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EC number: 222-326-4 | CAS number: 3426-43-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 20 to July 1, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- only 4 instead of 5 strains, as currently required, were tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- OB 134
- IUPAC Name:
- OB 134
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- The sample was dissolved in water at a concentration of 250 μg/0.1 ml.
A concentration range of 1000 (0.4 ml), 500 (0.2 ml), 250, 100 and 10 μg (0.1 ml) was generated per bowl, and these doses were tested for toxicity on strain TA 98. The lesion was not toxic at the given concentrations for TA 98 strain.
For individual experiments, the substance was dissolved at a concentration of 500 μg per dish and an additional dose of 2500 μg (in 0.5 ml) per dish was tested. - Vehicle / solvent:
- Distilled water.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluoren
- Remarks:
- TA 97, TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamin
- Remarks:
- TA 97, TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracen
- Remarks:
- TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluoren
- Remarks:
- TA 100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DOSES:
- TA 98, TA 100: 0, 10, 100, 500, 750, 1000, 2500 µg/plate
- TA 97, TA 1535: 0, 10, 100, 500, 750, 1000 µg/plate - Rationale for test conditions:
- TA 97 and TA 98 serve to detect shift mutations; TA 100 and TA 1535 serve to detect substitution mutations.
- Evaluation criteria:
- Two-fold increase modified rule. According to this rule, a positive result is such that there is a dose-effect relationship and the Rt / Rc ratio (revertant count at the tested dose to revertant count in negative control) reaches 2 or more. For weak mutagens, it is sufficient to obtain a reproducible dose-effect relationship.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic under experimental conditions.
- Executive summary:
Method
Ames assay carried out using 4 strains of Salmonella typhimurium, i.e. TA 97, TA 98, TA 100 and TA 1535, with and without metabolic activation by S9 mix. Each dose was tested in 3 replicates. The following doses were tested:
- TA 98, TA 100: 0, 10, 100, 500, 750, 1000, 2500 µg/plate.
- TA 97, TA 1535: 0, 10, 100, 500, 750, 1000 µg/plate.
Results
Non mutagenic under test conditions to any strains with or without metabolic activation.
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