Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
Some data on carcinogenic potential of the test substance can be found in literature (Scientific Committee on Occupational Exposure Limits (SCOEL), SCOEL/SUM/178, September 2010).
In a carcinogenicity oral study at estimated daily doses of 42 to 46 mg/kg bw, no significant occurrences of tumor were recorded. No control group was described in this study.
Although reliability of these data are limited, they indicate that chronic exposure of rats to the test substance shows no high carcinogenic potential.
In another study at estimated daily doses of 35 mg/kg bw during approximately 200 days, occurrences of tumors were significantly increased in mice exposed to the test substance together with sodium nitrite in drinking water. It was concluded that the combination of test substance in food with sodium nitrite in drinking water led to the formation of carcinogenic nitrosamines.
Due to the relatively short duration of exposure and the limited number of groups no conclusive decision can be drawn with respect to carcinogenicity of the test substance other than that sub-chronic exposure of mice to test substance shows no high carcinogenic potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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