Registration Dossier
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EC number: 943-242-0 | CAS number: -
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility (OECD 211, read-across).
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity of Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance neopentyl glycol dioleate (CAS 42222-50-4) was conducted. The source substance is representative to evaluate the long-term toxicity of Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers to aquatic invertebrates. Both substances are structurally very similar. The target substance is characterized as a diester of neopentylglycol esterified with mainly C18 unsaturated fatty acids. The main constituent of the source substance is the neopentyl glycol dioleate containing additional constituents of higher molecular weight. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13.
The study with the read-across substance neopentyl glycol dioleate (CAS 42222-50-4) was conducted according to OECD 211 (GLP) investigating the long-term toxicity to aquatic invertebrates (Schlechtriem, 2013). Daphnia magna was exposed in a semi-static test system to a limit Water Accommodated Fraction (WAF) loading rate of 1 mg/L for 21 d. Based on the very low water solubility of the test substance this loading rate represents the highest attainable loading rate for testing. No significant effects on reproduction or body length were observed, and the NOELR (21 d) was determined to be ≥ 1 mg/L.
Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that the target substance Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.
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