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Long-term toxicity to aquatic invertebrates

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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 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 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 PE esters with different fatty acid chain lengths (≥ C16 which is in the range of the target substance, or C5-C10). The target as well as the read-across substances contain the same alcohol (pentaerythritol).

The first 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). The test solution 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. A loading rate WAF of 135 mg/L (nominal) was applied in a limit test. 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 that2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)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.