Registration Dossier
Registration Dossier
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EC number: 203-966-3 | CAS number: 112-39-0
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, long term toxicity testing on fish species 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. Methyl palmitate is a readily biodegradable substance with a very low solubility in water (0.004 mg/L). Therefore, this substance is expected to be extensively biodegraded in conventional sewage treatment plants (STPs), in which additionally, a high degree of adsorption to sewage sludge can be expected. Considering these factors, should the substance be released into the aquatic compartment in the environment, discharged concentrations are expected to be low. The acute fish test conducted with methyl palmitate (Guhl, 2001) showed no effects up to the limit of the water solubility of the substance. The algae test (performed on a suitable read-across substance, in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5) showed no effects on biomass or growth rate (NOEC ≥ 0.023 mg/L). Furthermore, the results from the long-term study conducted on aquatic invertebrates available for a valid analogue substance (in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5), indicate that no toxicity up to the limit of water solubility of methyl palmitate is expected for these organisms either (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 methyl palmitate.
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