Benzoic acid, C9-11 , C10-rich, branched alkyl esters

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

Study period:

01/23/1996 - 02/21/1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report equivalent or similar to OECD 471

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 4

Qualifier:

equivalent or similar to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Test guideline 5

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Isodecyl Benzoate
- Physical state: Clear colourless liquid
- Analytical purity: 98.2%
- Lot/batch No.: C5-8
- Expiration date of the lot/batch: Assumed to be stable for duration of study
- Storage condition of test material: Room temperature
- Other: Alternate names: Benzoic Acid, C9-11-iso, C10 rich, alkyl esters, BENZOFLEX 131 plasticizer, VELATE 262 Coalescent

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Rat liver fraction (S-9)

Test concentrations with justification for top dose:

Isodecyl Benzoate was tested at 312.5, 625, 1250, 2500, and 5000 ug/plate levels

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Remarks:

N-Ethyl-N'-nitro-N-nitrosoguanidine; 9-Aminoacridine; 2-Nitrofluorene; 2-Aminoanthracene

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle 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 with metabolic activation
negative without metabolic activation

It was concluded that, when tested in dimethyl sulphoxide, Isodecyl Benzoate showed not evidence of mutagenic activity in the bacterial systems.

Executive summary:

Isodecyl Benzoate did not produce evidence of mutagenic activity in the bacterial systems tested, either in the presence or absence of metabolic activator.