Registration Dossier
Registration Dossier
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EC number: 285-533-9 | CAS number: 85116-81-0
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
NOELR (21d) >= 1 mg/L (OECD 211, Daphnia magna); read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity to aquatic invertebrates of Fatty acids C14-18 and C16-18
unsatd, esters with neopentyl glycol (CAS No. 85116-81-0) are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the category members Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS No. 68855-18-5) and 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) is conducted. Further justification is given within the endpoint summary in IUCLID section 6.1 and within the category justification in IUCLID section 13.
The study conducted with 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) was performed as a limit test according to OECD guideline 211 and GLP (Schlechtriem, 2013). The test organism Daphnia magna was exposed to the test substance in a semi-static system for 21 days, at a loading rate of 1 mg/L (WAF). No significant effect on reproduction was observed during the study, and the NOELR was determined to be ≥ 1 mg/L.
The key study conducted with Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS No. 68855-18-5) was performed according to OECD Guideline 211 and GLP, in a semi-static system (Parr, 2013). During 21 days, the test organism Daphnia magna was exposed to five test concentrations up to 0.0019 mg/L (measured, TWA). No significant effects on reproduction were observed during the study and the NOEC (21d) was reported to be ≥ 0.0019 mg/L.
Based on the available results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by similar ecotoxicological profiles and comparable structures, it can be concluded that Fatty acids, C14 -18 and C16 -18 -unsaturated, esters with neopentyl glycol will not exhibit effects on aquatic invertebrates up to the limit of
water solubility. As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the polyol esters category support this hazard assessment by showing a consistent pattern of results, i.e no toxic effects up to the limit water solubility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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