Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

TNS was not mutagenic in S. typhimurium or E. coli in the bacterial reverse mutation assay. It was also negative for chromosome aberrations in human peripheral blood lymphocytes. The aqueous dispersion of TNS (~20% solids and ~80% water) was administered directly in these in vitro studies without correction for active ingredient since the product does not exist as TNS alone and is always transported and used as the aqueous dispersion. An in vitro gene mutation study in mammalian cells was not performed because conducting an additional mammalian cell test will be unlikely to provide any further useful information about the potential in vivo mutagenicity of TNS. TNS is not anticipated to have genotoxic potential.


Short description of key information:
In vitro
Mutagenic effects – Bacterial, OECD 471. Aqueous dispersion of TNS administered, 1000 µg/plate, not mutagenic. Not classified as a mutagen. Reliability =1.
Clastogenic effects – Mammalian cells, OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test). Aqueous dispersion of TNS administered, 1000 µg/mL. Not clastogenic. Not classified as a mutagen. Reliability = 1

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is proposed for mutagenicity based on the lack of a response in bacterial cells and in human lymphocytes in vitro according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.