Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
Based on the available data, test material can cause uterine morphology changes but no mortality in the rats. 
Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via dermal route
Endpoint conclusion:
no study available (further information necessary)

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available (further information necessary)

Toxicity to reproduction: other studies

Additional information

A study was conducted to screen other drugs for their uterine morphology in the rats. The drugs tested include quinacrine-like compounds, and tetracycline and its analogues(exp. test article) which are known sclerosing agents. Tetracycline and its analogues produced quinacrine-like morphologic changes in the rat and showed no toxicity for the dose tested. It was indicated that no mortality but uterine necrosis was observed with test material.

Justification for classification or non-classification

It is inconclusive to classify the test substance based on the available data.

Additional information