Registration Dossier
Registration Dossier
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EC number: 839-353-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The reported test data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. It is this concluded that pNMC-hydroxide (8:1:1:) has no mutagenic activity on the growth of the bacterial strains under the test conditions used in this study.
No induction of chromosome aberrations in Chinese hamster V79 cells was observed following treatment with pNMC-hydroxide (8:1:1) up to and including 250 µg/ml, thus there is no evidence of any genotoxic activity of the test item under the conditions of this study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the findings of the Bacterial Reverse Mutation Assay (OECD471) and the Mammalian Chromosome Aberration test (OECD473) it is concluded that there is no need to classify pNMC-hydroxide as a mutagenic substance.
A harmonised classification (Muta.Cat.2) exists for Ni(OH)2, and as a result a similar classification is calculated with MeClas for this iUVCB. Available testing data with pNMC hydroxide, however, do not confirm this hazard. Awaiting the results of an in vitro gene mutation study in mammalian cells with pNMChydroxide as test substance, the substance is provisionally not classified for mutagenicity.
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