Sulisobenzone

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Sulisobenzone

EC Number:

223-772-2

EC Name:

Sulisobenzone

Cas Number:

4065-45-6

Molecular formula:

C14H12O6S

IUPAC Name:

5-benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid

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.