Reaction mass of 1,5-naphthylene diisocyanate and Amines, hydrogenated tallow alkyl

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

An in vitro genetic toxicity study has been conducted on one substance in the NDI category, Reaction product of 1,5-naphthylene diisocyanate and cyclohexylamine. In the bacterial reverse mutation assay (Ames test) (Thompson 2017) no significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria at any dose level, up to the maximum recommended, either with or with metabolic activation. Therefore, the test item was classified as non-mutagenic under the conditions of the test, and thus the other NDI category members are also considered to be non-mutagenic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

PU NDI substances all contain the same core structure, with either cyclic groups or linear alkyl chains attached. PU NDI structures are therefore similar between all category members, and organisms will be exposed to very similar compounds. Organisms would be exposed to common structures, only differing by the functional groups attached to the core structure. In the body, there may be metabolism of the PU NDI structures, however due to the structural similarity of the parent compounds any metabolites are also likely to be similar. 

Justification for classification or non-classification

A bacterial reverse mutation assay (Ames test) has been conducted on one substance in the NDI category (Thompson 2017). No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria at any dose level, up to the maximum recommended, either with or with metabolic activation. Therefore, the test item was classified as non-mutagenic under the conditions of the test, and thus the other NDI category members are also considered to be non-mutagenic.