Registration Dossier
Registration Dossier
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EC number: 247-569-3 | CAS number: 26266-58-0
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
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 Anhydro-D-glucitol trioleate (CAS No. 26266-58-0) to fish. The assessment was, therefore, based on studies conducted with the structurally similar category members Sorbitan stearate (CAS No. 1338-41-6) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS No.8007-43-0). This read across approach is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Anhydro-D-glucitol trioleate and Sorbitan, (Z)-9-octadecenoate (2:3) are both Sorbitan esters of unsaturated C18 fatty acids. Anhydro-D-glucitol trioleate mostly consists of triesters and Sorbitan, (Z)-9-octadecenoate (2:3) of di- and triesters. Since the bioavailability of diesters is expected to be higher, due to smaller molecule size, Sorbitan, (Z)-9-octadecenoate (2:3) can be considered a worst case read-across for anhydro-D-glucitol trioleate. The second read-across substance Sorbitan stearate also consists of Sorbitan esters of C18 fatty acids, but saturated. However, the substances are expected to have similar behaviour, based on data available on solubility, ready biodegradability and toxicity to aquatic organisms. Sorbitan stearate can also be seen as a worst case read-across, due to the smaller molecular size, potentially leading to better bioavailability.
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.
The saltwater key study conducted with Sorbitan, (Z)-9-octadecenoate (2:3) (CAS No. 8007-43-0) was performed as a according to the OECD Guideline 203 and GLP (Hudson, 2003). The marine fish Scophthalmus maximus was used as test organism. The fish were exposed to the nominal test concentration of 1000, 1800 and 3200 mg/L, prepared as water accommodated fractions (WAF). No mortalities were observed at any of the test concentrations, during the 96-hour test period, and a LC50 of > 3200 mg/L was reported.
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