Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
No reproductive or developmental toxicity studies are available for the registered substance. However, the ZDDP functionality is not expected to cause reproductive toxicity based on data for alkyl ZDDPs (see section 13 for alkyl ZDDP category document). In addition, the registered substance is expected to have very low bioavailability based on the TK analysis. Therefore, applying the data on TPP is a reasonable approach to assessing the hazard and risk.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion