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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 2,2’-dimethyl-4,4’-methylenebis(cyclohexylamine) (DMDC; CAS no. 6864-37-5) is performed against Annex XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment R.11: PBT Assessment (2014) were applied.

 

The available evidence on degradation is not sufficient for an assessment based on the Annex XIII criteria for persistence (P and vP). As the substance is concluded to be not readily biodegradable as well as to be hydrolytically stable, it should be considered potentially P/vP from a precautionary point of view until further data become available.

 

A measured log Kow of 2.3 and results from a bioaccumulation study according to OECD TG 305 C (BCF < 60) indicate that the substance is neither B nor vB.

 

Regarding aquatic toxicity the substance is not T since the lowest available chronic value is > 0.01 mg/L (experimental chronic toxicity data are available for Daphnia and algae. The chronic values are greater than 0.01 mg/L). Furthermore, results of the available short-term studies for fish, Daphnia and algae indicate that the L(E)C50 values are greater than the screening criterion of 0.1 mg/L (the lowest acute value is 4.6 mg/L for Daphnia). However, the substance is self-classified as STOT-RE. Identified target organs are skeletal muscle and liver. Hence, the substance fulfills the T-criterion.

Based on available data, no final conclusion can be drawn on the P/vP properties. The substance fulfills the T-criterion, but since it is not B/vB it can be regarded as not PBT and not vPvB.

Likely routes of exposure:

Dermal, inhalation