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Short-term toxicity to fish

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Description of key information

No effects up to the limit of water solubility (Ministry of the Environment, Government of Japan, 2005).

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol(CAS 93334-10-2)to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally related analogue substances sorbitan stearate (CAS 1338-41-6), sorbitan oleate (CAS 1338-43-8) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0) was conducted.
This read-across is justified as all substances share a comparable structure. Based on the specification the target substance Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol is characterized by the alcohol components sorbitol, sorbitan and 1,4:3,6-dianhydro-d-glucitol esterified as mono (mainly), -di- or tri-ester with mainly fatty acids of C18 and C18 unsaturated. The source substance sorbitan stearate (CAS 1338-41-6) is characterized as a mono-, di- and tri-ester of sorbitan with C16-C18 fatty acids. Sorbitan oleate (CAS 1338-43-8) consists of sorbitan and C18 unsaturated fatty acid, whereas Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0) is an ester (mono, di and tri) of sorbitan, sorbitol and 1,4:3,6-dianhydro-d-glucitol with C18 unsaturated fatty acid. Further justification is given within the endpoint summary 6.1 and within the analogue justification in section 13.

The key study with the source substance sorbitan stearate (CAS 1338-41-6) was performed according to “Circular on Test Methods of New Chemical Substances (Japan), Fish acute toxicity test” (GLP) with Oryzias latipes under semi-static test conditions (Ministry of the Environment, Government of Japan, 2005). A limit test concentration of 1000 mg/L (nominal) was prepared as Water Accommodated Fraction (WAF). No mortality was recorded after 96 h resulting in a LL50 (96 h) of > 1000 mg/L.
An additional study with the source substance sorbitan oleate (CAS 1338-43-8) confirmed this result (Brown, 1988). The documentation of the study is insufficient and was thus rated reliability 4. However, the result is in line with the key study. An LC50 (96 h) of > 1000 mg/L (nominal) was reported for Salmo gairdneri.

The third study was performed with Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0). The study was performed according to the OECD Guideline 203 and GLP (Hudson, 2003). The marine fish Scophthalmus maximus was used as test organism and exposed to the nominal loading rates 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 LL50 of > 3200 mg/L was reported.

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol will not exhibit short-term effects to fish up to the limit of water solubility.