Disodium oxybis[methylbenzenesulphonate]

Endpoint summary

Additional information

In vitro micronucleus test

Ditolylether disulfonic acid disodium salt, isomer mixture (up to 10 mM) was tested in the in vitro mammalian micronucleus test according to OECD TG 487 using Chinese hamster lung cells (V79) in the presence and in the absence of a metabolic activation system. Under the reported experimental conditions ditolylether disulfonic acid disodium salt, isomer mixture did not induce structural and/or numerical chromosomal damage in Chinese hamster V79 cells.

Therefore, ditolylether disulfonic acid disodium salt, isomer mixture is considered to be non-mutagenic with respect to clastogenicity and/or eugenicity in this in vitro Mammalian Cell Micronucleus Test.

 

Ames test

Ditolylether disulfonic acid disodium salt, isomer mixture was investigated for its potential to induce gene mutations in bacteria according to OECD TG 471 using plate incorporation methodology and pre-incubation methodology in the presence and absence of a metabolic activation system. The tested concentration range was up to 5000 µg/plate. Under the reported experimental conditions ditolylether disulfonic acid disodium salt, isomer mixture did not cause gene mutations in the tester strains used: Salmonella toyphimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA.

Therefore, ditolylether disulfonic acid disodium salt, isomer mixture is considered to be non-mutagenic in this bacterial reverse mutation assay.

 

HPRT

The study was performed to investigate the potential of ditolylether disulfonic acid disodium salt, isomer mixture to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 20 hours without metabolic activation. No precipitation of the test item was noted in the experiments. No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.

Therefore, under the reported experimental condiluons ditolylether disulfonic acid disodium salt, isomer mixture is considered to be non-mutagenic in the HPRT-locus using V79 cells of the Chinese Hamster.

 

Overall conclusion

The available in vitro studies with ditolylether disulfonic acid disodium salt, isomer mixture are GLP compliant and of high quality (Klimisch Score =1). Therefore, there is no reason to believe that these results would not be applicable in humans.

 

Justification for selection of genetic toxicity endpoint
No study was selected since all three in vitro studies were negative.

Short description of key information:
Clearly negative in vitro studies, both with and without metabolic activation:
Ditolylether disulfonic acid disodium salt, isomer mixture does not induce chromosomal aberrations in the in vitro MNT test and does not induce gene mutations in bacteria and not in mamalian cell systems.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available results no classification is needed.