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Long-term toxicity to fish

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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 Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS No. 95912-89-3). 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 obtained from the algal growth study is clearly above the limit of water solubility (< 0.05 mg/L). For Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS-No 95912-89-3) a long-term study according to OECD 211 is still ongoing. The Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of the new studies as soon as they are available.

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, 2012), 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 Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane 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.