Copper pyrithione CAS Active substance in Biocidal Products Product Type 21 (Antifouling products)

Size: px

Start display at page:

Download "Copper pyrithione CAS Active substance in Biocidal Products Product Type 21 (Antifouling products)"

Amy Osborne
6 years ago
Views:

Competent Authority Report According to Directive 98/8/EC CAS 14915378 Active substance in Biocidal Products Product Type 21 (Antifouling products)

1 Competent Authority Report According to Directive 98/8/EC CAS Active substance in Biocidal Products Product Type 21 (Antifouling products) Applicant: Arch Chemicals Inc. DOCUMENT III A Sections 1 3: Applicant, Identity and Physical and Chemical Properties Rapporteur Member State: Sweden

2 Table of Contents; DOC illa Sections 13 Section Al Applicant... 3 Section A2 Identity of Active Substance Section A2. l 0 Exposure data in confonuity with Annex VIIA to Council Directive 92/32/EEC (OJ No L, , p. 1) amending Com1cil Directive 67/548/EEC Justifications for nonsubmission of data m1der ~.6 Dissociation constant... 3 Deleted: Reference list of studies submitted (by Section No.)... 3 Deleted: Reference list of studies submitted (by Author)... ~ 2(39)

3 Doc III A1A3 Section Al Applicant Annex Points HA, I.1.1 to Applicant Arch Chemicals Inc. c/o Arch UK Biocides Ltd. Wheldon Road Castleford WFl 0 2JT United Kingdom 1.2 Manufacturer of Active Substance (if different) Name: 1.3 Manufacturer of product(s) (if different) 3(39)

4 Doc III A1 A3 Section A2 Annex Points IIA, II.2.1 to 2.9 Identity of Active Substance Subsection 2.1 Common name (IIA2.1) 2.2 Chemical name (IIA2.2) 2.3 Manufacturer s development code number(s) (IIA2.3) 2.4 CAS No and EC numbers (IIA2.4) copper pyrithione copper pyridinethione CASNo ECNo copper 2pyridinethiol1oxide 2pyridinethiol1oxide, copper salt copper Omadine (registered trademark of Arch Chemicals, Inc.) IUPAC: bis(1hydroxy1hpyridine2thionatoo,s)copper CAS: copper, bis[1hydroxy2(1h)pyridinethionatoo,s] Arch development code: Official use only X Other None 2.5 Molecular and structural formula, molecular mass (IIA2.5) Molecular formula C 10H 8N 2O 2S 2Cu Structural formula N + S O Cu O S N Molecular mass g/mol 2.6 Method of manufacture of the active substance (IIA2.1) 2.7 Specification of the purity of the active substance, as appropriate (IIA2.7) Confidential information, see Annex Confidential Data and Information >95% w/w 5 Batch analysis > 96.2 % w/w X2 2.8 Identity of impurities and additives, as appropriate (IIA2.8) Confidential information, see Annex Confidential Data and Information 4(39)

5 Doc III A1A3 Section Al Annex Points HA, to 2.9 Identity of Active Substance Isome1ic composition 2.9 The origin of the natural active substance 01 the precursor(s) of the active substanc.e (IIA2.9) Not applicable Not applicable Evaluation by Competent Authorities Date Materials and methods Conc.lusion EVALUATION BY RAPPORTEUR MEMBER STATE Reliability Acceptability Rema1 ks 5(39)

6 Doc III A 1A3 Section A2.10 Annex Points HA, Exposure data in conformity with Annex VIIA to Council Directive 92/32/EEC (OJ No L, , p. 1) amending Council Directive 67 /548/EEC Subsection Human exposure towa1 ds active substance Production i) Description of process Active substanc.e CPT is manufactured The site is registered tmder the Pollution Prevention and Control Regulations in Ireland. [CONFIDENTIAL INFORMATION EXCLUDED] Official use only Xl ii) Workplace description iii) Inhalation exposure iv) Dermal exposure Active substance [CONFIDENTIAL INFORMATION EXCLUDED] Active substanc.e [CONFIDENTIAL INFORMATION EXCLUDED] Active substanc.e [CONFIDENTIAL INFORMATION EXCLUDED] Xl Xl Xl Intended use(s) 1. Professional Users i) Description of application process ii) Workplace description iii) Inhalation exposure iv) Denna! exposure 2. Nonprofessional Users including the general public (i) via inhalational contact (ii) via skin contact For details please refer to Document IIB_S, IIC_ l 2 and Document IIIB5 For details please refer to Document IIB _ 8, IIC _ 12 and Document IIIB5 For details please refer to Document IIB_S, IIC_ l 2 and Document IIIB5 For details please refer to Document IIB _ 8, IIC _ 12 and Document IIIB5 For details please refer to Document IIB_S, IIC_ 12 and Document IIIB5 For details please refer to Document IIB_S, IIC_12 and Document IIIB5 (iii) via drinking CPT is not expected to be found in drinking water. For details please water refer to document II B chapter (39)

7 Doc III A1 A3 Section A2.10 Annex Points IIA, II.2.10 Exposure data in conformity with Annex VIIA to Council Directive 92/32/EEC (OJ No L, , p. 1) amending Council Directive 67/548/EEC (iv) via food (v) indirect viaenvironment CPT is not intended to be used during food production, food processing and in areas where food in transported and, stored. This is also the case for feeding stuffs. Thus, humans are not expected to be exposed to CPT via food. For details please refer to Document IIB_8, IIC_12 and Document IIIB Environmental exposure towards active substance Production (i) Releases into water (ii) Releases into air (iii) Waste disposal [For some more detailed information see Dossier preparation relating to the exposure assessment of biocidal products and the relevant Emission scenario documents. In addition the Technical Guidance Document for the Risk Assessment should be consulted.] Active substance [CONFIDENTIAL INFORMATION EXCLUDED] Active substance [CONFIDENTIAL INFORMATION EXCLUDED] Waste disposal Active substance [CONFIDENTIAL INFORMATION EXCLUDED] X1 X1 X Intended use(s) Affected compartment(s): water sediment air soil Predicted concentration in the affected compartment(s) water sediment For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document IIIB5 For details please refer to Document IIB_8, IIC_13 and Document 7(39)

8 Doc III AlA3 Section A2.10 Annex Points HA, Exposure data in conformity with Annex VIIA to Council Directive 92/32/EEC (OJ No L, , p. 1) amending Council Directive 67 /548/EEC au soil IIIB5 For details please refer to Document IIB _ 8, IIC _ 13 and Document IIIB5 For details please refer to Document IIB_8, IIC_l 3 and Document IIIB5 Evaluation by Competent Authorities EVALUATION BY RAPPORTEUR MEMBER STATE Date Materials and methods Conclusion Reliability Acceptability Remaiks 8(39)

9 Doc III A1 A3 Sample table: Table A2.10: Workplace exposure / Inhalation exposure (use addtional terminology from the TNsGs on Human exposure Exposure scenario Workplace operation PPE Year(s) of measurement Production Emptying, filling, weighing Gloves Number of measurements Type of measurements personal, TWA Formulation Cleaning Protective coverall area, shortterm Application MG../PT.. Brushing Gloves, goggles Exposure concentration 9(39)

10 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) 3.1 Melting point, boiling point, r elative density (IIA3.1) Method Purity/ Results Remarks/ Specification Justification GLP Reliability Refer ence Official (YIN) use only Melting point Boiling point I I I I II Bulk density/ relative density 10(39)

11 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmity/ Specification Results Remarks/ Justification GLP (YIN) Reliability Reference Official use only 3.2 Vapour pressure (IIA3.2) 11 (39)

12 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmity/ Specification Results Remarks/ Justification GLP (YIN) Reliability Reference Official use only 12(39)

13 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.3 Appearance (IIA3.3) Physical state Colour Odom 13(39)

14 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) 3.4 Absorption spectra (IIA3.4) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 14(39)

Doc III AlA3 Annex Points IIA, III.3.1.1 to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.

15 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point)..,_... Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.5 Solubility in wate1 (IIA3.5) 15(39)

16 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.6 Dissociation constant () 16(39)

17 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 17(39)

18 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) 3.7 Solubility in organic solvents, includin~ the effect of temperatm e on solubility (IIIA3.1) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.8 Stability in organic solvents used in b.p. and identity of relevant breakdown products (IIIA3.2) 18(39)

19 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Refer ence Official (YIN) use only 3.9 Partition coefficient noc.tanol/water (IIA3.6) 19(39)

20 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.10 Thermal stability, identity of relevant b1 eakdown products 20(39)

21 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) (IIA3.7) Method Pmity/ Specification Results Remarks/ Justification GLP (YIN) Reliability Reference Official use only 21(39)

22 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) 3.11 Flammability, including autoflammability and identity of combustion products (IIA3.8) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.12 Flashpoint (IIA3.9) 3.13 Surface tension (IIA3.10) I 22(39)

23 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 3.14 Viscosity () 3.15 Explosive properties (IIA3.11) 3.16 Oxidising prope1 ties (IIA3.12) 3.17 Reactivity towards container material (IIA3.13) 23(39)

24 Doc III AlA3 Annex Points IIA, III to 3.13, Annex Points IIIA, III.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Subsection (Annex Point) Method Pmi ty/ Results Remarks/ Specification Justification GLP Reliability Reference Official (YIN) use only 24(39)

25 Doc III AlA3 25(39)

26 Doc III AlA3 26(39)

27 Doc III AlA3 27(39)

28 Doc III AlA3 28(39)

Doc III AlA3 Annex Points HA, III.3.1.1 to 3.13, Annex Points IDA, 111.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.

29 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Evaluation by Competent Authorities EVALUATION BY RAPPORTEUR MEMBER STATE Date Evaluation of data submitted under section A3 29(39)

30 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

31 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

32 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

33 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

34 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

Doc III AlA3 Annex Points HA, III.3.1.1 to 3.

35 Doc III AlA3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point (39)

Doc III A1A3 Annex Points HA, III.3.1.1 to 3.13, Annex Points IDA, 111.1 to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.

36 Doc III A1A3 Annex Points HA, III to 3.13, Annex Points IDA, to 2 and TnsG Chapter 3, Pa1 t A, Point 3.6 and Point 3.14 Justifications for nonsubmission of data under.6 TnsG Chapter 3, Part A, Point 3.6 Dissociation constant JUSTIFICATION FOR NONSUBMISSION OF DATA Official use only Detailed justification: 36(39)

37 Doc III AlA3.6 TnsG Chapter 3, Part A, Point 3.6 Dissociation constant Evaluation by Competent Authorities Date Evaluation of applicant's justification EVALUATION BY RAPPORTEUR MEMBER STATE Conclusion Remarks 37(39)

38 Doc III A1 A3 Reference list of studies submitted (by Section No.) See document I 38(39)

39 Doc III A1 A3 Reference list of studies submitted (by Author) Se document I. 39(39)

Biocides Submission Manual

MANUAL Biocides Submission Manual Technical guide: using IUCLID 2 Biocides Submission Manual Version 4.0 BSM Technical guide: using IUCLID Reference: ECHA-14-B-21-EN Catalogue number: ISBN: DOI: Publ.