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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only 4 strains were used.
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Principles of method if other than guideline:
The tester strains of Salmonella typhimurium can only survive and grow on medium that contains excess histidine. However, in the presence of a mutagenic chemical, the defective histidine gene may be mutated back to the functional state, allowing the bacterium to grow on standard medium that does not contain supplemental histidine. These mutations, which lead to a regaining of normal activity or function, are called "back" or "reverse" mutations and they are counted. The performance of the test with and without an external metabolising system ensures the detection of the mutagenic action of the test substance itself as well as of its metabolites.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(6R-trans)-7-amino-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EC Number:
239-787-2
EC Name:
(6R-trans)-7-amino-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Cas Number:
15690-38-7
Molecular formula:
C8H10N2O4S
IUPAC Name:
(6R,7R)-7-amino-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Test material form:
solid: particulate/powder

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 102
Species / strain / cell type:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
Induced male Sprague Dawley rat liver S9
Test concentrations with justification for top dose:
25 to 5000 µg/plate.
Vehicle / solvent:
Dimethyl sulfoxide.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
dimethylsulfoxide
Positive controls:
yes
Positive control substance:
other: For strains tested in the absence of S9: TA98, 2-nitrofluorene or alternatively, 4-nitro-o-phenylenediamine, TA100 and TA1535, sodium azide, TA97, 9-aminoacridine. For strains tested with S9: All strains, 2-aminoanthracene or sterigmatocystin.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: each used strain
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative
Executive summary:

An Ames test with 4 strains of S. typhimurium was performed: HACA was negative in each strain and also with and without an external metabolic activation system, up to toxic concentrations.