Registration Dossier
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EC number: 297-083-0 | CAS number: 93334-10-2
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
LC50 (14 d) > 1000 mg/kg soil dw based on reproduction (OECD 207)
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of Fatty acids,
rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and
sorbitol (CAS 93334-10-2) to soil macroorganisms are available, in
accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across
to the structurally related analogue substance anhydro-D-glucitol
trioleate (CAS 26266-58-0) was conducted.
This read-across is justified as both 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 anhydro-D-glucitol trioleate (CAS 26266-58-0) is characterized
as a mono-, di- and tri-ester of sorbitol with mainly C18 unsaturated
fatty acids. Further justification is given within the endpoint summary
6.3 and within the analogue justification in section 13.
The key study was conducted according to OECD 207 (GLP) with the source substance anhydro-D-glucitol trioleate (CAS 26266-58-0; Harris, 2012) with the earthworm Eisenia fetida. No mortality occurred during the 14 d exposure period in artificial soil up to a nominal concentration of 1000 mg/kg soil dw. A LC50 (14 d) of > 1000 mg/kg soil dw was derived.
Based on the result from a structurally related read-across substance (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 soil macroorganisms. Furthermore, chronic data for Daphnia magna are available from the source substances sorbitan stearate (CAS 1338-41-6) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0), and no effects occurred up to the limit of water solubility. Aquatic data can be used as an indicator for potential effects on soil organisms (ECHA, 2012), and in the case of the target substance Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol (CAS 93334-10-2) effects are not to be expected.
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