Registration Dossier

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

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.

Justification for classification or non-classification