reach: chemical safety report (rip 3.2) wercs 2007 us user group albany

REACH: Chemical Safety Report (RIP 3.2)WERCS 2007 US User group Albany

27/06/2007

Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

Event –Erwin Annys

Annex I

• A chemical safety assessment consists of • Evaluation human health hazard

• Evaluation physicochemical hazard impact on human health

• Evaluation environmental hazard

• PBT en vPvB evaluation


Annex I

• If this ends up in a classification according to directive 67/548/EEG or 1999/45/EG or as PBT or vPvB• Exposure assessment

• Risk characterisation


Human health hazard assessment

• Objectives• Classification and labelling according to 67/548/EEC

• Determine the levels not to be exceeded upon exposure by man

• Derived no effect level DNEL

• « Treshold concentration »



• Following effects are evaluated • Toxicocinetics, metabolism and distribution

• Acute effects (toxicity, irritation and corrosion)

• Sensibilisation

• Toxicity repetitive administration

• CMR-effects



• The evaluation consists of four steps• Step 1: Evaluation of other information than on man

• Step 2: Evaluation of information on man

• Step 3: Classification and labelling

• Step 4: Derive DNEL and treshold concentration



• Step 1: Evaluation of other information than on man• Identification of hazard based on all available non human information

• Determine quantitative relationship between dose (concentration) and respons (effect)



• If not possible then semi quantitative or qualitative

• Describe all information (preferentially tabular) (LD50, NO(A)EL, LO(A)EL)

• If different studies available, use the one raising the highest concern


RegistrationToxicological information

8.1 Skin irritation or skin corrosion in vitro

8.1.1 In-vivo skin irritation x x x

8.2 Eye irritation in vitro

8.2.1 Eye irritation in vivo x x x

8.3 Skin sensitisation x x x x

8.4.1 In vitro gen mutation bacteries

8.4.2 Cytogenetic in vitro mammalian cells

8.4.3 In vitro genmutation mammalian cells

8.4.4 If pos, further mutagenicity testing x


Registration

8.5.1 Acute oral toxicity x EP/R x x x

8.5.2 Acute inhalation toxicity x x x

8.5.3 Acute dermal toxicitity x x x

8.6.1 Short term repeated toxicity x x x

8.6.2 Subchronical toxicitity x x

8.6.3 Repeated dose long term toxicity x

8.7.1 Screening toxicity reproduction/developmental x x x

8.7.2 Developmental toxicity x R x x

8.7.3 Reproductive toxicity 2 generations x x

8.8.1. Toxicokinetics

8.9 Cancerogenicity may be proposed x x



• Step 2: Evaluation of information on man • If nothing available, mention this explicitky



• Step 3: Classification and labelling• Directive 67/548/EEC, a comparison with the criteria of CMR

substances category 1 or 2 must be evaluated

• If not sufficient information to determine the endpoint, the registrant has to motivate this



• Step 4: Derive DNEL and treshold concentration• Based

• On results in step 1 - 3 • Expected exposure routes• Time, frequency

• More than one value may be necessary • Take care of relevant human populations

• Workers • Consumers • Indirect exposure via environment



• Upon determination of DNEL – treshold concentration consider following factors:• The uncertainty, result of variability experiments and interspecies

variations

• The nature and severity of the effect

• The sensitivity of the human population consideredde


Physicochemical hazard assessment


• Potential effects to human

• Explosivity

• Flammability

• Oxydising potential


Registration

Physico-chemical poperties V VI VII VIII

7.1 State

7.2 Melting/freezing point

7.3 Boiling point

7.4 Relative density

7.5 Vapour pression

7.6 Surface tension

7.7 Solubility in water

7.8 Partition coefficient octanol water

7.9 Flash point

7.10 Flammability

7.11 Explosivity

7.12 Auto ignition temperature

7.13 Oxidative properties

7.14 Granulometry

7.15 Stability in organic solvents en identity breakdown products

7.16 Dissociation constant

7.17 Viscositeit


Environmental hazard assessment


• Determine predicted no-effect concentration - PNEC


RegistrationEco-toxicological information

9.1.1 Short term toxicity Daphnia

9.1.2 Growth inhibition algae R

9.1.3 Short term toxicity fish x x x

9.1.4 Activated sludge respiration

9.1.5 Short term toxicity Daphnia

9.1.6 Long term toxicity fish x x

9.2.1.1 Biotic degradation easy test EP/R

9.2.1.2 Simulation testing degradation surface water

9.2.1.3 Soil simulating test

9.2.1.4 Sediment simulating test

9.2.1.5 Further confirmatory testing

9.2.2 Abiotic degradtion (hydrolysis)

9.2.3 Identification degradation products


Registration

9.3.1 Screening adsorption/desorption

9.3.2 Bioconcentration in aquatic species x x

9.3.3 Further adsorption/desorption testing

9.3.4 Environmental fate

9.4.1 Short term toxicity earth worms

9.4.2 Effects on micro-organisms in the soil

9.4.3 Toxicity short term plants

9.4.4 Long term toxicity earth worms

9.4.5 Toxicity long term invertebrates

9.4.6 Toxicity long term plants

9.5 Toxicity long term sediment

9.6 Toxicity long term birds x

Other tests

10 Detection and analytical methods



• Consider potential effects on the environment • Aquatic compartment (including sediment)

• Terrestrial compartiment

• Atmospheric compartiments

• Possible effects via food chain accumulation

• Potential effects on microbiological activity of sewage treatment



• The hazard assessment comprises three steps:• Step 1: Evaluation of information

• Step 2: Classification and labelling

• Step 3: Derivation Predicted No-Effect Concentration (PNEC)



• Step 1: Evaluation of information • The avaluation shall comprise:

• Hazard identification based on all available information

• Determine quantitative relationship between dose (concentration) and respons (effect)

• If not possible then semi quantitative or qualitative


Environmental hazard assessment• All information shall be briefly commented, if possible in table form

mentioning relevant test results (LC50 or NOEC) and test conditions (test duration, route of administration)

• If different studies available, use the one raising the highest concern



• Step 2: Classification and labelling • Directive 67/548/EEC

• If not sufficient information to determine the endpoint, the registrant has to motivate this



• Step 3: Derivation Predicted No-Effect Concentration (PNEC) • Based on the available informationthe PNEC for each environmental

sphere shall be established. de PNEC voor elk milieucompartiment bepaald. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (such as LC50 or NOEC).

• If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified


PBT and vPvB assessment

• The PBT and vPvB assessment is based on all information entered in the technical dossier. If the dossier only contains information on the endpoints requested for annex V and VI, then the registrant has to consider whether additional information has to be generated to make the PBT vPvB assessment possible



• The PBT and vPvB assessment comprises two steps :• Step 1: Comparison with the criteria

• Step 2: Emission characterisation


PBT and vPvB assessment • Step 1: Comparison with the criteria

• Compare with the criteria described in annex XII



•


PBT and vPvB assessment • Step 2: Emission characterisation

• If the substance fulfils the an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the quantities of the substance released to the different environmental compartments during all activities carried out by the M/I and all identified uses, and an identification of the likely routes by which the humans and the environment are exposed to the substance


Exposure assessment

• Objective• Quantitative or qualitative estimation of dose/concentration of substance

to which humans and environment are or may be exposed. The assessment has two steps

• Step 1: generation of exposure scenarios

• Step 2: exposure estimation


Exposure assessment • Step 1: generation of exposure scenarios

• Iterative

• For each identified use

• An exposure scenario gives the operating conditions and the risk management measures for production and use of the substance in all parts of the chain and covering the whole life cycle


Exposure assessment – Production processes

– The processes for the identified uses of the substances

– The applied risk management measures by the producer

– The risk management measures to reduce or avoid exposure of humans and environment to the substance during use, waste, disposal and recycling


Exposure assessment • Step 2: exposure estimation

• The exposure is estimated for each exposure scenario and contains three :

– Estimation of the emission

– Assessment of chemical fate and pathways

– Estimation of exposure levels


Exposure assessment • Emission in all relevant phases of the life cycle are estimated taking into

consideration the risk management measures • The characterisation of of possible transformation, degradation or reaction

products and an estimation of the distribution and fate shall be done • An estimation of the exposure levels for all populations

– Workers, consumers, indirect exposure• By each relevant exposure route

– Inhalation, oral, dermal and combinations • Considering

– Frequencies, duration


Risk characterisation

• The risk characterisation will be done for each exposure scenario

• Looking at the risks for all human populations and the environmental compartments



• The risk characterisation consists of• A comparison of the exposure of each human population known to be

likely to be exposed with the appropriate DNEL and treshold conc• A comparison of the predicted environmental concentrations in each

environmental sphere with the PNECs • An estimation of the likelihood and severity of an event occurring due to

the physicochemical properties of the substance



• For any exposure scenario the risk to humans and the environment can be considered to be adequately controlled, throughout the lifecycle of the substance that results from manufacture or identified uses if

• The exposure levels do not exceed the appropriate DNEL, treshold concentration and PNEC

• The likelihood and severity of an event occurring due to the physicochemical properties of the substance is negligible

reach: chemical safety report (rip 3.2) wercs 2007 us user group albany

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