Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Conclusion on classification
Conclusion on Classification
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
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. In Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X”, it is stated 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”.
A read-across approach was applied to this substance and data was compiled from representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.
Environmental fate and pathways
Biodegradation:
- Inherently biodegradable (60% degradable after 28d, OECD 301F)
Bioaccumulation:
- log Pow > 10 (QSAR)
Aquatic short-term toxicity
- Fish: no data available
- Aquatic invertebrates: EL50 (48 h) >100 mg/L (nominal loading rate, EU method C2; read-across)
- Algae: ErC50 (72 h) > 1.5 μg/L (measured, OECD 201)
Aquatic chronic toxicity
- Fish: no data available
- Aquatic invertebrates: no data available
- Algae: NOErC (72 h) ≥ 1.5 μg/L (measured, OECD 201)
Classification according to CLP
The substance Pentaerythritol tetrapalmitate (CAS 18641-58-2) is not rapidly biodegradable. In the available aquatic toxicity studies, no effects were observed up to 100 mg/L or up to the water solubility limit. Thus, the substance does not need to be classified and labelled as environmentally hazardous, according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).
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.
