Registration Dossier
Registration Dossier
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EC number: 915-790-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Stability in the environment:
In accordance with Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), information regarding phototransformation in air, as well as in water and soil, is not mandatory.
In Annex VIII column 2 of the REACH Regulation, it is suggested, that a study on the "Hydrolysis as function of pH" does not need to be conducted if the “substance is readily biodegradable". Evaluation of the three types of chemical structures which constitute the substance indicates that it is unlikely that any of these will undergo significant hydrolysis at environmentally relevant conditions of pH and temperature. Therefore the substance is not subject to hydrolysis and is stable.
Biodegradation:
Reliable biodegradation studies for reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs are available and included in the dossier. Reliable studies on the biodegradation in sediment and soil are not available, however waivers are applied for these endpoints.
For biodegradation in water, the key study result provided by Bayless (2013) indicates that although the test substance did not degrade > 70% by 28 days, can be considered inherently biodegradable as significant degradation did occur. Additional biodegradation studies with the test substance included in the dossier support this conclusion.
Waiver. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2, 9.2.1.3 and 9.2.1.4 respectively) do not need to be conducted if direct or indirect exposure of soil is unlikely or if the substance is readily biodegradable. Reliable measured data for simulation testing on ultimate degradation in surface water or sediment for reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs is not available. However, a waiver is being applied for these endpoints. Reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs. was found to be inherently biodegradable. No other data is requiring for assessing the biodegradation potential in soil and sediment.Indeed, the PEC/PNEC ratios for sediment and soil obtained in the exposure assessment of the substance is below 1. Based on the exposure assessment, the conduct of simulation tests of the degradation in sediment and soil are waived in accordance with column 2 of Annex IX chapter 9.2 of Regulation EC 1907/2006. In addition, the sediment and soil are not expected to be the compartments of concern as the substance has a log Kow of 2.51.
Bioaccumulation:
Reliable measured bioconcentration in aquatic/sediment and terrestrial information is not available for reaction mass of Amines, coco alkyl and ß-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs. and ß-Alanine, N-coco alkyl derivs. In accordance with column 2 of Annex IX of the REACH Regulation (9.3.2 Bioaccumulation in aquatic species) the study need not be conducted if the substance has a low potential for bioaccumulation, specifically where the log Kow is <3. Butler (2013) measured the partition coefficient log Kow which was then calculated as a weighted average to be 2.51. Therefore the requirement for a bioaccumulation study is waived.
Transport and distribution:
Reliable measured data for absorption are not available for the test substance. In accordance with column 2 of REACH Annexes XIII, the adsorption / desorption study (required in section 9.3.1 and 9.3.3) do not need to be conducted if, based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient). The log partition coefficient (Koc) of the test substance was predicted to be <3.0. Therefore, the test substance considered to have low potential for absorption and no further testing is required.
Waiver. In accordance with the REACH Regulations, determination of Henry’s Law constant is not a standard information requirement.
Waiver. In accordance with the REACH Regulations distribution is not a standard information requirement
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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