Registration Dossier
Registration Dossier
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EC number: 807-674-2 | CAS number: 109884-54-0
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 Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester (CAS 109884-54-0) 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 Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester to aquatic invertebrates. The target substance is characterized as a diester of neopentylglycol and mainly C18 isostearic acid with a minor amount of monoesters of neopentylglycol with C18 isostearic acid. The source substance neopentyl glycol dioleate is mainly defined as a diester of C18 and C18 unsaturated linear fatty acids and neopentylglycol. All substances share similar physico-chemical properties, only differ in the distribution of chain lengths of the fatty acid and do not share any functional group which might increase aquatic toxicity the read-across is suitable to investigate the aquatic toxicity using read-across. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment.
The study with the source substance neopentyl glycol dioleate (CAS 42222-50-4) investigated the long-term toxicity to aquatic invertebrates (Schlechtriem, 2013). The study was performed as a limit test according to OECD 211 and GLP (Schlechtriem, 2013). Daphnia magna was exposed to the test substance in a semi-static system for 21 d, at a nominal loading rate of 1 mg/L. 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 read-across 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 Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.
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