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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
further information relevant for the PBT assessment is necessary

An evaluation of the inherent properties of 3,3’,5,5’-tetramethyl-4,4’-diaminodicyclohexylmethane (TMDC, CAS no. 65962-45-0) 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 (2012) were applied.

- Based on a weight-of-evidence approach, the substance is considered to be not readily (rapidly) biodegradable (poorly biodegradable).

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/rapidly 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.

- Significant bioaccumulation in organisms is not to be expected for TMDC (CAS no. 65962-45-0) based on the read-across to the experimental data for DMDC (CAS no. 6864-37-5) which resulted in a BCF of < 60. TMDC has a measured log Kow of 3.0 at pH 11.0 and 23°C covering 95 area% of the substance confirming the low bioaccumulation potential. Therefore TMDC is not B/vB.

- With respect to the aquatic toxicity, the results of the available short-term studies indicate that the L(E)C50 values are greater than the screening criterion of 0.01 mg/L. The lowest acute value is 5.0 mg/L. The long-term toxicity studies for Daphnia and algae gave EC10 values of greater than 0.01 mg/L. Fish is also expected to have a long-term EC10 of greater than 0.01 mg/L since it was not the most sensitive test organism compared to aquatic plants and aquatic invertebrates. Based on available aquatic toxicity data the substance is not T. However, the substance is self-classified as H373 (STOT Rep. Exp 2). Identified target organs are skeletal muscle and liver. Hence, the substance fulfills the T-criterion.

In conclusion, TMDC (CAS no. 65962-45-0) should not be considered as a PBT/vPvB substance.

Likely routes of exposure:

Dermal, inhalation