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EC number: 286-056-9 | CAS number: 85186-72-7
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the water solubility limit.
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol to aquatic algae are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) and Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) was conducted. The target substance is mainly characterized as a tetraester of pentaerythritol and C16-C18 branched, saturated and unsaturated fatty acids. The source substance 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) is a tetraester of pentaerythritol and mainly C18 branched fatty acids as well as fatty acids of C14-C22. Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) is mainly characterized as a tetraester of C18 unsaturated fatty acids. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue 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 substance was used for the assessment.
The first study with the source substance 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) was performed according to OECD 201 (GLP). Pseudokirchneriella subcapitata was exposed under static conditions to nominal loading rates of 100, 180, 320, 560 and 1000 mg/L. The test solution was prepared as WAF (Water Accommodated Fractions) by adding the appropriate amount of test substance to the test solutions with subsequent stirring followed by settling. Because of the serial dilution from the highest concentration (1000 mg/L), only the 1000 mg/L test concentration was valid and could be used for evaluation of toxicity of the test substance. After the test duration of 72 h an EL50 > 1000 mg/L (nominal) based on growth rate was determined.
The second study was performed according to OECD 201 with the source substance Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4). The limit test was performed according to OECD 201. The green algae Desmodesmus subspicatus was exposed to a nominal loading rate of 100 mg/L. The test solution was prepared by adding the appropriate amount of test substance to the test medium with subsequent stirring followed by a filtration step. No effects on growth rate and biomass of Desmodesmus subspicatus up to the limit of water solubility were observed resulting in an EL50 (72 h) > 100 mg/L (nominal) and a NOELR (72 h) of ≥ 100 mg/L (nominal).
Based on the available 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 and comparable structure, it can be concluded that Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol will not exhibit effects on aquatic algae up to the limit of water solubility.
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