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:

Persistence Assessment

Substance meets screening criteria. Substance does not show any significant signs of biodegradation in screening studies. BIOWIN model 6 (MITI) does not indicate fast biodegradation. Substance is likely to be P and may also be vP.

Bioaccumulation Assessment

Substance does not meet screening criteria. Substance logKow=<4.5. Substance does not also meetc criteria according to Annex XIII as the measured BCF is in the range 62-160, which is well below the cut off of 2000 for B and 5000 for vB. Substance is therefore not B or vB.

Toxicity Assessment

Substance does not meet aquatic screening criteria. Acute aquatic toxicity (LC50 and EC50) values are all well above 0.1mg/l. Substance does not also meet criteria according to Annex XIII as the measured long term NOEC, as well as values from QSARs, are well in excess of 0.01mg/l. The substance is neither carcinogenic, mutagenic nor toxic to reproduction. However, the substance is classified for Specific Target Organ Toxicity for repeat effects STOT-RE) and therefore does meet the screening criteria for toxicity.

Likely routes of exposure:

Not required as substance is neither PBT nor vPvB so exposure characterisation is not required.