Registration Dossier
Registration Dossier
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EC number: 248-003-8 | CAS number: 26787-78-0
Endpoint summary
Administrative data
Description of key information
Key study: Test method OECD 422. GLP study. The NOAEL for the subacute repeated dose toxicity of amoxicillin trihydrate in rats by oral route was determined to equal or higher than 2450 mg/kg bw/day since no adverse effects were observed at the highest dose tested.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 450 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available study is a high quality subacute assay (Klimish score =1).
Additional information
Repeated dose toxicity (subacute):
A combined repeated dose toxicity study with reproduction/developmental toxicity screening was conducted with amoxicillin trihydrate according to OECD Guideline 422 (GLP study). The treatment of male and female rats with amoxicillin trihydrate at dose levels up to 2450 mg/kg-bw/day by repeated oral (gavage) administration revealed no consistent and dose-related effects. The no-observed-adverse-effect-level (NOAEL) of the test item was determined to be 2450 mg/kg b.w./day for parental toxicity.
Repeated dose toxicity (subchronic):
Data waiving (study scientifically unjustified): A sub-chronic toxicity study does not need to be conducted since there is sufficient information leading to the assumption that the substance has not a particular danger related to the repeated exposure. Further testing on vertebrate animals shall be omitted in accordance to the Annex XI of the REACH Regulation (EC) 1907/2006 and in accordance to animal welfare principles.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study is available.
Justification for classification or non-classification
Based on available information, the substance is not classified for specific target organ toxicity-repeated exposure (STOT-RE) according to the CLP criteria; Regulation (EC) No 1272/2008.
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