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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
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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
equivalent or similar to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Qualifier:
equivalent or similar to
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.