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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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There are no long-term fish studies available for Fatty acids, C16-18, 2-octyldodecyl esters (CAS 96690-38-9). 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.

A long-term study according to OECD 211 with the read-across substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was technically not feasible because of the characteristics of the substance (low water solubility, highly adsorptive). No suitable technical method could be established to perform the study adequately. However, available studies from other category members which are similar to Fatty acids, C16-18, 2-octyldodecyl esters 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.