Registration Dossier
Registration Dossier
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EC number: 269-027-5 | CAS number: 68171-38-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment 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.
Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) is readily biodegradable. This was shown in one study according to OECD guidance 301 (82.9% biodegradation after 28 d at the concentration of 12.9 mg test item/L). Read across data from analogue substances confirm the ready biodegradability of the substance. 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 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.
Toxic effects at concentrations < 0.1 mg/L were not observed in the aquatic tests with the substance itself. Used read across data did not reveal any toxic effects to aquatic organisms up to the water solubility limit. Moreover, isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) is not classified according to Regulation (EC) No. 1272/2008 (and further ATPs). Thus, 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 isooctadecanoic acid, monoester with propane-1,2-diol is not considered to be PBT/vPvB.
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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