Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
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 Assessment
The substances of the glycol esters category are readily biodegradable. All available screening studies, investigating the ready biodegradability of the substances, demonstrated degradation rates ≥ 60% after 28 days. Thus, the test substances of the glycol esters category do not meet the screening criterion for persistency and are not considered to be P or vP.
Bioaccumulation Assessment
Bioaccumulation is not a standard requirement according to Regulation (EC) No. 1907/2006, Annex VII-VIII. However, the substance is considered to be readily biodegradable and expected to be rapidly metabolised. Thus, bioaccumulation and secondary poisoning are very unlikely. The substance is not considered to be B or vB.
Toxicity Assessment
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546451-53-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated 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.
Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) of ≥ 0.02 mg/L for the read-across substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) (OECD 211). Moreover, Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (4th ATP). 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.
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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