Registration Dossier
Registration Dossier
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EC number: 203-577-9 | CAS number: 108-39-4
Carcinogenicity
Administrative data
Description of key information
There is no carcinogenicity bioassay or other chronic study available to assess the carcinogenic potential of m-cresol.
However, for read across purposes, the recently published studies on carcinogenicity with m/p-cresol mixture (60:40; US Department of Health and Human services 2007) is considered. .
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Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
There is no carcinogenicity bioassay or other chronic study available to assess the carcinogenic potential of m-cresol.
However, for read across purposes, the recently published studies on carcinogenicity with m/p-cresol mixture (60:40; US Department of Health and Human services 2007) will be considered.
In 2007, US Health and Human Services published a Toxicity and Carcinogenicity Study in which only male rats or only female mice were fed m/p-cresol mixture over a period of two years without interim kill. Neither absolute/relative organ weights nor blood biochemistry data were reported so far. The report contains only histopathological data.
Rat study
Male F344/N rats received in feed 0. 1500. 5000, and 15000 ppm daily for 105 weeks. Under the condition of these 2-year studies, there was equivocal evidence of carcinogenic activity on m/p-cresol based on the 4/50 male rats with renal tubular adenomas. The incidence of these neoplasms was not significant but exceeded the historical control data of the laboratory (1/297[feed studies]).
Mouse study
Female B6C3F1 mice received in feed 0, 1000, 3000, 10000 ppm for 106-107 weeks. Under the conditions of these 2-year studies there was some evidence of carcinogenic activity of m/p-cresol mixture based on the increased incidence of forestomach squamous cell papillomas. However, there is no human counterpart for the rodent forestomach (Proctor et al., Toxicol Sci 98, 313 -326, 2007). Therefore, the forestomach squamous cell paplillomas are of minor significance for the human situation. In addition, due to the corrosive property of the test substance, chronic irritation is expected to be th mode of action.
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