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EC number: 204-442-7 | CAS number: 121-00-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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 peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Hageman et al
- Year:
- 1 988
- Bibliographic source:
- Mutation Research
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Ames assay was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
Method
- Target gene:
- his+ gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA104
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 fractions prepared from Aroclor-treated rats
- Test concentrations with justification for top dose:
- 1, 10, 50, 100, 200, 500 or 1000 μg/plate
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: Without S9 mix Strain TA97: 4-nitro-o-phenylene-diamine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Witout S9: Strain TA100: sodium azide Strain
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: TA102 tert.-butylhydroperoxide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: Strain TA104: methylglyoxal
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Mutagenicity test consisting of the combination of the test compound, the bacterial tester strain, and S9 mix in soft agar. Positive and negative controls are usually also included in each assay. However, negative control are not included in the current study. After incubation at 37°C for 48 h, revertant colonies are counted. A liquid preincubation procedure was also applied for some of the experiments to provide with a more sensitive assessment of mutagenic activity.
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): N/A
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): N/A
NUMBER OF REPLICATIONS: Triplicate replications
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: N/A
OTHER EXAMINATIONS: N/A
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for no. of revertants/plate
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA104
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: Because BHA have antimicrobial properties a non-toxic dose range was established.
COMPARISON WITH HISTORICAL CONTROL DATA:
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Mutagencity of the test chemical Salmonella Microsome Assay
No. of his+ revertants per plate in strains
|
|
TA97 |
TA100 |
TA102 |
TA104 |
||||
Compound |
Dose μg/plate |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
BHA |
1 |
121 ±3 |
147± 9 |
83± 4 |
85± 8 |
243± 13 |
363 ±57 |
333 ±5 |
361 ±91 |
|
10 |
117 2 |
146 6 |
76 12 |
81 14 |
224 24 |
387 2 |
371 21 |
409 50 |
|
100 |
109 12 |
138 18 |
92 11 |
97 12 |
197 38 |
277 16 |
329 16 |
391 47 |
|
200 |
136 9 |
174 19 |
102 8 |
76 12 |
171 11 |
381 9 |
32811 |
47254 |
|
500 |
106 13 |
144 12 |
54 9 |
90 10 |
18 9 |
112 8 |
367 29 |
39268 |
|
1000 |
0 |
0 |
0 |
0 |
15 1 |
182 67 |
0 |
17 10 |
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- The test chemical dissolved in dimethylsulfoxide and given in the concentration of 1, 10, 100, 200, 500 or 1000 mg/plate, was not mutagenic in the Salmonella typhimurium strains TA97, TA100, TA102 and TA104 with and without metabolic activation by S9 liver fractions and hence it is not likely to be mutagenic as per the criteria mentioned in CLP regulation.
- Executive summary:
In a Salmonella/microsome assay, the mutagenic activity of the test chemical was evaluated in Salmonella typhimurium strains TA97, TA100, TA102 and TA104 with and without metabolic activation by S9 liver fractions from Aroclor-induced rats. At doses of 100 mg/plate, the phenolic antioxidant BHA exhibited toxic effects. However, a modification of the assay using the preincubation procedure with strain TA104 did not affect mutation frequencies. Therefore, exposure of the test chemical in Salmonella typhimurium, at concentrations below 500 mg/plate with or without metabolic activation by S9 liver fractions, is not regarded to be mutagenic.
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