Pentaerythritol tetraoleate

Short-term toxicity to aquatic invertebrates

Description of key information

No toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).

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) 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 VI-IX ofpentaerytritol tetraoleate (CAS 19321-40-5) 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 (≥ 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) and are tetra-esters. As it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results. The first reliable key study conducted 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 WAFs were prepared through direct addition of test substance to a stirring medium, then stirred before filtering. A nominal test concentration of 100 mg/L was tested, corresponding to < 10 mg test substance/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. For the second read across substance, short-term toxicity of decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) to aquatic invertebrates was investigated according to OECD 202 using Daphnia magna as test organism under static condition (Blattenberger, 2006). The test solutions 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. Results of a short term toxicity study on aquatic invertebrates to pentaerytritol tetraoleate (CAS 19321-40-5) investigated according to methods equivalent to OECD 202 confirm these data predictions (van Egmond, 1997). Although this study is classified as RL3 due to relevant methodological deficiencies; nevertheless, no immobility occurred in any of the treatments (nominal test concentrations of 1, 10 and 100 mg/L) resulting in an EC50 of > 100 mg/L. Based on the results from the 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 thatpentaerytritol tetraoleate (CAS 19321-40-5) will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L). 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 category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects to aquatic invertebrates or other aquatic organisms were observed up to the limit of water solubility.