Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Reference substance:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol 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.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol is readily biodegradable (74-78% degradation after 28 d, OECD 301 B), as shown in a study conducted according to international guidelines. Thus, the substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation
The bioaccumulation assessment was not conducted for the substance since it is not persistent and according to ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (2017) further generation of information on bioaccumulation is only necessary, if the P/vP criterion is fulfilled for the substance.
For a detailed reference list please refer to the CSR.
Toxicity
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol 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.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
For the substance Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol the available acute effect concentrations are ≥ 2.0 mg/L (above water solubility limit; algae). The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is readily biodegradable. Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
In conclusion Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol is not considered to be PBT/vPvB.
Reference
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.
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