Registration Dossier

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:

Justification

The PBT Assessment for Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) 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 substance is considered readily biodegradable according to OECD criteria based on read-across data. Thus, the substance does not meet the screening criterion for persistence and is not considered to be P or vP.

Bioaccumulation Assessment

Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) is readily biodegradable and therefore considered to be not P or vP. Therefore, no B-assessment was carried out since it is only required if the substance fulfills the P or vP criteria, according to the guideline (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment, 2017).

Toxicity Assessment

For Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1), the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentrations (daphnia, algae) are 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is readily biodegradable, indicating no persistence. Therefore, the criteria set out in Annex X of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.

Conclusion

In conclusion, the substance is not PBT/vPvB.