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Classification & Labelling & PBT assessment

PBT assessment

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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.

Propylene dinonanoate (CAS 41395-83-9) is readily biodegradable (82 - 100% biodegradation after 28 d), as shown in studies 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.

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.

Appropriate read across data showed no toxicity towards species from three trophic levels (fish, aquatic invertebrates and algae). Moreover, propylene dinonanoate (CAS 41395-83-9) is not classified according to the consolidated version of 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 propylene dinonanoate (CAS 41395-83-9) is not considered to be PBT/vPvB.