Registration Dossier
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EC number: 269-023-3 | CAS number: 68171-33-5
Short-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 for Daphnia magna (EU Method C.2)
Key value for chemical safety assessment
Additional information
There are no studies available on the toxicity of isopropyl isostearate (CAS No. 68171-33-5) to aquatic invertebrates. The assessment of short-term toxicity was therefore based on studies conducted with the structurally most similar category members, for which data is available, isopropyl palmitate (CAS No. 142-91-6) and isopropyl oleate (CAS No. 112-11-8). This read across approach is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the category justification in Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was entered into IUCLID. Nevertheless, as can be seen in the data matrix of the category justification in Section 13, all reliable data in the category support the hazard assessment for this endpoint, by showing a consistent pattern of results.
The key study with isopropyl palmitate (CAS No. 142-91-6) was performed according to EU Method C.2 and GLP (Kirch, 1998). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours, at nominal test concentrations of 1000 and 3000 mg/L (measured initial concentrations 0.72 and 1.68 mg/L). No immobilisation was observed at any of the test concentrations, and the EC50 was reported to be > 3000 mg/L.
The supporting study with isopropyl oleate (CAS No. 112-11-8) was performed according to the guideline AEP2 issued by the Ministry of Agriculture, Fisheries and Food of the United Kingdom (1984) (Clitherow, 1991). The marine test organism Crangon crangon was exposed to the test substance in a static system for 48 hours, at nominal test concentrations of 850, 1530, 2640, 4760 and 8500 mg/L. No mortality was observed at any of the test concentrations, and the LC50 was determined to be > 8500 mg/L.
Thus, based on theabove mentioned result, and due to the structural and profile similarities of the two substances, as are explained within the overall endpoint summary 6.1 it can be concluded that no toxicological short-term effects on aquatic invertebrates are expected up tothe limit ofwater solubility for isopropyl isostearate (CAS No. 68171-33-5).
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