Registration Dossier
Registration Dossier
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EC number: 218-059-8 | CAS number: 2044-64-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Short description of key information:
A combined repeated dose toxicity study with
reproduction/developmental toxicity screening test was conducted in year
2005/2006 according to OECD 422 and GLP. Crl:CD®(SD)IGS BR rats
(10/sex/dose level) were dosed with DMAA once daily by gavage at dose
levels of 0, 100, 300, or 1000 mg/kg bw/day. Following a 2 week
premating period, parental (P1) males and females were cohoused for up
to 2 weeks within their respective treatment groups to produce F1
litters. The NOEL for reproductive toxicity and F1 offspring was 1000
mg/kg bw/day, the highest dose level tested.
Justification for selection of Effect on fertility via oral route:
GLP compliant study conducted in accordance with international
guidelines.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study 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 data available the substance is not classified and labeled according to Regulation 1272/2008/EEC (CLP) and Directive 67/548/EEC (DSD).
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.
