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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is PBT / vPvB

The PBT Assessment for the test substance BAY 43-9006 (CAS 284461-73-0) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).


The test substance is not readily biodegradable in a study according to OECD 301 (2% degradation within 28 days). Thus, the test substance can be considered to be potentially fulfilling the criteria for Persistence (P) and (vP). Since the test substance is highly insoluble in water (< 0.1 mg/L), a simulation study according to OECD 308 (Aerobic transformation in aquatic sediment systems) was conducted. Results showed that the test substance was removed rapidly from the water fraction and bound to the sediment in both sediment-systems (DT50 for water was < 1 d at 22°C corresponding to 2.5 d at 12°C). The ultimate biodegradation in sediment was low and accounted for <1.1%. Because of the lack of relevant biodegradation, the test item is assumed to accumulate in the sediment. Within a further guideline study according to OECD 307 (Aerobic Transformation in soil) the DT50 of the test substance in aerobic sandy loam soil (Sevelen) were calculated to be 187 d at 20°C (corresponding to 397 d at 12°C). In conclusion, the P as well as the vP criterion is fulfilled for the test substance. 


A substance fulfills the very bioaccumulative criterion (vB) when the bioconcentration factor in aquatic species is higher than 5000. As an experimental fish study showed a bioaccumulation factor of 7300 the substance has to be classified as vB.


The test substance is classified as toxic for reproduction (assigned hazard phrases H360) and specific target organ toxic (assigned hazard phrase H372). In conclusion, the test substance is considered to met the T-criterion. 

Overall, the vP, the vB and T criteria are fulfilled and therefore the substance has to be classified as PBT and vPvB.

Likely routes of exposure:

As no emission of the substance occur, there are no routes via which humans or the environment are exposed.