Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
Reproduction/developmental toxicity screening test (equivalent to OECD 422, GLP)
- Parental and developmental NOAEL: 1000 mg/kg bw/day
Prenatal developmental toxicity study (equivalent to OECD 414, GLP)
- Maternal and developmental NOAEL: 1000 mg/kg bw/day
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

A NOAEL of 1000 mg/kg bw/day for developmental toxicity was established in the two available key studies and was based on the absence of adverse effects. The NOAEL was supported by two additional studies: one study was the pilot study for the other, a prenatal developmental toxicity study. Both studies established a NOAEL of 1000 mg/kg bw/day as well, based on the absence of adverse effects up to the highest dose tested.

Justification for classification or non-classification

Based on the NOAEL of 1000 mg/kg bw/day that was established and the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, t-BuTPP does not need to be classified for repro- or developmental toxicity.