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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Weisburger 1978: A statistically significant increase in vascular tumours was observed in male mice. Hepatocellular carcinomas were also increased in male mice, but not in a dose-related manner. No observations of tumours were reported for female mice.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Study duration:
chronic
Species:
mouse
Quality of whole database:
The quality of the database was very low.

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data is not considered to be reliable, or adequate for classification purposes.

The classification for this endpoint is inconclusive.

Additional information

The study indicates the test substance is not a potent carcinogen in the strain/sexes at the dose levels used; however, there is insufficient information to conclude that the data are robust. A full assessment of the carcinogenicity potential is not possible for the following reasons:

·        Overall the study is considered unreliable due to the lack of reported experimental details (rated Klimisch 3). 

·        Data are not available on a full compliant of the regulatory species/sex (female rats).

·        Limited data are presented within the report.

·        The substance was not found to be positive in genotoxicity studies.

·        The report did not make a clear position on the relation of tumours with treatment.

The available data is not considered to be reliable, or adequate for classification purposes.


Justification for selection of carcinogenicity via oral route endpoint:
None of the available data is considered to be reliable, or adequate for classification purposes.