Registration Dossier
Registration Dossier
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EC number: 473-780-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In an Ames test according to OECD guideline 471 (bacterial reverse mutation assay), NX 8000J was tested in doses up to 5000 µg/plate both in the absence and presence of S9-mix. Precipitation was observed at dose levels of 1500 µg/plate and higher. There were no signs of cytotoxicity or genotoxicity.
In a chromosome aberration test according to OECD guideline 473 (in vitro mammalian chromosome aberration test), NX 8000J was tested in doses up to 125 µg/ml both in the absence and presence of S9-mix. Precipitation was observed at dose levels of 125 µg/ml and higher. There were no signs of cytotoxicity or genotoxicity.
In a chromosome aberration test according to OECD guideline 476 (in vitro mammalian cell gene mutation test), NX 8000J was tested in doses up to 500 µg/ml both in the absence and presence of S9-mix. Precipitation was observed at dose levels of 62.5 µg/ml and higher. There were no signs of cytotoxicity or genotoxicity.
Short description of key information:
NX 8000J was negative in an Ames test, an in vitro chromosomal aberration and a gene mutation study in mammalian cells.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the in vitro genetic toxicity studies, NX 8000J does not need to be classified for genotoxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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