Registration Dossier
Registration Dossier
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EC number: 248-003-8 | CAS number: 26787-78-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In-vitro gene mutation in bacteria:
Supporting study: As reported in the WHO Food Additives Series: 66, the genotoxic effects of amoxicillin were determined in a bacterial reverse mutation assay (Ames test). The test substance was a mixture of amoxicillin and clavulanate potassium (4:1). The results showed no mutagenicity of the test material. Based on the results, it is concluded that amoxicillin is not mutagenic in the Ames bacterial mutation assay.
In-vitro cytogenicity study in mammalian cells or in-vitro micronucleus study:
Key study: Evaluation of the ability of amoxicillin to induce chromosome aberrations in human peripheral blood lymphocytes was determinated according to equivalent or similar OECD 473 Guideline. The test substance did not induce chromosomal aberrations in human peripheral blood lymphocytes both in the presence and absence of the metabolic activator up to 1000 µg/mL.
Key study: Evaluation of the ability of amoxicillin to induce genotoxicity in human peripheral blood lymphocytes was determinated according to equivalent or similar OECD 487 Guideline. Amoxicillin neither induced the formation of micronucleus nor decreased the nuclear division index in human peripheral blood lymphocytes both in the presence and absence of the metabolic activator up to 1000 µg/mL.
Supporting study: Evaluation of the ability of amoxicillin to induce genotoxicity in human peripheral blood lymphocytes was determinated according to equivalent or similar OECD 479 Guideline. Amoxicillin did not significantly decrease the proliferation index and mitotic index and also did not induce sister chromatid exchange (SCEs). Thus, it could be stated that amoxicillin neither inhibits DNA replication nor induces SCEs in human peripheral blood lymphocytes.
In-vitro gene mutation study in mammalian cells:
Key study: The genetic toxicity of the test substance was studied by an In vitro Mammalian Cell Gene Mutation Test (Mouse Lymphoma Assay) according to OECD Quideline 490 (GLP study). The test substance was found to be non-mutagenic with or without metabolic activation.
Justification for selection of genetic toxicity endpoint
No study was selectedd, since the studies were negatives.
Short description of key information:
In-vitro gene mutation in bacteria: Key study. Test method similar to OECD 471. The substance was not mutagenic.
In-vitro cytogenicity study in mammalian cells or in-vitro micronucleus study: Key studies. Test method similar to OECD 473 and OECD 487. The substance was negative with and withoug metabolic activation.
In-vitro gene mutation study in mammalian cells: Test method OECD 490. GLP study. The substance was negative with and without metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available information, the substance is not classified for mutagenicity according to CLP Regulation (EC) no. 1272/2008.
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