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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

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 further investigate the long-term toxicity to fish.

Key value for chemical safety assessment

Additional information

There are no studies available for the long-term toxicity of the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters to fish.

However, the available short-term toxicity studies for fish, daphnia and algae all indicate no potential for aquatic toxicity. Moreover, chronic data for aquatic invertebrates (OECD 211) and algae clearly show no effects up to the limit of water solubility. Since there is no indication in the short-term tests that invertebrates are less sensitive than fish, it is unlikely that a long-term test with fish will generate different results than the available long-term study with aquatic invertebrates.

Moreover, chronic exposure of aquatic organisms is highly unlikely due to the ready biodegradability of the substance, which is thus expected to be rapidly and ultimately degraded in sewage treatment plants. Thus, it is concluded that the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters does not exhibit chronic toxicity to fish up to the limit of water solubility. Based on these considerations and to avoid unnecessary vertebrate testing for animal welfare reasons, no further long-term test with fish was proposed.

In summary, 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.

 

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