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EC number: - | CAS number: -
Justification for classification
According to Article 13 of Regulation (EC) No. 1907/2006"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 substances. This avoids the need to test every substance for every endpoint”.
Since the group concept is applied to the members of the Polyol esters group, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.
Biodegradation: readily biodegradable (96 % after 28 d; EU Method C.4-C)
Expert statement: Bioaccumulation is assumed to be low.
Aquatic acute toxicity
For fish: no effects up to the limit of water solubility For aquatic invertebrates: no effects up to the limit of water solubility (read across) For algae/aquatic plants: no effects up to the limit of water solubility (read across)
Aquatic chronic toxicity
For fish: no data available For aquatic invertebrates: no effects up to the limit of water solubility (read across)
NOTE: Although chronic toxicity data is available for members within the polyol esters category in accordance to Regulation (EC) No 1907/2006, Annex IX 9.1 Aquatic toxicity, we plan a read across to proposed tests on long term toxicity to invertebrates for the PE esters CAS 68424-31-7 (tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol), CAS 15834-04-5, CAS 68424-30-6 and CAS 85049-33-8. CAS 68424-31-7 (C5, C7, C8 and C10) is a highly complex UVCB, with varying chain lengths and combinations of structures. CAS 15834-04-5 has the shortest chain length (C5) of PE esters, it is a mono-constituent and often is a constituent with many of the other polyol esters.Due to its smaller molecular size it is expected to have the highest bioavailability. CAS 68424-30-6 (C5, C7, C9 iso) was chosen on the basis of its isononanoic acid content to evaluate possible adverse effects.CAS 85049-33-8 was selected in order to confirm that no chronic toxicity to aquatic organisms occurs for the polyol esters with medium chain length of the category C8-C16 (even numbered). As soon as this data is available the hazard and chemical safetyassessment will be updated.
For algae/aquatic plant: no effects up to the limit of water solubility (read across)
Conclusion on classification
CLP: Fatty acids, C5-10 (linear and branched), tetraesters with pentaerythritol (CAS 68424-31-7) (CAS 68424-31-7) is readily biodegradable and has a low potential to bioaccumulate.The substance is considered to be not acutely toxic to fish, aquatic invertebrates or algae since not toxic effects were observed up to the limit of water solubility (< 1 mg/L). Data on chronic toxicity indicate no toxicological effects up to the limit of water solubility. Therefore, fatty acids, C5-10 (linear and branched), tetraesters with pentaerythritol (CAAS 68424-31-7) does not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (2nd ATP).
DSD: Fatty acids, C5-10 (linear and branched), tetraesters with pentaerythritol (CAS 68424-31-7) (CAS 68424-31-7) is readily biodegradable and has a low potential to bioaccumulate.The substance is poorly soluble in water and no effects occurred up to the water solubility limit (< 1 mg/L) in acute tests for fish, algae and aquatic invertebrates. The test substance does not need to be classified and labelled as environmental hazardous 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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