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Toxicological information

Genetic toxicity: in vitro

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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:
other: Study according to OECD Guideline with GLP conditions and good documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) maleate
EC Number:
205-524-5
EC Name:
Bis(2-ethylhexyl) maleate
Cas Number:
142-16-5
Molecular formula:
C20H36O4
IUPAC Name:
bis(2-ethylhexyl) but-2-enedioate
Constituent 2
Chemical structure
Reference substance name:
Dioctyl maleate
EC Number:
220-835-6
EC Name:
Dioctyl maleate
Cas Number:
2915-53-9
Molecular formula:
C20H36O4
IUPAC Name:
dioctyl but-2-enedioate
Details on test material:
- Chemicals denomination: Maleic Acid, Di-2-Ethylhexylester
- Purity (as cited in study report): ~95%
- Lot/batch No.: 3344
- Physical state: liquid
- Expiration date of the lot/batch: dec 2001
- Stability: 3 years (pure)
- Storage condition of test material: at room temperature

Method

Target gene:
his operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 (Phenobarbital, ß-Naphthoflavone induced)
Test concentrations with justification for top dose:
1st experiment: 8, 40, 200, 1000 and 5000 µg/plate
2nd experiment: 8, 40, 200, 1000 and 5000 µg/plate
concentration based on 100 % active substance
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: common solvent, solubility
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive controls:
yes
Positive control substance:
other: sodium azide, 9-Aminoacridine, 4-Nitro-o-phenylenediamine, 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in suspension with soft Top agar
Evaluation criteria:
According to guideline
Statistics:
no

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
with and without metabolic activation
Cytotoxicity / choice of top concentrations:
no 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 test item was not considered to be mutagenic
Executive summary:

The sample of "confidential substance name" with the batch number 3344 was tested in the Salmonella typhimurium Reverse Mutation Assay for the induction of reverse mutations in a bacterial test system. The assay was performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent experiments, both with and without metabolic activation by S9-mix. Solutions of the test substance were prepared in acetone and diluted with acetone just before use. The following concentrations were tested: 1st and 2nd test:   8, 40, 200, 1000 and 5000 ug/plate. The direct plate incorporation assay was utilized. The following results were obtained: Toxic effects were not noted. No enhanced revertant rates compared to concurrent negative controls were observed in all tested strains, neither in the presence nor in the absence of metabolic activation.

Therefore the test substance "confidential substance name" did not induce reverse mutations in the tested strains of Salmonella typhimurium in this bacterial mutagenicity test. In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test substance "confidential substance name" did not induce gene mutations in Salmonella typhimurium strains.

Subsequently, the test substance is considered not to be mutagenic in this bacterial mutagenicity test in vitro.