Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 921-836-0 | CAS number: 1190402-12-0
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
There are no long-term fish studies available for Mixed esters of fatty acid C16 and C16-C18-unsatd. with adipic acid and pentaerythritol.The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed. Available short-term studies for fish, daphnia and algae, all indicate no potential for aquatic toxicity. Moreover, the NOEC values obtained from the aquatic invertebrates (read-across data) and algal growth study is clearly above the limit of water solubility (< 1 mg/L).
Based on the short-term values, 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, 2008), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. 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 will be exposed to Mixed esters of fatty acid C16 and C16-C18-unsatd. with adipic acid and pentaerythritol since it will be ultimately degraded in sewage treatment plants. Thus, based on the above mentioned results, it is unlikely that the substance will exhibit chronic toxicity to fish up to the limit of water solubility. Hence, based on the information discussed and due to animal welfare reasons, no further long-term test with 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
