Registration Dossier
Registration Dossier
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EC number: 700-990-0 | CAS number: -
Endpoint summary
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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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