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EC number: 203-232-2 | CAS number: 104-74-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The information is from experimental study report and it is as per OECD Gudeline No. 471
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD 471 (Adopted 21st July 1997, Corrected: 26th June 2020)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-dodecylpyridinium chloride
- EC Number:
- 203-232-2
- EC Name:
- 1-dodecylpyridinium chloride
- Cas Number:
- 104-74-5
- Molecular formula:
- C17H30N.Cl
- IUPAC Name:
- 1-dodecylpyridin-1-ium chloride
- Details on test material:
- - Name of test material: 1-Dodecylpyridinium chloride
- Molecular formula: C17H30N.Cl
- Molecular weight: 283.884 g/mol
- Smiles: [Cl-].CCCCCCCCCCCC[n+]1ccccc1
- InChI: 1S/C17H30N.ClH/c1-2-3-4-5-6-7-8-9-10-12-15-18-16-13-11-14-17-18;/h11,13-14,16-17H,2-10,12,15H2,1H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid
- Purity: >98%
- Other: Test chemical was obtained from Merck
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: N1910594
- Manufacturing data of the lot/batch: 09.04.2019
- Expiration date of the lot/batch: 07.04.2024
- Purity: 94.24%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored at room temperature. (20-30 0C)
- Stability under storage conditions: The test item was stable under storage condition.
- Stability under test conditions: the test chemical was stable under test condition.
OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
- other information:
Method
- Target gene:
- Histidine Operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : A combination of phenobarbitone and β-naphthoflavone-induced rat liver microsomal enzymes (S9 homogenate) prepared in-house.
- method of preparation of S9 mix : S9 mix [Cofactors (Cofactor ingredients: D-glucose-6-phosphate, β-NADP, magnesium chloride, potassium chloride, sodium phosphate and Liver homogenate] was prepared prior to use in the study. The post-mitochondrial fraction (liver homogenate) was used at the concentration of 10 % (v/v) in the S9 mix.
- quality controls of S9: enzymatic activity - Test concentrations with justification for top dose:
- In both Trial I and Trial II, the following five concentrations of the Test Item were tested in triplicate plates along with the vehicle and positive controls.
0.00122, 0.00244, 0.00488, 0.0097656 and 0.01953125 mg/plate.
Justification: A slight reduction in the number of revertant colonies accompanied by a moderate inhibition of the background lawn growth was observed at 0.01953125 mg/plate, both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. No reduction in the number of revertant colonies or inhibition of the background lawn growth was observed at ≤ 0.097656 mg/plate, either in the presence (10% v/v S9 mix) or in the absence of metabolic activation when compared to the vehicle control data. Hence, considering the criteria that the highest test concentration should induce cytotoxicity determined by a decrease in the revertant colony count and/or diminution of the background lawn or precipitation formation in the final mixture under the actual test condition and evident to the unaided eye, 0.01953125 mg/plate was selected as the highest concentration of the Test Item for the main assay. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water
- Justification for choice of solvent/vehicle: The test Item was found to be soluble in distilled water (50 mg/ml). Hence, distilled water was selected as the vehicle for the study.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: (triplicate)
- Number of independent experiments : Two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density: Fresh bacterial cultures were prepared, which were in the late-log phase of growth at the time of use. The densities of the cultures were confirmed to be 1 to 2 ×109 bacteria/ml using a haemocytometer before the cultures were used in the test.
- Test substance added in medium; in agar (plate incorporation); preincubation
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition
- Evaluation criteria:
- The Test Item was deemed mutagenic if a biologically relevant increase in the mean number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control was observed.
A dose-dependent increase was considered biologically relevant if the threshold is was exceeded at more than one concentration.
A dose-dependent increase exceeding the threshold at only one concentration was judged as biologically relevant if reproduced in an independent experiment.
A dose-dependent increase in the number of revertant colonies below the threshold indicated a mutagenic potential if reproduced in an independent experiment. - Statistics:
- The mean number of revertant colonies and the standard deviation within the plates for each concentration were compared to the spontaneous reversion rates of the control. Microsoft Office Excel-based calculations were used for descriptive statistical analysis.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The results of Trial I (Plate incorporation assay) and Trial II (Preincubation assay) showed no significant increases in the mean number of revertant colonies of bacterial tester strains in the presence (10 % v/v S9) or absence of the metabolic activation system. Furthermore, no trend of an increased number of revertant colonies with increased dosing of the Test Item was observed. The vehicle and the strain-specific positive control values were within the lab historical control ranges, indicating that the test conditions were appropriate, and that the metabolic activation system functioned properly.
- Remarks on result:
- other: non mutagenic
Any other information on results incl. tables
Table1 Mean Revertant Colony Count – Preliminary Cytotoxicity Assay-I
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC (Distilled water) |
19 (NI) |
0.58 |
21 (NI) |
3.00 |
97 (NI) |
3.06 |
100 (NI) |
3.06 |
T1 (0.0390625) |
5 (CI) |
1.53 |
4 (CI) |
0.58 |
19 (CI) |
2.65 |
17 (CI) |
1.15 |
T2 (0.078125) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T3 (0.15625) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T4 (0.3125) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T5 (0.625) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T6 (1.25) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T7 (2.5) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T8 (5.0) |
0 (CI) |
0.00 |
0(CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
PC |
330 (NI) |
10.60 |
339 (NI) |
7.55 |
703 (NI) |
12.86 |
732 (NI) |
8.50 |
Key: VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, T1-T8 = Test Item concentration from lower to higher, NI = No Inhibition, CI = Complete inhibition, MI = Moderate inhibition.
Positive Controls:
2-Nitrofluorene |
TA98 (absence of metabolic activation) |
Sodium azide |
TA100 (absence of metabolic activation) |
Benzo[a]pyrene |
TA98 and TA100 (presence of metabolic activation) |
Table2 Mean Revertant Colony Count – Preliminary Cytotoxicity Assay-II
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC (Distilled water) |
20 (NI) |
2.89 |
19 (NI) |
1.15 |
93 (NI) |
3.21 |
93 (NI) |
3.21 |
T1 (0.000) |
21 (NI) |
2.00 |
21 (NI) |
2.52 |
92 (NI) |
3.61 |
93 (NI) |
5.13 |
T2 (0.00030) |
19 (NI) |
1.15 |
18 (NI) |
0.58 |
93 (NI) |
3.79 |
95 (NI) |
3.51 |
T3 (0.00061) |
19 (NI) |
2.31 |
19 (NI) |
1.15 |
94 (NI) |
4.51 |
96 (NI) |
3.06 |
T4 (0.00122) |
21 (NI) |
2.52 |
20 (NI) |
2.00 |
94 (NI) |
1.00 |
92 (NI) |
5.57 |
T5 (0.00244) |
17 (NI) |
1.53 |
21 (NI) |
2.00 |
93 (NI) |
4.16 |
90 (NI) |
3.06 |
T6 (0.00488) |
19 (NI) |
1.15 |
18 (NI) |
0.58 |
92 (NI) |
2.65 |
87 (NI) |
7.55 |
T7 (0.0097656) |
19 (NI) |
2.31 |
19 (NI) |
1.73 |
84 (NI) |
2.52 |
85 (NI) |
3.51 |
T8 (0.01953125) |
12 (MI) |
2.08 |
12 (MI) |
0.58 |
62 (MI) |
3.51 |
55 (MI) |
4.00 |
PC |
319 (NI) |
11.15 |
315 (NI) |
7.00 |
673 (NI) |
22.85 |
665 (NI) |
8.33 |
Key: VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, T1-T8 = Test Item concentration from lower to higher, NI = No Inhibition, MI = Moderate inhibition.
Positive Controls:
2-Nitrofluorene |
TA98 (absence of metabolic activation) |
Sodium azide |
TA100 (absence of metabolic activation) |
Benzo[a]pyrene |
TA98 and TA100 (presence of metabolic activation) |
Table3 Mean Revertant Colony Count in Trial I(Plate Incorporation Method)
Absence of metabolic activation (-S9) |
Presence of metabolic activation (+S9 10 % v/v S9 Mix) |
|||||||||||
Test Item Concentration (mg/plate) |
TA 1535 |
TA 1537 |
TA 102 |
TA 1535 |
TA 1537 |
TA 102 |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC (Distilled water) |
13 |
1.73 |
6 |
0.00 |
234 |
4.73 |
13 |
2.00 |
6 |
1.15 |
229 |
4.93 |
T1 (0.00122) |
13 |
2.00 |
6 |
1.15 |
223 |
4.73 |
12 |
0.58 |
7 |
1.15 |
228 |
9.54 |
T2 (0.00244) |
13 |
0.58 |
7 |
1.15 |
227 |
9.07 |
14 |
1.53 |
6 |
0.58 |
233 |
6.43 |
T3 (0.00488) |
12 |
1.53 |
7 |
1.73 |
227 |
9.07 |
13 |
0.58 |
6 |
1.73 |
228 |
8.19 |
T4 (0.0097656) |
12 |
1.73 |
5 |
1.15 |
227 |
8.54 |
12 |
1.73 |
5 |
0.58 |
219 |
6.51 |
T5 (0.01953125) |
10 |
1.15 |
2 |
1.15 |
207 |
9.54 |
9 |
1.15 |
3 |
1.15 |
189 |
5.13 |
PC |
326 |
9.07 |
191 |
5.13 |
1668 |
21.93 |
316 |
4.16 |
205 |
7.37 |
1690 |
16.80 |
Key: VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, T1-T5 = Test Item concentration from lower to higher.
Positive Controls:
2-Nitrofluorene |
TA98 (absence of metabolic activation) |
Sodium azide |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Table 4 Mean Revertant Colony Count in Trial II (Preincubation Method)
Absence of metabolic activation |
Presence of metabolic activation (+S9 10% v/v S9 Mix) |
|||||||||||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
||||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC (Distilled water) |
20 |
2.89 |
93 |
3.21 |
13 |
1.73 |
6 |
0.00 |
234 |
4.73 |
19 |
1.15 |
93 |
3.21 |
13 |
2.00 |
6 |
1.15 |
229 |
4.93 |
T1 (0.00122) |
21 |
2.52 |
94 |
1.00 |
13 |
2.00 |
6 |
1.15 |
223 |
4.73 |
20 |
2.00 |
92 |
5.57 |
12 |
0.58 |
7 |
1.15 |
228 |
9.54 |
T2 (0.00244) |
17 |
1.53 |
93 |
4.16 |
13 |
0.58 |
7 |
1.15 |
227 |
9.07 |
21 |
2.00 |
90 |
3.06 |
14 |
1.53 |
6 |
0.58 |
233 |
6.43 |
T3 (0.00488) |
19 |
1.15 |
92 |
2.65 |
12 |
1.53 |
7 |
1.73 |
227 |
9.07 |
18 |
0.58 |
87 |
7.55 |
13 |
0.58 |
6 |
1.73 |
228 |
8.19 |
T4 (0.0097656) |
19 |
2.31 |
84 |
2.52 |
12 |
1.73 |
5 |
1.15 |
227 |
8.54 |
19 |
1.73 |
85 |
3.51 |
12 |
1.73 |
5 |
0.58 |
219 |
6.51 |
T5 (0.01953125) |
12 |
2.08 |
62 |
3.51 |
10 |
1.15 |
2 |
1.15 |
207 |
9.54 |
12 |
0.58 |
55 |
4.00 |
9 |
1.15 |
3 |
1.15 |
189 |
5.13 |
PC |
319 |
11.15 |
673 |
22.85 |
326 |
9.07 |
191 |
5.13 |
1668 |
21.93 |
315 |
7.00 |
665 |
8.33 |
316 |
4.16 |
205 |
7.37 |
1690 |
16.80 |
Key: VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation,T1-T5 = Test Item concentration from lower to higher.
Positive Controls:
2-Nitrofluorene |
TA98 (absence of metabolic activation) |
Sodium azide |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
TA102 (absence of metabolic activation) |
Benzo[a]pyrene |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Table 5 Fold Increase
Trial I - Plate Incorporation Method |
Trial II – Preincubation Method |
|||||||||||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
VC (Distilled water) |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
T1 (0.00122) |
1.05 |
1.07 |
1.01 |
0.99 |
1.00 |
0.95 |
0.94 |
1.18 |
0.95 |
0.99 |
1.05 |
1.07 |
1.01 |
0.99 |
1.00 |
0.95 |
0.94 |
1.18 |
0.95 |
0.99 |
T2 (0.00244) |
0.88 |
1.13 |
1.00 |
0.97 |
0.97 |
1.05 |
1.11 |
1.12 |
0.97 |
1.02 |
0.88 |
1.13 |
1.00 |
0.97 |
0.97 |
1.05 |
1.11 |
1.12 |
0.97 |
1.02 |
T3 (0.00488) |
0.95 |
0.95 |
0.99 |
0.94 |
0.90 |
0.97 |
1.17 |
1.06 |
0.97 |
0.99 |
0.95 |
0.95 |
0.99 |
0.94 |
0.90 |
0.97 |
1.17 |
1.06 |
0.97 |
0.99 |
T4 (0.0097656) |
0.98 |
1.02 |
0.90 |
0.91 |
0.92 |
0.92 |
0.89 |
0.94 |
0.97 |
0.96 |
0.98 |
1.02 |
0.90 |
0.91 |
0.92 |
0.92 |
0.89 |
0.94 |
0.97 |
0.96 |
T5 (0.01953125) |
0.59 |
0.63 |
0.67 |
0.59 |
0.74 |
0.67 |
0.39 |
0.59 |
0.88 |
0.82 |
0.59 |
0.63 |
0.67 |
0.59 |
0.74 |
0.67 |
0.39 |
0.59 |
0.88 |
0.82 |
PC |
16.24 |
16.88 |
7.27 |
7.17 |
25.05 |
24.33 |
31.89 |
36.24 |
7.12 |
7.37 |
16.24 |
16.88 |
7.27 |
7.17 |
25.05 |
24.33 |
31.89 |
36.24 |
7.12 |
7.37 |
Key: VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, T1-T5 = Test Item concentration from lower to higher.
Table 6 S9 Efficacy Check- Summary
Summary of S9 efficacy check |
||||
|
TA100 |
TA1535 |
||
Mean |
SD |
Mean |
SD |
|
VC Distilled water (-S9) |
97 |
3.06 |
13 |
1.73 |
VC Distilled water (+S9) |
100 |
3.06 |
13 |
2.00 |
PC Benzo[a]pyrene (-S9) |
94 |
2.52 |
15 |
1.15 |
PC Benzo[a]pyrene (+S9) |
732 |
8.50 |
316 |
4.16 |
Key: VC = Vehicle control, PC = Positive control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the present study, it is concluded that N-Dodecylpyridinium Chloride [CAS No.: 104-74-5] is non-mutagenic as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system.
- Executive summary:
The mutagenicity of the test substnace, N-Dodecylpyridinium Chloride [CAS No.: 104-74-5] has been tested in Salmonella typhimurium tester strains (TA98, TA100, TA1535, TA1537, TA1538). The test was performed in two trials. Trial I was performed according to the plate incorporation method and both in the presence and absence of liver microsomal activation (S9 mix).Trial II was performed according to the preincubation method and both in the presence and absence of liver microsomal activation (S9 mix) The mammalian microsomal fraction (S9 mix) was prepared in-house from the combination of phenobarbitone and β-naphthoflavone-induced rat liver microsomal enzymes (S9 homogenate). The chemical was tested at concentrations 0.00122, 0.00244, 0.00488, 0.0097656 and 0.01953125 mg/plateboth in the presence (10 % v/v S9 mix) and absence of metabolic activation, along with the vehicle and positive controls. The maximal dose was selected based on the cytotoxicity observed in an initial dose range-finding study. The criteria used to evaluate a test were as follows: for a test chemical to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) and tripling (TA1537, TA1538) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose-response to increasing concentrations of the test chemical. If a dose-response with a less than 3-fold increase on TA1537 was observed, the response had to be confirmed in a repeat experiment. The test substance N-Dodecylpyridinium Chloride [CAS No.: 104-74-5] failed to produce double- or triple-fold in his+revertant counts up to 0.01953125 mg/plate, either in the presence (10 % v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data for both the experiment, that is trail I and trial II. The study was performed according to OECD 471 and considered to be reliable.(Klimisch 1)
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