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Description of key information

EC50 (16 h) > 10000 mg/L (ISO 10712)

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 memberspentaerytritol tetraoleate (CAS 19321-40-5) and decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 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 microorganisms. 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 fatty acid chain length of C16 and C18 of the first read-across substances are in the same range of those of the target substance. The second read-across substance covers the other end of the category with shorter fatty acid chain lengths (C5-10). All substances contain the same alcohol (pentaerythritol). The first study with the read-across substance pentaerytritol tetraoleate (CAS 19321-40-5) was conducted under static conditions according to ISO 10712 investigating aquatic microorganisms (Mead, 1997). In this GLP study an aqueous suspension of Pseudomonas putida was used as inoculum. A nominal test concentration of 10000 mg/L was used (prepared as WAF). The test substance did not inhibit the growth of Pseudomonas putida. Hence, the 16 h-EL50 was determined to be > 10000 mg/L based on the nominal test concentration. This result is confirmed by the result of the toxicity control of the biodegradation study with the read-across substance (Desmares-Koopmans, 1997). In this study according to OECD 301B a 14 d-NOEC of 15.6 mg/L could be determined, based on the inhibition control.

The 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 209 investigating aquatic microorganisms (Dickinson, 2008). In this GLP study non-adapted activated sludge obtained from a domestic sewage treatment plant was used as inoculum. Test concentrations of 10, 100 and 1000 mg/L were prepared. Test substance was added directly to the test vessels. The test substance did not inhibit the respiration rate of activated sludge microorganisms at any of the concentrations employed in the test. Hence, the 3 h-EC50 was determined to be > 1000 mg/L based on the nominal test concentration. Therefore it can be concluded that the test substance will not exhibit effects on the respiration rate of microorganisms.

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 effects to aquatic microorganism 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 microbial inhibtionorno toxic effects were observed to aquatic organisms up to the limit of water solubility.