1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxypropyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt (1:6)

Endpoint summary

Additional information

In vitro data:

Mutagenicity in bacterial reverse mutation assays (Ames test) has been investigated with the Stilbene fluorescent whitening agents with the CAS Numbers: 13863 -31 -5, 16090 -02 -1, 4193 -55 -9, 27344 -06 -5, 16470 -24 -9, 41098 -56 -0, and 67786 -25 -8. Negative results were obtained in all tests with and without metabolic activation. All relevant tester stains were tested and test item concentrations were adequate.

Clastogenicity in mammalian cells has been investigated in reliable studies with CAS 16090 -02 -1, 27344 -06 -5, and 16470 -24 -9 (chromosome aberration test according to OECD TG 473). Negative results were obtained in the presence and absence of metabolic activation.

In vivo data:

Induction of micronuclei in vivo was investigated in three reliable tests with mice which were orally treated with CAS number at doses of 5000 mg/kb bw: 16090 -02 -1, 13863 -31 -5, and 16470 -24 -9. No increase in the number of micronuclei were observed. No toxic effects were observed. Induction of chromosome aberration in vivo was investigated in two reliable tests with chinese hamsters which were orally treated with CAS 16090 -02 -1 and 13863 -31 -5 at doses of 5000 mg/kg bw. Both tests showed absence of clastogenic effects. No toxic effects were observed. Induction of dominant lethal effects in vivo was investigated in three reliable tests with mice which were orally treated with CAS 13863 -31 -5, 4193 -55 -9, and 67786 -25 -8. All test showed absence of dominant lethal mutations. Possible mutagenic potential of Stilbene fluorescent whitening agents has been investigated in vitro (bacterial reverse mutation assays (Ames tests), and chromosome aberration tests in mammalian cells) as well as in vivo (micronucleus assay in mice, chromosome aberration, dominant lethal test). All these tests consistently yielded negative results indicating that Stilbene fluorescent whitening agents have no mutagenic potential. It is concluded that these negative findings can also be transferred to the stilbenes which were not tested. Besides these negative findings on mutagenicity Stilbene fluorescent whitening agents and then, reading across, also the substance CAS 371756 -75 -1, are unlikely to be bioavailable after oral, dermal and inhalation exposure and therefore have not to be classified as germ cell mutagens.

Short description of key information:
Category assessment used to read across:
in vitro: Ames: negative; OECD 471
Chromosome aberration: negative; OECD 473
in vivo: MNT: negative; OECD 474
Chromosome aberration: negative;
Dominant lethal test: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for genetic toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for genetic toxicity under Regulation (EC) No. 1272/2008.