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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.