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EC number: 310-154-3 | CAS number: 121158-58-5
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:
- 1992-02-04 until 1992-03-02
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenol, dodecyl-, branched
- EC Number:
- 310-154-3
- EC Name:
- Phenol, dodecyl-, branched
- Cas Number:
- 121158-58-5
- Molecular formula:
- C18H30O
- IUPAC Name:
- 4-(3,4,5,6-tetramethyloctan-2-yl)phenol
- Reference substance name:
- Dodecylphenol, branched
- IUPAC Name:
- Dodecylphenol, branched
- Details on test material:
- - Name of test material (as cited in study report): Dodecylphenol T
- Substance type: technical product
- Physical state: liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: continuously production; 3630/81325
- Date of production: 1991-04-25
- Stability under test conditions: 1 year
- Storage condition of test material: not mentioned
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- plate incorporation test: 8 / 40 / 200 / 1000 / 5000 µg/plate
pre-incubation test: 8 / 40 / 200 / 1000 / 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- 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 strains TA 98 and TA 1538; Sodium azide (2.5 µg/plate) for TA 100 and TA 1535; Aminoacredine (25 µg/plate) for TA 1537, Aminoanthracene (10 µg/plate) for TA 100
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Aminoanthracene (10 µg/plate) with strain TA 100
- 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
- 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
- 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
- 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
- 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
- Species / strain:
- S. typhimurium TA 1538
- 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 - Remarks on result:
- other: strain/cell type: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
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 (yes/no) |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
27 ± 1 |
43 ± 6 |
no |
115 ± 25 |
108 ± 26 |
no |
11 ± 3 |
15 ± 1 |
no |
8 |
25 ± 1 |
39 ± 4 |
no |
105 ± 21 |
111 ± 10 |
no |
12 ± 5 |
19 ± 3 |
no |
40 |
21 ± 6 |
27 ± 7 |
no |
99 ± 14 |
107 ± 12 |
no |
9 ± 1 |
13 ± 6 |
no |
200 |
23 ± 5 |
33 ± 3 |
no |
124 ± 5 |
114 ± 20 |
no |
5 ± 1 |
16 ± 6 |
no |
1000 |
21 ± 1P |
40 ± 3P |
no |
118 ± 27P |
112 ± 32P |
no |
8 ± 2P |
8 ± 1P |
no |
5000 |
26 ± 4P |
32 ± 1P |
no |
112 ± 29P |
149 ± 6P |
no |
9 ± 5P |
14 ± 0P |
no |
Positive control |
158 ± 24 |
not tested |
no |
422 ± 12 |
2265 ± 72 |
no |
375 ± 5 |
not tested |
no |
*solvent control with DMSO; P = Precipitation; MA = metabolic activation
Table #2: Plate incorporation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[Strain TA 1538] |
||||
Conc. |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
16 ± 2 |
29 ± 4 |
no |
25 ± 2 |
38 ± 3 |
no |
8 |
11 ± 1 |
26 ± 2 |
no |
21 ± 4 |
36 ± 5 |
no |
40 |
15 ± 3 |
26 ± 7 |
no |
24 ± 8 |
37 ± 3 |
no |
200 |
10 ± 2 |
22 ± 2 |
no |
19 ± 3 |
38 ± 7 |
no |
1000 |
8 ± 3P |
20 ± 1P |
no |
21 ± 3P |
33 ± 2P |
no |
5000 |
7 ± 1P |
16 ± 6P |
no |
19 ± 3P |
35 ± 4P |
no |
Positive control |
295 ± 27 |
not tested |
no |
98 ± 9 |
not tested |
no |
*solvent control with DMSO; P = Precipitation; MA = metabolic activation
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(yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
26 ± 6 |
39 ± 4 |
no |
113 ± 4 |
129 ± 6 |
no |
8 ± 2 |
11 ± 3 |
no |
8 |
30 ± 2 |
29 ± 7 |
no |
107 ± 8 |
131 ± 12 |
no |
10 ± 6 |
12 ± 4 |
no |
40 |
29 ± 10 |
34 ± 6 |
no |
97 ± 7 |
128 ± 17 |
no |
7 ± 4 |
15 ± 5 |
no |
200 |
28 ± 3 |
29 ± 6 |
no |
89 ± 18 |
108 ± 21 |
no |
9 ± 2 |
17 ± 4 |
no |
1000 |
23 ± 2P |
36 ± 4P |
no |
86 ± 8P |
107 ± 4P |
no |
9 ± 2P |
12 ± 1P |
no |
5000 |
21 ± 3P |
38 ± 1 |
no |
80 ± 16P |
155 ± 23P |
no |
8 ± 2P |
42 ± 10P |
no |
Positive control |
131 ± 12 |
not tested |
no |
468 ± 13 |
2250 ± 282 |
no |
414 ± 34 |
not tested |
no |
*solvent control with DMSO; P = Precipitation; MA = metabolic activation
Table #4: Preincubation test: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[Strain TA 1538] |
||||
Conc. |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
13 ± 2 |
11 ± 3 |
no |
19 ± 7 |
26 ± 2 |
no |
8 |
9 ± 6 |
16 ± 11 |
no |
21 ± 5 |
28 ± 1 |
no |
40 |
7 ± 2 |
16 ± 7 |
no |
22 ± 5 |
31 ± 6 |
no |
200 |
9 ± 4 |
12 ± 2 |
no |
15 ± 5 |
33 ± 5 |
no |
1000 |
4 ± 1P |
16 ± 4P |
no |
18 ± 2P |
38 ± 4P |
no |
5000 |
3 ± 2P |
56 ± 22P |
no |
24 ± 4P |
68 ± 12P |
no |
Positive control |
45 ± 14 |
not tested |
no |
84 ± 15 |
not tested |
no |
*solvent control with DMSO; P = Precipitation; MA = metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
According to Ames a test article which caused no mutagenic effects at a concentration of 5000 µg/plate will be called non-mutagenic.
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