Registration Dossier

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:
2007
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:
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
Name:
Unnamed
Type:
Constituent
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).