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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl hydrogen maleate
EC Number:
231-048-2
EC Name:
2-ethylhexyl hydrogen maleate
Cas Number:
7423-42-9
Molecular formula:
C12H20O4
IUPAC Name:
2-ethylhexyl hydrogen maleate
Test material form:
liquid

Method

Species / strainopen allclose all
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S-9 fraction
Test concentrations with justification for top dose:
4, 20, 100, 500, 2500 and 10000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9-mix: 9-Aminoacridine (TA 1537), 2-Aminoanthracene (TA 1537), Methylhydrazone Derivative (TA98, TA1538, TA100), Streptocotocine (TA1535), ENNG (E. coli WP 2 uvr A)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: + S9-mix: 2-Aminoanthracene (TA 1537, TA 98, TA 1538, TA 100, TA 1535, E. coli WP 2 uvr A)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: The plates were incubated at 37 °C for 2 days

NUMBER OF REPLICATIONS: 4

Evaluation criteria:
A chemical is considered to have a positive response if the number of induced revertants is more than double the spontaneous mutations

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium, other: TA1537, TA98, TA1538, TA100, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, the test substance showed no mutagenic activity.
Executive summary:

A bacterial reverse mutation assay (Ames test), equivalent to OECD guideline 471, is available to investigate the mutagenicity of the test substance. The test was performed with five histidine-requiring strains of Salmonella typhimurium (TA1537, TA98, TA1538, TA100, TA1535) and with the tryptophan-requiring strain, Escherichia coli WP2 uvr A. The test was performed with the following test item concentrations (in DMSO) with and without metabolic activation (S9- mix): 4, 20, 100, 500, 2500 and 10000 µg/plate. Under the conditions of this study, the test substance showed no mutagenic activity in strains of Salmonella typhimurium and Escherichia coli with and without metabolic activation.