Registration Dossier
Registration Dossier
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EC number: 249-530-6 | CAS number: 29240-17-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Studies are not available for the registered substance. See section 13 of IUCLID for the read across justification document.
A study according to OECD 422 for a structural analogue is used.
For tert-butyl peroxypivalate an OECD 422 (combined repeated dose fertility/developmental screening) (50, 150, 310 mg/kg bw/ d) is available (Wistar rats; vehicle sunflower oil). The systemic NOAEL for this study is 150 mg/kg bw/d. Effects observed are: 310 mg/kg bw/d: salivation (m/f), reduced bodyweight gain (m) and during lactation period (f), reduced food consumption (m/f), increased kidney weights (m), pup mortality (probably related to material tox.), reduced litter weight/weight gain; 150mg/kg bw/d salivation (m/f), reduced food consumption (m/f). 50mg/kg bw/d: no effects observed. Effects on reproductive performance were not observed. The NOAEL for development is 150 mg/kg bw/day based on effects on mean litter weight, mean pup weight and increased extra uterine mortality at the highest dose level.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 310 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- One K1 study is available
Effects on developmental toxicity
Description of key information
See above.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- One K1 study is available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information on toxicity to reproduction, the test item was not classified and labelled according to Regulation EC (No) 1272/2008 (CLP), as amended for the 17th time in Regulation (EU) 2021/849.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
