Bis(2-ethylhexyl) maleate

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Species / strain 2

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 results

Test results 1

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

Test results 2

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.