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EC number: 232-360-1 | CAS number: 8007-43-0
Justification for classification
According to Article 13 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.
Annex XI, “General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substance. This avoids the need to test every substance for every endpoint”.
Since the group concept is applied to the members of the Sorbitan esters category, data will be generated from representative category members to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.
Brief description of the data relevant for classification
Biodegradation: 84.5% of CO2 evolution (OECD 301 B)
Expert statement: Bioaccumulation is expected to be low.
Aquatic acute toxicity
For fish: 96 h, LC50 (Scophthalmus maximus): No effects up to the limit of water solubility
For aquatic invertebrates: 48 h, EL50 (Acartia tonsa): No effects up to a loading rate of 100 mg/L
For algae/aquatic plants: 72 h, ErC50 (Skeletonema costatum): No effects up to a loading rate of 100 mg/L
Aquatic chronic toxicity
For fish: no data available
For aquatic invertebrates: 21 d, NOEC (Daphnia magna): no effects up to the limit of water solubility (preliminary result)
For algae/aquatic plant: 72 h, NOErC (Pseudokirchneriella subcapitata): No effects up to a loading rate of 100 mg/L; read-across
Conclusion on classification
Based on the data above, Sorbitan, (Z)-9-octadecenoate (2:3) is considered to be rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L or above the water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan, (Z)-9-octadecenoate (2:3) does not need to be classified and labelled as acute aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).
Valid chronic toxicity data are available - the lowest NOECs are > 1 mg/L or above the water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan, (Z)-9-octadecenoate (2:3) does not need to be classified and labelled as long-term aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).
The acute aquatic toxicity L(E)C50 values are > 100 mg/L or above the water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan, (Z)-9-octadecenoate (2:3) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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