniture care products 1

Laundry and dishwashing products 1

Chemicals used in extractive industries not covered by other end uses

1

Paper industry 1

Personal care products not covered by other end use 1

Photographic supplies 1

Water treatment products 1

Personal vaporiser 1

Any other end use not covered above 1

End use definitions used in the above table:

Adhesive and sealants means an end use to fasten other materials together or stop the passage of liquid or gas. Examples include:

glues

binders

adhesives

pastes

sealants




fillers

putties

solder and caulking compounds

Apparel and footwear care products means an end use to care for apparel and footwear products intended for consumer and commercial use. Examples include:

Footwear polishes.

Waxes and stains to waterproof and improve appearance and other desirable properties.

Apparel surface treatment products for water, stain or flame resistance.

Arts, crafts and hobby materials means an end use in arts, crafts, and hobbies. Examples include:

crafting paints

crafting glue

adhesives (e.g. solder and hot-melt adhesives)

fixatives

finishing spray coatings and modelling clay

Explosives means an end use for producing a sudden expansion, usually accompanied by production of heat and large changes in pressure. Examples include:

pyrotechnics

high explosives and propellants

igniter

primer

initiatory

illuminants

smoke and decoy flares

incendiaries

Fuel, oil, fuel/oil additives and related products means an end use as:




Liquid fuels in containers used for cooking, heating or for power in vehicles or appliances.

As a fuel additive to inhibit corrosion, provide lubrication, increase efficiency of use, or decrease production of undesirable by-products.

Examples of liquid fuels include:

gasoline

diesel fuels

propane

butane

kerosene

lamp oils

white gas (naphtha)

natural gas

Examples of additives include:

stabilisers

anti-knock agents

corrosion inhibitors

detergents

fuel dyes

oxygenates

antioxidants

odour agents

Lubricants and greases means an end use in a liquid, paste or spray to reduce friction, heat generation and wear between solid surfaces. Examples include:

engine oils

transmission, brake and hydraulic fluids

gear oils

calcium, sodium, lithium, and silicone-based greases




Personal care products – limited environmental release means an end use in solid or hardening personal care products (including cosmetics) that are primarily disposed to landfill. Examples include:

baby wipes

facial tissues

nail care products including nail polish and remover

Tattoo ink means an end use in a combination of industrial chemicals that: contains one or more colouring agents; and is applied to the dermal layer of the skin for the purposes of colouring the skin. Examples include:

pigments

dyes

resins

Paints and coatings means an end use to paint or coat substrates intended for consumer or commercial use. Examples include:

decorative coatings

automotive coatings

transportation coatings

wood finishes

powder coatings

coil coatings

packaging finishes

general industrial coatings

automotive refinish

industrial maintenance and protective coatings

marine coatings

thinners

removers

Plastics and polymer industry means an end use in manufacturing of plastics or polymers. Examples include:




monomers

initiators

additives

Chemicals used in construction not covered by other end uses means an end use in construction materials, except where another category covers the end use. Examples include:

additives in cements and dry mortar

additives to bitumen for road repair

internal release agents for thermo-set laminating resins

resins in particle board manufacture

wood substitutes used to make mouldings

resins used in the manufacture of composite materials

Fabric, textile and leather products not covered by other end uses means an end use to impart colour and other desirable properties onto fabric, textiles, and leather products that are intended for consumer or commercial use. These properties include:

water/soil/stain repellence

wrinkle resistance

flame resistance

Examples of this type of product include:

textile dyes

textile finishing agents

leather tanning products

leather dyes

leather finishing agents, leather conditioner and surface treatment products

Electronic industry means an end use in manufacture of electronic components. Examples include:

chemicals in vapour deposition




electroless plating

electroplating

etching

high vacuum evaporation/sputtering

laminate processing

soldering

photolithography

Ink, toner and colourant products means an end use for:

writing

printing

creating an image on paper and other substrates

applied to substrates to change their colour or hide images


pigmented liquid

toners or powders used in copy machines and toner/printer cartridges

inks used in writing equipment

inks for stamps and correction fluids and tapes

This category does not include pigments and colourants added to paints and coatings.

Air care products means an end use to odourise or deodorise indoor air in homes, offices, motor vehicles, and enclosed spaces and intended for consumer or commercial use. Examples include:

aerosol sprays

liquid/solid/gel diffusers

air fresheners

scented candles

incense

Anti-freeze and de-icing products means an end use:




as an additive to fluids, especially water, to reduce the freezing point of the mixture

applied to surfaces to melt or prevent build-up of ice


anti-freeze liquids

de-icing liquids (windshield de-icers, aircraft de-icers)

de-icing solids (ice melting crystals)

lock de-icers

Automotive care products means an end use to clean and care for exterior and interior surfaces of automotive vehicles intended for consumer or commercial use. Examples include:

car waxes

polishes

waterproofing products for windshield or automotive window glass

cleaners

sealers

car wash solutions

vinyl/rubber/plastic protectants

automotive carpet and upholstery cleaners

wheel and tire care products

exterior trim protectants

touch-up paint products

Cleaning and furniture care products means an end use (intended for consumer or commercial use) to:

Remove dirt, grease, stains, and foreign matter from furniture and furnishings.

To cleanse, sanitise, bleach, scour, polish, protect, or improve the appearance of surfaces.

Examples include:




cleaners used on glass, floors, tub and tile, ovens and drains

scouring powders

dusting products

waxes

polishes

stain repellent sprays

Laundry and dishwashing products means an end use in:

liquid, granular, gel and unit dose packets/tablets to remove food residue from dishes

remove dirt from textiles

enhance properties of textiles

remove stains from textiles

Examples include:

dishwashing detergent and laundry detergents

stain removers and fabric enhancers

bleach

rinse aids

lime and rust removers

dry cleaning products used in non-aqueous cleaning processes

Chemicals used in extractive industries not covered by other end uses means an end use in:

mining

onshore drilling

related activities such as extraction, cementing, hydraulic fracturing, refining

Paper industry means an end use in paper manufacturing. Examples include:

effluent treatment chemicals

maintenance chemicals




deposit and cleaning agents

defoamers

surfactants

biocides

coagulants

polymeric retention aids

coagulants

clay

resins

Personal care products not covered by other end uses means an end use for cosmetic use, except those covered under the personal care products - limited environmental release end use category. Examples include:

bath and shower products

make-up products

hair, oral and skin care products

secondary sunscreen products

deodorants

perfumes

Photographic supplies means an end use to take photographic images, develop and process film, and make photographic prints that are intended for consumer or commercial use. Examples include:

Processing solutions (for developing, stopping, and fixing photos).

Chemicals used in the manufacture or processing of film or photographic paper.

Water treatment products means an end use to treat water in cooling and heating systems (including industrial heat-exchanger systems) and potable water supplies. Examples include:

chemicals used in pH buffers

scale and corrosion inhibitors




flocculating agents

ion exchange resins

biocides and slime inhibitors

This category does not include end uses to treat municipal water supplies or other large-scale water supplies for human or animal consumptions or irrigation. We cover these as end uses with a designated kind of release to the environment.

Personal vaporisers means an end use in a device that produces a vapour or aerosol that is intended to be inhaled into the lungs. Examples include:

e-cigarettes

e-cigars

e-hookah pens

e-pens

e-pipes

vape pens

Environment exposure band 1You are reading Chapter 5 of the Categorisation Guidelines

The following information is to work out your introduction's indicative environment risk for environment exposure band 1.

Relevant General Rule(s): section 29 environment hazard band, section 30 indicative environment risk, Section 31 information required to demonstrate categorisationThe indicative environment risk for your chemical is low when:

The environment exposure band is 1.

Your industrial chemical does not have any environment hazard band D characteristics.




The indicative environment risk for your chemical is very low when:

The environment exposure band is 1.

Your industrial chemical does not have any environment hazard band C and D characteristics.

If the indicative environment risk for your introduction is not low or very low, then it is medium to high.

Indicative environment risk is defined in our Glossary


If you determine that your chemical has a hazard characteristic, then the hazard band relevant to that characteristic applies. If a hazard band applies then you have the information necessary to determine the indicative environment risk for the introduction and you don't need to consider the remaining hazard characteristics in that hazard band (or lower hazard bands).

However, please note that you might need information on these other hazard characteristics to meet other obligations such as applications requirements (for Assessed introductions under AICIS).


Summary: Environment exposure band 1

How to determine indicative environment risk is low

If any of these hazard band D definitions apply to your chemical, the indicative environment risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

How to determine indicative environment risk is very low




If any of these hazard band C and D definitions apply to your chemical, the indicative environment risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

Environment exposure band 1 — low risk You are in Chapter 5 of the Categorisation GuidelinesThe following information is to work out your introduction's indicative environment risk for environment exposure band 1.

Before you startEnsure you have read and understood our hazard characteristics general information in Chapter 3 — Hazard bands.

Relevant General Rules: section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is low when:

the environment exposure band for the introduction is 1 and your industrial chemical does not have any environment band D hazard

characteristics

Indicative environment risk is defined in our GlossaryWe have summarised information about working out hazard characteristics at the start of exposure band 1.

Hazard band D characteristicsThe following definitions apply to chemicals that do fall into environment hazard band D.

If any of these definitions apply to your chemical, the indicative environment risk for your introduction is not low risk.

If the introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 on specified classes of introduction.




Definitions persistent, bioaccumulative and toxic ozone depleting chemicals synthetic greenhouse gas contains arsenic, cadmium, lead or mercury adverse effects mediated by an endocrine mode of action

Hazard band D: persistent, bioaccumulative and toxicThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.

Persistent, bioaccumulative and toxic, to determine the indicative environment risk, means:

the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists in Chapter 3 of these Categorisation Guidelines based on being persistent, bioaccumulative and toxic or

the chemical meets the criteria for: o persistence (in air, water, soil or sediment)o bioaccumulation (aquatic, terrestrial or food chain bioaccumulation

potential) ando aquatic toxicity (acute or chronic toxicity to fish, invertebrates,

algae or other aquatic plants) as defined in the following table.

Hazard characteristic

Environmental medium / Compartment / Trophic level

Criteria

Persistence Environmental medium

Air Half-life (T½) ≥ 2 days

Water Half-life (T½) ≥ 60 days

Soil Half-life (T½) ≥ 6 months

Sediment Half-life (T½) ≥ 6 months

Bioaccumulation Compartment Aquatic BAF ≥ 2000 or BCF ≥ 2000 or log Kow ≥ 4.2 (if BAF and BCF are not available)

Terrestrial log Koa > 6 and log Kow ≥ 2






Criteria

Food chain bioaccumulation potential

BMF > 1

Toxicity (Aquatic) Trophic level - acute

Fish 96h LC50 ≤ 1mg/L

Invertebrates 48h EC50 ≤ 1mg/L

Algae or other aquatic plants

72 or 96h ErC50 ≤ 1mg/L

Trophic level - chronic

Fish Chronic NOEC or ECx ≤ 0.1mg/L

Invertebrates Chronic NOEC or ECx ≤ 0.1mg/L


Chronic NOEC or ECx ≤ 0.1mg/L

Otherwise, to determine that it’s low risk, you need to show that this definition doesn’t apply by:

confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on it being ‘persistent, bioaccumulative and toxic’

Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not low risk, if you know that the ‘ozone depleting chemicals’ definition in the Rules applies to your chemical.

Hazard band D: synthetic greenhouse gasThe indicative environment risk for your introduction is not low risk, if you know that the ‘synthetic greenhouse gas’ definition in the Rules applies to your chemical.




Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not low risk, if your chemical contains arsenic, cadmium, lead or mercury.

Hazard band D: adverse effects mediated by an endocrine mode of actionThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.

Adverse effects mediated by an endocrine mode of action, to determine the indicative environment risk, means:

The chemical meets all of the following: o It shows an adverse effect in an intact organism or its progeny,

which is a change in the: morphology physiology growth development reproduction or lifespan

o of an: organism system or (sub)population

o That results in an: impairment of functional capacity an impairment of the capacity to compensate for additional

stress, or an increase in the susceptibility to other influences

o it has an endocrine activity, which is the capacity to alter the function(s) of the endocrine system

o the adverse effect is a consequence of the endocrine activity

or

o the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse environmental effects mediated by an endocrine mode of action


as described in EU guidance for identifying endocrine disruptors[1]

taking into account the guidance provided in OECD GD 150[2]



DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018The indicative environment risk for your introduction is not low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.


To determine that the indicative environment risk is low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by:

confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action







Kyoto Protocol, Synthetic Greenhouse Gases under Annex A — organic chemicals that contribute to the greenhouse effect










Environment exposure band 1 — very low risk You are in Chapter 5 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is very low when:

the environment exposure band is 1 your industrial chemical does not have any environment bands C and D

hazard characteristics



Hazard band D (start here) Hazard band C



DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018For specific hazard characteristics, go to each hazard band (using the above links).

We have summarised information about working out hazard characteristics at the start of exposure band 1.

Hazard band D hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into environment hazard band D.

If any of these definitions apply to your chemical, the indicative environment risk for your introduction is not very low risk.

If your introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 on specified classes of introduction.

persistent, bioaccumulative and toxic ozone depleting chemicals synthetic greenhouse gas contains arsenic, cadmium, lead or mercury adverse effects mediated by an endocrine mode of action

Note: The definitions and information requirements for hazard band D are the same as in our section Environment exposure band 1 - low risk (Hazard band D hazard characteristics).

Hazard band D: persistent, bioaccumulative and toxicThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.


the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on being persistent, bioaccumulative and toxic or


potential) and




o aquatic toxicity (acute or chronic toxicity to fish, invertebrates, algae or other aquatic plants) as defined in the following table.



Criteria









BMF > 1

Toxicity (Aquatic) Trophic level - acute




72 or 96h ErC50 ≤ 1mg/L








DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018Otherwise, to determine that it’s very low risk, you need to show that this definition doesn’t apply by:

confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on it being ‘persistent, bioaccumulative and toxic’

Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not very low risk, if you know that the ‘ozone depleting chemicals’ definition in the Rules applies to your chemical.

Hazard band D: synthetic greenhouse gasThe indicative environment risk for your introduction is not very low risk, if you know that the ‘synthetic greenhouse gas’ definition in the Rules applies to your chemical.

Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not very low risk, if your chemical contains arsenic, cadmium, lead or mercury.

Hazard band D: adverse effects mediated by an endocrine mode of actionThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.




o of an:




organism system or (sub)population





or





The indicative environment risk for your introduction is not very low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.


To determine that the indicative environment risk is very low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by:

confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action

Hazard band C hazard characteristicsDefinitionsThe hazard characteristics you need to check are:




very toxic to any aquatic life persistent and bioaccumulative

Hazard band C: very toxic to any aquatic life

The indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Very toxic to any aquatic life, to determine the indicative environment risk, means:

the chemical is known to cause: o toxic injury to an organism following short term aquatic exposure oro adverse effects to an organism during aquatic exposures

determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as:

acute aquatic toxicity (category 1) or chronic aquatic toxicity (category 1)

or

the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists at the bottom of this page (and also in Chapter 3 of these Guidelines), based on its potential to be very toxic to any aquatic life

or

an in vivo study on the chemical: o conducted following OECD test guidelines:

201 202 or 203

o results in an experimental: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants

o of ≤ 1mg/L

or

o conducted following OECD test guidelines: 201 210 or 211

o results in an experimental NOEC or ECX to fish or invertebrates or algae or other aquatic plants of:

≤ 0.1mg/L for chemicals that are not readily biodegradable or

≤ 0.01mg/L for chemicals that are readily biodegradable

or




an in silico model of the chemical: o conducted using ECOSAR profiler for acute aquatic toxicity, results

in an in-domain prediction of ≤ 1mg/L for the: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants


confirming that your chemical(or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on it being very toxic to aquatic life

Hazard band C: persistent and bioaccumulativeThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Persistent and bioaccumulative, to determine the indicative environment risk, means:

the chemical(or the chemical of which it is an ester or salt) is on environment hazard band lists (shown below and in Chapter 3 of the Guidelines), based on being persistent and bioaccumulative or

the chemical meets the criteria for: o persistence (in air, water, soil or sediment) ando bioaccumulation (aquatic, terrestrial or food chain bioaccumulation

potential) as defined in the following table.





Environmental medium / Compartment

Criteria









BMF > 1


Confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of the Categorisation Guidelines (also at the bottom of this page), based on it being persistent and bioaccumulative.

















Environment exposure band 2You are reading Chapter 5 of the Categorisation GuidelinesThe following information is to work out your introduction's indicative environment risk for environment exposure band 2.

Relevant General Rule(s): section 29 environment hazard band, section 30 indicative environment riskThe indicative environment risk for your introduction is low risk when:

The environment exposure band for the introduction is 2. Your industrial chemical does not have any environment band D hazard

characteristics.



DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018The indicative environment risk for your introduction is very low risk when:

the environment exposure band for the introduction is 2 your industrial chemical does not have any environment bands B, C and D







applications requirements (for Assessed introductions under AICIS)




If any of these hazard band D definitions apply to your chemical, the indicative environment risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.


If any of these hazard band B, C and D definitions apply to your chemical, the indicative environment risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.




Environment exposure band 2 — low riskYou are in Chapter 5 of the Categorisation Guidelines


Before you start


Relevant General Rule(s): section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is low when:

The environment exposure band for the introduction is 2. Your industrial chemical does not have any environment band D hazard

characteristics.



Hazard band D characteristicsThe following definitions apply to chemicals that do fall into environment hazard band D.


If the introduction is a specified class of introduction — refer to (Chapter 6 specified classes of introduction).




Definitions persistent, bioaccumulative and toxic ozone depleting chemicals synthetic greenhouse gas contains arsenic, cadmium, lead or mercury adverse effects mediated by an endocrine mode of action except that

there are additional requirements for persistent, bioaccumulation and toxic









Criteria






Bioaccumulation

Compartment Aquatic BAF ≥ 2000 or BCF ≥ 2000 or log Kow ≥ 4.2 (if BAF and BCF are not available)






Criteria



BMF > 1

Toxicity (Aquatic)

Trophic level - acute




72 or 96h ErC50 ≤ 1mg/L






Otherwise, to determine that it’s low risk, you need to show that this definition doesn’t apply. How you do this depends on the environment categorisation volume for your introduction.

If your introduction’s environment categorisation volume is ≤ 100kg

You need to confirm that the chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on it being persistent, bioaccumulative and toxic.

If your introduction’s environment categorisation volume is > 100kg but ≤ 1,000kg

You need to do both of the following:

Confirm that the chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines, based on it being persistent, bioaccumulative and toxic.

Determine that this definition doesn’t apply by showing that your chemical is at least one of the following:

o not persistento not bioaccumulativeo not very toxic to aquatic life

Persistence:




You can assume your chemical is persistent if the chemical is inorganic. You can assume your chemical is not persistent if the chemical is a

biochemical or a biological substance. Otherwise, to show that your chemical is not persistent, you need:

o Measured ready biodegradability (conducted following OECD TG 301) for the chemical or from suitable read-across information, showing:

it degrades by > 70% within a 28 day period, or the BOD/COD ratio is ≥ 0.5

Bioaccumulation:

You can assume your chemical is not bioaccumulative if: o it has a molecular weight > 1,000g/molo it is a high molecular weight polymero it is an inorganic chemical (except where it contains arsenic,

cadmium, lead or mercury)o it meets the criteria for ready biodegradability (according to OECD

TG 301), oro it has a solubility in water that is > 5g/L

Otherwise, to show that your chemical is not bioaccumulative, you need one of the following studies/results:

o An in domain in silico prediction (using KOWWIN) for the partition coefficient (log Kow) of the chemical of < 4.2.

o Measured partition coefficient (log Kow; conducted following OECD TG 107, 117, 123) for the chemical or from suitable read-across information of < 4.2.

o Measured bioconcentration factor (BCF; following OECD TG 305) or bioaccumulation factor for the chemical or from suitable read-across information of < 2,000.

If you have multiple studies/results, the weight given will be:

measured bioconcentration factor (BCF) > measured partition coefficient (log Kow) > in silico prediction for the partition coefficient (log Kow)

Aquatic toxicity:

You can assume your chemical will not meet the criteria for aquatic toxicity if:

o it has a molecular weight > 1,000g/mol and does not have an overall cationic charge

o it is a high molecular weight polymer and does not have an overall cationic charge, or

o it is a gas that is not expected to partition to the aquatic compartment




Overall cationic charge means the chemical:

contains at least one net positively charged atom or associated groups of atoms covalently linked to the molecule that are likely to be positively charged at 4 < pH < 9

has a combined functional group equivalent weight of all such atoms or associated groups of atoms that is less than 5,000 g/mol, other than if:

o it is a solid that has a solubility in water of < 0.1mg/L, and will be in its solid phase during all end uses, or

o it is not dispersible in water, and will be in its solid phase during all end uses

To determine that your chemical does not meet the criteria for aquatic toxicity, you need three studies/results that cover fish, invertebrates and algae. These studies/results can be:

o an in domain in silico prediction (using ECOSAR) that the chemical has a toxicity of:

> 1mg/L (fish - LC50, invertebrates - EC50, algae ErC50)o an in vivo test result on the chemical or from suitable read-across

information of: > 1mg/L for fish (LC50 following OECD TG 203) > 1mg/L for invertebrates (EC50 following OECD TG 202), or > 1mg/L for algae (ErC50 following OECD TG 201)

or

o an in vivo test result on the chemical or from suitable read-across information of:

NOEC or ECX > 0.1mg/L for chemicals that are not readily biodegradable, or

NOEC or ECX > 0.01mg/L for chemicals that are readily biodegradable conducted following:

OECD TG 210 for fish OECD TG 211 for invertebrates, and OECD TG 201 for algae

Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not low risk, if you know that the ‘ozone depleting chemicals’ definition in the General Rules applies to your chemical.

Hazard band D: synthetic greenhouse gasThe indicative environment risk for your introduction is not low risk, if you know that the ‘synthetic greenhouse gas’ definition in the General Rules applies to your chemical.




Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not low risk, if you know your chemical contains arsenic, cadmium, lead or mercury.










or








The indicative environment risk for your introduction is not low risk, if, based on this analysis, the ‘adverse effects mediated by an endocrine mode of action’ definition applies to your chemical.



Confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse environmental effects mediated by an endocrine mode of action.

















Environment exposure band 2 — very low riskYou are in Chapter 5 of the Categorisation Guidelines


Before you start


Relevant section of the Rules: section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is very low when:

the environment exposure band for the introduction is 2 your industrial chemical does not have any environment bands D, C and B






Work out if the industrial chemical you are introducing has any of the hazard characteristics in;

hazard band D (start here) hazard band C hazard band B





If the introduction is a specified class of introduction — refer to Chapter 6 specified classes of introduction.


Note: These definitions and information requirements below are the same as in our section how to work out if the indicative risk is low for environment exposure band 2 except that there are additional requirements for persistent, bioaccumulation and toxic.




DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018Persistent, bioaccumulative and toxic, to determine the indicative environment risk, means:







Criteria









BMF > 1

Toxicity (Aquatic)





72 or 96h ErC50 ≤ 1mg/L









Otherwise, to determine that it’s very low risk, you need to show that this definition doesn’t apply. You need to do both of the following:

Confirm that the chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on it being persistent, bioaccumulative and toxic.



Persistence:





Bioaccumulation:













Aquatic toxicity:














or




OECD TG 210 for fish




OECD TG 211 for invertebrates, and OECD TG 201 for algae

Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not very low risk, if you know that the ‘ozone depleting chemicals’ definition in the Rules applies to your chemical.

Hazard band D: synthetic greenhouse gas

The indicative environment risk for your introduction is not very low risk, if you know that the ‘synthetic greenhouse gas’ definition in the Rules applies to your chemical.

Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not very low risk, if you know your chemical contains arsenic, cadmium, lead or mercury.






o That results in an: impairment of functional capacity




an impairment of the capacity to compensate for additional stress, or

an increase in the susceptibility to other influenceso it has an endocrine activity, which is the capacity to alter the

function(s) of the endocrine systemo the adverse effect is a consequence of the endocrine activity

or








Confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse environmental effects mediated by an endocrine mode of action.

Hazard band C hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into environment hazard band C.







Hazard band C: very toxic to any aquatic lifeThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.





or


or


201 202 or 203


o of ≤ 1mg/L

or








or



Otherwise, to determine the indicative environment risk, one of items 1 or 2 applies:

1. You can assume the ‘very toxic to any aquatic life’ definition does not apply to your chemical if:

it has a molecular weight >1,000g/mol and does not have an overall cationic charge

it is a high molecular weight polymer that does not have an overall cationic charge, or

it is a gas that is not expected to partition to the aquatic compartment






2. To determine that the ‘very toxic to any aquatic life’ definition does not apply to your chemical, you need one of the following:

in-domain in silico predictions (using ECOSAR) that the chemical has toxicity of >1 mg/L to:

o fish (LC50)o invertebrates (EC50), ando algae (ErC50)

or

in vivo test results on the chemical or from suitable read-across information of >1 mg/L for:

o fish (LC50 conducted following OECD TG 203)o invertebrates (EC50 conducted following OECD TG 202), and




o algae (ErC50 conducted following OECD TG 201)

or

in vivo test results on the chemical or from suitable read-across information for:

o fish (conducted following OECD TG 210),o invertebrates (conducted following OECD TG 211), ando algae (conducted following OECD TG 201) of:


NOEC or ECX > 0.01mg/L for chemicals that are readily biodegradable

or

a combination of in-domain in silico predictions for the chemical and in vivo test result(s) on the chemical or from suitable read-across information (using the above programs/test guidelines and specified outcomes) for fish, invertebrates and algae.







Environmental medium / Compartment Criteria






Bioaccumulation Compartment Aquatic BAF ≥ 2000 or BCF ≥ 2000 or log Kow ≥ 4.2 (if




BAF and BCF are not available)



BMF > 1

Otherwise, to determine that it’s very low risk, you need to show that your chemical is not persistent or not bioaccumulative.

Persistence:



o measured ready biodegradability (conducted following OECD TG 301) for the chemical or from suitable read-across information, showing:


Bioaccumulation:






o Measured partition coefficient (log Kow; conducted following OECD TG 107, 117, 123) for thechemical or from suitable read-across information of < 4.2.







Hazard band B hazard characteristicsDefinitionsThe following definition applies to chemicals that do fall into hazard band B for environment.

If this definition applies to your chemical, the indicative human health risk for your introduction is not very low risk.

If the introduction is a specified class of introduction — refer to Chapter 6 specified classes of introduction

This section on working out if the indicative risk is very low has a definition on toxic to any aquatic life.

Hazard band B: toxic to any aquatic lifeThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Toxic to any aquatic life, to determine the indicative environment risk, means:

The chemical is known to cause: o toxic injury to an organism following short term aquatic exposure, oro adverse effects to an organism during aquatic exposures


acute aquatic toxicity (category 2), or chronic aquatic toxicity (category 2)

or

An in vivo study on the chemical: o conducted following OECD test guidelines:

201 202, or 203

o results in an experimental: LC50 (96h) to fish EC50 (48h) to invertebrates, or ErC50 (72 or 96h) to algae or other aquatic plants

o of > 1mg/L but ≤ 10mg/L

or

o conducted following OECD test guidelines:




201 210, or 211


> 0.1mg/L but ≤ 1mg/L for chemicals that are not readily biodegradable, or

> 0.01mg/L but ≤ 0.1mg/L for chemicals that are readily biodegradable

or

An in silico model of the chemical: o conducted using ECOSAR profiler for acute aquatic toxicity, results

in an in-domain prediction of > 1mg/L but ≤ 10mg/L for the: LC50 (96h) to fish EC50 (48h) to invertebrates, or ErC50 (72 or 96h) to algae or other aquatic plants


1. You can assume the ‘toxic to any aquatic life’ definition does not apply to your chemical if:



it is a gas that is not expected to partition to the aquatic compartment.






2. To determine that the ‘toxic to any aquatic life’ definition does not apply to your chemical, you need one of the following:

In-domain in silico predictions (using ECOSAR) that the chemical has toxicity of > 10mg/L to:

o fish (LC50)o invertebrates (EC50)




o algae (ErC50)or

In vivo test results on the chemical or from suitable read-across information of > 10mg/L for:

o fish (LC50 conducted following OECD TG 203),o invertebrates (EC50 conducted following OECD TG 202), ando algae (ErC50 conducted following OECD TG 201),

or

In vivo test results on the chemical or from suitable read-across information for:


NOEC or ECX > 1mg/L for chemicals that are not readily biodegradable, or


or

A combination of in-domain in silico predictions for the chemical and in vivo test result(s) on the chemical or from suitable read-across information (using the above programs/test guidelines and specified outcomes) for:

o fish,o invertebrates, ando algae









Environment exposure band 3You are reading Chapter 5 of the Categorisation Guidelines


The environment exposure band for the introduction is 3. Your industrial chemical does not have any environment band C and D

hazard characteristics.

The indicative environment risk for your introduction is very low when:

The environment exposure band is 3, and Your industrial chemical does not have any environment bands A, B, C and

D hazard characteristics.





However, please note that you might need information on these other hazard characteristics to meet other obligations such as applications requirements (for Assessed introductions under AICIS).







If any of these hazard band C and D definitions apply to your chemical, the indicative environment risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.


If any of these hazard band A, B, C and D definitions apply to your chemical, the indicative environment risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

Environment exposure band 3 — low riskYou are in Chapter 5 of the Categorisation Guidelines


Before you start



the environment exposure band is 3 and your industrial chemical does not have any environment band D and C

hazard characteristics (defined below).


Work out if the industrial chemical you are introducing has any of the hazard band characteristics in:




hazard band D (start here) hazard band C



Hazard band D hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band D for environment.


If the introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.

persistent, bioaccumulative and toxic ozone depleting chemicals synthetic greenhouse gas contains arsenic, cadium, lead or mercury adverse effects mediated by an endocrine mode of action




the chemical meets the criteria for: o persistence (in air, water, soil or sediment)




o bioaccumulation (aquatic, terrestrial or food chain bioaccumulation potential) and

o aquatic toxicity (acute or chronic toxicity to fish, invertebrates, algae or other aquatic plants) as defined in the following table.



Criteria









BMF > 1

Toxicity (Aquatic)





72 or 96h ErC50 ≤ 1mg/L






Otherwise, to work out that it is low risk, you need to do both of the following:







Persistence:





Bioaccumulation:










Aquatic toxicity:

















or





Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not low risk, if you know that the 'ozone depleting chemicals’ definition in the General Rules applies to your chemical.





Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not low risk, if you know your chemical contains arsenic, lead or mercury.










or

o the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known




adverse environmental effects mediated by an endocrine mode of action






To work out that the indicative environment risk is low, you need to show that the ‘adverse effects mediated by an endocrine mode of action’ definition doesn’t apply by confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action. , based on its known adverse effects mediated by an endocrine mode of action.

___________________________________________________________________________________________________

Hazard band C hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band C for environment.


If the introduction is a specified class of introduction, additional requirements apply — refer Chapter 6 specified classes of introduction.


___________________________________________________________________________________________________




Hazard band C: very toxic to any aquatic lifeThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.





or


or


201 202 or 203


o of ≤ 1mg/L

or





or





o conducted using ECOSAR profiler for acute aquatic toxicity, results in an in-domain prediction of ≤ 1mg/L for the:

LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants






Overall cationic charge means the chemical: contains at least one net positively charged atom or associated groups of

atoms covalently linked to the molecule that are likely to be positively charged at 4 < pH < 9







or


o fish (LC50 conducted following OECD TG 203)o invertebrates (EC50 conducted following OECD TG 202), ando algae (ErC50 conducted following OECD TG 201)



DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018or





or


Hazard band C: persistent and bioaccumulativeThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.







Criteria









Criteria



Bioaccumulation

Compartment

Aquatic BAF ≥ 2000 or BCF ≥ 2000 or log Kow ≥ 4.2 (if BAF and BCF are not available)



BMF > 1

Otherwise, to determine that it is low risk, you need to show that your chemical is not persistent or not bioaccumulative.

Persistence:





Bioaccumulation:


cadmium, lead or mercury)




o it meets the criteria for ready biodegradability (according to OECD TG 301), or

o it has a solubility in water that is > 5g/L























Environment exposure band 3 — very low riskYou are in Chapter 5 of the Guidelines


Before you start


Relevant General Rule(s): section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is very low when:

the environment exposure band is 3, and




your industrial chemical does not have any environment bands D, C, B and A hazard characteristics (defined below).


Work out if the industrial chemical you are introducing has any of the hazard band characteristics in:

hazard band D (start here) hazard band C hazard band B hazard band A






Note: These definitions and information requirements for hazard band D are the same as in our section Environment exposure band 3 – low risk (Hazard band D hazard characteristics)












Criteria






Bioaccumulation

Compartment








Criteria


BMF > 1

Toxicity (Aquatic)





72 or 96h ErC50 ≤ 1mg/L






Otherwise, to work out that it is very low risk, you need to do both of the following:




Persistence:

You can assume your chemical is persistent if the chemical is inorganic.




You can assume your chemical is not persistent if the chemical is a biochemical or a biological substance.

Otherwise, to show that your chemical is not persistent, you need: o Measured ready biodegradability (conducted following OECD TG

301) for the chemical or from suitable read-across information, showing:


Bioaccumulation:










Aquatic toxicity:


















or





Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not very low risk, if you know that the 'ozone depleting chemicals’ definition in the Rules applies to your chemical.

Hazard band D: synthetic greenhouse gasThe indicative environment risk for your introduction is not very low risk, if you know that the ‘synthetic greenhouse gas’ definition in the Rules applies to your chemical.




Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not very low risk, if you know your chemical contains arsenic, lead or mercury.










or











Confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action.

Hazard band C hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into environment hazard band C.




Note: The definitions and information requirements for hazard band C are the same as in our section: Environment exposure band 3 – low risk (Hazard band C hazard characteristics).




DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018Very toxic to any aquatic life, to determine the indicative environment risk, means:




or


or


201 202 or 203


o of ≤ 1mg/L

or





or





DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018Otherwise, to determine the indicative environment risk, one of items 1 or 2 applies:













or



or








or









Criteria






Bioaccumulatio Compartment Aquatic BAF ≥ 2000 or BCF ≥






Criteria

n 2000 or log Kow ≥ 4.2 (if BAF and BCF are not available)



BMF > 1

Otherwise, to determine that it's very low risk, you need to show that your chemical is not persistent or not bioaccumulative.

Persistence:





Bioaccumulation:













Hazard band B characteristicsDefinitionsThe following definition applies to chemicals that do fall into environment hazard band B.

If any of this definition applies to your chemical, the indicative environment risk for your introduction is not very low risk.







or





201 202, or 203



or

o conducted following OECD test guidelines: 201 210, or 211




or











o it is a solid that has a solubility in water of < 0.1mg/L, and will be in its





solid phase during all end uses, oro it is not dispersible in water, and will be in its solid phase during all end

uses



o fish (LC50)o invertebrates (EC50)o algae (ErC50)

or



or





or






Hazard band A hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into environment hazard band A.



harmful to any aquatic life has bioaccumulation potential industrial chemicals (other than polymers) that do not meet the criteria for

ready biodegradability contains aluminium, chromium, copper, nickel, silver, selenium or zinc polymers that have an overall cationic charge at pH 4 to 9 polymers that are not stable

Hazard band A: harmful to any aquatic lifeThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Harmful to any aquatic life, to determine the indicative environment risk, means:

the chemical is known to cause: o harmful injury to an organism following short-term aquatic exposure

oro adverse effects to an organism during aquatic exposures

determined in relation to the life-cycle of the organism, as described the GHS, with the chemical classified as follows:

acute aquatic toxicity (category 3) chronic aquatic toxicity (category 3 or 4)

an in vivo study on the chemical: o conducted following OECD test guidelines 201, 202 or 203, results

>10 mg/L but ≤100 mg/L in an experimental: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants

or




o conducted following OECD test guidelines 210, 211 and/or 201, results in an experimental NOEC or ECX to fish and/or invertebrates and/or algae or other aquatic plants of:

> 0.1mg/L but ≤ 1mg/L for chemicals that are not readily biodegradable


o conducted using ECOSAR profiler for acute aquatic toxicity, results

in an in-domain prediction of >10 mg/L but ≤100 mg/L for: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants


1. You can assume the ‘harmful to any aquatic life’ definition does not apply to your chemical if:









2. To determine that the ‘harmful to any aquatic life’ definition does not apply to your chemical, you need one of the following:



or






or



NOEC or ECX > 1mg/L

or

a combination of in-domain in silico predictions for the chemical and in vivo test result(s) on the chemical or from suitable read-across information (using the above programs/test guidelines and specified outcomes) for:


Hazard band A: has bioaccumulation potentialThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Has bioaccumulation potential, to determine the indicative environment risk, means the chemical (other than a polymer) has a:

bioconcentration factor (BCF) ≥ 500 but < 2000, or partition coefficient (log Kow) ≥ 4.0 but < 4.2 (where BCF is not available)


1. You can assume the ‘has bioaccumulation potential’ definition does not apply to your chemical if:

it has a molecular weight > 1,000g/mol

or

it is a high molecular weight polymer with: o < 25% low molecular weight oligomeric species < 1,000g/mol ando < 10% low molecular weight oligomeric species < 500g/mol




or

it has a solubility in water that is > 5g/L

2. To determine that the ‘has bioaccumulation potential’ definition does not apply to your chemical, you need one of the following:

In domain in silico prediction (using KOWWIN) that the chemical has a partition coefficient (log Kow) of < 4.0.

Measured partition coefficient (log Kow, conducted following OECD TG 107, 117, 123) for the chemical or from suitable read-across information of < 4.0.

Measured bioconcentration factor (BCF, conducted following OECD TG 305) or bioaccumulation factor for the chemical or from suitable read-across information of < 500.

If you have multiple studies/results the weight given will be:

Measured bioconcentration factor (BCF) > measured partition coefficient (log Kow) > in silico prediction for the partition coefficient (log Kow)

Hazard band A: industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradabilityThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradability, to determine the indicative environment risk, means the chemical does not meet the criteria for ready biodegradability as described in OECD TG 301.

Otherwise, to determine the indicative environment risk, one of items 1, 2 or 3 applies:

1. you can assume your chemical does not meet the criteria for ‘ready biodegradability’ if:

it is highly volatile and you expect it to predominately partition to the air compartment, or

it is an inorganic chemical

2. you can assume your chemical does meet the criteria for ‘ready biodegradability’ if it is a biochemical or a biological substance

3. to determine that your chemical meets the criteria for 'ready biodegradability' you need:




measured ready biodegradability (conducted following OECD TG 301) for the chemical or from suitable read-across information, showing:

o the chemical degrades by > 70% within a 28 day period, oro the BOD/COD ratio is ≥ 0.5.

Hazard band A: contains aluminium, chromium, copper, nickel, silver, selenium or zincThe indicative environment risk for your introduction is not very low risk if you know your chemical contains aluminium, chromium, copper, nickel, selenium, silver or zinc.

Hazard band A: polymers that have an overall cationic charge at pH 4 to 9The indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Polymers that have an overall cationic charge at pH 4 to 9, to determine the indicative environment risk, means the polymer:

Contains at least one net positively charged atom or associated groups of atoms covalently linked to the molecule that are likely to be positively charged at 4 < pH < 9.

Has a combined functional group equivalent weight of all such atoms or associated groups of atoms that is less than 5,000g/mol, other than if:

o it is a solid that has a solubility in water of < 0.1mg/L, and will be in its solid phase during all end uses or


Hazard band A: polymers that are not stableThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Polymers that are not stable, to determine the indicative environment risk, means the polymer substantially degrades, decomposes or depolymerises during use.

Degrades, decomposes or depolymerises means a polymeric substance breaks down into simpler, smaller weight substances as the result of, but not limited to:

oxidation




hydrolysis heat sunlight attack by solvents or microbial action

Substantially means 'considerably', 'meaningfully' or 'to a significantly large extent'. We do not intend the meaning to include the slow, natural degradation that occurs during, say, the weathering of paint.

Otherwise, to determine the indicative environment risk if the industrial chemical is a polymer, one of items 1 or 2 applies:

1. You can assume the ‘polymers that are not stable’ definition does apply to your chemical if:

o the polymer is designed to be pyrolysed or burnto the polymer is designed or reasonably anticipated to substantially

photodegradeo the polymer is designed or reasonably anticipated to substantially

biodegradeo the polymer is explosiveo the polymer is hydrolytically unstable (T½ <12 hours)o the polymer is a biopolymero the polymer is a polysaccharideo the polymer contains polyethylene glycol (PEG) functionalities and has a

solubility in water of > 200 mg/L (unless the empirical data indicates the polymer does not substantially biodegrade), or

o the polymer contains polypropylene glycol (PPG) functionalities and has a solubility in water of > 200 mg/L (unless the empirical data indicates the polymer does not substantially biodegrade)

2. You can assume the ‘polymers that are not stable’ definition does not apply to your chemical if:

None of the criteria in option 1 are met, or The polymer is protected from environmental degradation, decomposition

or depolymerisation due to its encapsulation during use, including but not limited to, polymers used in cements, paints, adhesives, hot melts, and extrusion moulding.






Environment exposure band 4You are reading chapter 5 of the Categorisation Guidelines

The following information is to work out if your introduction's indicative environment risk for environment exposure band 4.

Relevant section of the Rule(s): section 29 environment hazard band, section 30 indicative environment riskThe indicative environment risk for your chemical is low when:

the environment exposure band is 4 and your industrial chemical does not have any environment hazard band B, C

and D characteristics (see link below)

The indicative environment risk for your chemical is very low when:

the environment exposure band is 4 and your industrial chemical does not have any environment hazard band A, B,

C and D characteristics (see link below)

If the indicative human health risk for your introduction is neither low nor very low, then it is medium to high.





applications requirements (for Assessed introductions under AICIS)

Ensure you have read and understood our hazard characteristics general information in Chapter 3 — Hazard bands





How to determine if indicative environment risk is low

If any of these hazard band B, C and D definitions apply to your chemical, the indicative environment risk for your introduction is not low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

How to determine if indicative environment risk is very low

If any of these hazard band A, B, C and D definitions apply to your chemical, the indicative environment risk for your introduction is not very low risk. If your introduction is a 'specified class of introduction', extra requirements apply.

Environment exposure band 4 — low riskYou are in Chapter 5 of the Guidelines


Before you start


Relevant General Rules: section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your introduction is low when:

the environment exposure band for the introduction is 4, and your industrial chemical does not have any environment band B, C and D

hazard characteristics.




DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018You need to work out if the industrial chemical you are introducing has any of the hazard characteristics in:

Hazard band D (start here) Hazard band C Hazard band B






This section on working out if the indicative risk is low has definitions on:

persistent, bioaccumulative and toxic ozone depleting chemicals synthetic green house gas contains arsenic, cadmium, lead or mercury adverse effects mediated by an endocrine mode of action












Criteria






Bioaccumulation

Compartment




BMF > 1

Toxicity Trophic Fish 96h LC50 ≤ 1mg/L






Criteria

(Aquatic) level - acute



72 or 96h ErC50 ≤ 1mg/L






Otherwise, to determine that it’s low risk, you need to:

confirm that the chemical (or the chemical of which it is an ester or salt) is not on the environment hazard band list at the bottom of this page (and Chapter 3 of these Categorisation Guidelines), based on it being persistent, bioaccumulative and toxic, and

determine that this definition doesn’t apply by showing that your chemical is at least one of the following:

o not persistento not bioaccumulativeo not very toxic to aquatic life.

Persistence:





Bioaccumulation:













Aquatic toxicity:

















or





Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not low risk, if you know that the ‘ozone depleting chemicals’ definition in the General Rules applies to your chemical.


Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not low risk if you know your chemical contains arsenic, cadmium, lead or mercury.













or











confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action.



If the introduction is a specified class of introduction — refer to chapter 6 specified classes of introduction.

This section on working out if the indicative risk is low has definitions on:


Hazard band C: very toxic to any aquatic lifeThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.








or


or


201 202 or 203


o of ≤ 1mg/L

or





or



















or



or





or





Hazard band C: persistent and bioaccumulativeThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.







Criteria






Bioaccumulation

Compartment



Food chain bioaccumulatio

BMF > 1






Criteria

n potential

Otherwise, to determine that it’s low risk, you need to show that your chemical is not persistent or not bioaccumulative.

Persistence:





Bioaccumulation:













Hazard band B hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band B for environment.


If the introduction is a specified class of introduction — refer Chapter 6 specified classes of introduction.

This section on working out if the indicative risk is low has a definition on toxic to any aquatic life.

Hazard band B: toxic to any aquatic lifeThe indicative environment risk for your introduction is not low risk, if you know that the following definition applies to your chemical.





or


201 202, or 203



or

o conducted following OECD test guidelines:




201 210, or 211




or



















or



or





or



















Environment exposure band 4 — very low riskYou are in Chapter 5 of the Categorisation Guidelines





Before you start


Relevant General Rules: section 29 environment hazard band, section 30 indicative environment risk, section 31 information required to demonstrate categorisationThe indicative environment risk for your chemical is very low when:

the environment exposure band is 4 and your industrial chemical does not have any environment hazard band A, B,

C and D characteristics



Hazard band D (start here) Hazard band C Hazard band B Hazard band A











Note: These definitions and information requirements below are the same as in our section Environment exposure band 4 – low risk (Hazard band D hazard characteristics).









Criteria










Criteria


Bioaccumulation

Compartment




BMF > 1

Toxicity (Aquatic)





72 or 96h ErC50 ≤ 1mg/L






Otherwise, to determine that it's very low risk, you need to:




confirm that the chemical (or the chemical of which it is an ester or salt) is not on the environment hazard band list in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on it being persistent, bioaccumulative and toxic, and

determine that this definition doesn’t apply by showing that your chemical is at least one of the following:

o not persistento not bioaccumulativeo not very toxic to aquatic life.

Persistence:





Bioaccumulation:










Aquatic toxicity:

















or





Hazard band D: ozone depleting chemicalsThe indicative environment risk for your introduction is not very low risk, if you know that the ‘ozone depleting chemicals’ definition in the General Rules applies to your chemical.




Hazard band D: synthetic greenhouse gasThe indicative environment risk for your introduction is not very low risk, if you know that the ‘synthetic greenhouse gas’ definition in the General Rules applies to your chemical.

Hazard band D: contains arsenic, cadmium, lead or mercuryThe indicative environment risk for your introduction is not very low risk if you know your chemical contains arsenic, cadmium, lead or mercury.










or

o the chemical (or the chemical of which it is an ester or salt) is on environment hazard lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known




adverse environmental effects mediated by an endocrine mode of action




The indicative environment risk for your introduction is not very low risk, if based on this analysis, the 'adverse effects mediated by an endocrine mode of action' definition applies to your chemical.



confirming that your chemical (or the chemical of which it is an ester or salt) is not on environment hazard band lists in Chapter 3 of these Categorisation Guidelines (also at the bottom of this page), based on its known adverse effects mediated by an endocrine mode of action.






Note: These definitions and information requirements below are the same as in our section: Environment exposure band 4 – low risk (Hazard band C hazard characteristics).









or


or


201 202 or 203


o of ≤ 1mg/L

or





or



















or



or








or









Criteria









Criteria



Bioaccumulation

Compartment




BMF > 1

Otherwise, to determine that it’s very low risk, you need to show that your chemical is not persistent or not bioaccumulative.

Persistence:





Bioaccumulation:


cadmium, lead or mercury)




o it meets the criteria for ready biodegradability (according to OECD TG 301), or

o it has a solubility in water that is > 5g/L







Hazard band B hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band B for environment.


If the introduction is a specified class of introduction — refer Chapter 6 specified classes of introduction.

This section on working out if the indicative risk is very low has a definition on toxic to any aquatic life.

Note: The definition and information requirements below are the same as in our section Environment exposure band 4 – low risk (Hazard band B hazard characteristics).









or


201 202, or 203



or

o conducted following OECD test guidelines: 201 210, or 211




or






DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 20181. You can assume the ‘toxic to any aquatic life’ definition does not apply to your chemical if:












or



or








or



Hazard band A hazard characteristicsDefinitionsThe following definitions apply to chemicals that do fall into hazard band A for environment.




harmful to any aquatic life has bioaccumulation potential industrial chemicals (other than polymers) that do not meet the criteria for

ready biodegradability contains aluminium, chromium, copper, nickel, silver, selenium or zinc polymers that have an overall cationic charge at pH 4 to 9 polymers that are not stable

Hazard band A: harmful to any aquatic lifeThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Harmful to any aquatic life, to determine the indicative environment risk, means:

the chemical is known to cause: o harmful injury to an organism following short-term aquatic exposure

or




o adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described the GHS, with the chemical classified as follows:

acute aquatic toxicity (category 3) chronic aquatic toxicity (category 3 or 4)

an in vivo study on the chemical: o conducted following OECD test guidelines 201, 202 or 203, results

>10 mg/L but ≤100 mg/L in an experimental: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants

or

o conducted following OECD test guidelines 210, 211 and/or 201, results in an experimental NOEC or ECX to fish and/or invertebrates and/or algae or other aquatic plants of:

> 0.1mg/L but ≤ 1mg/L for chemicals that are not readily biodegradable


in an in-domain prediction of >10 mg/L but ≤100 mg/L for: LC50 (96h) to fish EC50 (48h) to invertebrates or ErC50 (72 or 96h) to algae or other aquatic plants


1. You can assume the ‘harmful to any aquatic life’ definition does not apply to your chemical if:











DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 20182. To determine that the ‘harmful to any aquatic life’ definition does not apply to your chemical, you need one of the following:



or



or



NOEC or ECX > 1mg/L

or

a combination of in-domain in silico predictions for the chemical and in vivo test result(s) on the chemical or from suitable read-across information (using the above programs/test guidelines and specified outcomes) for:


Hazard band A: has bioaccumulation potentialThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Has bioaccumulation potential, to determine the indicative environment risk, means the chemical (other than a polymer) has a:

bioconcentration factor (BCF) ≥ 500 but < 2000, or partition coefficient (log Kow) ≥ 4.0 but < 4.2 (where BCF is not available)




DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 20181. You can assume the ‘has bioaccumulation potential’ definition does not apply to your chemical if:

it has a molecular weight > 1,000g/mol

or

it is a high molecular weight polymer with: o < 25% low molecular weight oligomeric species < 1,000g/mol ando < 10% low molecular weight oligomeric species < 500g/mol

or

it has a solubility in water that is > 5g/L

2. To determine that the ‘has bioaccumulation potential’ definition does not apply to your chemical, you need one of the following:

In domain in silico prediction (using KOWWIN) that the chemical has a partition coefficient (log Kow) of < 4.0.

Measured partition coefficient (log Kow, conducted following OECD TG 107, 117, 123) for the chemical or from suitable read-across information of < 4.0.

Measured bioconcentration factor (BCF, conducted following OECD TG 305) or bioaccumulation factor for the chemical or from suitable read-across information of < 500.

If you have multiple studies/results the weight given will be:

Measured bioconcentration factor (BCF) > measured partition coefficient (log Kow) > in silico prediction for the partition coefficient (log Kow)

Hazard band A: industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradabilityThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Industrial chemicals (other than polymers) that do not meet the criteria for ready biodegradability, to determine the indicative environment risk, means the chemical does not meet the criteria for ready biodegradability as described in OECD TG 301.

Otherwise, to determine the indicative environment risk, one of items 1, 2 or 3 applies:

1. you can assume your chemical does not meet the criteria for ‘ready biodegradability’ if:




it is highly volatile and you expect it to predominately partition to the air compartment, or

it is an inorganic chemical

2. you can assume your chemical does meet the criteria for ‘ready biodegradability’ if it is a biochemical or a biological substance

3. to determine that your chemical meets the criteria for 'ready biodegradability' you need:

measured ready biodegradability (conducted following OECD TG 301) for the chemical or from suitable read-across information, showing:

o the chemical degrades by > 70% within a 28 day period, oro the BOD/COD ratio is ≥ 0.5.

Hazard band A: contains aluminium, chromium, copper, nickel, silver, selenium or zincThe indicative environment risk for your introduction is not very low risk, if you know that your chemical contains aluminium, chromium, copper, nickel, silver, selenium or zinc.

Hazard band A: polymers that have an overall cationic charge at pH 4 to 9The indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.

Polymers that have an overall cationic charge at pH 4 to 9, to determine the indicative environment risk, means the polymer:

Contains at least one net positively charged atom or associated groups of atoms covalently linked to the molecule that are likely to be positively charged at 4 < pH < 9.

Has a combined functional group equivalent weight of all such atoms or associated groups of atoms that is less than 5,000g/mol, other than if:

o it is a solid that has a solubility in water of < 0.1mg/L, and will be in its solid phase during all end uses or


Hazard band A: polymers that are not stableThe indicative environment risk for your introduction is not very low risk, if you know that the following definition applies to your chemical.



DRAFT CATEGORISATION GUIDELINES – FOR CONSULTATION ONLY 09 March 2018Polymers that are not stable, to determine the indicative environment risk, means the polymer substantially degrades, decomposes or depolymerises during use.

Degrades, decomposes or depolymerises means a polymeric substance breaks down into simpler, smaller weight substances as the result of, but not limited to:

oxidation hydrolysis heat sunlight attack by solvents or microbial action

Substantially means 'considerably', 'meaningfully' or 'to a significantly large extent'. We do not intend the meaning to include the slow, natural degradation that occurs during, say, the weathering of paint.

Otherwise, to determine the indicative environment risk if the industrial chemical is a polymer, one of items 1 or 2 applies:

1. You can assume the ‘polymers that are not stable’ definition does apply to your chemical if:

o the polymer is designed to be pyrolysed or burnto the polymer is designed or reasonably anticipated to substantially

photodegradeo the polymer is designed or reasonably anticipated to substantially

biodegradeo the polymer is explosiveo the polymer is hydrolytically unstable (T½ <12 hours)o the polymer is a biopolymero the polymer is a polysaccharideo the polymer contains polyethylene glycol (PEG) functionalities and has a

solubility in water of > 200 mg/L (unless the empirical data indicates the polymer does not substantially biodegrade), or

o the polymer contains polypropylene glycol (PPG) functionalities and has a solubility in water of > 200 mg/L (unless the empirical data indicates the polymer does not substantially biodegrade)

2. You can assume the ‘polymers that are not stable’ definition does not apply to your chemical if:

None of the criteria in option 1 are met, or The polymer is protected from environmental degradation, decomposition

or depolymerisation due to its encapsulation during use, including but not limited to, polymers used in cements, paints, adhesives, hot melts, and extrusion moulding.




Chapter 6 — Specified classes of introductionLearn here about the additional information, reporting and record-keeping requirements for these introductions.

Summary: Chapter 6

About specified classes of introductions

Human health hazard bands for specified classes of introductions

Environment hazard bands for specified classes of introductions

Terms relating to record keeping for specified introductions of industrial chemicals

Specified classes of introduction is defined in our Glossary

About specified classes of introductionsYou are reading Chapter 6 of the Categorisation Guidelines

Relevant section of the Rules: section 7 specified classes of introductions

As these classes of introductions have greater potential for particular hazards or for high levels of human/environmental exposure, many have:

extra information requirements you need to meet when working out hazard bands

different indicative risk outcomes

extra reporting and record keeping requirements

Chapter 6 – draft Categorisation Guidelines of 288

www.nicnas.gov.au Freecall: 1800 638 528 phone: + 61 2 8577 8800



On this page we provide the extra hazard information requirements for the introduction of an industrial chemical that are a:

UV filter

polyhalogenated organic chemical

highly branched organic chemical

or has an end use in:

an article with food contact

a personal vaporiser

in tattoo ink

a biocide

We also provide definitions for certain record-keeping requirements for introduction of an industrial chemical:

that is a UV filter

for an end use in an article with food contact

Human health hazard bands for specified classes of introductionsYou are reading Chapter 6 of the Categorisation Guidelines

Relevant section of the Rules: section 25 human health hazard band, section 31 information required to demonstrate categorisation





Working out the indicative human health riskThe method for working out the indicative human health risk for specified introductions is the same as for other introductions, except that you will need to consider both:

Hazard characteristics described in Chapter 4 – indicative human health risk.

Hazard characteristics requirements we describe here.

Introducing a UV filter – exposure band 3You will have extra information requirements if:

Your introduction is in human health exposure band 3, and

Your chemical has a molar extinction/absorption coefficient:

o Of greater than 1,000Lmol-1cm-1.

o At wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101).

The extra requirements are information on whether your chemical has any of the following hazard characteristics, mediated by exposure to light:

carcinogenicity,

mutagenicity or genotoxicity, and

sensitisation

Information you may use includes:

In vivo or in vitro studies where the methods have been modified to include photo-activation.

Justification why your chemical would not cause these hazards mediated by exposure to light (which may involve in vitro phototoxicity results).





Introducing a chemical with an end use in an article with food contact – exposure band 3You will have extra information requirements if your introduction has a total introduction volume of greater than 1,000kg but less than or equal to 10,000kg in a registration year. Note that this requirement already applies to introductions greater than 10,000kg in a registration year.

The extra requirements are for working out if the ‘specific target organ toxicity after repeated exposure’ definition applies for your chemical. To determine indicative human health risk, one of items 1, 2 or 3 applies:


o It is corrosive or severely irritating to the skin (GHS Category 1), or

o It is likely to be corrosive to the skin (i.e. the chemical is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5), with high buffering capacity (if relevant).


o It is a high molecular weight polymerunless, it is known to be corrosive or severely irritating.

o It is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion unless the GRAS conclusion does not apply to the exposures you expect from industrial use of the chemical.


o In vivo study conducted following OECD test guideline 407 on the chemical or suitable analogue, in which the NOAEL is ≥ 300mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or





o In vivo study conducted following OECD test guideline 408 or 409 on the chemical or suitable analogue, in which the NOAEL is ≥ 100mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or



o In vivo study conducted following OECD test guideline 412 on the chemical or suitable analogue, in which the NOAEC is ≥ 750ppmV/6h/day (for gases) or ≥ 3mg/L/6h/day (for vapours) or ≥ 0.6mg/L/6h/day (for dusts/mists), or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or

o In vivo study conducted following OECD test guideline 413 on the chemical or suitable analogue, in which the NOAEC is ≥ 250ppmV/6h/day (for gases) or ≥ 1mg/L/6h/day (for vapours) or ≥ 0.2mg/L/6h/day (for dusts/mists)or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced.

Introducing a chemical for an end use in a personal vaporiser – exposure bands 2 and 3Any acute toxicity or specific target organ toxicity after repeated exposure information required according to Chapter 4 of these Categorisation Guidelines must be on the inhalation route.





Introducing a chemical for an end use in tattoo ink – exposure bands 2 and 3You will have extra information requirements if your chemical has a molar extinction/absorption coefficient:

Of greater than 1,000Lmol-1cm-1, and

At wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101).

When working out whether your chemical has skin sensitisation or skin irritation hazard characteristics you need to consider if these hazard characteristics are mediated by exposure to light.

Information you may use includes:

In vivo or in vitro studies where the methods have been modified to include photo-activation.

Justification why your chemical would not cause these hazards mediated by exposure to light (which may involve in vitro phototoxicity results).

Introducing a polyhalogenated organic chemical – exposure band 3You need extra information to confirm the chemical does not have the following human health band C hazard characteristics.

Hazard band C: Reproductive toxicity

You must have an in vivo study on the chemical or suitable read-across information, to determine that the ‘reproductive toxicity’ definition does not apply to your chemical.

Hazard band C: Developmental toxicity

You must have an in vivo study on the chemical or suitable read-across information, to determine that the ‘developmental toxicity’ definition does not apply to your chemical.





Environment hazard bands for specified classes of introductionsYou are reading Chapter 6 of the Categorisation Guidelines

Relevant section of the Rules: section 29 environment hazard band, section 31 information required to demonstrate categorisation

Working out the indicative environment riskThe method for working out the indicative environment risk for specified introductions is the same as for other introductions, except that you will need to consider both:

Hazard characteristics described in Chapter 5 – indicative environment risk.

Hazard characteristics requirements we describe here.

Introducing a highly branched organic chemical – exposure bands 2, 3 and 4Any persistence information required according to Chapter 5 of these Categorisation Guidelines (for example to determine if the chemical is persistent, bioaccumulative and toxic) needs to be measured data on the chemical itself.

If the information indicates the chemical is persistent the only acceptable information for determining toxicity to aquatic life (where required in Part 5 of these Categorisation Guidelines) is:

In vivo test results for chronic toxicity to aquatic life. You must have in vivo test results on the chemical or from suitable read-across information for:





o Fish (conducted following OECD test guideline 210),

o Invertebrates (conducted following OECD test guideline 211), and

o Algae (conducted following test guideline 201).

Introducing a chemical for an end use as a biocide - exposure bands 2, 3 and 4Any toxicity information required according to Chapter 5 of these Categorisation Guidelines (for example to determine if the chemical is very toxic to any aquatic life) needs to be in vivo test results for chronic toxicity to aquatic life. This means you must have in vivo test results on the chemical or from suitable read-across information for:

Fish (conducted following OECD test guideline 210),

Invertebrates (conducted following OECD test guideline 211), and

Algae (conducted following OECD test guidelines 201)





Terms relating to record keeping for specified introductions of industrial chemicalsYou are reading Chapter 6 of the Categorisation Guidelines

Relevant section of the Rules: section 49 introductions of industrial chemicals that are internationally-assessed for the environment, section 51 other introductions where highest indicative risk is low risk

There are terms in these sections of the General Rules relating to specified classes of introductions where you must refer to these Categorisation Guidelines to see the meanings. The terms and their meanings follow.

Toxicokinetics information, in relation to an industrial chemical that is a UV filter, means information on:

The systemic exposure of the chemical by the oral route, which may be determined using:

o An in vivo study on the chemical conducted following test guideline 417, or

o An in vivo study on the chemical that tests for specific target organ toxicity following repeated oral exposure in which toxicokinetic parameters are also measured.

The systemic exposure of the chemical by the dermal route, which may be determined using:

o An in vivo study on the chemical conducted following test guideline 417,

o An in vivo study on the chemical conducted following test guideline 427 (to predict skin absorption),

o An in vivo study on the chemical that tests for specific target organ toxicity following repeated dermal exposure in which toxicokinetic parameters are also measured, or





o An in vitro study on the chemical conducted following test guideline 428 (to predict skin absorption).

The relationship between the systemic exposure and dose level of the study.

The relationship between systemic exposure and time course of the study.

Toxicokinetics information may also include information on:

The distribution of the chemical within the body.

The metabolism of the chemical within the body.

The excretion of the chemical from the body.

Photostability information, in relation to an industrial chemical that is a UV filter, means:

Information on the chemical to demonstrate its stability in light, including the degree to which it degrades after exposure to UV light.

Potential for interaction with other UV filters, in relation to an industrial chemical that is a UV filter, means:

Information on the potential for the chemical to interact with any other UV filters that are likely to be used in the same end use product with the chemical. This can include:

o An appropriate study.

o Information on the chemical characteristics of the chemical and other relevant UV filters.

The potential for the industrial chemical to migrate to food, in relation to the introduction of a chemical that has an end use in an article with food contact, means:

Quantitative information on the extent of the chemical’s transfer from the article to food. This is not required if the chemical is of low concern following migration to food.





Chapter 7 — Polymers of low concernRelevant General Rule: Schedule 1, Part 1, Clause 1(d), section 20(7)(b)These rules require that a polymer must be stable to be a polymer of low concern. This chapter provides a definition to help you establish if your polymer meets the stability criterion.

The polymer is stableThe polymer is stable, for establishing that a polymer is a polymer of low concern , means the polymer does not substantially degrade, decompose or depolymerise during use.

Degrades, decomposes or depolymerises means a polymeric substance breaks down into simpler, smaller weight substances as the result of, but not limited to, oxidation, hydrolysis, heat, sunlight, attack by solvents or microbial action.

Substantially means 'considerably', 'meaningfully' or 'to a significantly large extent'.





Chapter 8 — Equivalent test guidelines

To determine the indicative risk to human health and the environment, and the test guidelines identified in Chapter 3 Working out hazard bands that don't apply, Chapter 4 Indicative human health risk and Chapter 5 Indicative Environment health risk, you can use a study that has been conducted under an equivalent test guideline.

For this purpose, we consider the test guidelines identified below for the relevant hazard characteristics to be equivalent to those identified in Chapters 3-5. The identified non-OECD test guidelines have been drawn from three international sources:

European Chemicals Agency Guidance on Human health Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance (July 2017) [available electronically at https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf]

European Chemicals Agency Guidance on Environment Information Requirements and Chemical Safety Assessment Chapter R.7b: Endpoint specific guidance (June 2017) [available electronically at https://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf]

US EPA OCSPP Harmonised Test Guidelines - Master List (December 2016) [available electronically at https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic]

NB: Some OECD test guidelines do not currently have internationally validated equivalent test guidelines.




https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic

https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/master-list-test-guidelines-pesticides-and-toxic

https://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf

https://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf

https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf

https://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf


Human health hazard characteristics

Acute toxicity (fatal or toxic) and specific target organ toxicity after a single exposureOECD test guideline 420, 423, 425 or deleted 401 equivalent test guidelines:

EU Annex V test methods B.1, B.1 bis, B.1 tris

OCSPP 870.1100, OPPT 798.1175 or OPP 81-1

OECD test guideline 402 or draft 434 equivalent test guidelines:

EU Annex V test method B.3

OCSPP 870.1200, OPPT 798.110 or OPP 81-2

OECD test guideline 403 or 436 or draft 433 equivalent test guidelines:

EU Annex V test methods B.2 or B.52

OCSPP 870.1300, OPPT 798.1150 or OPP 81-3

Specific target organ toxicity after repeated exposureOECD test guideline 407 equivalent test guidelines:


OCSPP 870.3050

OECD test guideline 410 equivalent test guidelines:


OCSPP 870.3200 or OPP 82-2

OECD test guideline 412 equivalent test guideline:



EU Annex V test method B.26Chapter 8 – draft Categorisation Guidelines

of 288www.nicnas.gov.au Freecall: 1800 638 528 phone: + 61 2 5877 8800



OCSPP 870.3100, OPPT 798.2650 or OPP 82-1



OCSPP 870.3150 or OPP 82-1



OCSPP 870.3250, OPPT 798.2250 or OPP 82-3



OCSPP 870.3465, OPPT 798.2450 or OPP 82-4



OCSPP 870.4100, OPPT 798.3260 or OPP 83-1



OCSPP 870.4300, OPPT 798.3320 or OPP 83-5



Skin corrosionOECD test guideline 430 equivalent test guidelines:


EURL ECVAM DB-ALM protocol No.115



EURL ECVAM DB-ALM protocols No.118 and 119

OECD test guideline 435 equivalent test guideline:Chapter 8 – draft Categorisation Guidelines






EU Annex V test method B.4.

OCSPP 870.2500, OPPT 798.4470 or OPP 81-5

Skin irritationOECD test guideline 439 equivalent test guidelines:


EURL ECVAM DB-ALM protocols No.131, 135 and 138


EU Annex V test method B.4.

OCSPP 870.2500, OPPT 798.4470 or OPP 81-5

Serious eye damageOECD test guideline 437 equivalent test guidelines:


EURL ECVAM DB-ALM protocols No. 98 and 124



EURL ECVAM DB-ALM protocol No. 80





OCSPP 870.2400, OPPT 798.4500 or OPP 81-4





Eye irritationOECD test guideline 437 equivalent test guidelines:


EURL ECVAM DB-ALM protocols No. 98 and 124







EU Annex V test methods B.5

OCSPP 870.2400, OPPT 798.4500 or OPP 81-4

Skin sensitisationOECD test guideline 442C equivalent test guidelines:

EU Annex V test methods B.59


OECD test guideline 442D equivalent test guidelines:



OECD test guideline 442E equivalent test guidelines:




OCSPP 870.2600, OPPT 798.4100 or OPP 81-6

OECD test guideline 429 equivalent test guidelines

EU Annex V test method B.42Chapter 8 – draft Categorisation Guidelines




OECD test guideline 442A equivalent test guideline:


OECD test guideline 442B equivalent test guideline:


CarcinogenicityOECD test guideline 451 equivalent test guidelines:


OCSPP 870.4200, OPPT 798.3300 or OPP 83-2



OCSPP 870.4100, OPPT 798.3260 or OPP 83-1



OCSPP 870.4300, OPPT 798.3320 or OPP 83-5



OCSPP 870.3050



OCSPP 870.3200 or OPP 82-2





OCSPP 870.3100, OPPT 798.2650 or OPP 82-1

OECD test guideline 409 equivalent test guidelines:Chapter 8 – draft Categorisation Guidelines





OCSPP 870.3150 or OPP 82-1



OCSPP 870.3250, OPPT 798.2250 or OPP 82-3



OCSPP 870.3465, OPPT 798.2450 or OPP 82-4

MutagenicityOECD test guideline 471 equivalent test guidelines:

EU Annex V test methods B.13 and B.14

OCSPP 870.5100, OPPT 798.5100, OPPT 798.5265 or OPP 84-2



OCSPP 870.5300, OPPT 798.5300 or OPP 84-2



GenotoxicityOECD test guideline 473 equivalent test guidelines:


OCSPP 870.5375, OPPT 798.5375 or OPP 84-2.


EU Annex V test method B. 49







OCSPP 870.5395, OPPT 798.5395 or OPP 84-2



OCSPP 870.5385, OPPT 798.5385or OPP 84-2



Reproductive and developmental toxicityOECD test guideline 421 equivalent test guideline:

OCSPP 870.3550


OCSPP 870.3650



OCSPP 870.3700, OPPT 798.4900 or OPP 83-3

OECD test guideline 443 equivalent test guidelines






OCSPP 870.3800, OPPT 798.4700 or OPP 83-4

Chemicals with adverse effects known to be mediated by an endocrine mode of actionOECD test guideline 440 equivalent test guideline:

OCSPP 890.1600






OCSPP 890.1400


OCSPP 890.1100


OCSPP 890.1350



OCSPP 870.3800, OPPT 798.4700 or OPP 83-4






OCSPP 870.3650


OCSPP 890.1300

Environment hazard characteristics

Acute aquatic toxicity (Very toxic or toxic)OECD test guideline 203 equivalent test guidelines:

ISO 10229

EU Annex V test method C.1

OCSPP 850.1075, OPP 72-1 and OPP 72-3






ISO 6341

EU Annex V test method C. 2

OCSPP 850.1010 or OPP 72-2


EU Annex V test methods C.3

OCSPP 850.4550, OPPT 797.1050, OPP 122-2 or OPP 123-2

BioaccumulationOECD test guideline 107 equivalent test guidelines:

EU Annex V test methods A.8

OCSPP 830.7550, OPPT 796.1550 or OPP 63-11



OCSPP 830.7570, OPPT 796.1570 or OPP 63-11




EU Annex V test methods C. 13

OCSPP 850.1730 or OPP 72-6

PersistenceOECD test guideline 301 equivalent test guidelines:

EU Annex V test methods C. 4 (A-F)

OCSPP 835.3110, OPPT 796.3180, 796.3200, 796.3220, 796.3240 or 796.3260


OCSPP 835.2120 or OPP 161-1




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