Registration Dossier
Registration Dossier
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EC number: 944-288-4 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects on aquatic invertebrates up to the limit of water solubility, read across.
Key value for chemical safety assessment
Additional information
Data on the acute toxicity of the target substance Fatty acids, C8-12, isopentylesterto aquatic invertebrates are not available. The assessment was therefore based on a study conducted with the structurally similar substances Isopropyl myristate (CAS 110-27-0) and octyl oleate (CAS 2306-88-9) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.
The toxicity of the source substance Isopropyl myristate (CAS 110-27-0) was tested according to EU Method C.2 under GLP conditions (Küch, 1995). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours. Three different methods were used for the preparation of test solutions: 1) direct addition to 100 mg/L, 2) direct addition to 100 mg/L with removal of undissolved test substance and 3) 3-5 times saturation without separation of undissolved material. The direct addition of test material resulted in an oily film at the surface, and up to 100% immobilisation of the Daphnids. Method 2 and 3 did not lead to an oily film. Significant effects on the mobility of Daphnids were not observed. Thus, the immobilisation, observed for method 1, is most probably due to physical effects caused by undissolved test substance. It can therefore be concluded that the test substance had no significant toxic effect on the test organism up to the limit of water solubility. An EC50 (48 h) of > 0.05 mg/L based on the measured substance concentration was reported. Comparable results were reported in a supporting study on the acute toxicity of the source substance octyl oleate (CAS 2306-88-9) to Daphnia magna. The study was performed according to the Appendix of the EU-guideline 92/69/EWG (GLP; Wierich, 2000). The test organisms were exposed to the test substance in a static system at nominal test concentrations of 1.0, 3.0, 10, 30 and 100 mg/L. The test solutions were prepared by separating the water phase and undissolved test substance (oil drops) by pipetting. However, Daphnids got stuck to undissolved test solution at the water surface. Thus undissolved test substance was transferred to the test solutions. This is also indicated by a measured concentration of 23.6 mg test substance/L. The value exceeds water solubility of the substance. After 48 hours of exposure an EC50 (48 h) >100 mg/L (i.e. greater than the water solubility) was determined. Although the study is considered reliable (Klimisch score 2), due to the uncertainty of the method used, the results should be treated with caution.
Based on the results of the read across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) toxic effects ofFatty acids, C8-12, isopentylesterto aquatic invertebrates are not expected.
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