Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.

Additional information