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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

Experimental data on the long-term toxicity of Isohexadecyl 12-[(1-oxooctadecyl)oxy]octadecanoate (CAS 97338-28-8) to fish are not available. 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. Consequently, in accordance to Annex VIII, 9.1.3., column 2, no further long-term toxicity test to fish is proposed. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if aquatic 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.

The acute toxicity test with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) indicates no toxic effects to fish. Since fish cannot be identified as the most sensitive organism, a long-term test on Daphnia magna following OECD guideline 211 was conducted. After 21 d, no mortality was observed in the limit concentration treatments but the reproductive performance (mean offspring per parent animal) was significantly reduced by 58.5%, resulting in a NOEC (21 d) for reproduction of < 7.0 µg/L (nominal). Thus, and for reasons of animal welfare, long-term testing on fish is not proposed.