Registration Dossier

Administrative data

Description of key information

The test substance did not induce papillomas in a 31-week repeated dose study with dermal application in mice.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

There are no data available from guideline studies for carcinogenicity that comply with today’s standards. However, the results from an elderly 31-week study with dermal application of the test substance in mice did not provide evidence for carcinogenic effects of the test substance (Jepson et al., 1977). In this study, the test substance was applied with a soft brush on a shaved area of the upper part of the back, approx. "the size of a finger nail". Applications were thrice a week, over 31 consecutive weeks. Mortality, development of papillomas and other skin reactions as well as amyloid deposition in the kidney, spleen and liver were observed. No information was provided on clinical observations. Survival after 31 weeks was 10 out of 11 in the low-dose group (0.15 %), 10 out of 10 in the mid-dose group (1.5 %) and 8 out of 9 in the high-dosegroup (15 %). No information was provided as to the causes of death. The test substance did not induce papillomas. Slight dysplasia was reported in two high-dose animals; hyperplasia occurred in one mid-dose and seven high-dose mice. 3 of the high-dose animals had degenerative changes (amyloid deposition) in the kidney, but not in spleen nor liver.

Justification for classification or non-classification

The database concerning carcinogenicity of the test substance is insufficient for a final assessment (data lacking).