Registration Dossier
Registration Dossier
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EC number: 604-571-2 | CAS number: 147127-20-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Type of information:
- experimental study
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: EPAR Scientific discussion
- Title:
- Viread - EPAR Scientific discussion
- Year:
- 2 006
- Bibliographic source:
- European Medicines Agency
Materials and methods
- GLP compliance:
- yes
Test material
- Reference substance name:
- 202138-50-9
- Cas Number:
- 202138-50-9
- IUPAC Name:
- 202138-50-9
Constituent 1
Method
- Target gene:
- In vitro mouse lymphoma assay and an in vitro UDS test on rats hepatic cells.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- other: rats hepatic cells
- Metabolic activation:
- with and without
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Mutagenicity: Ames test negative, mutagenic in the “in vitro” mouse lymphoma assay. Negative in “in vivo”
mouse micronucleus assay.
The mutagenic potential of tenofovir DF was evaluated in a standard battery of in vitro and in vivo
tests. Tenofovir DF was positive in the in vitro mouse lymphoma assay, equivocal in the Ames tests
(positive in one assay using the strain of Salmonella typhimurium TA 1535 with or without
activation). Tenofovir DF was negative in the in vivo micronucleus assay in mouse (doses up to 2000
mg/kg orally). To clarify these findings and complete the information on the genotoxicity of tenofovir
DF, additional in vitro and in vivo UDS test on rats hepatic cells have been performed in order to
assess the ability of tenofovir DF (or metabolites) to cause DNA damage by measuring UDS induced
in vivo in primary hepatocytes cultured in vitro. The tenofovir DF was considered as weakly positive
in this assay, showing that tenofovir can induce DNA damage and supporting the previous mutagenic
potential results. These results will have to be considered in the light of the final assessment of the
rodent carcinogenicity studies.
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