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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The MeClas tool determined that there is no need to classify pNMC oxide (generic composition) for the Mutagenicity endpoint

The outcome of two genotoxicity tests with pNMC oxide (8:1:1:) (AMES test and the chromosomal aberration test) confirmed that there is no conclusive evidence to classify the tested substance for this specific endpoint.

  • Bacterial Reverse Mutation Assay (e. g. Ames test): Negative (TA98, TA100, TA1535, TA1537, WP2uvrA-), OECD 471, EU Method B.13/14;
  • Mammalian C

hromosome Aberration Test: Negative, OECD 473, EU Method B.10.available for this endpoint.

There are currently no in vivo testing data available for this endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, an in vivo mutagenicity test is required to confirm that the substance should not be classified for this endpoint when no positive effects are observed in the in vitro mutagenicity test. No in vivo study is currently available, but application of the mixture rules using the hazard properties of the pNMC oxide properties (MeClas-calculation) shows that there is no requirement to classify pNMC oxide for the mutagenicity endpoint (no hazard identified).

Taking into account the MeClas-calculation and the negative response in the two in vitro mutagenicity tests with the substance, it is concluded that pNMC oxide should not be classified for this hazard endpoint.

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