specifications in the application form for environmental

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Specifications in the o S T Iapplication form for environmental assessment of wood preservatives

X

UMWELTBMDESAMT

Publications by the Federal Environmental'Agencyin the TEXTS series are available subject to advancepayment of DM 15,- (7,67 Euro) by bank transfer, crossed chequeor paying-in form to

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Publisher: Federal Environmental Agency (Umweltbundesamt)Postfach 55 00 22, '14191 Berlin • - • „

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Edited by: Section W 1.4 ■Ewe-Jens Lucks .

English translation by M.U.L. Seaman, Revised by Federal Environmental Agency

Price: , DM 15,-(7,67 Euro)

Berlin, September 2000

DISCLAIMER

Portions of this document may be illegible in electronic image products. Images are produced from the best available original document.

Specifications in the application form for environmental assessment of wood preservatives

Foreword:

In 1990, the Federal Environmental Agency, the former Federal Health Office and the industry elaborated a catalog of test criteria for wood preservatives, as a basis for environmental and health risk assessment.

Due to recent developments, particularly in environmental assessment, it appeared timely to revise the contents and structure of the catalog in order to render it more precise, comprehensive and comprehensible.

The new catalog, which is now designed as application form, in addition to providing criteria on physico-chemical characteristics, active ingredients and products, for the first time includes specific tests on eluates (leachates from preservative-treated wood, see annex 1), which have become obligatory due to the preceding evaluation of efficacy required by Guideline EN 84 as a prerequisite for placing wood preservatives on the market (with the exception of preparations against blue-stain fungus). . _

Directive 98/8ZEC of the European Parliament and Council of 16 February 1998, which went into effect on 14 May 1998, on the Placing on the Market of Biocidal Products provides for licensing and registration procedures for wood preservatives. The application form has therefore been designed to conform to the data requirements of the Directive, as listed in annexes H A and IIB (common data core sets on active substances and biocidal products), and HI A und III B (additional data sets for active substances and biocidal products).

= The application form, however, represents the maximum requirements with respect to wood preservatives, and it will probably be impossible to provide documentation for each and every one of its items. In these cases, it would be adequate to provide a conclusive explanation.

After the Directive 98/8/EC is implemented into national law (on 13 May 2000), additional adaptations to existing legislation may become necessary, and the practical implementation of the licensing procedure may lead to further modifications of the structure and requirements of the application form.

Report Cover Sheet

1. Report No. 2. 3. '* UBA-FB4. Report Title

Requirements on application form for environmental assessment of wood preservative products

5. Autor(s), Family Name(s), First Name(s) editor staff: Lucks, Uwe-Jens

6. Performing Organisation (Name, Address)

German Federal Environmental Agency - (Umweltbundesamt)P:O.B. 33 00 22 ’D-14191 Berlin

7. Sponsoring Agency (Name, Address)

Umweltbundesamt,'Postfach 33 00 22, D-14191 Berlin

8. Report Date August 2000

9. Publication Date September 2000

10. UFOPLAN-Ref. No.

11. No. of Pages 55 -

12. No. of Reference 63

13. No. of Tables, Diagrams 4 fables

14. No. of Figures

15. Supplementary Notesco-authors: BAM: Rudolph,D.; Schoknecht,U.; BgW: Reifenstein.H.; UBA: Berger,G.; Boehringer.U.; Franke.Ch; Giese.H.; Herrmann,M.; Jahn.B; Jakobi,H.-W.; Lucks,U.-J.; Ronnefahrt,!.; RoB.H.; Schenke,H.-D.; Wagner,B.; IUCT(FhG): Kdrdel.W.

16. Abstract .In 1990 the former Federal Health Office (Bundesgesundheitsamt) and the Federal Environmental Agency (Umweltbundesamt) jointly elaborated a catalogue of test requirements necessary for assessing the impact of wood preservatives on man and environment. Based on several years of experience, a revision was deemed necessary. Complying with the provisions of the Directive 98/8/EC of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market, which have to be transposed into national laws, the regulatory bodies BAM, BgW and UBA, in cooperation with industry and academia (IUCT), developed an

1 amended application form for wood preservatives. The provisions laid down there include different sets of data for wood preservatives, depending on the intended uses/hazard classes, e.g. physico-chemical and ecotoxicological properties, data on exposure, fate and behaviour in the environment and on waste management. The tests should be conducted according to standardized test protocols.Next to the list of data requirements explanations and justifications are given on why the data are needed and how they contribute to the risk assessment. Furthermore recommendations are given on which test guidelines should preferably be followed to generate the data.In addition, annex I includes a proposal for a test guideline on howto screen leachates from preservative-treated wood surfaces for their ecotoxic potential to aquatic organisms.

17. Keywordswood preservatives, application form, testing of leachates, ecotoxicology

18. Price 19. 20.

l

CONTENTS

A. General section page 1

B. Specific section page 9

-Release of active substances into the environment page 10

-Behavior in the environment page 11

-Ecotoxicological investigations page 12

-Waste disposal page 14

C. Conclusions page 15

Requirements for the assessment of theexposure of wood preservatives appendix 1

Requirements for the assessment of biodegradation / bioaccumulationof the active substances in wood preservatives appendix 2

Requirements for the assessment of the aquatic and terrestrial ecotoxicity of wood preservatives

appendix 3

Recommendations for disposal of remaindersof contaminated timber appendix 4

Determination of the potential ecotoxicity of leachates of timber treated with wood preservatives annex 1

Specifications in the avvlication form

for environmental assessment of wood preservatives

A. General Section

0. Name and/or trade name of the product:

0.1 Name and address of the applicant:

Contact person: ' Phone / Telefax / e-mail:

0.2 Name and address of the producer / manufacturer;, production / formulation site:

Contact person: , Phone / Telefax / e-mail:

0.3 Names and addresses of the distributors: '

0.4 Documents considered:

Declaration^) of consent (EVE) enclosed:

by the initial applicant:

by the manufacturers) of the active substance(s):

is (are) enclosed in the application having the code no.

for active substance(s):

Yes D No n

Yes □ No D

Remarks:

Place Date Company / signature

of the application dated:Code no.: ,

1. Data on the product ' .

1.1 Composition of the product:the following must be identified by name and function: active substances, fixatives, wetting agents and emulsifiers, solvents, dyes, binders and all other components, in percentage by weightin enclosure no.: enclosed Yes ^3 No D

1.1.1 Safety data sheets, for each component and for the productin enclosure no.: enclosed Yes D No D

If the chemical composition is not stated, the corresponding declaration of consent (EVE) of the proprietor of the formula must be enclosed.

1.2 Data on the production volume

1.2.1 Year in which production was initiated: ___________

1.2.2 Annual production (t/a) in the past 3 years:in the year ______in the year ‘ ______in the year ______

1.2.3 Production volume at present, or planned (t/a):in the year ______

: 1 in the year ______in the year _____ _in the year , ______

1.3 Type of formulation

1.4 pH value of the product at 20 °C: ■ •

1.5 Density according to OECD Guideline 109 orEEC Method A3 at 20 °C: g/cm3

1.6 Is dust emission by the product possible? Yes D No n

1.7: - \ -

Chemical breakdown products after applicationYes □ No □in enclosure no.: enclosed

of the application dated:Code no.:

1.8 Type and size of the package (g, kg, ml or 1):

1.9 Classifications, product labelling and restrictions according to chemicals regulations

- in enclosure no.: enclosed

Applicability of the Ordinance on Hazardous Substances:

■ Classification (type of hazard):

Hazard symbol:

R-phrases:

S-phrases:

Remarks on user safety:

1.10 Proposed technical instruction sheet and package text

Yes D No D

Yes D No D

1.10.1 Technical instruction sheet

in enclosure no.:1.10.2 Package text

in enclosure no.:

.1.11 Data on combustion behavior

1.11.2 Combustion behavior

in enclosure no.:

1.11.3 Combustion residues / products

in enclosure no.:

enclosed Yes D No □

enclosed Yes D No n

°C

enclosed Yes □ No D

enclosed Yes D No n

1.11.1 Flash point according to EEC Method A.9:

Remarks:

of the application dated: Code no.: ■

2. Data on the use of the product

2.1 Expected protective effect upon application:

2.2 Proposed application methods:

2.3 Application rates in each area of use / hazard class (GK):

GK (ml/m2)* Number of work operations(kg / m3)(g/m2)

* Please indicate appropriate dimension

2.4 Waiting periods:

2.5 Fixation periods:

.2.6 Exposure during applicationWorkplace Consumer Environment .

in enclosure no.: enclosed Yes □ NoCI

2.7 Percentage data on the consumers:industrial use: %professional use: %do-it-yourself use: %

Remarks: .

of the application dated:Code no.: .

3. Data on the active substance (in the case of products with several active substances, these pagesmust be filled out separately for each active substance)

3.1 Common Name, e.g. according to ISO or experimental designation / synonym:

3.2 Chemical name (IUPAC):

3.3 CAS no.: ' - ____ - ;___

EC no.: _____ - - - ___ - __

3.4 Molar mass: __________.______ g/mol

3.5 Molecular formula:

3.6 Structural formula:

in enclosure no.:

3.7 Degree of purity:

3.8 Isomers:

enclosed Yes n No n

(g/kg)

(%) "

3.9 Impurities:


3.10 Target organisms:

3.11 Mode of action:

3.12 Melting point according to OECD Guideline 102 or EEC Method A. 1 : ____ .____°C

3.13 Boiling point according to OECD Guideline 103 x .or EEC Method A.2: _____ .____ °C, at ____ kPa

3.14 Density according to OECD Guideline 109 or 'EEC Method A3: x _____ .___ g/cm3 at 20°C

3.15 Vapor pressure according to OECD Guideline 104 or EEC Method A.4:- ___;______ Pa, at _

__________ Pa, at _- __________ Pa, at _

Vapor pressure curve

in enclosure no.: enclosed

°C°C°c

3.16 Saturation concentration

in enclosure no.: enclosed Yes D No n

3.17 Solubility in water according to OECD Guideline 105 or EEC Method A6: pH 7: .

: pH___ -____ ___________________ .pH___._____: ____________

3.18 Solubility in solvents according to DAPA appendix 1.4 (g/1):

3.19 Surface tension according to OECD Guideline 115 or EfiC Method A5:________ mN/min enclosure no.: enclosed Yes D No 1—3


3.20 Partition coefficient Pow according to OECD Guideline 107 or 117, or EEC Method' A.8:

in enclosure no.: enclosed Yes 1—3 No D3.21 Dissociation constant pKa according to OECD Guideline 112 :____ .____

3.22 Hydrolysis as function of pH according to OECD Guideline 111 or EEC Method C.7in enclosure no.: . enclosed Yes D No D

3.23 UV/VIS absorption spectrum according to OECD Guideline 101in enclosure no.: enclosed Yes D No D

3.24 Thermal stability according to OECD Guideline 113

in enclosure no.: enclosed Yes D No D

3.25 Phototransformation according to OECD Guidance Document on Direct ‘ Phototransfbrmation of Chemicals in Water

in enclosure no.: enclosed Yes ^3 No E33.26 Photo-oxidative degradation according to OECD Environment Monograph No. 61

in enclosure no.: . enclosed Yes ^3 No Q

.3.27 Stability against other chemical and physical factors

(with regard to no.s 3.15,3.17,3.20,3.22, 3.25, 3.26: cf. appendix 1)

Remarks:


4. Chemical analysis of the active substance^ (in the case of products with several activesubstances, this page must be filled out separately for each active substance)

4.1 Description of the method to determine the degree of purity


Analytical procedure for the determination of each active substance:

— in the wood preservative in enclosure no.: enclosed Yes LJ No D— in air in enclosure no.: ' enclosed Yes D No n

— in soil in enclosure no.: , , enclosed Yes D No D

- in water in enclosure no.: ' enclosed Yes □ No n- in blood / urine in enclosure no.: enclosed Yes D No □

- in organic tissues in enclosure no.: enclosed YesD No n

— in treated timber in enclosure no.: enclosed - Yes □no n

- in/on adsorption-relevant materials

in enclosure no.: enclosed Yes D Nod

Remarks:


B. Specific Section (in the case of products with several active substances, these pages must be filled out separately for each ingredient)

5. Requirements for health risk assessment according to Federal Health Gazette - Bundesgesundhbl. - 1/90, pp. 28-32 to be inserted here.

of the explication dated:Code no.: -

6. Data on the release of active substances into the environment(in the case of products with several active substances, this page must be filled out separately for each active substance, for each product component, and/or for the product; cf. appendix 1)

6.1 Evaporation from treated- timber, determined by an adequate procedure; l e.g. DIN VENV 1250-1

in enclosure no.: enclosed Yes EH No D6.2 Leaching from treated timber, determined by an adequate procedure;

e.g.: "Determination of the potential ecotoxicity in leachates of wood treated with wood preservatives" ("Ermitthmg des okotoxischen Potentials in Eluaten von mit Holzschutzmitteln behandelten Holzem"; cf. annex 1)

in enclosure no.: enclosed Yes No EH6.3 Summary of data on environmental release

in enclosure no.: . enclosed Yes EH No EH

Remarks:


7. Behavior in the environment (active substancefs) / product / leachate)(in the case of products with several active substances, this page must be filled out separately for each active substance and/or for the product/leachate; cf. appendices 1 and 2)

7.1

7.1.1

Behavior in soil

Adsorption / desorption in soil according to OECD Guideline


106Yes □

7.1.2 Degradation, transformation and metabolism according to BBA Guideline, part IV, 4-1

in enclosure no.: enclosed No □7.2 Behavior in water

7.2.1 Elimination by adsorption to sewage sludge according toV

. UBA guideline proposal in enclosure no.: enclosed Yes d No E37.2.2 Degradability in the aquatic environment (freshwater) according to OECD 301 A-F or

OECD 302 B or OECD 302 C, or according to BBA Guideline, part IV, 5-1in enclosure no.: enclosed Yes D No D

7.2.3 Degradation in seawater according to OECD Guideline 306in enclosure no.: enclosed Yes D No D

7.3 Bioaccumulation according to OECD Guideline 305 (Draft)in enclosure no.: enclosed Yes D No D

7.4 Behavior in the air

in enclosure no.: enclosed Yes n no n7.5 Summary of data on behavior in the environment

in enclosure no.: enclosed Yes D NoD

Remarks:


8. Ecotoxicological investigations (active substance's) / product and/or environmentallyrelevant product components)(in the case of products with several active substances, this section mustbe filled out separately for each active substance, for the product components, and/or for the product; cf. appendix 3) .

- * ■8.1 Aquatic organisms .

8.1.1 Algae according to OECD Guideline 201 or EEC Method C.3 or

DIN 38412, part 33 in enclosure no.: enclosed Yes EH .No EH8.1.2 Daphnia according to OECD Guideline 202 / 211 or EEC Method C.2 or

. DIN 38412, part 30, in enclosure no.: enclosed Yes EH No EH8.1.3 Fish according to OECD Guideline 203 / 204 / 210 or EEC Method C.l or

DIN 38412, part 31, in enclosure no.: enclosed Yes EH No EH8.1.4 Microorganisms .

Freshwater bacteria, e.g. Pseudomonas test according to DIN 38412, part 27 '

in enclosure no.: enclosed Yes EH No EH- ■ ' " - , ' '

Marine bacteria, e.g. luminescent bacteria test according to DIN 38412, part 34

: in enclosure no.: enclosed Yes EH No EH8.1.5 Others according to Guideline 96/12/EEC .

in enclosure no.: . - , enclosed Yes EH No D .

8.1.6 Other experience

in enclosure no. :

8.2 Terrestrial organisms

enclosed Yes EH No EH

8.2.1 Invertebrates according to OECD Guideline 207 or Guideline 88/ 302/ EECrin enclosure no.: enclosed Yes EH No EH


8.2.2 Plants according to OECD Guideline 208


8.2.3

8.2.4.

8.2.5

8.2.6

Microorganisms according to BBA Guideline,- part VI, 1- 1, or DIN EN 252 and

DIN V ENV 807 in enclosure no.: enclosed Yes LJ No LJ

Possible toxic effects on bats

in enclosure no.: enclosed Yes d No n

Others according to Guideline 96/ 12/ EEC

in enclosure no.: enclosed Yes D no n

Other experience

in enclosure no.: enclosed Yes D No □

8.3 Overall evaluation of 8.1 and 8.2 for Federal Environmental Agency (UBA) andFederal Institute for Health Protection of Consumers and Veterinary Medicine (BgW)in enclosure no.: enclosed Yes ^3 No D

Remarks:

9. Waste disposal ( cf. appendix 4)

9.1 Dumping ^

9.1.1 Possible leachable transformation / degradation products within the dumping sitein enclosure no.: enclosed Yes D No D

Page 14 of the application dated:Code no.:

9.2 Waste incineration

9.2.1 Incineration products (as emissions)

in enclosure no.: enclosed Yes □ NoD

9.2.2 Leachable incineration products (as residues)


9.3 Recommendations for disposal '

Yes □ No □

9.3.1 Residues of the wood preservative, contaminated packaging materials / containers

in enclosure no.: enclosed Yes D No CZ39.3.2 Treated timber

in enclosure no.: enclosed Yes D No D" 9.4 Overall evaluation for Federal Environmental Agency (UBA) and Federal Institute for

Health Protection of Consumers and Veterinary Medicine (BgW)in enclosure no. : enclosed Yes D No D

Remarks:


C. Conclusions

10. Overall evaluation

Overall evaluation


Concluding remarks:

Precise explanations are given in the "Instruction sheet for filling out the specifications in the application form for environmental assessment of wood preservatives" ("Anleitung zum Aus- jullen der Anforderungen an den Antrag auf vmweltbezogene Bewertimg von Holzschutz- mitteln").If it is considered unnecessary to submit research results, then the reasons must always be stated.The instruction sheet for filling out the application is not to be submitted.

Appendix 1/1

Data requirement profile for the assessment of the exposure of wood preservatives

In addition to general data such as the structural formula of the active substance(s), as well as the quantities, frequency and methods of application, which must always be stated, the following data are required for the evaluation of exposure:

Hazard Classes

Requirements for the assessment of the exposure of wood preservatives '

§; Data on , , GK1 GK2 GK3 GK4

' ;»B:: i'ls GENERAL DATA

1 Solubility in water at pH 7 X X X X

2 Solubility in water at pH 4 and pH 9 X X

3 pKa ' . ' X X

4 Vapor pressure ' X X X X

5 Pow ■ X X X X

SOIL / WATER / SEWAGE SLUDGE

6 Hydrolysis X X

7 Leaching from treated timber X X

8 Adsorption to / desorption from soil X X

9 Distribution in water / sediment / sewage sludge X

AIR (vapor pressure > 1CT Pa]) "

10 Evaporation from treated timber X X X X

11 Photolysis . X X X X

12 Photo-oxidative degradation optional, depending on the results of 6,10 and 11

Appendix 1/2

re 1) the tests must be conducted according to OECD Guideline 105 or EEC Method A.6

re 2) the tests must be conducted according to OECD Guideline 105 or EEC Method A.6

re 3) the tests must be conducted according to OECD Guideline 112 -

re 4) the tests must be conducted according to OECD Guideline 104 or EEC Method A.4; at a vapor pressure of the active substance > 10*3 [Pa] at 20°C, evaporation studies should

, be conducted, because the aerial pathway is regarded as a relevant environmental compartment; studies on leaching behavior are unnecessary in this case

re 5) the tests must be conducted according to OECD Guidelines 107 or 117, or EEC Method A 8 . ,

re 6) the tests must be conducted according to OECD Guideline 111 or EEC Method C.7

re 7) the tests must be conducted according to Annex 1 (Determination of the ecotoxicological potential in leachates of timber treated with wood preservatives)

re 8) the tests must be conducted according to OECD Guideline 106;1 ■ instead of performing this test, the elution water from leaching .experiments, section B,

item 6.2, may be tested in percolation experiments in the laboratory (following BBA Test Guideline for Pesticides, part IV, 4-2 "Percolation behavior of pesticides" -

- "Versickerungsverhalten fur Pflanzenschutzmittel") or in field experiments (following BBA Test Guideline for. Pesticides, part IV, 4-3 "Lysimeter studies on the penetration of pesticides into the subsoil" - "Lysimeteruntersuchungen zur Verlagerung von Pflanzenschutzmitteln in den XJntergrand'). This test replaces the tests in item 9 on water / sediment

re 9) the tests must be conducted according to BBA Guideline for Testing Pesticides in the Licensing Procedure, part TV, 5-1 "Degradability and fate in the water/sediment system" - "Abbaubarkeit and Verbleib im Wasser/Sediment-System"

_ DBA Guideline Proposal, April 1996: Adsorption / Desorption of Organic Chemicals in Sewage Sludge

re 10) the tests must be conducted according to an adequate determination procedure, provisionally e.g. DIN V ENV 1250-1

re 11) according to OECD Guidance Document on Direct Phototransformation of Chemicals in Water

re 12) according to OECD Monograph No’61 :

There are at present no special test guidelines for seawater. .

Appendix 2

Requirements for the assessment of biodegradation / bioaccumulationof the active substances in wood preservatives

GK . „ ' ### #

1) Aerobic biodegradation in SOIL X* X

2) Aerobic biodegradation in WATER X* X X

3) Bioaccumulation - : X* X X

— * does not apply to wood preservatives for outdoor use when the active substance(s) is/are fixed with a coating layer devoid of active substance(s)

The tests must be conducted according to the following guidelines:

1) BBA Pesticide Guideline, part IV, 4-1 (modified)

2) a) GK 3 and GK 4: OECD 301 A-F or OECD 302 B or 302 C or BBA Pesticide Guideline, part IV, 5-1 (modified) 'b) Seawater: OECD Guideline 306 (= Biodegradability in Seawater)

3) OECD Guideline 305

It may become necessary to conduct degradation studies with leachates from timber (eluates).

Appendix 3/1

Data requirement profile for the assessment of the ecotoxicity of wood preservatives

Requirements for the assessment of the aquatic and terrestrial ecotoxicity of woodpreservatives'

ActfvesubsWceW . ### GK3

aauatic ecotoxicitvX X X X X

1 \ * i

1) (Green) algae

2) Daphnia acute / chronic X X X X X

3) Fishes acute / chronic X X X X X

4) Microorganisms X X X

5) other aquatic organisms X X , X

terrestrial ecotoxicitv6) Invertebrates (X) (X) X X

7) Plants (X) (X) ' X X

8) Microorganisms X X

9) Vertebrates " X X

Products31 \ , sV1 \ ' ' ' \ , y 'iaquatic ecotoxicitv1) (Green) algae (X) (X) X , X X

2) Daphnia acute / chronic (X) (X) X X X

3) Fishes acute / chronic (X) (X) X X X

4) Microorganisms ' X X X

5) other aquatic organisms -

terrestrial ecotoxicitv6) Invertebrates X X

,7) Plants - . X X

8) Microorganisms X X

9) Vertebrates

Appendix 3/2

x Tests of the product (formulation) must in principle also be provided for hazard classes 1and 2, as far as required in item 1.9. For leachates (GK 3 and 4) they must be submitted if:

— interactions may occur between different active substances (the formulation contains more than one active substance),

— interactions may occur between active substances and other components,— active substances or other components with high aquatic or terrestrisal ecotoxicity are

used and the product is to be employed in hazard classes GK 3, GK 4, or in'contact with seawater. -

— labelling or a hazard symbol are required (iterative approach) •

re 1) the tests must be conducted according to OECD Guideline 201 or EEC Method C.3; with the product according to DM 38412, part 33

re 2) the tests must .be conducted according to OECD Guideline 202 / 211 or EEC Method C.2; with the product according to DM38412, part 30

re 3) the tests must be conducted according to OECD Guideline 203 (acute) / OECD 204 prolonged to 21 days or 210 (chronic) or EEC Method C.l; with the product according to DM 38412, part 31

re 4) the tests must be conducted according to e.g. DM 38412, part 27 (Pseudomonas test ‘ on inhibition of oxygen consumption)

re 5) active substance(s): the tests must be conducted according to 96/12/EECproducts: test guideline^ not defined, but tests possible according to 96/12/EEC

re 6) the tests must be conducted according to OECD Guideline 207 or Guideline 88/302/EEC (acute) / ISO/DIS 11268-2 (chronic) .

re 7) the tests must be conducted according to OECD Guideline 208

re 8) in the case of active substances which are already in use as active substances in pesticides, the results of BBA Guideline part VI, 1-1 must be submitted; in other cases, the results of tests according to DMEN 252 andOM V ENV 807 must be submitted

re 9) active substance(s): the tests must be conducted according to 96/12/EECproducts: test guidelines not defined, but tests possible according to 96/12/EEC

* Seawater

8.1.1 Algae , ISO/DIS 10253.28.1.2 Crustaceans . ISO/ CD 14669; EPA-660/ 3-75-0098.1.3 Fish OECD Guideline 210 or EPA-660/ 3-75-009;8.1.4 Microorganisms DM38412, part 34

Whenever necessary, toxicity tests must be conducted with leachates of treated timber (see annex 1). .

Appendix 4

Recommendations for disposal of remainders of contaminated timber

Contamination by WP type: : Rto,IL<noS"*0n

Salts containing chromate 030204 SAD/(HMD) special need for monitoring

Organometallic complex compounds without chromium, such as CuHDO

030203 SAD/(HMV) special need for monitoring

Other salts, not fixating " 030204 SAD / (HMD) special need for monitoring ~

HgCl2 030204 SAD /(HMD) special need for monitoring

Tar oil 170303 SAY/(HMV) need for monitoring -

solvent-based WP 030202\

SAW (HMV) special need for monitoring

X" '

*HMD Hausmulldeponie = domestic waste dump

HMV Hausmullverbrennungsanlage = domestic waste incineration facility

SAD Sonderabfalldeponie = toxic waste dump

. SAY ' Sonderabfallverbrennungsanlage = toxic waste incineration facility

in parenthesis: in small quantities or at low contamination levels

. ** special need for monitoring(as toxic waste) in the case of quantities superior to 2.000 kg per year according to the Ordinance on the Classification of Waste Requiring Special Supervision - Bestimmungsverordmmg - of 10.09.1996 (BGB1.1 p. 1366 ff.) ,

The numbers in column 2 give the appropriate waste type list no. of the European Waste Catalog. /

Comment: After 01.01.1999 the six-digit code of the European Waste Catalog must be used instead of the German Waste Type Catalog that applied until then (Ordinance on the Introduction of the European Waste Catalog - Verordnung zur Einjuhrung des Europaischen Abfallkatalogs (EAK-Verordmmg), in its latest version), Federal Law Gazette -BGB1. -1, p. 2705, 1996). ’ .

ANNEX 1

DETERMINATION OF THE POTENTIAL ECOTOXICITY OF LEACHATES OF TIMBER TREATED WITH WOOD PRESERVATIVES

A. SCREENING TEST

INTRODUCTION

Leaching processes may occur when timber treated with wood preservatives is exposed to the elements out of doors. The teachable components in treated timber may have harmful or toxic effects on neighboring environmental compartments. This needs to be taken into consideration in risk assessments of wood preservatives for outdoor use.

Wood preservatives are often complex formulations of substances with different leaching and fixation characteristics. It must consequently be assumed that the quantitative and qualitative composition of the leachate will differ significantly from that of the original product. Therefore, the ecotoxicological properties of the leachate can usually not be deduced by adding up the expected effects of the various ingredients, nor can they be inferred from the characteristics of the initial product.

An assessment of the environmental characteristics may be based on existing - valid research results (e.g. analytical data on leaching behavior / ecotoxicological test results on the product) that obviate any need for further or additional testing.

In the absence of test data, the first step will be to estimate the ecotoxicological characteristics of the wood preservative and/or of the treated timber as realistically as possible on the basis of leachate tests. '

Samples of treated timber are subjected to accelerated aging in laboratory tests. After application of the product and subsequent drying, the timber samples are immersed in water (under intermittent subatmospheric pressure) to simulate outdoor leaching processes. The leaching solutions are changed at defined intervals.

Data for an assessment of the environmental characteristics of treated timber can already be obtained at an early stage of product development, in combination with tests of the efficacy of the wood preservative.

1

OBJECTIVES AND RELEVANCE

This instruction sheet is designed to provide a guideline for testing the possible ecotoxicity of leachates on fish, daphnia, algae and luminescent bacteria ("ecotoxicological profile").

The. results can serve as a screening step in an assessment procedure for wood preservatives of hazard classes 3 (treated timber outdoors, but without direct contact to soil and water, fully exposed) and 4 (treated timber outdoors, with direct contact to soil and water) (EN 335, part 1). , .

PRINCIPLES OF THE TEST PROCEDURE

. Timber samples with sealed ends (cross-cut wood) are treated with the wood preser-vative following the manufacturer's instructions. After drying or fixation (in accordance with the fixation time recommended by the manufacturer) the timber samples are repeatedly subjected to leaching. Diluted leachates are tested with respect to their harmful or toxic effects on aquatic organisms. The tests employ species that are representative of different trophic levels (fish, daphnia, algae and luminescent bacteria).

The leachate concentration to be used in the limit tests is derived from a predetermined standard exposure ratio of treated timber surface to leaching water volume ("reasonable worst case scenario": 1 m2 / T m3). ■

Leachates of untreated timber serve as controls for separate assessment of the possible effects stemming from the natural components in the timber samples (background values). z

METHODOLOGY OF THE LEACHING PROCEDURE

Small timber samples (5 by 2.5 by 1.5 cm, with the long side parallel to the grain) are made from straight knot-free pinewood. The blocks should have neither knots nor resinous sections. The surface of the wood should have an oblique cut displaying the growth rings. The timber samples are first conditioned to a humidity of about 12% (according to EN 113). The number of growth rings per 10 mm should be stated. The short ends of the samples (cross-cut wood) are sealed with an adequate coating (e.g. Pyrotect varnish) before the wood preservative is applied.

The quantity of wood preservative used in the treatment should correspond to the highest recommended dose. The application procedure (including prescribed.fixation periods) depends on the use for which the timber is intended or on the manufacturer's instructions. - .

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1 Applications corresponding to hazard classes 3 and 4 (according to EN 335 - part 1 (1992)) should,follow the method described in EN 84 (exception: a shorter drying period of 24 hours, instead of 14 days in the case of preservatives for wood of GK 3). The first leachate (2 hours) and the second leachate (24 hours) are united into a combined leachate (E0), adjusted to a volume of 1 liter, and employed in the, subsequent ecotoxicological tests. The leachates should be tested as soon as possible after they are prepared. Any necessary short-term storage should be at 4°C ± 2°C (max: 48 h), or by freezing at about -18°C (max. 2 months).

METHODOLOGY OF THE ECOTOXICOLOGICAL TESTS

Determination of the toxicity to fish

To achieve the exposure ratio of 1 m2 treated wood surface to 1 m3 leaching water volume, the leachates (E0) of the treated and untreated timber samples are diluted by 1:40 with the test water prescribed in the, appropriate guideline. The test is conducted according to OECD Guideline 203 or 92/69/EEC, part C.1, with the diluted leachates of treated and untreated timber samples, and with the dilution water that serves as control. The leachate is classified as "acutely non-toxic to fish" with respect to the standard test scenario described above if the survival rate of the test fishes surpasses 90%. .

Determination of the toxicity to daphnia

To achieve the exposure ratio of 1 m2 treated wood surface to 1 m3 leaching water volume, the leachates (E0) of the treated and untreated timber samples are diluted by 1:40 with the test water prescribed in the appropriate guideline. The test is conducted according to OECD Guideline 202 or 92/69/EEC, part C.2, with the diluted leachates of treated and untreated timber samples, and with the dilution water that serves as control. The leachate is classified as "acutely non-toxic to daphnia" with respect to the standard test scenario described above if at least 90% of the 20 daphnia retain their mobility.

Determination of the toxicity to algae

For the algae test 2.5 ml of leachate (E0) are mixed with 77.5 ml dilution water, 10 ml culture medium and 10 ml of inoculum with 105 cells per ml, for a. total volume of 100 ml test solution, corresponding to a dilution of 1:40 (test concentration according to the "reasonable worst case scenario"). The test is conducted according to OECD Guideline 201 or 92/69/EEC, part C.3, with the diluted leachates of treated and untreated timber samples, and with the dilution water that serves as control. The leachate is classified as "non-toxic to algae", if biomass production or growth rate are reduced by less than 25%.

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Determination of the inhibitory effect on light emission of the photobacterium Vibrio fischeri (formerly Photobacterium phosphoreum)

The test is conducted according to DIN 38412 part 34 ("Determination of the inhibitory effect of waste water on the light emission of Photobacterium phosphoreum” - "Bestimmung der Hemmwirkung von Abwasser auf die Lichtemission von Photobacterium phosphoreum") or according to ISO drafts 11348-1, 11348-2 or 11348-3 with the following modifications. The only concentrations tested are leachates (E0) of treated and untreated timber samples diluted by a factor of 1:40. To this end, the leachates are diluted accordingly with deionized water. The leachate is classified as "non-toxic" if the inhibitory effect of the leachate from the treated timber sample does not surpass the inhibitory effect of the leachate from the untreated timber sample by more than 20%.

TEST REPORT

The report should provide a detailed description of the testing procedure,

The points named below for each test should be used as a checklist to avoid overlooking any aspects of importance to the interpretation of the test results.

• Composition of the wood preservative and application procedure- active substances.- solvents- other additives .- recommended application quantities- instructions regarding the application procedure . '

• Treatment of the timber samples• - manufacture of the timber samples , ': type of wood, number of growth rings per 10 mm

adjustment of the humidity of the wood- sealing of the cross-cut surfaces '- quantity of wood preservative applied per m2- description of the application procedure- drying after application, duration, method .

• Preparation of the leachate- detailed description of the method, including time periods- pH value of the leachate- Method and duration of storage of the leachate prior to analysis and ecotoxicological

testing . r

• Determination of the concentrations of the active substances in the leachate detailed description of the method, including

- extraction procedure ,- clean up

- concentration procedure

4

- preparation of calibration curves- detection limits and standard recovery- equipment parameters .

Fish test

• fish species employed, size, origin *• holding of the fish before the test, possible conditioning• adjustment of the pH of the leachate• detailed description of the experimental procedure ,• pH values in the test vessels at the beginning and at the end of the test .• oxygen concentrations in the test vessels at the beginning and at the end of the test• temperature at the beginning and at the end of the test• number of dead fish• other behavioral characteristics in the test fish• any deviations from the guideline, and any circumstances which may possibly have

influenced the results.

Daphnia test

• origin and age of the daphnia, possible conditioning• preparation of the dilution water• adjustment of the pH of the leachate• test temperature, test vessels, number of daphnia per vessel •• pH values in the test vessels at the beginning and at the end of the test• oxygen concentrations in the test vessels at the beginning and at the end of the test• source and intensity of light .• determination of the sensitivity of the daphnia by use of reference substances (e.g.

potassium dichromate)• exceptional behavior of the daphnia during the test• number of daphnias incapable of swimming in each test vessel• any deviations from the guideline, and any circumstances which may possibly have

influenced the results.

Algae test

• test organisms, origin, previous culture, algal strain• algal rearing including cultivation conditions .• adjustment of the pH of the leachate• preparation of thp dilution water, of the culture medium and of the inoculum• pipetting procedure for each test vessel• pH values in the test vessels at the beginning and at the end of the test

• incubation of test and control vessels, test temperature, source and intensity of light• fluorescence determination, equipment and calibration• data on cell density in each test and control vessel• evaluation of the data• any deviations from the guideline, and any circumstances which may possibly have

influenced the results. '

5

Luminescent bacteria test

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origin of the leachate, duration and conditions of storage pH of the leachate pre-treatment of the samples, if any reference substances (if used) origin of the bacteria, batch number production date of the bacterial suspension storage temperature of the bacteria, if they were frozen deviations from the guideline, and any circumstances which may possibly have influenced the results date on which the test was conductedstatement of all data in tabular form _ ' ,calculation of the inhibition of light emission ,

6

REFERENCES

Wegen, H.-W., U.-J. Lucks

EN 84

EN 113

EN 335

DIN 38412 Teil 34

EN ISO 11348

OECD 201

OECD 202

OECD 203

92/69/EWG

Ecotoxicological behaviour of leachates from superficially treated timber as an approach for a test strategy of environmental risk assessment in wood preservation, 4th. International Symposium "The Challenge Safety and Environment in Wood Preservation", 2-3 February 1998, Cannes-Mandeiieu (France). International Research Group on Wood Preservation IRG/WP 98-50101, pp. 95-112

Holzschutzmittel - Beschleunigte Alterung von behandeltem Holz vor biologischen Prufungen; Auswaschbeanspruchung. Deutsche Fassung EN 84: (1989)

Bestimmung der Grenze der Wirksamkeit gegenuber holzzerstdrenden Basidiomyceten, die auf Agar gezuchtet werden (1986)

Definition der Gefahrdungsklassen fur einen biologischen Befall - Teil 1: Allgemeines (1992) ,

Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung: Testverfahren mit Wasserorganismen (Gruppe L); Bestimmung der Hemmwirkung von Abwasser auf die Lichtemission von Photobacterium phosphoreum - Leuchtbakterien-Abwassertest mit konservierten Bakterien (L 34) (Juli 1997)

Wasserbeschaffenheit - Bestimmung der Hemmwirkung von Wasser- proben auf die Lichtemission von Vibrio fischeri (Leuchtbakterientest) -Teil 1: Verfahren mit frisch gezuchteten Bakterien -Teil 2: Verfahren mit tiefgefrorenen Bakterien -Teil 3: Verfahren mit gefriergetrockneten Bakterien

OECD Guideline for Testing of Chemicals: Alga, Growth Inhibition Test (adopted 7th June 1984)

OECD Guidelines for Testing of Chemicals: Daphnia sp„ Acute Immobilisation Test (Draft Proposal for updating Guideline 202, Draft Document, July 1999)

OECD Guideline for the Testing of Chemicals: Fish, Acute Toxicity Test (adopted 17th July 1992 )

Directive 92/69/EEC of the Commission of 31 July 1992, annex V• - part C.1 Acute toxicity to fish• - part C.2 Acute toxicity to daphnia• - part C.3 Algae inhibition test

7

t

Instructions

for filling out the."Specifications in the application form for environmental assessment of wood preservatives"

including the references for the test guidelines

1. Preliminary remarks:

The Federal Health Office and the Federal Environmental Agency developed a joint testing catalog some eight years ago, after intensive discussions with experts from science, public administrations, and the industry. This catalog served as the basis for a comprehensive health risk and environmental assessment of wood preservatives (Federal Health Gazette - Bundes- gesundhbl. -1/90, pp. 28-32). .

The past several years' experience with this testing catalog has demonstrated a certain need to revise the segment on environmental assessment.

- The requirements listed in the catalog were somewhat imprecise in some sections, leavingtoo much discretion for the answers. The applications submitted to government agencies thus often necessitated further inquiries, and it was not always easy to evaluate the data with the required accuracy. A new catalog has to be elaborated, and it must be structured as far as possible in a fashion permitting the answers to be given by ticking appropriate choices. '

- The former catalog had to be revised as a whole: Some questions have proved unnecessary,others needed to be added. .

- To improve the acceptance of the new application procedure on the part of the applicants, the catalog now justifies and explains the data required and the testing procedures prescribed or recommended, as well as requirements for data quality. These justifications and

• explanations were already included in the 1990 testing catalog; since they directly accompanied the data requirements, however, many of the applicants quite unnecessarily returned them to the government agencies along with the data. In order to avoid this in the future, a compact "instruction sheet" is now separated from the actual "application sheet".

- In addition, to improve the handling of the applications by government agencies, the application sheet needs to be organized according to administrative criteria, making it easy to identify the sections of interest to the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgW), to the Federal Environmental Agency (DBA), or both, to facilitate separate evaluations.

The novel application form, which has largely been agreed upon by the relevant agencies and the industry, follows annexes H A and II B of the Directive 98/8/EC of the European Parliament and Council on the Placing on the Market of Biocidal Products of 16 February 1998; it anticipates annexes IH A and HI B with regard to wood preservatives and thus represents the maximal catalog. It may become necessary to adapt the application sheet to the final version of the annexes, and a need for additional modifications may still arise in the course of the trial runs.However, its extent allows for the voluntary nature of the Quality Label award, as well as for the current construction legislation, which provides an inadequate legal basis for comprehensive environmental protection.

2

2. General comments: - --

The application has the following structure:

Section Agency concernedA General section BgW; DBA ,B Specific section BgW; DBA .

*(-toxidty studies . . BgW; UBA summary only)-exposure concentrations UBA;-environmental fate and behavior UBA;-ecotoxicological studies UBA; BgW no. 8.3 only-waste disposal . UBA; BgW no. 9.4 only

C Conclusions UBA, BgW

* The requirements for toxicity studies are not included in the application and instruction forms, nor in the references, because they hardly differ from the original catalog (see Federal Health Gazette - Bundesgesundhbl. - 1/90).

The corresponding sections of the applications must be submitted to the appropriate evaluating agencies, i.e. Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgW) and Federal Environmental Agency (DBA).

It is not essential to provide data and documentation for each and every item of the application. Nevertheless, an answer must be provided for every item. When the documentation of test data is unnecessary from the standpoint of scientific knowledge, or if testing is technically impossible, then the reasons need to be given. Existing valid research results and data that obviate additional investigations may also be submitted for the purpose of risk assessment.

Enclosures are required for many of the items on the application form. These enclosures with detailed information and test data should be submitted in stable folders; a flexible folder may be used for the application itself but it should include separating sheets stating the pages and numbers of the application form to indicate the corresponding documents. In any case, the documents need to be sorted and labelled so that it will be possible to assign them to the individual items in the application.

' , " • \

If an applicant submits several applications on the same active ingredient, either simultaneously or over a period of time, it will be unnecessary to enclose the documentation on that ingredient every time. A note with the date of the correspondence and the code no. of the application containing the documents will be sufficient.

In the case of combined formulations (products with several active ingredients), the corresponding sections of the application need to be completed for each active ingredient; the same applies to the completion of data sheets concerning the requirements for-testing products, active ingredients, and leachates. The applicant must make the needed number of copies of the forms.

If annexes referred to by the applicant have been submitted some time back, the applicant needs to confirm that the experiments and procedures performed in the past still conform to the present state of scientific knowledge and to current technological standards.

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It is unnecessary-for an applicant to submit documentation, or to cause documentation to be submitted, on an active ingredient when this is already held by BgW and TJBA - e.g. in the context of a pesticide licensing procedure or some other wood preservative assessment procedure - provided that the manufacturer of the active ingredient or the initial applicant (e.g. in transfers) delivers a letter of access (declaration of consent, “EVE”) permitting the use of these documents in the application procedure for the (new) wood preservative. The declaration of consent must state the date and code no. of the application for which the documents were submitted. •

A declaration of consent must be delivered by every applicant who does not himself submit documentation on an ingredient, referring instead to the documents of the manufacturer of the ingredient or of the initial applicant

The test guidelines are listed by title in column 3 of the instruction sheet below, and they are given in detail in the second section (references) of the instruction sheet; appendices 1 to 4 of the application explain the requirements for the different hazard classes. The test guidelines named there are not compulsory. Other scientifically accepted test norms may be employed in special cases; this must be justified for each such case. It is advisable, however, to use the internationally recognized test guidelines of OECD and the European Union, so that the experimental results will also be accepted in licensing procedures initiated in other countries.

The application form, including the annex, appendices and instruction form, will initially be published in the UBA Texte series, and they will later be available in the form of an application form or diskette at the:

Gutegemeinschaft Holzschutzmittel e.V. •Karlstrasse 21D-60329 Frankfurt am Main •Germany .

3%:

Instruction sheet

1

Item no. Required data Test guideline Explanation Reasons0. Name, trade name of

productDesignation (name, number) of the experiment (if applicable)

...

0.1 Applicant ... Name, address, contact person, telephone, telefax, email

Contact person, telephone, telefax, e-mail for rapid inquiries ,

0.2 Manufacturer ... Name, address, contact person, telephone, telefax, email

Contact person, telephone, telefax, e-mail for rapid inquiries

0.3 Distributors) ' ... Name(s), addresses) • If not identical with 0.1 and/or 0.21.1 Composition of the

product (active substances, fixatives, wetting agents and , emulsifiers, solvents, dyes, binders and other components, with their respective functions, in percentage weight) .

Information required is the composition (ISO common names in German spelling) of the distributed formulation of the product, expressed as percentage by weight. Other industrial formulations that have been used in manufacturing the product must be given either by naming the individual components, or by stating the trade name, composition and manufacturer of that preformulation. This information maybe sent to the regulating agencies by the manufacturer of the preformulation. As to the function of the product components, the principal function must be stated (e.g. chromium compounds are to be listed as fixatives rather than dyes)

Core data for assessment

1.1.1 Safety data sheets for each component

— For the product, active substances, other components For professional users

1.2 Data on the production volume

The quantities produced (annually) are not important for "local" health risk and environmental assessment, i.e. preserved timber at the site of its use - the dosage per m2 or m3 is decisive in this respect. Production volume permits an estimate of tlie quantities released into the environment, providing an indication of local emissions.

1.2.1 Year in which production was initiated

see 1.2

1.2.2 Annual production in the past 3 years

... ... see 1.2

1.2.3 Production volume at present, or planned

... ... see 1.2

2Item no. Required data Test guideline Explanation Reasons1.3 Type of formulation — Powder, solution, emulsion, paste etc. For the assessment of human and environmental

exposure1.4 pH value of product --- pH value of the formulation distributed Required for labelling of the product1.5 Density of product OECD Guideline 109, EEC

A.3, or CIPAC MT 3.2... Basic data

1.6 Possibility of dust emission

—- ... Assessment of human exposure

1.7 Breakdown products after application -

Description of the known or presumed conversion products in the timber, particularly with regard to the active substance(s)

Health risk and environmental assessment depends on the form in which the active substance(s) are present or fixed in the wood during the use of treated timber ■

1.8 Type and size of the package

... Description of the materials, and of the quantities or volumes placed on the market ,

The size of the papkage permits an estimate of the consumer groups concerned or exposed

1.9 Classification, labelling and restrictions according to legal provisions on chemicals.

According to the Ordinance on Hazardous Substances,e.g.: R+S phrases, Xi, Xri, N

Workplace safety, user and environmental protection

1.10 Proposed technical instruction sheet and package text-

Notes on user and environmental protection with respect to the use and the processing of the product and the treated timber

Information of the government agencies with respect to the information material provided to consumers .

1.10.1 Technical instruction sheet

... ... - Information for professional users

1.10.2 Package text ... ... • , Information for consumers in general -1.11 Data on combustion

behaviorThis concerns data on the behavior of the product and of treated timber in case of accidental burning

Important information for health risk and environmental assessment. The conditions of accidental burning may be very different from those of deliberate incineration for waste disposal purposes (see item no. 9.2)

1.11.1 Flashpoint EEC A.9 The lowest temperature at which the vapors of a liquid can be ignited

Indication of the fire hazard and risk of explosion

1.11.2 Combustion behavior -— Data on the flammability, e.g.: flammable, highly flammable, explosive

Behavior of a substance upon its ignition ,

1.11.3 Combustion residues / products

Combustion residues in the ashes (and oxidation stage in the case of inorganic substances) and combustion products in the waste gas (whether or not .retainable by filters)

Formation of fumes and combustion products of relevance to health or the environment

3

Item no. Required data Test guideline Explanation Reasons2. Data on the use of the

product 'Important data with regard to the efficacy of the product. They form the basis for the assessment of the risks to human health and the environment

2.1 Expected protective effect upon application

The destructive organisms (pests) should be named, as specifically as possible

2.2 Proposed application procedures

The application procedure proposed must correspond to the advertised application procedure

The application procedure is of decisive importance with regard to human health and the environment during application and use

2.3 Application rates required in each area of use / hazard class (GK).

The quantities and concentrations prescribed in the official tests of efficacy are decisive for the assessment of the risks to human health and the environment; the corresponding value must be identified in the application sheet. Units that do not apply must be crossed out

The quantities which need to be applied represent fundamental parameters that determines the exposure in various environmental media

2.4 Waiting periods Waiting periods until rooms may be used again after application of the wood preservative in pest control procedures, as recommended by the manufacturer

The correct determination of, and adherence to waiting periods and waiting conditions is necessary to avoid human and environmental exposure, as well as fire hazards

2.5 Fixation periods Fixating wood preservatives fix to the fibers and undergo changes due to chemical reactions in the wood during, and particularly after impregnation. Freshly impregnated timber must be protected from precipitation for some time. The fixation period must be adhered to

Correct determination of fixation periods and fixation conditions ensures that treated timber will give off the least amount of active substances by leaching and evaporation during construction, thus taking environmental and health protection aspects into consideration

2.6 Exposure during application

The applicant should give a verbal estimate of the exposure (in the course of appropriate application) of users and the environment

Basic information on the various exposures

2.7 Percentage data on the user groups

The applicant is expected to provide an estimate of the proportions of potential users (industry, professionals, do-it-yourselfers)

Information required to estimate the locations or sectors of use. Essential information on type and magnitude of health and environmental impacts

3. Data on the active, substance

see item no. 1.7 see item no. 1.7

3.1 Common name, e.g, according to ISO or experimental designation or synonym

Commonly used chemical names (e.g. Permethrin), or experimental number

Basic information

4Item no. Required data Test guideline Explanation Reasons3.2 Chemical name Chemical name according to IUPAC - Unequivocal identification of the compound3.3 CAS no.

EC no. -Chemical Abstracts Service according to annex I of EU Guideline 67/548/EEC

Serves for identification and as "control" designation for items no. 3,1 and 3.2. Particularly useful as term for search procedures

3.4 Molar mass ... Basic information3.5 Molecular formula »-■ Basic information3.6 Structural formula --- ... , Basic information3.7 Degree of purity —- Degree of purity of the technical-grade active sub

stanceThis information is important for the evaluation and assessment of eco/toxicological test results

3.8 Isomers . ... Type and quantity of the isomers of the technical- grade active substance

Isomers often have different properties

3.9 Impurities Type and quantity of the impurities in the technical- grade active substance (except isomers), if these are of possible relevance to the protection of health and the environment - ■

see item no. 3.7 . .

3.10 Target organisms ... Targeted effect (e.g. insecticide, fungicide)3.11 Mode of action ... e.g. contact or food poison; information on the action

mechanism, e.g. esterase inhibitor...

3.12 Melting point OECD Guideline 102 orEEC A.l

Physico-chemical property Information on the state of aggregation; physical state at room temperature

3.13 Boiling point OECD Guideline 103 orEEC A.2

At the standard pressure of 101.3 kPa The boiling point is one of the values desccribing the fate of a substance in the various environmental compartments; data on the physical state .

3.14 Density OECD Guideline 109 orEEC A.3 ,

At 20°C, if possible For the conversion of mass into volume

3.15 Vapor pressure OECD Guideline 104 orEEC A.4

At 20°C or 25°C and at least 3 temperatures in the range 0°C - 50°C .

Calculation of the volatility from water (computation of Henry's constant). Extent of the volatility with respect to its distribution and diffusion in air, and its uptake by inhalation

3.16 Saturation concentration

... Determined from the vapor pressure according to the general gas laws (see 3.15)

Important for the loading of (diffusion in) closed rooms

3.17 Solubility in water OECD Guideline 105 orEEC A.6

Preferably at 20°C and pH 7, as well as in the range between pH 4 and pH 9

Extent of the mobility in water and soil. Calculation of the volatility from water (computation of Henry's constant)

3.18 Solubility in solvents DAPA annex 1.4 The solvents must be named Basic information '

5Item no. Required data Test guideline Explanation Reasons3.19 Surface tension OECD Guideline 115 or

EEC A.5The surface activity is determined in distilled water at an active substance concentration of 90% of the saturation concentration (1 g/1 at most, however) and at a temperature of about 20° C (plus/minus 0.5°C)

Provides an indication of the potential for a compound to pass from the aquatic environment into organisms, as well as of its potential bioaccumulation; cf. item no.7.3; indication of the capability to adsorb to solid surfaces

3.20 Partition coefficient n-octanol/water (Pow)

OECD Guideline 107, 117 or EEC A.8 .

The value must be given on a logarithmic scale (log Pow); data on the test temperature

see 3.19; indicates the bioaccumulation potential; computation of adsorption constants (soil, sediment, sewage sludge)

3.21 Dissociation constant (pK„) in water

OECD Guideline 112 Information on whether the substance is an acid or base

This property determines behavior and transport in the natural environment

3.22 Hydrolysis as a function of pH

OECD Guideline 111 orEEC C.7

Tested at environmentally relevant pH values (pH 4 - pH 9) s

Hydrolysis is a principal (abiotic) pathway for degradation of compounds in the environment. The result of this test also determines which compounds (original substance or breakdown products) need to be tested further. Consideration of elimination processes in assessments of exposure in the hydrosphere

3.23 UV / VIS absorption spectrum

OECD Guideline 101 In the wavelength range of > 200 nm to about 750 nm

Indicates the wavelengths at which a compound is susceptible to photochemical degradation

3.24 Thermal stability OECD Guideline 113 Serves to determine the thermal stability or temperature of decomposition

May indicate a need for additional testing

3.25 Phototransformation OECD Guidance Document on Direct Phototransformation .of Chemicals in Water

Brief general data on the stability of the active substance to UV and solar irradiation

Photodegradation represents another abiotic degradation pathway, besides hydrolysis

3.26 Photo-oxidativedegradation

OECD Environment Monograph No.61

Data on the reaction rate constant(s) at 25°C. Serves to compute the atmospheric half-life ’

Data on the stability of a substance to 03 and/orOH radicals; needed to estimate elimination processes in assessments of atmospheric exposure

3.27 Stability against other chemical and physical factors

Concerns other material changes not reflected by previously mentioned test results

Data on other degradation products that may need to be considered in an assessment

4. Chemical analysis of the active substance

Detailed comprehensible description of simple and widely applicable laboratory methods that can be performed with standard equipment and moderate effort (including references, if applicable). Determination and detection limits, recovery rates and their variability. Determination of the active substance, and its reaction and degradation products

Important for the performance of many tests; e.g. in monitoring, and for identification of the a.i..In this respect, field methods are of equal

importance as methods for waste analysis

6Item no. Required data Test guideline Explanation Reasons4.1 Description of the

method to determine the degree of purity

■Description of the procedure without consideration of a matrix

4.2 Analytical procedurefor determination ofthe respective activesubstance• in the wood preser

vative• in the air• in soil• in water• in organic liquids

(e.g. blood, urine)• in organic tissues• in treated timber• in/on adsorption

relevant materials

- - , ■

e.g. in house dust or as a result of migration processes

6. Data on the release of active substances into the environment

- .

6.1 Evaporation from treated timber

Tests must be conducted with an adequate method, e.g.DIN VENV1250-1

If the vapor pressure is greater thanlO'3 Pa and ifDIN EN 73 indicates loss of active substances from the wood

6.2 Leaching from treated timber

Test must be conducted according to annex 1, "Determination of the potential ecotoxicity of leachates from timbef treated with wood preservatives"

Only required for products designed for use in GK 3 or GK 4, or in seawater; leaching water (eluate) of treated timber. - •

Required for the assessment of various exposure scenarios

6.3 Summary of data on environmental release

Water: Determination of the concentration in water, and of the effective concentration, to determine potential risk.Air: Evaporation behavior is a basis for deciding whether the results on photochemical-oxidative degradation need to be submitted

Water: If a potential risk exists, adequate steps must be taken to reduce that risk.

Air: Trigger value to test photochemical-oxidative degradation and to assess the photochemical ozone creation potential (POCP) „

7

Item no. Required data Test guideline Explanation Reasons .7. Behavior in the envi

ronment (active substance^)/product/ leachates)

These requirements mainly apply to active substance^); if the data on acute ecotoxicity of the product or leachate indicate a contribution of other product components independent of that of the active substance^), then items 7.1 and 7.2 require data on the relevant product components. First indications are given by the hazard characteristics according to their classification and/or the ecotoxicity values of these substances

Besides the active substances, other components of the product may in some cases be the actual cause of environmentally harmful effects, due to their ecotoxic effect on non-target organisms and their comparatively high content in the product. These data serve to assess the relevance of this aspect

7.1 Behavior in soil (only in the case of relevant substances)

7.1.1 Adsorption / desorption

OECD Guideline 106 ' Applies only to GK 3 / GK 4; compulsory if relevant concentrations may enter the soil; cf. appendix 1 item 8 of the application

Assessment of the mobility of substances in the soil; assessment of the risk of groundwater contamination

7.1.2 Degradation, transformation and metabolism

BBA Guideline part IV, 4-1 (modified: low concentrations that are just sufficient for analysis: without test levels 2 and 3) •

Only required for active substances in GK 3 (not in products used on windows and outer doors) and GK4; laboratory tests with a duration of more than 100 days (screening test).Test results: Primary degradation, mineralization, bound residues (cannot be conducted adequately with leachates)

Assessment of persistence in the soil as inherent property of a substance, particularly mineralization and bound residues. The BBA test is applied to (active) substance(s) and/or product components for which degradation data have not yet been established, only if they were shown to be ecologically relevant in the leaching test (item no. 6.2)

7.2 Behavior in water (only in the case of relevant substances)

***"" .

7.2.1 Elimination by adsorption to sewage sludge

UBA guideline proposal,April 1996 .

Only required if there is reason to assume that adsorption to sewage sludge is a significant elimination pathway in sewage treatment plants (in addition to biological degradation and volatility).Test result: Sorption coefficient K (stated as log K,0)

Adsorption to sewage sludge must be considered a possible elimination pathway particularly in exposure studies with organic (active) substances of low solubility and poor biodegradation. Adsorption may affect the digestibility and use of the1 sewage sludge for spreading on land

7.2.2 Degradability in the aquatic environment (freshwater)

Level 1 (ready biodegradability): one of tests in OECD 301 A-F; level 2 (inherent biodegradability): test OECD302 B or C; level 3 (degradability, and fate in a water- sediment system): level 2 of BBA Guideline part IV, 5-1

Only needs to be conducted with active substances in GK 3 (not in products used on windows and outer doors) and GK4 (including cases of mere ground contact).Test results of level 3: Primary degradation, mineralization, bound residues (with leachates, only levels 1 and 2 are possible, with limited significance)

Assessment of the persistence in water as an inherent property of a substance, or for the assessment of PEC; cf. item no.7.1.2

8Item no. Required data Test guideline Explanation - Reasons7.2.3 Degradation in sea

waterOECD Guideline 306 Must be conducted with (active) substances and/or

leachates in the case of exposure to seawater.Test results: Diagram of mineralization over time

Assessment of the persistence in the marine environment

7.3 Bioaccumulation OECD Guideline 305 (Draft) Only required for (active) substances in GK 3 (not in products used on windows and outer doors) and GK4, or in cases of exposure to seawater, if in addition- log Pow > 3- or surface tension £ 50 mN/m (at c 3 1 g/1)- or indications resulting from the molecular

structure (e.g. nitrogen as in pyridinium compounds)

Test results: Bioconcentration factor BCF and rate constants for.uptake (kt) and depuration (k2)

Assessment of possible chronic risks to aquatic • organisms due to long-term accumulation

7.4 Behavior in the air 1 In consideration of PC data relevant to air Cf. item no.s 3.15, 3.23, 3.25, 3.26, 6.27.5 Summary of data on

behavior in the environment

This requires a description (quantitative as far as possible, but qualitative at the least) of the passage by the substance from one environmental compartment to another, as well as its equilibrium distribution among the individual compartments, the different elimination pathways and elimination rates, and the bioaccumulation, in consideration of the relevant physico-chemical properties (cf. section 3).This should provide an overall description of the substance's fate after its release into the environment

Information and data are used for the determination of exposure, which is required for the assessment of the substance 1

8. Ecotoxicological - investigations (active substance(s) / product / leachate)

The tests must be conducted with the active substance^), and/or the product (GK 1 and 2) if necessary. Tests with the leachate need to be submitted if- the product is to be used for GK 3, GK 4 or in contact

with seawater- and interactions may occur between different active

substances- or interactions may occur between'active substances and

other components- or the product contains active substances or other

components having high aquatic or terrestrial ecotoxicity. .

Leachate tests: see annex 1 ("Determination of the potential ecotoxicity of leachates of timber treated with wood preservatives")

Regardless of exposure the following tests must be conducted with the respective active substance - in the aquatic sector, algae, daphnia and fish test (iteratively, to determine possible labelling requirements); in the terrestrial sector, tests with invertebrates (inch bees) and plants. The tests serve to determine inherent properties of the active substance. Moreover, these data are needed for classification of the active substance (core data set).In the case of exposure to the aquatic environment, long-term tests are required if chronic effects appear possible. ‘Incase of exposure to the terrestrial environment, an earthworm reproduction test is required if the acute test does not preclude a risk

9Item no. Required data Test guideline Explanation Reasons8.1 Aquatic organisms The results of the toxicity tests should provide infor

mation on possible harmful effects of product components on aquatic organisms, singly and/or in combination. The individual active substances should be tested first

Cf. item no. 8

8.1.1 Algae OECD Guideline 201 orEEC C.3, DIN 38412, part33 (modified)

Seawater: ISO/ DIS 10253.2

A test on the effects of the active substance(s) on algae is compulsory (core data set). A test on the effects of the product / leachate on algae is required, if the product is to be used in GK 3 (in possible contact with water) or GK 4 or seawater and contamination of the water body is to be expected.-> see explanation to item no. 8.

Green algae are accepted test species belonging to a certain trophic level, that of tire primary producers, and they represent an essential component of aquatic ecosystems

8.1.2 Daphnia OECD Guideline 202/211 or EEC C.2, DIN 38412, part 30 (modified)

Seawater: ISO/ CD 14669, EPA-660/3-75-009

A test on the effects of the active substance(s) on daphnia is compulsory (core data set). If the results of the acute test (48 h) do not preclude a risk to daphnia, then a daphnia reproduction test must be conducted with the active substance. If the product is to be licensed for use in GK 3 or GK 4 or in contact with seawater, then a test of the leachate is required (cf 8.1.1). •->see explanation to item no. 8

Daphnia are accepted test species belonging to a certain trophic level, that of the primary consumers, and they represent an essential component of aquatic ecosystems

8.1.3 Fish OECD Guideline 203 / 204 or 210 or EEC C.l; DIN 38412, part 31 (modified).

Seawater: OECD Guideline 210; EPA-660/3-75-009

A test on the effects of the active substance(s) on fish is compulsory (core data set). If the results of the acute test (96 h) do not preclude a risk to fish, then a test on long-term toxicity to fish must be conducted with tire active substance. If the product is to be licensed for use in GK 3 or GK 4 or in contact with seawater, a test of the leachate is also required (cf 8.1.1).

Fish are accepted test species belonging to a certain trophic level, that of the secondary consumers, and they represent an essential component of aquatic ecosystems

- '

->see explanation to item no. 8

•

10Item no. Required data Test guideline Explanation Reasons -8.1.4 Microorganisms

a) Freshwater bacteria, e.g.

Only required for poorly degradable (active) substances, or in timber leachates in GK 3 (not in products used on windows and outer doors) and GK 4, or exposure to seawater. Test results: a) DIN 38412, part 27 -rate of oxygen consumption

Assessment of a possible disruption of aquatic biodegradability dub to toxicity to bacteria

-

Pseudomonas tests, DIN 38412, part 27 or 8, or other methodsb) Marine bacteria, here: luminescent bacteria. DIN 38412, part 34

at various dilutions.DIN 38412, part 8 - Growth-dependent turbidity atvarious test concentrationsb) Intensity of (he luminescence at various dilutions

8.1.5 Others Cf. Guideline 96/12/EEC of 08 March 1996

All known experimental data and test procedures on the toxicity of the active substance(s)/product to other aquatic organisms must be named. In case of specific indications (active substance adsorbs strongly to the sediment and has a toxic effect on reproduction in daphnia), a test e.g. on sediment-dwelling organisms such as chironomids maybe required for approval of tlie product in GK 4

If, for instance, sediment-dwelling organisms are exposed to the substance and this constitutes a risk, appropriate tests are required to investigate of the matter

8.1.6 Other experience ---

8.2 Terrestrial organisms The results of the toxicity tests should provide information on possible harmful effects of product components on terrestrial organisms, singly and/or in combination. The individual active substances should be tested first

Cf. item no.8

8.2.1 Invertebrates OECD Guideline 207 or Guideline 88/302/EEC

ISO/DIS 11268-2

A test on the acute effects of the active substance(s) on earthworms is compulsory (core data set). If the product is to be licensed for use in GK 3 (not in products used on windows and outer doors) and GK 4 (possible ground contact), then a test of the product or product components (leachate) is required (cf. 8.1.2).->see explanation to item no. 8If the results of the acute test do not preclude a risk to earthworms, then an earthworm reproduction test with the product may be required

Earthworms are accepted test species belonging to a certain trophic level (consumers/decomposers), and they represent an essential component of terrestrial ecosystems

11Item no. Required data Test guideline Explanation Reasons8.2.2 Plants OECD Guideline 208 A test on the effects of the active substance(s) on

plant growth is compulsory (core data set). If the product is to be applied to timber for use in gardening or agriculture, then suitable tests with the product/ leachate/timber may be required; the tests must be agreed upon with the regulatory agencies.-> see explanation to item no. 8

Plants belong to the trophic level of the producers, and they represent an essential component of terrestrial ecosystems

8.2.3 Microorganisms If active substance is also employed in pesticides: BBA Guideline part VI, 1-1. .

The result of the BBA test provides information on the effects of the product on the soil microflora.The results of DIN efficacy tests only describe

Serves to assess a possible impairment of terrestrial biodegradability due to toxicity to bacteria, as well as being an independent criterion with

Else: DIN EN 252 andDIN V ENV 807

efficacv in the wood. It is necessary to examine whether a method for the determination of the effects on microorganisms in the soil needs to be developed

respect to steps for the protection of the soil microflora

8.2.4 Bats —*• Fed. LawGaz.-BGBl. -1/ 1106-1112, 21 July 1993 This stresses the special protection of bats!8.2.5 Others Guideline 96/ 12/EEC of 08 All known experimental data on the toxicity of the - > '

March 1996 active substance(s) to non-target organisms (e.g. toxicity to birds) must be named

8.2.6 Other experience —- —- ' —

8.3 Overall evaluation " Overall evaluation based on the data in 8.1 and 8.2, considering all relevant data from the international literature known to the applicant, if these may contribute to the assessment of the effects of the active substance (s) or formulation on terrestrial organisms

Overall evaluation of all test species investigated is necessary for a comprehensive assessment of the preparation, because a product may have different effects on different organisms

9. Waste disposal --- - ' — — .9.1 Dumping Tech. Guideline Municipal

Solid Waste (TA Siedlungs- abfall: particularly appendixB - classification criteria for dumping), Federal Gazette - BAnz. - 99 a of 14 May 1993. Tech. Guideline on Special Waste (TA Sonderabfall, part 1, particularly appendix D - classification criteria for dumping above-ground),Joint Ministerial Gazette - GMBl. -No.8 (1991) p.139

In the case of domestic wastes and similar wastes of commercial origin.

In the case of wastes that require special monitoring (special wastes) , -

12Item no. Required data Test guideline Explanation Reasons9.1.1 Possibly teachable .

transformation and degradation products in the dumping site

Analysis methods according to 2.4 appendix A, Technical Guideline on MunicipalSolid Waste (TA Siedlungsabfall)

9.2 Waste incineration see K. Clausen, M. Herrmann & E.D. Pick: Labor- Verbrennungsversuche zur thermischen Behandlung von Pflanzenschutzmittel-Resten (Laboratory incineration experiments on the thermic treatment of pesticide residues), UWSF 4(3), 136-145 (1992)

Possible formation of environmentally relevant combustion products

9.2.1 Incineration products (as emissions) .

17th Federal Ordinance on Immission Control (17. BImSchV, BGBl. especially §3 and §5), Federal Law Gazette 1 1990, p. 2545

--- .

9.2.2 Leachable incineration products (as residues)

Analysis methods according to 2.4 appendix A, Technical Guideline on MunicipalSolid Waste (TA Siedlungsabfall)

_ '

9.3 Recommendations for disposal

In the case of wastes named in appendix C.IV of the Technical Guideline on Wastes part 1 (TA Abfall)

Classification of the waste into a waste category of the Waste Type Catalog; requires the notification of the Waste Control Authority (special waste).

9.3.1 Residues of the wood preservative, contaminated packaging materials / containers

According to legislation on wastes, contaminated materials are regarded in the same way as the contaminants themselves

9.3.2 Treated timber According to legislation on wastes, contaminated materials are regarded in the same way as the contaminants themselves; see: S. Bringezu & A. Vofi: Hin- weise zur Entsorgung von holzschuizmittelbehandel- tem Altholz (Notes on the disposal of timber treated with wood preservatives), Mull und Abfall 10, pp. 727-738 (1993) '

It is necessary to introduce labelling of treated timber, so that it may be disposed of by an appropriate procedure after use .

9.4 Overall evaluation Summary of the facts in section 9 . - mmm . "10. Overall evaluation - For all relevant sections 1 to 9

1

Referenced test guidelines for the application procedure for wood preservativest '

1.5: Density

OECD Guideline 109: 'OECD Guidelines for Testing of Chemicals "Density of Liquids and Solids", adopted 27.07.1995;

OECD (Organisation for Economic Co-operation and Development), Paris 1993

Annex to Commission Directive 92/69/EEC of July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; Part A: Methods for the determination of physico-chemical properties, A.3: Relative density. Official Journal of the European Communities L 383,29.12.1992

Collaborative International Pesticides Analytical Council: CIPAC Handbooks 1 (1970), 1A (1980), 1 B (1983), C (1985), D (1988), E (1993), F (1995) and G (1995), Analysis of Technical and Formulated Pesticides, Black Bear Press, Cambridge

1.11.1: Flash point

Official Journal of the European Communities L 383,29.12.1992, A.9

. 3.12: Melting point .

OECD Guideline 102: 'OECD Guidelines for Testing of Chemicals "Melting Point / Melting Range", adopted 27.07.1995

Official Journal of the European Communities L 383,29.12.1992, A. 1

3.13: Boiling Point ‘

OECD Guideline 103:OECD Guidelines for Testing of Chemicals "Boiling Point / Boiling Range", adopted 27.07.1995


3.14: Density

, see 1.5 ,

. 3.15: yapour pressure • .

OECD Guideline 104:OECD Guidelines for Testing of Chemicals "Vapour Pressure Curve", adopted 27.07.1995


3.17: Solubility in water

OECD Guideline 105: ■OECD Guidelines for Testing of Chemicals "Water Solubility", adopted 27.07.1995

Official Journal of the European Communities L 383,29.12.1992, A.6\

3.18: Solubility in solvents

Deutscher Arbeitskreis fur Pfianzenschutzanalydk (DAPA)

( 2

3.19: Surface tension . .OECD Guideline 115: 'OECD Guidelines for Testing of Chemicals "Surface Tension of Aqueous Solutions", adopted

27.07.1995 . , •


3.20: Partition coefficient P„w

OECD Guideline 107 or 117: .107: OECD Guidelines for Testing of Chemicals "Partition Coefficient (n-octanol/water): Shake Flask

Method", adopted 27.07.1995 _117: OECD Guidelines for Testing of Chemicals "Partition Coefficient (n-octanol/water): HPLC

Method", adopted 30.03.1989


3.21: Dissociation constant pK, ,

OECD Guideline 112: . -OECD Guidelines for Testing of Chemicals "Dissociation Constants in Water", adopted 12.05.1981 -

3.22: Hydrolysis as a function of pH • 1

OECD Guideline 111: . ,OECD Guidelines for Testing of Chemicals "Hydrolysis as a Function of pH", adopted 12.05.1981

Official Journal of the European Communities L 383,29.12.1992, A.7 -

3.23: UV/VIS absorption spectrum

OECD Guideline 101: 'OECD Guidelines for Testing of Chemicals "UV-VIS Absorption Spectra", adopted 12.05.1981 .

3.24: Thermal stability ,

OECD Guideline 113:OECD Guidelines for Testing of Chemicals "Screening Test for Thermal Stability and Stability in Air",

adopted 12.05.1981 .

3.25: Photolytic stability '

Guidance Document on Direct Phototransformation of Chemicals in Water, OECD, Paris, 1997

3.26: Photochemical oxidative degradation

OECD Environment Monograph No.61 "The Rate of Photochemical. Transformation of Gaseous Organic Compounds in Air under Tropospheric Conditions". OECD, Paris, 1992

6.1: Evaporation from treated timber .DIN VENY 1250-1: ’"Verfahren zur Bestimmung derAbgabe von Wirkstoffen und anderen Schutzmittelbestandteilen aus

behandeltem Holz, Teil 1 '.Laboratoriumsverfahren zur Gewinnung von Analysenproben zur Bestimmung der Abgabe durch Verdunstung"; Deutsches Institut fur Normung, Berlin 1995

3

6.2: Leaching from treated timber

Determination of the potential ecotoxicity of leachates of timber treated with wood preservatives (draft), see annex 1

7.1.1: Adsorption/desorption to soil

OECD Guideline 106:OECD Guidelines for Testing of Chemicals "Adsorption - Desorption Using a Batch Equilibrium Method", adopted 21. January 2000

7.1.2: Degradation, transformation and metabolism in the soil

BBA Guideline, part IV, 4-1:Richtlinien fur die amtliche Prujung von Pflanzenschutzmitteln, TeilW, 4-1, Verbleib von Pflanzen

schutzmitteln jm Boden -Abbau, Umwandlung undMetabolismus; Biologische Bundesanstalt fur Land- und Forstwirtschaft, Braunschweig, December 1986

7.2.1: Elimination by adsorption to sewage sludge

UBA Guideline proposal, April 1996: Adsorption/Desorption organischer Chemikalien an Klar- schlammen

7.2.2: Degradability in the aquatic environment (freshwater)

OECD Guideline 301:OECD Guideline for Testing of Chemicals "Ready Biodegradability", adopted 17.07.1992

- 301 A, DOC Die - away Test- 301 B, C02 Evolution Test -301 C, Modified MTHTest (I)- 301D, Closed Bottle Test

• - 301E, Modified OECD Screening Test; - 301 F, Manometric Respirometry Test -

OECD Guideline 302 B: ,OECD Guideline for Testing of Chemicals "Zahn-Wellens/ EMPA Test", adopted 17.07.1992

OECD Guideline 302 C:OECD Guideline for Testing of Chemicals "Inherent Biodegradibility: Modified Mil l Test (II)",

adopted 12.05.1981

BBA Guideline, part IV, 5-1:Richtlinien fur die Prujung von Pflamenschutzmitteln im Zulassungsverfahren, TeilW, 5-1, Abbau-

barkeit und Verbleib von Pflanzenschutzmitteln im Wasser/Sediment-System; Biologische Bundes anstalt fur Land- und Forstwirtschaft, Braunschweig, December 1990

7.2.3: Degradation in seawater

OECD Guideline 306: .OECD Guidelines for Testing of Chemicals "Biodegradability in Seawater", adopted 17.07.1992 OECD (Organisation for Economic Co-operation and Development), Paris, 1992

7.3: Bioaccumulation

OECD Guideline 305:

4

OECD Guidelines for Testing of Chemicals, Proposal for Updating Guideline 305, Bioconcentration: Flow-through Fish Test, adopted 14.06.1996 -

8.1.1: AlgaeCommission Directive 92/69/EEC of July 1992 adapting to technical progress for the seventeenth time

Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; annex V, Methods for the determination of physico-chemical properties, toxicity and ecotoxicity; part C.3: Algal inhibition test. Official Journal of the European Communities L 383 A/179-186, 29.12.1992

OECD Guideline 201:OECD Guidelines for Testing of Chemicals, "Alga, Growth Inhibition Test", adopted 07.06.1984

DIN 38412, part 33, Testverfahren mit Wasserorganismen (GruppeL), Bestimmung der nicht giftigen Wirkungvon Abwasser gegenuber Grunalgen (Scenedesmus-Chlorophyll-Fluoreszenztest) uber Verdunnungsstufen (L 33)), March 1991. .

Seawater: ISO/DIS 10253.2, Water quality - Marine algal growth inhibition test with Skeletonema costatum and Phaeodactylum tricomutum, 1994 '

8.1.2: Daphnia

OECD Guideline. 202:OECD Guidelines for Testing of Chemicals, "Daphnia spec.; Acute Immobilisation Test”, Draft

Proposal For Updating Guideline 202, Draft Document, July 1999

OECD Guideline 211:OECD Guidelines for Testing of Chemicals, “Daphnia magna Reproduction Test”, Proposal For .

Updated Guideline 211, Draft 1998, adopted 2l. November 1998 -

Commission Directive 92/69/EEC of July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; annex V, Methods for the determination of physico-chemical properties, toxicity and ecotoxicity; part C.2: Acute toxicity for Daphnia. Official Journal of the European Communities L 383 A/172-178, 29.12.1992 "

DIN 38412, part 30, Testverfahren mit Wasserorganismen (Gruppe L), Bestimmung der nicht akut giftigen Wirkungvon Abwasser gegenuber Daphnien uber Verdunnungsstufen (L 30), March 1989

Seawater ISO/CD 14669, Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda, Crustacea), 1996

EPA-660/3-75-009, Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians, April 1975 . -

8.1.3: Fish

OECD Guideline 203:OECD Guidelines for Testing of Chemicals, "Fish, Acute Toxicity Test", adopted 17.07.1992

Commission Directive 92/69/EEC of July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative . provisions relating to tire classification, packaging and labelling of dangerous substances; annex V, Methods for the determination of physico-chemical properties, toxicity and ecotoxicity; part C.l: Acute toxicity for fish. Official Journal of the European Communities L 383 A/163-171,29.12.1992

OECD Guideline 204:OECD Guidelines for Testing of Chemicals, "Fish, Prolonged Toxicity Test, 14-Day Study”, adopted

04.04.1984 .

OECD Guideline 210:OECD Guidelines for Testing of Chemicals, "Fish, Early-Life Stage Toxicity Test", adopted17.07.1992

DIN 38412, part 31, Testverfahren mit Wasserorganismen (Gruppe L), Bestimmung der nicht akut giftigen Wirkung von Abwasser gegenuber Fischen fiber Verdfinnungsstufen (L 31), March 1989

' Seawater: EPA-660/3-75-009, Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians, April 1975

OECD Guideline 210: 'OECD Guidelines for Testing Chemicals; "Fish, Early-Life Stage Toxicity Test", adopted 17.07.1992

8.1.4: Microorganisms ’

Freshwater bacteria: e.g. DIN 38412, part 27:Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung; Testverfahren mit

Wasserorganismen (Gruppe L); Bestimmung der Hemmwirkung von Abwasser auf den .Sauerstqffverbrauch von Pseudomonas putida (Pseudomonas-Sauerstoffverbrauchshemmtest) (L 27); November 1992

Seawater: DIN 38412. part 34: •Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung; Testverfahren mit

Wasserorganismen (Gruppe I); Bestimmung der Hemmwirkung von Abwasser auf die Lichtemission von Photobacterium phosphoreum -Leuchtbakterien-AbwassertestmitkonserviertenBakterien (L 34); March 1991; along with DIN 38412, part 341, Erweiterung des Verfahrens DIN38412 - L 34 ( , L 341), October 1993 .

8.1.5: Others • ‘

- Commission Directive 96/12/EEC of March 1996 adapting Council Directive 91/414/EEC on the: Placing of the Market of Pesticides, annex I: Ecotoxicological studies. Official Journal of the

European Communities L 65/21-27 •

8.3.1: Invertebrates »

OECD Guideline 207:OECD Guidelines for Testing of Chemicals, "Earthworm, Acute Toxicity Test", adopted 04.04.1984

OECD Guideline for Testing of Chemicals, “Earthworm Reproduction Test (Eisenia fetida / andrei)”,Proposal for a new Guideline, Draft January 2000

Commission Directive 88/302/EEC of November 1987 adapting to technical progress for the ninth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; annex V, Methods for the determination of physico-chemical properties, toxicity and ecotoxicity; part C: Toxicity for earthworms: test in artificial soil. Official Journal of the European Communities L 133/95-98, 30.05.1988

ISO/DIS 11268-2, Soil Quality - Effects of pollutants on earthworms (Eisenia fetida), Part 2, Method for the determination of effects on reproduction, 1993 ,

6

8.3.2: Plants - ’ :

OECD Guideline 208:OECD Guidelines for Testing of Chemicals, "Terrestrial Plants, Growth Test", adopted 04.04.1984

OECD Guideline for Testing of Chemicals, “Terrestrial (non-target) plant testing: (Part A) Seedling Emergence Test and (Part B) Vegetative Vigour Test”, Proposal for revision of guideline 208, Draft June 1999

• < "

8.3.3: Microorganisms

BBA Guideline, part VI, 1-1: 1Richtliniefur die amtliche Prufimg vohPflanzenschutzmitteln, Teil VI, 1-1,zweite Auflage, Auswirk-

vngen auf die Aktivitdt der Bodenmikroflora; Biologische Bundesanstalt fur Land- und Forstwirt- schaft, Braunschweig, March 1990

DIN EN 252: , 'Freiland-Prufverfahren zur Bestimmung det relativen Schutzwirkung eines Holzschutzmittels im

Erdkontakt, April 1990

DINVENV 807: ,Wood preservatives - preliminary norm (bluebook); Prufverfahren fur die Bestimmung der Grenze der

Wirksamkeit gegen Moderfaule und andere erdbewohnende Mikroorganismen\ May 1994■ _ . ■ X • . '

8.3.4: Others

Commission Directive 96/12/EC of March 1996 adapting Council Directive 91/414/EEC on the Placing of the Market of Pesticides, annex I: Ecotoxicological studies. Official Journal of the European Communities L 65/21-27 -

9.1: Dumping . -

" a) Dritte Allgemeine Verwaltungsvorschrifi zum Abfallgesetz (TA Siedlungsabfall): Technische: Anleitung zur Verwertung, Behandlung und sonstigen Entsorgung von Siedlungsabfallen. 14 May

1993 (BAnz.Nr.99 a, 1993) "

b) Zweite Allgemeine Verwaltungsvorschrifi zum Abfallgesetz (TA Sonderabfall), Teil 1: Technische Anleitung zur Lagerung, chemisch/physikalischen, biologischen Behandlung, Verbrennung und Ablagerungvon besonders uberwachungsbedurftigen Abfallen. 12 March 1991. (GMB1.1991, Nr.8, p.139)

9.1.1: Possibly teachable transformation and degradation products within the dumping site

a) Dritte Allgemeine Verwaltungsvorschrifi zum Abfallgesetz (TA Siedlungsabfall): Anhang A Nr. 2.4mtiAhhang B, Technische Anleitung zur Verwertung, Behandlung und sonstigen Entsorgung von Siedlungsabfallen. 14 May 1993 (BAnz. Nr.99 a, 1993). (Leaching procedure, analysis methods and classification criteria for dumping) ■

b) Zweite Allgemeine Verwaltungsvorschrifi zum Abfallgesetz ( TA Sonderabfall), Teil 1: Anhang B mit Anhang D, Technische Anleitung zur Lagerung, chemisch/physikalischen, biologischen

. Behandlung, Verbrennung und Ablagerung von besonders uberwachungsbedurftigen AbfSillen.12 March 1991 ( GMB1. Nr. 8, p. 139, 1991). (Sampling, leaching procedure, analysis methods and classification criteria for dumping above-ground).

7

9.2.1: Incineration products as emissions

Siebzehnte Verordnung zur Durchfuhrung des Bundesimmissionsschutzgesetzes (Verordnung uber- Verbremungsanlagen JurAbfalle und ahnliche brennbare Stoffe-17.BImSchV). 23 November 1990 (BGB1.1 Nr.64, p. 2545), (in particular § 5,17. BImSctiV, emission limits).

9.2.2: Leachable incineration products as residues

Dritte Allgemeine Verwaltungsvorschriftzum Abfallgesetz (TA Siedlungsabfall): AnhangANr. 2.4 mitAnhang B, Technische Anleitung zur Verwertung, Behandlung und sonstigen Entsorgung von Siedlungsabfallen. 14 May 1993 ( BAnz.Nr.99 a, 1993 ). (Leaching procedure, analysis methods and classification criteria for dumping).

9.3: Recommendations for disposal

Zweite Allgemeine Verwaltungsvorschrift zum Abfallgesetz (TAAbfall), Teil 1: Technische Anleitung zur Lagerung, chemisch/physikalischen, biologischen Behandlung, Verbrennung und Ablagerung von besonders uberwachungsbedUrftigenAbfdllen. 12 March 1991. (GMB1.1991, Nr.8, p. 139)

iff a-'. Aids*#