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 testing in surface water, water/sediment systems and natural soils were performed. The calculated persistence DT50 values for the water phase are below the criteria of PBT and vPvB. The results of the water/sediment studies indicate that the substance is mainly partitioned into the sediment. The calculated persistence DT50 values in the water sediment systems and in the natural soils strongly varies, with some values above the P/vP trigger. However, the formation of carbon dioxide indicates the potential for mineralization of the test item and its transformation products. Therefore, the substance is not expected to have a potential for accumulation in the environment.  

Bioaccumulation Assessment

The bioaccumulation potential of the test item is considered to be low. An experimental study according to OECD 305 is available investigating the bioaccumulation of the test item in freshwater fish. A BCF of < 2 resulted which is clearly below the trigger value of 2000 to fulfil the B-criterion and 5000 to fulfil the vB-criterion. Thus, the criteria according to Annex XIII of Regulation (EC) No 1907/2006 are not met and the substance is not considered to be B or vB.

 

Toxicity Assessment

Long-term toxicity testing with freshwater sediment organisms resulted in the lowest effect concentration among all available experimental studies (EC10 (28 d) = 0.00071 mg a.s./L; OECD 219). The effect concentration is < 0.01 mg/L. Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are met and the substance is considered to meet the T-criterion.

In conclusion, the substance is not PBT/vPvB.