Registration Dossier
Registration Dossier
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EC number: 926-072-1 | CAS number: -
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:
- 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
- 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
Constituent 1
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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