Registration Dossier
Registration Dossier
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EC number: 208-726-1 | CAS number: 539-82-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2006-2007
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic Toxicity Evaluation of Ethyl Valerate in Salmonella/E.coli Mutagenicity Test or Ames Test.
- Author:
- National Toxicology Program
- Year:
- 2 007
- Bibliographic source:
- National Toxicology Program (2007). Available online at: https://tools.niehs.nih.gov/cebs3/ui/?study=002-02151-0001-0000-2
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Only TA 98 and TA 100 used
- Deviations:
- yes
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl valerate
- EC Number:
- 208-726-1
- EC Name:
- Ethyl valerate
- Cas Number:
- 539-82-2
- Molecular formula:
- C7H14O2
- IUPAC Name:
- ethyl pentanoate
Constituent 1
- Specific details on test material used for the study:
- No details reported.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli, other: pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Concentrations ranging from 50 to 10000 μg/plate (no details reported).
- Vehicle / solvent:
- Dimethyl sulfoxide
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium in agar plate. No further details reported.
DURATION
- Preincubation period: 20 minutes at 37 ºC.
- Exposure duration: 2 days.
- Expression time (cells in growth medium): No details reported.
- Selection time (if incubation with a selection agent): No details reported.
- Fixation time (start of exposure up to fixation or harvest of cells): No details reported.
SELECTION AGENT (mutation assays): No details reported.
NUMBER OF REPLICATIONS: Each strain tested at least twice. No further details reported.
NUMBER OF CELLS EVALUATED: No details reported. - Rationale for test conditions:
- No details reported.
- Evaluation criteria:
- No details reported.
- Statistics:
- No details reported.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli, other: pKM101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test item was found to be negative in the Ames test (with or without metabolic activation).
- Executive summary:
The test item was found to be negative in the Ames test (with or without metabolic activation).
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