Registration Dossier
Registration Dossier
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EC number: 269-495-0 | CAS number: 68258-72-0
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: bulk
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- Reference substance:
- 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are used as information to decide whether 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) may potentially fulfil the PBT or vPvB criteria.
Persistence Assessment
Based on the available data, 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate is not readily biodegradable. Thus, the substance may potentially fulfil the P/vP criteria.
Bioaccumulation Assessment
The bioaccumulation potential of 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate is expected to be low. This assumption is based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The high molecular weight of the substance significantly reduces the absorption due to steric hindrance to cross biological membranes. It can be concluded that the bioaccumulation potential of 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate is negligible. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the substance is not considered to be B or vB.
Toxicity Assessment
All available data demonstrate no toxicity up to the water solubility limit. Moreover, the target substance is not classified according to Regulation (EC) No 1272/2008 (CLP) considering Regulation (EU) No 605/2014 (6th ATP). Thus, the criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are not met and the target substance is not considered to meet the T criterion.
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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