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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

NOELR (21d) ≥ 16 mg/L for Daphnia magna (OECD 211); 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 aquatic invertebrates. 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 of Sorbitan fatty acid esters with partly overlapping compositions. 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 aquatic invertebrate 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 1338-41-6) was performed according to OECD guideline 211 and GLP (Ministry of the Environment, Government of Japan, 2006). The test organism Daphnia magna was exposed to the test substance in a semi-static system for 21 days, at nominal concentrations of 5, 16, 50, 160 and 500 mg/L. The test concentrations 5 and 16 mg/L were prepared using tetrahydrofuran as pre-solvent. Before the test, the solvent was removed and the solution was filtered. The higher concentrations were prepared without solvent as water accommodated fractions (WAF). Since a solvent was used, the lower concentrations are not actual loading rates and these test concentrations cannot be evaluated as WAF. No inhibition of reproduction was observed during the test, in fact, the number of juveniles produced at 5 and 16 mg/L was higher than in the control. At the three higher concentrations, 100% mortality of the parental daphnia occurred, and reproduction could not be evaluated. The reported measured values for the three highest concentrations (4.65, 11.9, 17.1 mg/L) were significantly above the water solubility of the substance. Therefore, it can be assumed that undissolved test material was present and probably caused the mortality observed at the higher concentrations. Due to the methodological deficiencies in this test, the reported NOEC and EC50 need to be taken with caution. Nevertheless, at nominal concentration of 16 mg/L the test solution was reported to be clear and colourless during the test period, and no adverse effects occurred. The corresponding measured concentration 1.44 mg/L is clearly above the water solubility of Sorbitan stearate (0.01 mg/L) and was probably only attained due to the use of solvent. Therefore, 16 mg/L is used as NOELR. Sorbitan stearate is thus not expected to have adverse effects on the reproduction of daphnia magna up to the limit of water solubility.