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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.

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Additional information

There are no long-term fish studies available for tetradecyl oleate (CAS 22393-85-7). Available short-term toxicity studies for fish, daphnia and algae, all indicate no potential for aquatic toxicity. Moreover, a NOEC obtained from an algal growth study is clearly above the limit of water solubility.

For the most similar LCAE category member dodecyl oleate (CAS 36078-10-1) a long-term study according to OECD 211 is still ongoing. But it is not expected that the results from the new study will lie out of the overall ecotoxicological profile of the category. Nevertheless, 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. Moreover, available studies from other category members showed no chronic toxicity to aquatic invertebrates up to the water solubility limit.

As there was no sign that invertebrates are less sensitive than fish in the short-term tests, it cannot be expected that a long-term test with fish will generate different results then the long-term toxicity tests with aquatic invertebrates. 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 will 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. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed.