Registration Dossier
Registration Dossier
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EC number: 241-640-2 | CAS number: 17661-50-6
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
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 tetradecyl stearate (CAS 17661-50-6) 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, 2014), 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 dodecyl oleate (CAS 36078-10-1) indicates no toxic effects to fish. Since fish was not identified as the most sensitive organism, a long-term test on Daphnia magna is available for the source substances dodecyl oleate (CAS 36078-10-1 and (Z)-octadec-9-enyl oleate (CAS 3687-45-4) as recommended by the Guidance document. Testing according to OECD guideline 211 with the source substances dodecyl oleate and (Z)-octadec-9-enyl oleate indicates no toxic effects of the substance on survival and reproduction of Daphnia magna up to the limit of water solubility (NOEC (21 d) ≥ 100 mg/L; NOELR (21 d) ≥ 100 mg/L) (Brunswick-Titze, 2013; Höger, 2013).
Based on these results from two structurally related source substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, long-term effects of tetradecyl stearate on fish are not to be expected. Thus, and for reasons of animal welfare, long-term testing on fish is not proposed.
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