Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Principles of method if other than guideline:
Only TA98 and TA100 strains used.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-formyl-4-nitrophenoxy)hexanoic acid
EC Number:
608-880-3
Cas Number:
335153-21-4
Molecular formula:
C13H15NO6
IUPAC Name:
2-(2-formyl-4-nitrophenoxy)hexanoic acid

Method

Target gene:
Salmonella typhimurium
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix

Results and discussion

Test results
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Test suggests mild cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The substance is considerd non-mutagenic.
Executive summary:

The assay was conducted on two strains (TA98, TA100), of Salmonella typhimurium in the presence and absence of an exogenous mammalain activation system. All positive controls exhibited a statistically increase in the number of revertants as compared to the negative control and untreated groups, demonstrating the functionality of the assay. A statistically significant increase in the number of colonies was not observed with the test substance in the Reverse Mutation Assay. A slight decrese in the mean number of revertants were observed with the 5000ug/plate gropus in the TA100 strain without metabolic activation suggesting mild cytotoxicity. Based on the criteria of the study protocol, the substance is considered non-mutagenic.