Registration Dossier
Registration Dossier
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EC number: 947-851-2 | CAS number: -
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:
- 06 February 2018 to 21 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- D,L- Menthol / D,L-Isomenthol
- Molecular formula:
- C10H20O
- IUPAC Name:
- D,L- Menthol / D,L-Isomenthol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Liver homogenates from rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment I (plate incorporation test):
All strains with and without S9: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II (pre-incubation test):
All strains without S9: 3, 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate
Strains TA 1535, TA 1537, and TA 100 with S9 mix: 3; 10; 33; 100; 333; and 1000 μg/plate
Strain TA 98 and WP2 uvrA with S9 mix: 10; 33; 100; 333; 1000; and 2500 μg/plate
Top dose concentrations based on results of the initial toxicity test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen based on its solubility properties and its nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (-S9 at 10ug/plate in TA98 and 50 ug/plate in TA1537); methyl methane sulfonate (-S9 at 2.0uL/plate in WP2 uvrA); 2-aminoanthracene (+S9 at 2.5 ug/plate in all strains)
- Remarks:
- The positive control 2-aminoanthracene was only tested with metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
- Cell density at seeding: 108-109 cells/mL
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
NUMBER OF REPLICATIONS: 3 replicate plates were kept in the dark for 48 hours at 37 ºC
DETERMINATION OF CYTOTOXICITY
- Method: manually counting cells and observing the reduction in the number of revertants.
- Any supplementary information relevant to cytotoxicity: Not specified
OTHER EXAMINATIONS: Precipitation of the test item was observed in the incubated overlay agar plate in both experiments. The undissolved particles had no influence on the results.
- Rationale for test conditions:
- Following standard guidelines
- Evaluation criteria:
- The number of revertant colonies on the plates, with and without the test compound, were compared to evaluate mutagenicity. A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of cytotoxicity.
- Statistics:
- Not reported
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:
- 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
- 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:
- E. coli WP2 uvr A
- 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 specified
- Effects of osmolality: Not specified
- Evaporation from medium: Not specified
- Water solubility: Not specified
- Precipitation: The test item showed signs of precipitation in experiment I (with metabolising system) and II (with metabolising system). The undissolved particulates had no effect on the recorded data.
- Definition of acceptable cells for analysis: Not specified
- Other confounding effects: Not specified
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: The data set without S9 are: TA 1535 (334-1816); TA 1537 (43-157); TA 98 (211-627); TA 100 (498-2767); WP2 uvrA. The data set with S9 are: TA 1535 (176-668); TA 1537 (83-434); TA 98 (360-6586); TA 100 (536-6076); WP2 uvrA (167-1265).
- Negative (solvent/vehicle) historical control data: The data set without S9 are: TA 1535 (6-25); TA 1537 (6-19); TA 98 (13-43); TA 100 (78-209); WP2 uvrA (27-63). The data set with S9 are: TA 1535 (7-26); TA 1537 (7-30); TA 98 (15-58); TA 100 (73-208); WP2 uvrA (28-72).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Revertant colonies
Any other information on results incl. tables
Table 1- Induction of revertants in Salmonella typhimurium and Escherichia coli by the test item in the absence of a metabolising system (Experiment I)
Strain |
Dose level per plate (µg) |
Mean revertants per plate |
Standard deviation |
Ratio treated/solvent |
Individual revertant colony counts |
TA 1535 |
3 |
9.7 |
2.5 |
0.9 |
7,10, 12 |
10 |
10.0 |
3.6 |
0.9 |
14,9,7 |
|
33 |
14.7 |
1.2 |
1.4 |
14,16,14 |
|
100 |
9.0 |
4.4 |
0.8 |
6,7,14 |
|
333 |
4.7 |
0.6 |
0.4 |
5,4,5 |
|
1000 |
8.3 |
1.2 |
0.8 |
7 R, 9 R, 9 R |
|
2500 |
8.7 |
1.5 |
0.8 |
7 M R,9 M R, 10 MR |
|
5000 |
6.7 |
1.2 |
0.6 |
6 M R, 6 M R, 8 M R |
|
Solvent control |
10.7 |
1.5 |
|
9,12,11 |
|
Negative control |
8.3 |
1.2 |
|
9,9,7 |
|
TA 1537 |
3 |
7.7 |
1.2 |
0.9 |
9,9,7 |
10 |
10.7 |
0.6 |
1.2 |
11,10,11 |
|
33 |
5.3 |
0.6 |
0.6 |
6,5,5 |
|
100 |
8.3 |
2.1 |
0.9 |
6,9,10 |
|
333 |
6.7 |
2.1 |
0.7 |
6,5,9 |
|
1000 |
3.7 |
1.5 |
0.4 |
5 R, 2 R, 4 R |
|
2500 |
6.0 |
1.0 |
0.7 |
5 R, 7 R, 6R |
|
5000 |
4.3 |
2.1 |
0.5 |
6 R, 5 R, 2 R |
|
Solvent control |
9.0 |
0.0 |
|
9, 9, 9 |
|
Negative control |
7.3 |
2.3 |
|
6, 6, 10 |
|
TA 98 |
3 |
19.3 |
4.7 |
0.9 |
14, 23, 21 |
10 |
20.3 |
5.5 |
0.9 |
26, 15, 20 |
|
33 |
19.3 |
4.0 |
0.9 |
15, 20, 23 |
|
100 |
24.7 |
7.5 |
1.1 |
25, 17, 32 |
|
333 |
18.7 |
3.5 |
0.9 |
22, 15, 19 |
|
1000 |
21.0 |
6.2 |
1.0 |
14 R, 26 R, 23 R |
|
2500 |
15.0 |
5.3 |
0.7 |
17 R, 19 R, 9 R |
|
5000 |
10.0 |
1.0 |
0.5 |
11 R, 10 R, 9 R |
|
Solvent control |
21.7 |
5.8 |
|
25, 25, 15 |
|
Negative control |
29.3 |
7.1 |
|
37, 28, 23 |
|
TA 100 |
3 |
136.7 |
22.9 |
0.9 |
163, 121, 126 |
10 |
148.3 |
15.6 |
1.0 |
150, 163, 132 |
|
33 |
137.3 |
15.5 |
0.9 |
150, 142, 120 |
|
100 |
154.7 |
8.7 |
1.0 |
145, 157, 162 |
|
333 |
107.0 |
5.2 |
0.7 |
104, 104, 113 |
|
1000 |
32.3 |
10.0 |
0.2 |
40 R, 36 R, 21 R |
|
2500 |
34.3 |
8.0 |
0.2 |
42 R, 26 R, 35 R |
|
5000 |
26.7 |
4.7 |
0.2 |
32 R, 25 R, 23 R |
|
Solvent control |
153.7 |
28.3 |
|
146, 130, 185 |
|
Negative control |
181.7 |
3.2 |
|
183, 178, 184 |
|
WP2 uvrA |
3 |
22.0 |
3.0 |
0.7 |
19, 22, 25 |
10 |
25.0 |
4.4 |
0.8 |
23, 22, 30 |
|
33 |
30.0 |
5.3 |
1.0 |
26, 28, 36 |
|
100 |
31.0 |
4.0 |
1.0 |
27,31,35 |
|
333 |
27.0 |
1.0 |
0.9 |
26,27,28 |
|
1000 |
23.7 |
8.3 |
0.8 |
21,33,17 |
|
2500 |
22.0 |
1.0 |
0.7 |
21, 33, 22 |
|
5000 |
14.0 |
3.5 |
0.5 |
16, 10, 16 |
|
Solvent control |
29.7 |
3.5 |
|
33, 26, 30 |
|
Negative control |
37.0 |
6.1 |
|
41, 40, 30 |
M= Manuel count
R= Reduced background growth
P= Precipitate
Table 2- Induction of revertants inSalmonella typhimuriumandEscherichia coliby the test item in the presence of a metabolising system (Experiment I)
Strain |
Dose level per plate (µg) |
Mean revertants per plate |
Standard deviation |
Ratio treated/solvent |
Individual revertant colony counts |
TA 1535 |
3 |
11.3 |
4.0 |
1.0 |
7,10, 15 |
10 |
12.3 |
2.9 |
1.1 |
14,14,9 |
|
33 |
9.0 |
3.0 |
0.8 |
9,12,6 |
|
100 |
11.7 |
2.5 |
1.0 |
12,9,14 |
|
333 |
10.7 |
5.5 |
0.9 |
16,5,11 |
|
1000 |
3.3 |
1.5 |
0.3 |
3 M R, 5 M R, 2 M R |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R,0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R P, 0 R P, 0 R P |
|
Solvent control |
11.3 |
5.1 |
|
7,17,10 |
|
Negative control |
10.0 |
1.0 |
|
10,9,11 |
|
TA 1537 |
3 |
14.0 |
1.7 |
1.2 |
15,15,12 |
10 |
8.7 |
1.5 |
0.7 |
7,10,9 |
|
33 |
10.0 |
1.0 |
0.9 |
9,10,11 |
|
100 |
9.3 |
3.8 |
0.8 |
5,12,11 |
|
333 |
12.0 |
2.0 |
1.0 |
12,14,10 |
|
1000 |
2.3 |
0.6 |
0.2 |
3 M R, 2 M R, 2 M R |
|
2500 |
0.7 |
1.2 |
0.1 |
0 R, 2 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R P, 0 R P, 0 R P |
|
Solvent control |
11.7 |
2.5 |
|
9, 14, 12 |
|
Negative control |
9.7 |
3.2 |
|
12,11,6 |
|
TA 98 |
3 |
33.0 |
8.9 |
1.3 |
36, 40,23 |
10 |
30.0 |
2.0 |
1.2 |
28,30,32 |
|
33 |
34.3 |
6.4 |
1.3 |
38,38,27 |
|
100 |
26.7 |
4.7 |
1.0 |
23,32,25 |
|
333 |
28.0 |
11.5 |
1.1 |
40,27,17 |
|
1000 |
11.7 |
2.5 |
0.5 |
12 M R, 9 M R, 14 M R |
|
2500 |
2.3 |
1.2 |
0.1 |
1 M R, 3 M R, 3 M R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R P, 0 R P, 0 R P |
|
Solvent control |
25.7 |
5.5 |
|
31,20,26 |
|
Negative control |
32.0 |
4.0 |
|
36,28,32 |
|
TA 100 |
3 |
142.3 |
16.7 |
1.0 |
161, 137, 129 |
10 |
116.0 |
4.4 |
0.8 |
121, 113, 114 |
|
33 |
123.3 |
10.1 |
0.9 |
122, 134, 114 |
|
100 |
135.3 |
7.1 |
1.0 |
143, 129, 134 |
|
333 |
100.3
|
21.0 |
0.7 |
79, 121, 101 |
|
1000 |
27.0 |
8.2 |
0.2 |
36 M R, 25 M R, 20 M R |
|
2500 |
0.7 |
0.6 |
0.0 |
1 R, 1 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R P, 0 R P, 0 R P |
|
Solvent control |
137.7 |
8.6 |
|
136, 147, 130 |
|
Negative control |
157.7 |
14.2 |
|
173, 155, 145 |
|
WP2 uvrA |
3 |
33.0 |
2.0 |
1.1 |
35,33,31 |
10 |
30.7 |
2.3 |
1.0 |
28,32,32 |
|
33 |
39.7 |
8.1 |
1.3 |
47,31,41 |
|
100 |
33.7 |
9.5 |
1.1 |
41,23,37 |
|
333 |
27.3 |
8.1 |
0.9 |
36,26,20 |
|
1000 |
23.0 |
3.6 |
0.7 |
22 R, 27 R, 20 R |
|
2500 |
6.7 |
0.6 |
0.2 |
7 M R, 7 M R, 6 M R |
|
5000 |
7.3 |
0.6 |
0.2 |
8 M R P, 7 M R P, 7 M R P |
|
Solvent control |
31.3 |
4.6 |
|
26,40,28 |
|
Negative control |
40.3 |
3.8 |
|
43, 42, 36 |
M= Manuel count
R= Reduced background growth
P= Precipitate
Table 3- Induction of revertants in Salmonella typhimurium and Escherichia coli by the test item in the absence of a metabolising system (Experiment II)
Strain |
Dose level per plate (µg) |
Mean revertants per plate |
Standard deviation |
Ratio treated/solvent |
Individual revertant colony counts |
TA 1535 |
3 |
9.3 |
4.5 |
0.8 |
9,5,14 |
10 |
8.7 |
3.2 |
0.8 |
5,10,11 |
|
33 |
10.7 |
0.6 |
1.0 |
10,11,11 |
|
100 |
9.3 |
2.1 |
0.8 |
10,11,7 |
|
333 |
4.0 |
3.0 |
0.4 |
7 R,4 R,1 R |
|
1000 |
0.3 |
0.6 |
0.0 |
1 R, 0 R, 0 R |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
Solvent control |
11.0 |
1.0 |
|
12,10,11 |
|
Negative control |
12.0 |
4.4 |
|
10,17,9 |
|
TA 1537 |
3 |
8.7 |
3.5 |
1.0 |
9,12,5 |
10 |
7.3 |
1.5 |
0.8 |
9,6,7 |
|
33 |
8.3 |
3.1 |
0.9 |
11,5,9 |
|
100 |
8.7 |
3.5 |
1.0 |
9,5,12 |
|
333 |
5.7 |
2.9 |
0.6 |
9,5,4 |
|
1000 |
0.3 |
0.6 |
0.0 |
0 R, 1 R, 0 R |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R, 0 R ,0 R |
|
Solvent control |
9.0 |
1.7 |
|
10,10,7 |
|
Negative control |
10.0 |
3.6 |
|
7,14,9 |
|
TA 98 |
3 |
20.7 |
1.2 |
0.8 |
20,20,22 |
10 |
29.0 |
3.6 |
1.2 |
28,33,26 |
|
33 |
24.3 |
6.4 |
1.0 |
28,17,28 |
|
100 |
26.7 |
2.9 |
1.1 |
25,30,25 |
|
333 |
14.7 |
4.6 |
0.6 |
20,12,12 |
|
1000 |
0.7 |
1.2 |
0.0 |
2 R, 0 R, 0 R |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
Solvent control |
24.3 |
3.2 |
|
28,22,23 |
|
Negative control |
28.0 |
5.3 |
|
32,22,30 |
|
TA 100 |
3 |
120.0 |
5.2 |
0.9 |
126,117,117 |
10 |
134.7 |
16.8 |
1.0 |
120,131,153 |
|
33 |
137.0 |
1.7 |
1.0 |
135,138,138 |
|
100 |
120.0 |
9.5 |
0.9 |
111,130,119 |
|
333 |
47.3 |
4.5 |
0.3 |
52,47,43 |
|
1000 |
9.3 |
2.5 |
0.1 |
12 R, 9 R, 7 R |
|
2500 |
0.3 |
0.6 |
0.0 |
1 R, 0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R,0 R, 0 R |
|
Solvent control |
137.3 |
8.0 |
|
129,138,145 |
|
Negative control |
203.7 |
35.0 |
|
169,239,203 |
|
WP2 uvrA |
3 |
24.0 |
3.5 |
0.9 |
28,22,22 |
10 |
24.3 |
4.0 |
0.9 |
25,20,28 |
|
33 |
29.0 |
2.6 |
1.1 |
31,26,30 |
|
100 |
29.3 |
9.3 |
1.1 |
19,32,37 |
|
333 |
18.3 |
4.2 |
0.7 |
15,17,23 |
|
1000 |
0.7 |
0.6 |
0.0 |
0 R, 1 R, 1 R |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
5000 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
Solvent control |
27.3 |
0.6 |
|
27,27,28 |
|
Negative control |
31.0 |
1.0 |
|
31,32,30 |
R= Reduced background growth
Table 4- Induction of revertants in Salmonella typhimurium and Escherichia coli by the test item in the absence of a metabolising system (Experiment II)
Strain |
Dose level per plate (µg) |
Mean revertants per plate |
Standard deviation |
Ratio treated/solvent |
Individual revertant colony counts |
TA 1535 |
3 |
10.3 |
1.5 |
1.0 |
12,9,10 |
10 |
9.7 |
3.2 |
1.0 |
11,6,12 |
|
33 |
11.3 |
5.5 |
1.1 |
15,5,14 |
|
100 |
11.7 |
2.9 |
1.2 |
15,10,10 |
|
333 |
10.3 |
4.7 |
1.0 |
14,5,12 |
|
1000 |
1.0 |
1.0 |
0.1 |
0 R, 2 R, 1 R |
|
Solvent control |
10.0 |
1.0 |
|
10,9,11 |
|
Negative control |
9.7 |
3.2 |
|
11,12,6 |
|
TA 1537 |
3 |
14.0 |
2.0 |
0.9 |
14,16,12 |
10 |
16.0 |
2.6 |
1.1 |
15,19,14 |
|
33 |
11.7 |
0.6 |
0.8 |
11,12,12 |
|
100 |
13.0 |
2.6 |
0.9 |
12,11,16 |
|
333 |
7.0 |
2.0 |
0.5 |
9,7,5 |
|
1000 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
Solvent control |
15.0 |
2.6 |
|
12,17,16 |
|
Negative control |
16.3 |
4.6 |
|
19,11,19 |
|
TA 98 |
10 |
40.7 |
5.1 |
1.1 |
42,35,45 |
33 |
42.3 |
4.0 |
1.2 |
47,40,40 |
|
100 |
36.0 |
7.9 |
1.0 |
30,33,45 |
|
333 |
13.3 |
2.9 |
0.4 |
10,15,15 |
|
1000 |
1.3 |
0.6 |
0.0 |
1 R, 1R, 2 R |
|
2500 |
0.3 |
0.6 |
0.0 |
0 R, 0 R, 1 R |
|
Solvent control |
36.7 |
3.5 |
|
40, 33, 37 |
|
Negative control |
46.3 |
3.8 |
|
48, 49, 42 |
|
TA 100 |
3 |
112.0 |
12.1 |
0.9 |
105, 126, 105 |
10 |
125.3 |
18.6 |
1.0 |
146, 120, 110 |
|
33 |
127.7 |
7.1 |
1.0 |
129, 134, 120 |
|
100 |
96.3 |
14.5 |
1.7 |
96, 111, 82 |
|
333 |
17.0 |
3.6 |
0.1 |
14, 16, 21 |
|
1000 |
0.3 |
0.6 |
0.0 |
1 R, 0 R, 0 R |
|
Solvent control |
130.7 |
6.1 |
|
136, 132, 124 |
|
Negative control |
189.0 |
1.0 |
|
190, 188, 189 |
|
WP2 uvrA |
10 |
31.7 |
9.0 |
0.8 |
42,27,26 |
33 |
36.3 |
11.5 |
0.9 |
36,48,25 |
|
100 |
36.7 |
5.0 |
0.9 |
36,32,42 |
|
333 |
38.3 |
11.0 |
0.9 |
31,33,51 |
|
1000 |
18.0 |
3.6 |
0.4 |
14,21,19 |
|
2500 |
0.0 |
0.0 |
0.0 |
0 R, 0 R, 0 R |
|
Solvent control |
41.0 |
7.0 |
|
36,38,49 |
|
Negative control |
46.7 |
1.5 |
|
45,48,47 |
R= Reduced background growth
Table 5- Concentrations where the test item showed reduced background growth
Strain |
Experiment 1 |
Experiment 2 |
||
|
Without S9 mix |
With S9 mix |
Without S9 mix |
With S9 mix |
TA 1535 |
1000-5000 |
1000-5000 |
333-5000 |
1000 |
TA 1537 |
1000-5000 |
1000-5000 |
1000-5000 |
1000 |
TA 98 |
1000-5000 |
1000-5000 |
1000-5000 |
1000-2500 |
TA 100 |
1000-5000 |
1000-5000 |
1000-5000 |
1000 |
EP2 uvrA |
/ |
1000-5000 |
1000-5000 |
2500 |
Table 6- Concentrations where the test item showed toxic effects based on the reduction in the number of revertants
Strain |
Experiment 1 |
Experiment 2 |
||
|
Without S9 mix |
With S9 mix |
Without S9 mix |
With S9 mix |
TA 1535 |
333 |
1000-5000 |
333-5000 |
1000 |
TA 1537 |
1000 |
1000-5000 |
1000-5000 |
1000 |
TA 98 |
/ |
2500-5000 |
1000-5000 |
333-2500 |
TA 100 |
1000-5000 |
1000-5000 |
333-5000 |
333-1000 |
EP2 uvrA |
/ |
2500-5000 |
1000-5000 |
1000-2500 |
Applicant's summary and conclusion
- Conclusions:
- Under the reported experimental conditions, no biological relevant increase in the number of revertant colonies were observed. Therefore, the test item is considered to not induce mutagenic effects via the processes of base pair changes or frameshifts within the genome of the tested amino stains used up to the highest concentration (5000 µg/plate).
- Executive summary:
The potential mutagenicity of the test item was investigated in an Ames test with the Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) and Escherichia coli strain (WP2uvrA) in the presence and absence of a metabolising system in the concentration range of 3-5000 µg/plate. Each assay was observed for precipitation, normal background lawn and for the number of revertant colonies. Precipitation was observed in both experiments.
Under the reported experimental conditions, no biological relevant increase in the number of revertant colonies were observed. Therefore, the test item is considered to not induce mutagenic effects via the processes of base pair changes or frameshifts within the genome of the tested amino stains used up to the highest concentration (5000 µg/plate).
This study (2018) is GLP-compliant and follows the OECD Test Guideline 471 and is therefore reliable without restrictions (Klimisch 1).
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