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Administrative data

Description of key information

Repeated dose toxicity
Dermal NOAEL 20 mg/kg in rats (OECD TG 410)
Inhalation NOAEC 19 mg/m3 in rats (OECD TG 412)
Inhalation BMCL10 36.20 mg/m3

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
36.2 mg/m³

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
20 mg/kg bw/day

Additional information

The dermal toxicity of the test material was assessed after topical application of the test substance to the shaved intact skin of Crl:CD BR rats. The test material was dispersed in Neutral Oil 100 N for non-occluded application for 6 hrs/day, 5 days/week for 4 weeks.

Daily application of the test material to the skin of rats for four weeks at doses up to and including 60 mg/kg/day had a No-Observed Effect Level (NOEL) for systemic toxicity of 20 mg/kg/day. The test material exposure resulted in increased absolute and relative adrenal weights in both males and females of Group 5 (60 mg/kg/day). The minimum effect level was 60 mg/kg/day. In both males and females, local skin irritation at the application site was observed at all dose levels of the test material, the duration and severity of which were dose-dependent. Treatment-related gross and histopathologic effects were confined to the skin (epidermis and dermis) and underlying subcutaneous tissues at the treatment site. Doses of 60 mg/kg/day proved severely irritating to the skin of rats.   

Crl: CD BR rats, received nose-only inhalation exposures for 6 hours per day, 5 days a week, for four weeks to air or vapors of the test material. On the basis of the most sensitive indicator of toxicity, the histopathological changes seen in the nasal cavities, the no-observed effect-level (NOEL) following four-weeks of nose-only inhalation exposure to the test material was 19 mg/M3. The LOAEL in the 28 day rat vapor inhalation study was 129 mg/m3.

Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: nose

Repeated dose toxicity: dermal - systemic effects (target organ) glandular: adrenal gland; other: skin

Justification for classification or non-classification

The test material is not classified based on the results of the dermal toxicity. Although, a classification for inhalation appears to be warranted based on a LOAEL of 129 mg/m3 seen in the 28 day rat, no further classification is needed based on the corrositivity of the material. Effects observed in the upper respiratory tract in 28 day study rat inhalation study were determined to be point of contact (local) effects.