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EC number: 306-523-3 | CAS number: 97281-24-8
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility.
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity of Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) and Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS 68855-18-5) was conducted. The source substances are representative to evaluate the short-term toxicity of the target substance to fish. 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 was conducted with the source substance fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6). The study was performed according to OECD 202 "Daphnia sp. Acute Immobilization Test and Reproduction Test", Part 2 (1993) under semi-static conditions (Mobil Business Resources Corp. (MBRC); Ecotoxicology Laboratory, 1996). This test guideline is similar to OECD 211 which was adopted in 1998. The study period of 15 days does not meet the criteria of today standard methods recommending 21 days study duration. However, according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2016) the study can be regarded as valid for a long-term evaluation as corresponding criteria were fulfilled (e.g. 80% survival in the control, surviving females produce three broods in 21 days or less, > 60 brood neonates per female in the control on average). In addition, all requested endpoints could be determined (time to first brood, number of offspring produced per female, growth and survival) and NOELR values for survival or reproductive endpoints could be calculated. In this study Daphnia magna were exposed to nominal loading rates of 0, 24, 97, 242, 1018 and 2570 mg/L (prepared as water accommodated fraction, WAF). No effects were observed up to the highest test concentration resulting in a NOELR (15 d) of ≥ 2570 mg/L based on reproduction and immobilization.
The second study was conducted with the source substance Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS 68855-18-5). It was performed according to OECD 211 (GLP), in a semi-static system (Harlan Laboratories, 2013). During 21 d the test organism Daphnia magna was exposed to five test concentrations up to 0.0019 mg/L measured (TWA). No significant effects on reproduction were observed during the study and the NOEC (21 d) was reported to be ≥0.0019 mg/L.
Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure and the supporting result for the target substance itself, it can be concluded that Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane will not result in chronic effects on aquatic invertebrates up to the limit of water solubility.
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