Registration Dossier
Registration Dossier
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EC number: 701-203-3 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the water solubility limit.
Key value for chemical safety assessment
Additional information
Since no experimental studies investigating the short-term toxicity of sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) (CAS 9005-65-6) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related read-across substance sorbitan oleate (CAS 1338-43-8) was conducted. Both substances are considered to be similar based on their chemical structure. The target substance is characterized as a monoester of sorbitan and a C18 unsatd. fatty acid (degree of ethoxylation: 3 and 5) whereas the source substance consists of sorbitol monoesterified with C18 unsatd. fatty acid. The source substance is listed on Annex IV of Regulation (EC) No 1907/2006 and is thus considered to cause minimum risk because of its intrinsic properties. This read-across is justified in detail in the overall summary (IUCLID section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.
The available study with the source substance sorbitan oleate was conducted according to “PARCOM (1991) Ring Test Protocol: Acute toxicity to marine copepod Acartia tonsa” (GLP) with the marine copepod Acartia tonsa (Hudson, 1999). Nominal concentrations up to 10000 mg/L were tested in this study as Water Accommodated Fractions (WAF). No mortality was recorded after 48 h resulting in a LL50 > 10000 mg/L.
Based on the available result from one structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded thatsorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated)(CAS 9005-65-6) will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.
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