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Carcinogenicity

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Description of key information

Category assessment:
Not carcinogenic upon feeding to rats
Not photocarcinogenic upon skin painting of mice
No tumour-promoting potential on 8-methoxypsoralen-induced carcinogenicity

Key value for chemical safety assessment

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 carcinogenicity 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 carcinogenicity under Regulation (EC) No. 1272/2008.

Additional information

There are three combined chronic / carcinogenicity studies (Bayer AG 1978a,c,d), the test substances (CAS 16090 -02 -1, 4404 -43 -7, and 16470 -24 -9) were administered to 50 Wistar rats/sex/dose in diet at dose levels of 0, 100, 1000, 10000 ppm for 24 months. There were no compound related effects in mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, urinanalysis, organ weights, or gross and histologic pathology. The NOAEL is for females and males 10000 ppm/day.The various statistically significant differences observed with CAS 16090 -02 -1 (increase/decrease) in organ weights (absolute in males), number of reticulocytes/trombocytes, and ALAT (GPT) activities and serum protein were considered to be of no toxicological relevance and did therefore not provide any evidence of toxicity of the test substance at any of the dose levels tested. At the doses tested, there were in tested substances not a treatment related increase in tumor incidence when compared to controls.

Further studies were done in order to investigate wheter the test substance has a carcinogenic effect onto skin under light exposure.

There were eight studies available investigating the increase or the appearance of skin tumors after several ultraviolet light exposures after dermal exposure to CAS 16090 -02 -1, 4404 -43 -7, 16470 -24 -9, and 13863 -31 -5. Photocarcinogenesis testing involved pretreating hairless mouse skin with the test compounds, 8 -methoxypsoralen (8 -MOP; known phototoxic agent), or solvent only before each daily exposure to simulated solar ultraviolet light. In terms of tumor yield and tumor development time, photocarcinogenesis was enhanced by 8 -MOP, but not by test substances.

All these tests consistently yielded negative results indicating that Stilbene fluorescent whitening agents have no carcinogenic potential. It is concluded that these negative findings can also be transferred to the stilbenes which were not tested.

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