Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Dermal effects:

One volunteer had a patch of skin covered with dry RDX for 2 days. No irritation was observed following removal of the gauze coverings (Von Oettingen et al, 1949). An accurate dose could not be determined because of the lack of information provided in the study. Another study reported dermatitis in workers exposed to RDX fumes of unknown levels and for unknown duration (Sunderman, 1944), but the author was unable to identify the component of the fumes which was responsible for the skin lesions observed among operators at the plant.

Dermatitis was observed in rabbits exposed once to 27 mg/kg RDX in acetone, 37.5 mg/kg RDX in cyclohexanone, or 165 mg/kg RDX in DMSO (McNamara et al, 1974); the dermatitis persisted for at least 30 days and was most pronounced in the rabbits exposed to 165 mg/kg RDX in DMSO. Slight erythema was noted in guinea pigs exposed once to 1,000 mg/kg (McNamara et al, 1974).

In rabbits repeatedly exposed to 165 mg/kg RDX in DMSO 5 days/week for 4 weeks, dermatitis was observed after 14 and 30 days of exposure; no dermal effects were observed at 16.5 mg/kg RDX in DMSO or in rabbits administered lower RDX doses in cyclohexanone (37.5 mg/kg/day) or acetone (27 mg/kg/day) vehicles (McNamara et al, 1974).

However, the authors considered that no significant difference was observed between the signs of irritation obtained with the solvents alone and the RDX solution in the solvents.

Furthermore, one GLP study performed with Mononitroso-RDX in rabbit exposed to a single occlusive 24 h application was showed that the chemical did not cause any irritation of the intact or abraded skin (Snodgrass, 1984).

Ocular effects:

There are limited human data regarding the ocular toxicity of RDX. Conjunctivitis was reported by workers exposed to RDX fumes (Sunderman, 1944); no information was provided regarding exposure levels or duration of exposure.

Cataracts were observed in guinea pigs exposed through cutaneous or intradermal applications of RDX in solvents. However, the incidence of cataracts did not appear to be greater than that found after exposure to the solvents alone. This suggests that RDX itself did not contribute to cataract formation (McNamara, 1974).

Furthermore, one GLP study performed with Mononitroso-RDX in rabbit exposed to a single 24 h application was showed that the chemical did not cause any irritation to the eyes of rabbits under either unwashed or washed conditions (Snodgrass, 1984).

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 Irritating to skin and to eye.