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ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL Committee for Risk Assessment RAC Annex 1 Background document to the Opinion proposing harmonised classification and labelling at Community level of amines, coco alkyl ECHA/RAC/CLH-O-0000002195-77-01/A1 EC number: 262-977-1 CAS number: 61788-46-3 Adopted 2 December 2011 1 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL CONTENTS PROPOSAL FOR HARMONISED CLASSIFICATION AND LABELLING............................................................7 JUSTIFICATION.........................................................................................................................................................10 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES.................................10 1.1 Name and other identifiers of the substance...................................................................................................10 1.2 Composition of the substance.........................................................................................................................10 1.3 Physico-chemical properties...........................................................................................................................11 2 MANUFACTURE AND USES..............................................................................................................................15 3 CLASSIFICATION AND LABELLING...............................................................................................................15 3.1 Classification in Annex I of Directive 67/548/EEC........................................................................................15 3.2 Classification in Annex VI of Regulation (EC) 1272/2008............................................................................15 3.3 Self classification............................................................................................................................................15 4 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................16 4.1 Degradation....................................................................................................................................................16 4.1.1 Stability...............................................................................................................................................16 4.1.2 Biodegradation....................................................................................................................................16 4.1.2.1 Biodegradation estimation.....................................................................................................16 4.1.2.2 Screening tests.......................................................................................................................16 4.1.2.3 Simulation tests.....................................................................................................................18 4.1.3 Summary and discussion of persistence..............................................................................................18 4.2 Environmental distribution.............................................................................................................................18 4.2.1 Adsorption/desorption.........................................................................................................................18 4.2.2 Volatilisation.......................................................................................................................................18 4.2.3 Distribution modelling........................................................................................................................18 4.3 Bioaccumulation.............................................................................................................................................19 4.3.1 Aquatic bioaccumulation.....................................................................................................................19 4.3.1.1 Bioaccumulation estimation..................................................................................................19 4.3.1.2 Measured bioaccumulation data............................................................................................19 4.3.2 Terrestrial bioaccumulation.................................................................................................................22 4.3.3 Summary and discussion of bioaccumulation.....................................................................................23 4.4 Secondary poisoning.......................................................................................................................................23 5 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................24 5.1 Toxicokinetics (absorption, metabolism, distribution and elimination).........................................................27 5.1.1 Summary of toxicokinetics, metabolism and distribution...................................................................27 5.1.1.1 Absorption.............................................................................................................................27 5.1.1.2 Distribution...........................................................................................................................28 5.1.1.3 Metabolism............................................................................................................................28 5.1.1.4 Excretion...............................................................................................................................28 5.2 Acute toxicity.................................................................................................................................................28 2 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL 5.2.1 Acute toxicity: oral..............................................................................................................................28 5.2.1.1 Amines, coco alkyl................................................................................................................28 5.2.1.2 Amines, tallow alkyl.............................................................................................................30 5.2.1.3 Amines, hydrogenated tallow alkyl.......................................................................................30 5.2.1.4 Octadecylamine.....................................................................................................................31 5.2.1.5 (Z)-Octadec-9-enylamine......................................................................................................31 5.2.2 Acute toxicity: inhalation....................................................................................................................32 5.2.2.1 Amines, coco alkyl................................................................................................................32 5.2.2.2 Amines, tallow alkyl.............................................................................................................32 5.2.2.3 Amines, hydrogenated tallow alkyl.......................................................................................32 5.2.2.4 Octadecylamine.....................................................................................................................33 5.2.2.5 (Z)-Octadec-9-enylamine......................................................................................................33 5.2.3 Acute toxicity: dermal.........................................................................................................................33 5.2.3.1 Amines, coco alkyl................................................................................................................33 5.2.3.2 Amines, tallow alkyl.............................................................................................................33 5.2.3.3 Amines, hydrogenated tallow alkyl.......................................................................................34 5.2.3.4 Octadecylamine.....................................................................................................................34 5.2.3.5 (Z)-Octadec-9-enylamine......................................................................................................34 5.2.4 Acute toxicity: other routes.................................................................................................................34 5.2.4.1 Aspiration hazard..................................................................................................................34 5.2.5 Summary and discussion of acute toxicity..........................................................................................35 5.2.5.1 Oral........................................................................................................................................35 5.2.5.2 Inhalation...............................................................................................................................36 5.2.5.3 Dermal...................................................................................................................................36 5.2.5.4 Aspiration..............................................................................................................................36 5.3 Irritation..........................................................................................................................................................37 5.3.1 Skin.....................................................................................................................................................37 5.3.1.1 Amines, coco alkyl................................................................................................................37 5.3.1.2 Amines, tallow alkyl.............................................................................................................39 5.3.1.3 Amines, hydrogenated tallow alkyl.......................................................................................41 5.3.1.4 Octadecylamine.....................................................................................................................43 5.3.1.5 (Z)-Octadec-9-enylamine......................................................................................................45 5.3.2 Eye.......................................................................................................................................................46 5.3.2.1 Amines, coco alkyl..............................................................................................................................46 5.3.2.2 Amines, tallow alkyl............................................................................................................................46 5.3.2.3 Amines, hydrogenated tallow alkyl.....................................................................................................46 5.3.2.4 Octadecylamine...................................................................................................................................46 5.3.2.5 (Z)-Octadec-9-enylamine....................................................................................................................47 5.3.3 Respiratory tract..................................................................................................................................47 5.3.4 Summary and discussion of irritation..................................................................................................47 5.3.4.1 Skin irritation.......................................................................................................................................47 5.3.4.2 Eye irritation........................................................................................................................................48 5.3.4.3 Respiratory irritation...........................................................................................................................48 5.4 Corrosivity......................................................................................................................................................48 5.5 Sensitisation....................................................................................................................................................48 5.5.1 Skin.....................................................................................................................................................48 5.5.1.1 Human data...........................................................................................................................48 5.5.1.2 Animal data...........................................................................................................................49 5.5.2 Respiratory system..............................................................................................................................50 5.5.3 Summary and discussion of sensitisation............................................................................................50 5.6 Repeated dose toxicity....................................................................................................................................50 5.6.1 Repeated dose toxicity: oral................................................................................................................51 5.6.1.1 Amines, coco alkyl................................................................................................................51 5.6.1.2 Amines, tallow alkyl.............................................................................................................51 5.6.1.3 Amines, hydrogenated tallow alkyl.......................................................................................53 5.6.1.4 Octadecylamine.....................................................................................................................54 3 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL 5.6.1.5 (Z)-Octadec-9-enylamine......................................................................................................56 5.6.2 Repeated dose toxicity: inhalation.......................................................................................................57 5.6.3 Repeated dose toxicity: dermal...........................................................................................................58 5.6.3.1 Amines, coco alkyl................................................................................................................58 5.6.3.2 Amines, tallow alkyl.............................................................................................................58 5.6.3.3 Amines, hydrogenated tallow alkyl.......................................................................................58 5.6.3.4 Octadecylamine.....................................................................................................................58 5.6.3.5 (Z)-Octadec-9-enylamine......................................................................................................58 5.6.4 Other relevant information..................................................................................................................59 5.6.5 Summary and discussion of repeated dose toxicity.............................................................................59 5.7 Mutagenicity...................................................................................................................................................62 5.7.1 In vitro data.........................................................................................................................................63 5.7.1.1 Amines, coco alkyl................................................................................................................63 5.7.1.2 Amines, tallow alkyl.............................................................................................................63 5.7.1.3 Amines, hydrogenated tallow alkyl.......................................................................................63 5.7.1.4 Octadecylamine.....................................................................................................................63 5.7.1.5 (Z)-Octadec-9-enylamine......................................................................................................64 5.7.1.6 Other primary alkyl amines...................................................................................................65 5.7.2 In vivo data..........................................................................................................................................65 5.7.2.1 Amines, coco alkyl................................................................................................................65 5.7.2.2 Amines, tallow alkyl.............................................................................................................65 5.7.2.3 Amines, hydrogenated tallow alkyl.......................................................................................65 5.7.2.4 Octadecylamine.....................................................................................................................65 5.7.2.5 (Z)-Octadec-9-enylamine......................................................................................................65 5.7.3 Human data.........................................................................................................................................66 5.7.4 Other relevant information..................................................................................................................66 5.7.5 Summary and discussion of mutagenicity...........................................................................................66 5.8 Carcinogenicity...............................................................................................................................................68 5.8.1 Carcinogenicity: oral...........................................................................................................................68 5.8.1.1 Amines, coco alkyl................................................................................................................68 5.8.1.2 Amines, tallow alkyl.............................................................................................................68 5.8.1.3 Amines, hydrogenated tallow alkyl.......................................................................................68 5.8.1.4 Octadecylamine.....................................................................................................................68 5.8.1.5 (Z)-Octadec-9-enylamine......................................................................................................68 5.8.2 Carcinogenicity: inhalation.................................................................................................................68 5.8.3 Carcinogenicity: dermal......................................................................................................................68 5.8.4 Carcinogenicity: human data...............................................................................................................68 5.8.5 Other relevant information..................................................................................................................68 5.8.6 Summary and discussion of carcinogenicity.......................................................................................69 5.9 Toxicity for reproduction................................................................................................................................69 5.9.1 Effects on fertility................................................................................................................................69 5.9.1.1 Amines, coco alkyl................................................................................................................69 5.9.1.2 Amines, tallow alkyl.............................................................................................................69 5.9.1.3 Amines, hydrogenated tallow alkyl.......................................................................................71 5.9.1.4 Octadecylamine.....................................................................................................................71 5.9.1.5 Octadecenylamine.................................................................................................................71 5.9.2 Developmental toxicity.......................................................................................................................72 5.9.2.1 Amines, coco alkyl................................................................................................................72 5.9.2.2 Amines, tallow alkyl.............................................................................................................72 5.9.2.3 Amines, hydrogenated tallow alkyl.......................................................................................72 5.9.2.4 Octadecylamine.....................................................................................................................72 5.9.2.5 (Z)-Octadec-9-enylamine......................................................................................................72 5.9.3 Human data.........................................................................................................................................74 5.9.4 Other relevant information..................................................................................................................74 5.9.5 Summary and discussion of reproductive toxicity...............................................................................74 5.10 Other effects...................................................................................................................................................76 4 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL 5.11 Derivation of DNEL(s) or other quantitative or qualitative measure for dose response.................................76 6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES..............................77 7 ENVIRONMENTAL HAZARD ASSESSMENT..................................................................................................78 7.1 Aquatic compartment (including sediment)....................................................................................................78 7.1.1 Toxicity test results.............................................................................................................................78 7.1.1.1 Fish........................................................................................................................................78 7.1.1.2 Aquatic invertebrates.............................................................................................................82 7.1.1.3 Algae and aquatic plants........................................................................................................83 7.1.1.4 Sediment organisms..............................................................................................................91 7.1.1.5 Other aquatic organisms........................................................................................................91 7.1.2 Calculation of Predicted No Effect Concentration (PNEC)................................................................91 7.2 Terrestrial compartment..................................................................................................................................91 7.3 Atmospheric compartment..............................................................................................................................91 7.4 Microbiological activity in sewage treatment systems...................................................................................91 7.5 Calculation of Predicted No Effect Concentration for secondary poisoning (PNEC_oral)............................91 7.6 Conclusion on the environmental classification and labelling........................................................................91 JUSTIFICATION THAT ACTION IS REQUIRED ON A COMMUNITY-WIDE BASIS........................................94 OTHER INFORMATION............................................................................................................................................94 REFERENCES.............................................................................................................................................................95 APPENDIX..................................................................................................................................................................104 5 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL TABLES Table 1: Summary of physico-chemical properties......................................................................................................11 Table 2: Screening tests on ready biodegradability......................................................................................................16 Table 3: Growth rates for tallow alkyl amine and coco alkyl amine............................................................................17 Table 4: Comparison of physico-chemical properties influencing bioaccumulation....................................................22 Table 5: Overview of the primary alkyl amines/amine mixtures included in this BD *................................................25 Table 6: Viscosity of alkyl amine mixtures (Source: MSDS).......................................................................................34 Table 7: Scores for erythema/oedema obtained with hydrogenated tallow alkyl amines (‘Lilamin AC-HBG-P’) in female rabbits$..............................................................................................................................................................41 Table 8: Scores for erythema/oedema obtained with octadecylamine (‘Genamin 18 R 100 D’ in female rabbits$......44 Table 9: Overview of repeat-dose studies with primary alkyl amines..........................................................................61 Table 10: Overview of mutagenicity studies with primary alkyl amines......................................................................66 Table 11: Overview of reproduction toxicity studies with primary alkyl amines.........................................................74 Table 12: Most relevant results of toxicity tests using fish...........................................................................................79 Table 13: Most relevant results of acute toxicity tests with aquatic invertebrates........................................................84 Table 14: Most relevant results of toxicity tests with algae..........................................................................................88 Table 15: Decisive criteria for environmental classification........................................................................................92 6 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL PROPOSAL FOR HARMONISED CLASSIFICATION AND LABELLING Substance Name: Amines, coco alkyl EC Number: 262-977-1 CAS number: 61788-46-3 Registration number(s): Purity: > 96 % Impurities: ca. 3.5 % secondary fatty acid amines ca. 0.5 % tertiary fatty acid amines < 0.05 fatty acid nitriles Proposed classification based on Regulation (EC) No 1272/2008 criteria: (cid:1) With regard to human health: With regard to human health, RAC has agreed to include Asp Tox 1; H304 (May be fatal if swallowed and enters airways) in the original proposal by Germany and the resulting classification is: Acute Tox. 4; H302 (Harmful if swallowed) Skin Corr. 1B; H314 (Causes severe skin burns and eye damage) STOT SE 3; H335 (May cause respiratory irritation) Asp Tox. 1; H304 (May be fatal if swallowed ane enters airways) STOT RE 2; H373 (May cause damage to organs (gastro-intestinal tract, liver, immune system) through prolonged or repeated exposure) (cid:1) With regard to the environment: Aquatic Acute 1; H400 (Very toxic to aquatic life) Aquatic Chronic 1; H410 (Very toxic to aquatic life with long lasting effects) Proposed classification based on Directive 67/548/EEC criteria: The coco alkyl amines have already been prioritised under ESR (Regulation No (EEC) 793/93). The group approach and risk assessment were also agreed at a technical level (TCNES). However, the risk evaluation work for this substance was not finalised by 1 June 2008, but reported in a Transitional Dossier to ECHA and the European Commission.1 With regard to human health, the following classification is proposed: 1The work which has been done under the ESR (EEC) No 793/93 is documented in an ANNEX XV Transitional Report including the EU Risk Assessment Report R070_410_412_429_430_0811_ENV_HH.DOC. 2 The results of the TC C&L 04/2006 meeting are documented in the ECBI/92/06 Rev. 1 report of the ECB. 7 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL Xn; R22-48/22; R65 C; R35; Concentration limits: C; R35: C > 10% C; R34: 5% < C < 10% Xi; R36/37/38: 1% < C < 5% The provisional classification with regard to the environment as outlined below has already been agreed at TC C&L 09 2005 and was confirmed at TC C&L 04 2006.2 Classification: N; R50-53 Specific concentration limits: C ≥ 2.5%: N, R50-53, 0.25% ≤ Cn < 2.5%: N, R51-53, 0.025% ≤ Cn < 0.25%: R52-53, Proposed labelling: Acc. to Reg. (EC) No 1272/2008: Pictograms: GHS05 GHS07 GHS08 GHS09 Signal Word: Danger Hazard statements: H302 (Harmful if swallowed) H304 May be fatal swallowed and enters airways H314 (Causes severe skin burns and eye damage) H335 (May cause respiratory irritation) H373 (May cause damage to organs (gastro-intestinal tract, liver, immune system) through prolonged or repeated exposure) H410 (Very toxic to aquatic life with long lasting effects) Precautionary statements: Acc. to Dir. 67/548/EEC: C; N R: 22-35-37-48/22-65-50/53 S: (1/2-)26-36/37/39-45-60-61-62 Proposed specific concentration limits: The original proposal by Germany suggested a specific concentration limit with an M-factor of 10 for classification and labelling with regard to the environment, which had already been agreed by the TC C&L. 8 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL Since the M-factor proposed by Germany does not separate M-factors for acute and chronic classifications as stipulated in the 2nd ATP of the CLP Regulation, RAC has agreed to include separate M-factors as follows: M-factor (acute): 10 M-factor (chronic): 10 Proposed notes: None 9 ANNEX 1 – BACKGROUND DOCUMENT TO RAC OPINION ON AMINES, COCO ALKYL JUSTIFICATION 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES The typical chain length distribution of Coco alkyl amines is: C 0.5 % 6 C 8 % 8 C 7 % 10 C 50 % 12 C 18 % 14 C 8 % 16 C 1.5 % 18 C 6 % 18’ C 1 % (Ullmann, 1985) 18’’ The content of primary amines is > 99 %. 1.1 Name and other identifiers of the substance Chemical Name: Coconut oil alkyl amine EC Name: Amines, coco alkyl CAS Number: 61788-46-3 IUPAC Name: Coco alkyl amines 1.2 Composition of the substance Chemical Name: Coconut oil alkyl amine EC Number: 262-977-1 CAS Number: 61788-46-3 IUPAC Name: Coco alkyl amines Molecular Formula: unspecified Structural Formula: H N C6-18(even numbered) and C18unsaturated H13-37 H Molecular Weight: unspecified Typical concentration (% w/w): > 95 Concentration range (% w/w): 95 - 99 10

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5.2.1.2 Amines, tallow alkyl . 5.2.1.3 Amines, hydrogenated tallow alkyl. the mean recovery rate (about 51%) as an indicator for the actual test
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5.2.1.2 Amines, tallow alkyl . 5.2.1.3 Amines, hydrogenated tallow alkyl. the mean recovery rate (about 51%) as an indicator for the actual test

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