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Toxicological information

Genetic toxicity: in vitro

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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:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment - Test material
Author:
COSMETIC INGREDIENT REVIEW
Year:
1983
Bibliographic source:
Journal of the American College of Toxicology

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate mutagenic effects of the given test chemical by the Ames Salmonella /Mammalian-Microsomal Assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Benzophenones-4
- Molecular formula- C14H12O6S
- Molecular weight: 308.3088 g/mole
- Substance type:Organic
- Physical state: pale ivory-colored powder
- Purity: 99% (lab-grade)
- Impurities (identity and concentrations): No data available.
- InChI: 1S/C14H12O6S/c1-20-12-8-11(15)10(7-13(12)21(17,18)19)14(16)9-5-3-2-4-6-9/h2-8,15H,1H3,(H,17,18,19)
- Smiles: c1(cc(c(cc1O)OC)S(=O)(=O)O)C(=O)c1ccccc1

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not applicable
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver microsomal S-9 cell fraction
Test concentrations with justification for top dose:
1.0 - 1000 µg/plate
Vehicle / solvent:
Vehicle(s)/solvent(s) used: DMSO
Justification for choice of solvent/vehicle: The chemical is soluble in DMSO.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
No data
Rationale for test conditions:
No data
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TAl00, TA1535, TA1537, and TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
not specified
Additional information on results:
RANGE-FINDING/SCREENING STUDIES: Preliminary cytotoxicity studies determined the dose range of the compound to be used.
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
The test chemical tested negative for mutagenicity in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 in the presence and absence of S9 activation system.
Executive summary:

The chemical was tested for mutagenicity in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 at multiple doses ranging from 1 to 1000 µg/plate, with and without Aroclor-induced rat liver microsomal S9 cell fraction. Dose levels were selected based on preliminary cytotoxicity studies. The results in the main study were evaluated against solvent control data. The test chemical was conclusively non-mutagenic in all strains with and without metabolic activation up to 1000 µg/plate. It was not specified whether positive controls were included or not, however, a number of other chemicals that were investigated in the study tested positive for mutagenicity in the presence, but not in the absence, of the metabolic activation system. This indicates that the metabolic activation system was functioning.