Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

6 subjects previously exposed to fumes from the Bachman reaction were tested with condensate from the reaction mixture (Sunderman, 1944). According to the reactions observed on the volunteers, only 2 subjects were extremely sensitive and showed a severe skin reaction from the fume condensate. Repeated exposure failed to produce any sensitivity reaction in human (Sunderman, 1944).

Sensitization studies of the test substance in acetone, cyclohexanone, and DMSO were conducted using the experimental methods of Landsteiner and the others who followed his classic procedures (McNamara et al, 1974).

Sensitization effects were evaluated using the Draize test as recommended by the US Department of Agriculture, Food and Drug Administration. Young adult guinea pigs of both sexes were exposed to the test compounds by topical application to the skin and by intradermal injection. Solutions of RDX did not produce skin sensitization in guinea pigs when administered intradermally or topically (McNamara et al, 1974).

Furthermore, one GLP study performed with Mononitroso-RDX in guinea pig was showed that the chemical is not expected to produce a sensitization reaction (Snodgrass, 1984).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the results obtained in the animal studies and the classification criteria of Regulation EC n°1272/2008 (CLP), RDX is not considered as Skin sensitising.