Registration Dossier

Toxicological information


Currently viewing:

Administrative data

Description of key information

Two carcinogenicity studies, one via oral route and one via inhalation route, have been conducted.

Key value for chemical safety assessment

Carcinogenicity: via oral route

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

Carcinogenicity: via inhalation route

Endpoint conclusion
Dose descriptor:
113 mg/m³

Additional information

In both carcinogenicity studies, tumors were observed at the initial contact point with the test material. In the case of the oral gavage study, tumors were observed in the forestomach of rats. A high incidence (100% for females, 81% for males) of squamous cell carcinomas of low-grade malignancy was observed in the forestomach of animals at risk (>18 months) from the 10 mg/kg group. In the 2 mg/kg group forestomach tumours were found at a lower incidence (7% for females, 14% for males), whereas this turnour was not found in control animals.

In the inhalation study, tumors were observed in the respiratory tract, with one exception all tumors were in the nasal cavity. One tumor was a bronchial papilloma. A short-term 30 -exposure regimen (6 hours/day, 5 days/week) with 100 ppm epichlorohydrin produced malignant squamous cell carcinomas of the nasal cavity in 15 of 140 rats and respiratory tract papillomas in 3 rats. Among 100 rats, lifetime exposure to 30 ppm yielded 1 malignant squamous carcinoma of the nasal cavity plus 1 nasal papilloma. No nasal or respiratory tract tumors were produced by lifetime exposure of 100 rats to 10 ppm.

Carcinogenicity: via oral route (target organ): digestive: stomach

Carcinogenicity: via inhalation route (target organ): respiratory: nose

Justification for classification or non-classification