Registration Dossier
Registration Dossier
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EC number: 248-319-6 | CAS number: 27203-92-5
Carcinogenicity
Administrative data
Description of key information
A long-term carcinogenicity study was performed in rats (dosing duration of 104 weeks) at doses up to and including 75 mg/kg/day (450 mg/m2) for male rats and 100 mg/kg/day
(600 mg/m2) for female rats. These doses are approximately 1.8-fold and 2.4-fold higher than the maximum daily human dosage of 246 mg/m2. No evidence of carcinogenicity was observed with tramadol in male or female rats. A carcinogenicity study was also conducted in p53(+/-)-heterozygous mice (dosing duration of 26 weeks) at doses up to and including 150 mg/kg/day (450 mg/m2) for male and female mice. This dose is approximately 1.8-fold higher than the maximum daily human dosage of 246 mg/m2. No evidence of carcinogenicity was observed in male or female mice.
Source: FDA [Internet]. U.S. Food and Drug Administration. Available from: http://www.fda.gov/
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
