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Short-term toxicity to fish

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Description of key information

No toxic effects up to the limit of water solubility for Oryzias latipes (Circular on Test Methods of New Chemical Substances (Japan), Fish acute toxicity test); read-across

Key value for chemical safety assessment

Additional information

No studies are available on the toxicity of Sorbitan tristearate (CAS 26658-19-5) to fish. The assessment was, therefore, based on a study conducted with the structurally similar category member Sorbitan stearate (CAS No. 1338-41-6). This read across approach is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Sorbitan tristearate and Sorbitan stearate are both Sorbitan esters of saturated C18 fatty acids. Since the Sorbitan stearate mainly consists of monoesters, it can be considered a worst case read-across to Sorbitan tristearate, which is expected to be less bioavailable due to its molecular size (MW 879-982). 

The key study conducted with Sorbitan stearate (CAS No.1338-41-6) was performed as a limit test, according to the Circular on Test Methods of New Chemical Substances (Japan), in a semi-static system, using Oryzias latipes as test organism (Ministry of the Environment, Japan, 2005). The fish were exposed to the nominal test concentration of 1000 mg/L, prepared as water accommodated fractions (WAF). No mortalities were observed at the test concentration, during the 96-hour test period, and the LL50 was determined to be > 1000 mg/L. The reported measured value LC50 > 13.7 mg/L is far above the solubility of the test substance and is therefore questionable. Since additionally the substance is an UVCB and the test was performed as WAF, the nominal loading rate was considered more appropriate to be used for the assessment.

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