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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:

An evaluation of the inherent properties of T000625 is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

 

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in an OECD 301B study. The substance is concluded to be P/vP.

 

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The log Kow of T000625 was determined according to OECD guideline 117. The Pow value of the test item at 20°C and pH 7 was 4.2,  and is below the trigger value of 4.5. The substance is therefore not considered B or vB.

 

The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. In a 72-h growth inhibition test with the unicellular green alga Pseudokirchneriella subcapitata according to the OECD guideline 201, the 72h-NOEC and 72h-ErC10 for growth rate were 0.23 and 0.42 mg/L, respectively, which is above the trigger value of 0.01 mg/L. However, the substance is classified as toxic for reproduction category 2. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), the substance does fulfill the screening criterium for being considered as T.

 

To conclude, T000625 is not considered a PBT or a vPvB substance according to the EU criteria.