Registration Dossier

Administrative data

toxicity to reproduction
Data waiving:
exposure considerations
Justification for data waiving:

Data source

Materials and methods

Test material


Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

In view of no data being presented in the 28 day oral toxicity study that indicated effects to the reproductive organs and there being no similarity with known reproductive toxcins, it is not considered justified to perform a new animal test.
Executive summary:

There is predicted to be low exposure to workers under controlled workplace conditions and no exposure to the general public. EUSES modelling with ConsExpo suggests a low risk of accumulation in food and drinking water.

The absence of relevant systemic effects in the 28 day oral study and the low exposure would suggest it is inappropariate to perform further animal studies to meet this end point. If the tonnage exceeds 100 t per annum or if use types change that could lead to increased human exposure, testing may be necessary.