Registration Dossier
Registration Dossier
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EC number: 287-824-6 | CAS number: 85586-21-6
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
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
Key value for chemical safety assessment
Additional information
According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. Fatty acids, C16-C18, methyl esters (CAS No. 85586-21-6) is a readily biodegradable and poorly soluble substance (< 1 mg/L). Due to these characteristics, extensive biodegradation and adsorption to activated sludge within conventional STPs can be expected and therefore, only low concentrations are likely to be released into the water phase and directly bioavailable to fish species. Furthermore, the acute fish tests conducted with structurally related category members (in accordance with Regulation (EC) No. 1907/2006, Annex XI, section 1.5), showed no toxic effects of the compounds after 96 and 48 h respectively. The other acute studies available for aquatic invertebrates and algae (performed on analogue substances, according to Regulation (EC) No. 1907/2006, Annex XI, 1.5) also showed no toxicity. A chronic test on aquatic invertebrates according to OECD 211 is available as well for an analogue category member showing no effects on either mortality or reproduction endpoints (NOEC (21 d) ≥ 0.22 mg/L).
Based on the results of the acute tests, fish species are not expected to show a higher sensitivity compared to aquatic invertebrates and algae, for which chronic values are available. In fact, for those SCAE Me category members for which effects have been observed in aquatic organisms, fish was the less sensitive species.
Considering this fact and all the above arguments, long-term toxicity testing on fish is not deemed necessary for the hazard assessment of Fatty acids, C16-C18, methyl esters.
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