Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
no further testing for developmental toxicity is necessary because the substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment and the classification and labelling of the substance
Justification for type of information:
Clear indication for adverse effect on fertility and development of F1 pups was observed in the screening study. According to above classification criteria there was “clear evidence” for developmental toxicity. Since no serious deficiencies in study design can be located classification of  N-((3(5)-Methyl-1H-pyrazol-1-yl)methyl)acetamid into category 1B is most appropriate.
Therefore no further testing is required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion