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EC number: 201-280-9 | CAS number: 80-46-6
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
- Study period:
- 1996-02-06 until 1996-03-11
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- p-(1,1-dimethylpropyl)phenol
- EC Number:
- 201-280-9
- EC Name:
- p-(1,1-dimethylpropyl)phenol
- Cas Number:
- 80-46-6
- Molecular formula:
- C11H16O
- IUPAC Name:
- 4-(2-methylbutan-2-yl)phenol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): phenol, 4-(1,1-dimethylpropyl)-
- Lot/batch No.: 20409018
Constituent 1
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:
- Aroclor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- five dose levels from 0.6 to 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- aqua bidest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Nitrofluorene (2.5 µg/plate) for the strain TA 98; Sodium azide (5.0 µg/plate) for strain TA 100 and (2.5 µg/plate) for strain TA 1535; Aminoacredine (25 µg/plate) for TA 1537
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- aqua bidest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Aminoanthracene (2.5 µg/plate) with all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation, performed in two independent tests
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 96 hours
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: not mentioned
OTHER EXAMINATIONS:
- Other: Determination of the frequency of induced or spontaneous reversion to histidine independence with negative controls (H2O), solvent controls (DMSO), test substance concentrations and positive controls; determination of the titers of overnight cultures
OTHER: none - Evaluation criteria:
- According to Ames a test article which caused no mutagenic effects at a concentration of 5000 µg/plate will be called non-mutagenic.
- Statistics:
- no statistics performed
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not measured
- Effects of osmolality: not applicable
- Evaporation from medium: not applicable
- Water solubility: not mentioned
- Precipitation: no
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: not performed
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
ADDITIONAL INFORMATION ON CYTOTOXICITY: none
Any other information on results incl. tables
Table #1: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
21 ± 4 |
31 ± 6 |
no |
109 ± 13 |
106 ± 4 |
no |
9 ± 3 |
9 ± 2 |
no |
3 |
19 ± 8 |
29 ± 1 |
no |
108 ± 17 |
117 ± 6 |
no |
7 ± 3 |
11 ± 3 |
no |
10 |
22 ± 5 |
32 ± 3 |
no |
109 ± 8 |
108 ± 12 |
no |
7 ± 2 |
10 ± 7 |
no |
30 |
15 ± 6 |
32 ± 3 |
no |
101 ± 6 |
119 ± 15 |
no |
10 ± 3 |
10 ± 3 |
no |
100 |
20 ± 6 |
30 ± 6 |
no |
108 ± 7 |
113 ± 13 |
no |
10 ± 1 |
10 ± 1 |
no |
300 |
5 ± 3B |
19 ± 5 |
no |
24 ± 29B |
99 ± 13 |
no |
3 ± 1B |
1 ± 2B |
no |
Positive control |
77 ± 18 |
1596 ± 89 |
no |
435 ± 11 |
1831 ± 31 |
no |
278 ± 19 |
192 ±26 |
no |
* = solvent control with DMSO ; B = background lawn reduced
Table #2: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
||
Conc. |
- MA |
+ MA |
Cytotoxic |
0* |
7 ± 1 |
11 ± 3 |
no |
2 |
7 ± 1 |
10 ± 3 |
no |
6 |
6 ± 3 |
10 ± 3 |
no |
20 |
5 ± 2 |
16 ± 5 |
no |
60 |
7 ± 2 |
13 ± 2 |
no |
200 |
0 ± 0A |
6 ± 2 |
no |
Positive control |
71 ± 6 |
192 ±25 |
no |
* solvent control with DMSO ; A = Absence of background lawn
Table #3: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
39 ± 8 |
33 ± 3 |
no |
151 ± 8 |
102 ± 3 |
no |
9 ± 2 |
12 ± 1 |
no |
1 |
43 ± 13 |
24 ± 8 |
no |
104 ± 19 |
120 ± 11 |
no |
10 ± 3 |
14 ± 3 |
no |
3 |
45 ± 9 |
31 ± 3 |
no |
97 ± 21 |
123 ± 18 |
no |
11 ± 3 |
12 ± 2 |
no |
10 |
53 ± 2 |
35 ± 4 |
no |
127 ± 4 |
114 ± 15 |
no |
8 ± 2 |
12 ± 3 |
no |
30 |
42 ± 10 |
34 ± 2 |
no |
114 ± 8 |
128 ± 11 |
no |
8 ± 3 |
12 ± 1 |
no |
100 |
49 ± 4 |
34 ± 1 |
no |
7 ± 12B |
125 ± 21 |
no |
0 ± 0A |
10 ± 4 |
no |
Positive control |
135 ± 13 |
903 ± 191 |
no |
496 ± 32 |
1006 ± 121 |
no |
235 ± 35 |
188 ± 18 |
no |
*solvent control with DMSO ; B = background reduce lawn ; A = Abscence of background lawn
Table #4: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
||
Conc. |
- MA |
+ MA |
Cytotoxic |
0* |
19 ± 2 |
15 ± 4 |
no |
0.6 |
20 ± 4 |
13 ± 54 |
no |
2 |
16 ± 5 |
13 ± 4 |
no |
6 |
16 ± 1 |
15 ± 2 |
no |
20 |
16 ± 5 |
12 ± 1 |
no |
60 |
1 ± 1B |
15 ± 1 |
no |
Positive control |
72 ± 12 |
135 ± 24 |
no |
*solvent control with DMSO ; B = background reduce lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
p-tert.-Amylphenol did not induce a mutagenic effect in S. thyphimurium. It is therefore not considered to be a bacterial mutagen. - Executive summary:
P-tert amylphenol was tested for its ability to induce reverse mutations in an in vitro bacterial system.
Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 were treated with the test compound by the Ames test plate incorporation as well as the preincubation method. This was the practice in 1996; a 5th strain to detect oxidizing mutagens was not performed in this study.
Five dose levels covering the range between 0.6 and 5000 microg/plate, in triplicate both with and without the addition of a metabolising system (Aroclor 1254 induced rat liver S9 mix) were employed.
All four bacterial strains exhibited mutagenic responses to the appropriate positive control substances.
Solvent controls were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range.
Mutagenic activity of the test compound to one or more of the tester strains was not observed in either experiment with and without metabolic activation.
It is therefore concluded, that P-tert amylphenol is not a bacterial mutagen.
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