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EC number: 263-423-1 | CAS number: 62125-22-8
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No chronic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).
Key value for chemical safety assessment
Additional information
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to two structurally related category members decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) was conducted to fulfill the data requirements according to Annex IX of 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) in regard to long-term toxicity to aquatic invertebrates.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 read-across substances cover the variability of the sub-category with different fatty acid chain lengths (longer fatty acid chains, C16-C18, which are in the range of the target substance, or shorter chains, C5-C10). The target as well as the read-across substances contains the same alcohol (pentaerythritol).
The first GLP study with the read-across substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) was conducted under semi-static conditions according to OECD 211 using Daphnia magna as test organism (Letinski & Bragin, 2011). A loading rate of 135 mg/L (nominal) was applied in the limit test. The WAF was prepared by adding the appropriate amount of test substance with subsequent stirring and sampling of the aqueous portions (WAFs) through the outlet at the bottom of the vessels. No significant effect on reproduction was observed in the treatment throughout the test period of 21 d. Hence, the 21 d-NOELR is determined to be > 135 mg/L on the basis of the nominal test concentration
For the read-across substance fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) a limit test under semi-static conditions according to OECD 211 and GLP was performed (Schlechtriem, 2013). Daphnia magna was exposed to a nominal concentration of 1 mg/L prepared as WAF. No significant effects on reproduction occurred resulting in a NOELR of ≥ 1 mg/L, i.e. no effects up to the water solubility limit (< 0.05 mg/L) occurred.
Based on the available results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile, it can be concluded that 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) will not exhibit long-term effects to 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 were observed to aquatic invertebrates or other aquatic organisms up to the limit of water solubility.
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