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Short-term toxicity to aquatic invertebrates

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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 two structurally related category membersfatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) anddecanoic 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 VII-IX of 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) 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 categoryjustification 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 PE esters with different fatty acid chain lengths (C18 which is identical to those of the target substance, or C5-C10). The target as well as the read-across substances contain the same alcohol (pentaerythritol).

The key study with the read-across substance fatty 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 using Daphnia magna as 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.

Another 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 performed under static conditions and GLP according to OECD 202 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 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.

Based on these results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)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.