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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
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Test with strains TA98, TA100, TA 1535 and TA 1537
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzophenone
- Supplier: Aldrich
- Analytical purity: 99%

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:
S9 mix
Test concentrations with justification for top dose:
0 - 1000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sodium azide, 4-nitro-o-phenylenediamine, 9-aminoacridine and 2-aminoanthracene
Details on test system and experimental conditions:
Testing comparable to guideline
Evaluation criteria:
mutagenic response: dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold
nonmutagenic response: no increase in the number of revertants
questionable response: absence of a clear-cut dose-related increase in revertants, dose-related increases in the number of revertants not reproducible or response was of insufficient magnitude to support a determination of mutagenicity
Statistics:
not further specified

Results and discussion

Test results
Key result
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:
no cytotoxicity
Remarks:
tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
RANGE-FINDING/SCREENING STUDIES: Benzophenone was tested initially with tester strain TA100 in the presence and absence of the metabolic activation system, over a wide dose range with an upper limit of 10 mg/plate, or less when solubility problems were encountered. A concentration of 1000 µg/plate was slightly toxic and was therefore selected as highest dose.

Any other information on results incl. tables

See attached documents

Applicant's summary and conclusion

Conclusions:
Benzophenone did not significatly increase the number of revertant colonies both in the absence or presence of a metabolic system and is therefore considered non-mutagenic in this test system.
Executive summary:

Benzophenone was tested in the Salmonella pre-incubation assay, which was performed in duplicate with and without metabolic activation. Concurrent positive control substances confirmed the sensitivity of the test system.

Benzophenone did not induce mutations in S. typhimurium strains in any of the concentrations tested and is therefore considered non-mutagenic in this test system.