Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are used to decide if the substance fulfils the PBT or vPvB criteria.

Persistence Assessment

The substance is considered as potentially P and vP. Aerobic and anaerobic simulation tests in water/sediment systems and natural soils were performed. The substance was not readily degraded under anaerobic and aerobic conditions. The major pathway of dissipation was adsorption to the sediment and soil by forming non-extractable residues. The calculated persistence DT50 values for entire water/sediment systems ranged between 69 and 578 days. For soils lower DT50 values were determined, which ranged from 11 to 72 days under aerobic conditions. The formation of carbon dioxide indicates the potential for mineralization of the substance. Therefore, the substance is not expected to have a potential for accumulation in the environment. 

Bioaccumulation Assessment

The substance has a log Pow of -1.362 at pH7 and 23 °C which is below the trigger of 4.5. Thus, the substance does not meet the screening criterion and is not B/vB.

Toxicity Assessment

The substance is classified as STOT Rep. Exp. 2 (H373) according to Regulation (EC) No 1272/2008. Thus, it meets the criteria in Annex XIII of Regulation (EC) No 1907/2006 and is considered to be toxic (T).

In conclusion, the substance is not PBT/vPvB.