Registration Dossier
Registration Dossier
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EC number: 306-082-7 | CAS number: 95912-86-0
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. There are no long-term fish studies available for fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0). Available short-term toxicity studies for fish and algae, all indicate no potential for aquatic toxicity. Moreover, a long-term study with Daphnia magna according to OECD 211 did not result in any impact on reproduction and mobility. All available studies from other category members showed no chronic (or acute) toxicity to aquatic organisms up to the water solubility limit.Based on the short-term results, fish cannot be identified as the most sensitive taxonomic group. According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3” (ECHA, 2012), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. This is not the case for this substance. The Guidance states that if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish.Due to its ready biodegradability it is not likely that aquatic organisms are exposed to the test substance, since it will be ultimately degraded in sewage treatment plants. Thus, based on the above mentioned results, it can be excluded that any substance within the category would exhibit chronic toxicity to fish up to the limit of water solubility. Hence, due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish was proposed. Thus, the chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. In accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed.
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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