Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB.


The results reported in sections 4.1 Degradation and 4.3 Bioaccumulation of the CSR, even when not conclusive, indicate that the P (Persistence) and B (Bioaccumulation) criteria for ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate (AF-366) cannot be excluded. However, considering the poor solubility of the substance in water (0.078 mg/L), further testing on persistence and bioaccumulation properties is hardly feasible from a technical point of view and is therefore not proposed. Based on the results of the aquatic toxicity studies documented in section 7.1 Aquatic compartment (including sediment) and the data on mammalian toxicity (chapter 5. Human Health Hazard Assessment) of the CSR, AF-366 can be considered not toxic (not T).

In conclusion, AF-366 is not identified as PBT nor as vPvB substance on the basis of the relevant data provided and discussed in section 8.1 of the CSR (reported in the endpoint study record "PBT assessment.001").

Likely routes of exposure: