Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

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 Sorbitan isooctadecanoate (CAS No. 71902-01-7) to fish. The assessment was, therefore, based on studies 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. Both substances are UVCBs with partly overlapping composition of Sorbitan fatty acid esters. Sorbitan isooctadecanoate consists of Sorbitan mono-, di and triesters of C18 fatty acid, with a methyl group at the penultimate carbon (iso-structure). Sorbitan stearate is also a Sorbitan ester of C16-18 fatty acids. The branching at the penultimate carbon of Sorbitan isooctadecanoate is not expected to be relevant for acute fish toxicity, since both substances are poorly soluble in water (< 0.1 mg/L) and readily biodegradable. Additionally, short-term daphnia studies, available for both substances, demonstrated similarly low toxicity.

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.