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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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
Species / strain:
S. typhimurium TA 98
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
Species / strain:
S. typhimurium TA 100
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
Species / strain:
S. typhimurium TA 1535
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
Species / strain:
S. typhimurium TA 1537
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
Species / strain:
S. typhimurium TA 1538
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
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

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.