Registration Dossier

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Reference
Reference Type:
publication
Title:
No information
Year:
1972
Bibliographic source:
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work), p. V4 274 (1974).

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: unspecified oil
Details on exposure:
Among 8 BD rats given weekly sc doses of 16 mg/kg bw in oil (total dose, 784 mg/kg bw).
Among 12 BD rats receiving 8 mg/kg bw in oil weekly for 394 days (total dose, 466 mg/kg bw)
Duration of treatment / exposure:
394 days
Frequency of treatment:
weekly
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
16 mg/kg bw
Basis:
no data
Remarks:
Doses / Concentrations:
8 mg/kg bw
Basis:
no data

Results and discussion

Results of examinations

Details on results:
Among 8 BD rats given weekly sc doses of 16 mg/kg bw in oil (total dose, 784 mg/kg bw).. 4/6 survivors developed local sarcomas within 236-414 days, 1 with metastases to lung.
Among 12 BD rats receiving 8 mg/kg bw in oil weekly for 394 days (total dose, 466 mg/kg bw).. 7/11 showed local sarcomas, 3 of which had metastasized to lung and regional lymph nodes. Mean tumor induction time was 500 days. One rat liver carcinoma. No control data were reported.

Applicant's summary and conclusion