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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
EC Number:
926-072-1
Cas Number:
198479-63-9
Molecular formula:
C29H25NO2
IUPAC Name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
Test material form:
solid: particulate/powder

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Concentrations: 33, 100, 333, 1000, 2500, 5000 ug/plate
Each concentration, including the controls, was tested in triplicate.

Results and discussion

Test results
Species / strain:
bacteria, other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Any other information on results incl. tables

The plates incubated with the test item showed normal background growth up to 5000 ug/plate with and without metabolic activation.

a minor toxic effect, evident as a reduction in the number of revertants, was observed without metabolic activation in strain TA 1537 at 5000 ug/plate.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with TSE 2 at any dose lever, neither in the presence nor absence of S9 mix. There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Applicant's summary and conclusion

Conclusions:
The test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore it's considered to be non-mutagenic in thi Salmonella typhi. and Escherichia coli reverse mutation assay.

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