Registration Dossier
Registration Dossier
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EC number: 204-500-1 | CAS number: 121-82-4
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
Justification for selection of carcinogenicity via oral route endpoint:
The carcinogenic potential of RDX was evaluated in orally exposed rats and mice; no evidence of carcinogenicity was observed in two rat studies.
In mice, an increase in the combined incidence of hepatocellular adenomas and carcinomas was observed in females only.
However, a re-evaluation of these data using current diagnostic criteria resulted in a reclassification of some hepatocellular adenomas as foci of cytoplasmic alterations.
As a result of the re-analysis, the combined incidence was significantly higher than concurrent controls at 35 mg/kg/day, but not at 100 mg/kg/day and the incidence in the 35 mg/kg/day group was within the range of historical control data.
The investigators suggested that the study provided equivocal evidence of carcinogenicity. The International Agency for Research on Cancer (IARC) and the Department of Health and Human Services (DHHS) have not classified the carcinogenicity of RDX. EPA classified RDX as a group C carcinogen, possibly carcinogenic to humans; however, this evaluation was done prior to the re-evaluation of mouse tumor data. EPA is currently reevaluating RDX.
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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