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EC number: 263-423-1 | CAS number: 62125-22-8
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No toxic 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 a structurally related category memberfatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) and decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) 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 toxicity to aquatic invertebrates. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category 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 read-across substances cover the variability of the sub-category with different fatty acid chain lengths (longer fatty acid chains, C18, which are in the range of the target substance, or shorter fatty acid chains, C5-C10). The target as well as the read-across substances contain the same alcohol (pentaerythritol) and are tetra-esters.
The first study with the read-across substancefatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol(CAS 68604-44-4) was performed under static conditions and GLP according to EU Method C.2 usingDaphnia magnaas test organism (Wierich, 1998). The WAF was prepared by adding the appropriate amount of test substance with subsequent stirring and filtering. A nominal test concentration of 100 mg/L was tested, corresponding to < 10 mg/L (detection limit). No immobilisation was observed in the treatment and the control throughout the test period of 48 h. Hence, the 48 h-EL50 is determined to be > 100 mg/L based on the nominal test concentration. This result is confirmed by a supporting study, conducted according to OECD 202 (Junghans, 2010). Also in this limit test an EL50 > 100 mg/L based on nominal values could be determined.
Additionally, a 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 static conditions according to OECD 202 and GLP usingDaphnia magnaas test organism (Blattenberger, 2006). The WAFs were 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. Loading rate WAFs of 62, 132, 251, 503 and 1072 mg/L were tested. No immobilisation was observed in any treatment and the control throughout the test period of 48 h. Hence, the 48 h-EL50 is determined to be > 1072 mg/L based on the nominal test concentration.
Moreover, a supporting test with2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8)was performed similar to OECD 202 (Marshall, 1997). Daphnia magna was exposed to test concentrations of 1, 10 and 100 mg/L. The test result should be evaluated with caution due to relevant methodological deficiencies; nevertheless, no immobility occurred in any of the treatments resulting in an EC50 of > 100 mg/L.
Based on the 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 that2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)will not exhibit short-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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