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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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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).

Persistency

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

The bioaccumulation assessment was not conducted for the substance since it is not (very)persistent. According to the 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. Since this is not the case no B-assessment was performed.

For a detailed reference list please refer to the CSR or IUCLID section 13.

 

Toxicity

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check TPE-D-2114576587-30-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 29 Nov 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.

The most sensitive effect concentration for short-term toxicity to aquatic algae and cyanobacteria are > 0.1 mg/L. Therefore, the substance does not meet the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 and it is concluded that the substance is not T.

In conclusion, the substance is not PBT/vPvB.