Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In-vitro Studies: Bacterial systems

In an Ames-Test (GINC, Japan) a dose-dependent tendency in the increase of mutated colonies was observed in strain TA100, TA 98 and TA1537 without S9 mix and in strain TA100 with S9 mix. In the trials which were repeated twice, the number of mutated colonies in the TA1535 group was 1.5 to 2 times higher than that of the solvent control, but it could not be determined to be definitely positive. A confirmative test was carried out with regard to the TA1535 strains with and without S9 mix to confirm its reproducibility, but a clear mutagenicity-inducing effect was not observed. On the other hand, the positive control substance induced two times or more of mutated colonies in each tester strain, compared to the solvent control group. In addition, remarkable changes such as precipitation were not observed during the tests.

In-vitro Studies: Mammalian cell gene mutation test

An HPRT Locus Assay (BASF SE, 2010) with CHO cells was performed with 4-nitrotoluene-2-sulphonic acid. In the study the test substance did not lead to a relevant increase in the number of mutant colonies either without S9 mix or after the addition of a metabolizing system in two experiments performed independently of each other. The mutant frequencies at any concentration were within or slightly above the range of the concurrent negative control values and within the range of the historical negative control data.

In-vitro studies: Chromosomal aberrration and micronucleus tests

In the in vitro Chromosomal Aberration Test in Chinese hamster cells with 4-nitrotoluene-2 -sulphonic acid, no tendency of inducing the chromosomal structural aberration and ploidy cells was observed in either dose (GINC, Japan). On the other hand, a remakable induction of chromosomal structural aberrration was recognized in cells treated with MMC (positive control). In case of the test substance group, no tendency of inducing the chromosomal structural aberrration and ploidy cells was observed in either dose in the absence and presence of S9 mix. On the other hand, a remarkable induction of chromosomal structural aberration was recognized only in the presence of S9 mix for the cells treted with CP (positive crontrol). In each test system of continous treatment and shortterm treatment, a decrease in pH value for the culture fluid was recognized in all test doses, it has returned to the neutral range at the exchange of culture fluid or the completion of culture.


Short description of key information:
4-nitrotoluene-2-sulphonic acid showed a tendency toward mutagenicity in an Ames test in Salmonella typhimurium strains TA100, TA98 and TA1537 without an exogenous metabolic activation system, and in strain TA100 with an exogenous metabolic activation system (GINC, Japan).
4-nitrotoluene-2-sulphonic acid did not induce structural chromosomal aberrrations or polyploidy in CHL cells, with or without an exogenous metaboic activation system (GINC, Japan).
4-Nitrotoluene-2sulphonic acid was not mutagenic in the HPRT locus assy in CHO Cells (BASF SE, 2010).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

no classification required

GHS classification (EU GHS, CLP 1272/2008):

no classification required