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EC number: 233-546-5 | CAS number: 10226-30-9
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:
- From December 9th 2015 to January 14th 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-chlorohexan-2-one
- EC Number:
- 233-546-5
- EC Name:
- 6-chlorohexan-2-one
- Cas Number:
- 10226-30-9
- Molecular formula:
- C6H11ClO
- IUPAC Name:
- 6-chlorohexan-2-one
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine-requiring auxotroph strains of Salmonella typhimurium and tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coli WP2 uvrA).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: uvrB and rfa mutated
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: uvrA mutated
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of liver rats
- Test concentrations with justification for top dose:
- Initial mutation test: 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate.
Confirmatory mutation test: 1.581, 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate.
The maximum test concentration was 5000 μg test item/plate since the numbers of revertant colonies were mostly in the normal range, no citotoxicity was observed and there was no precipitation up to the highest dose tested (TA98 and TA100 with and without metabolic activation). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO) and distilled water
- Justification for choice of solvent/vehicle: The solubility of the test item was examined using Distilled water, Dimethyl sulfoxide (DMSO) and N,N-dimethylformamide (DMF). The test item was insoluble at 100 mg/mL concentration using Distilled water as vehicle. However, a clear solution was achieved observed at the same concentrations using DMSO and DMF as vehicles. Due to the better biocompatibility, DMSO was selected as vehicle (solvent) for the study.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
1.Plate incorporation (initial mutation test): Molten top agar was prepared and kept at 45°C. 2 mL of top agar was aliquoted into individual test tubes (3 tubes per control or concentration level). The equivalent number of minimal glucose agar plates was properly labelled. The test item and other components were prepared freshly and added to the overlay (45°C). This solution was mixed and poured on the surface of minimal agar plates. After preparation, the plates were incubated at 37°C for 48 hours.
2.Pre-incubation (confirmatory mutation test): Before the overlaying, the test item formulation (or vehicle/solvent or reference control), the bacterial culture and the S9 mix or phosphate buffer were added into appropriate tubes to provide direct contact between bacteria and the test item (in its vehicle/solvent). The tubes (3 tubes per control or concentration level) were gently mixed and incubated for 20 min at 37ºC in a shaking incubator. After the incubation period, 2 mL of molten top agar was added to the tubes; the content was mixed up and poured onto minimal glucose agar plates as described for the standard plate incorporation method. After preparation, the plates were incubated at 37°C for 48 hours.
DURATION
- Preincubation period: 20 minutes (confirmatory mutation test)
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): The lack of amino-acid in the medium. Only the mutants can grow due to their capability to synthesize the essential amino acid.
NUMBER OF REPLICATIONS: 3 (test item, negative and positive controls).
DETERMINATION OF CYTOTOXICITY
- Method: other: inhibition of bacterial lawn of auxotrophic cells.
OTHER:
- Method of counting: The colony numbers on the untreated / negative (vehicle/solvent) / positive control and test item treated plates were determined by manual counting. - Rationale for test conditions:
- Solubility: The solubility of the test item was examined using Distilled water, Dimethyl sulfoxide (DMSO) and N,N-dimethylformamide (DMF).
Concentration dose range-finding: The revertant colony numbers and the inhibition of the background lawn of auxotrophic cells of two of the tester strains (Salmonella typhimurium TA98, TA100) were determined at the concentrations of 5000, 2500, 1000, 316, 100, 31.6 and 10 μg/plate of the test item. The plate incorporation method was used. - Evaluation criteria:
- A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- the number of reversions was more than two times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA98, TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
The test item was considered to have shown no mutagenic activity in this study if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
Results and discussion
Test resultsopen allclose all
- 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 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 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:
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- 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
- Genotoxicity:
- positive
- Remarks:
- at 5000 μg/plate
- 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:
- 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:
- 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:
- 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:
- 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
- Genotoxicity:
- positive
- Remarks:
- at 1581 and 5000 μg/plate
- 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:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitate was observed in the preliminary concentration range finding test, however precipitate was observed in the confirmatory mutation test in all examined strains with/and or without metabolic activation at 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES: Concentrations of 5000, 2500, 1000, 316, 100, 31.6 and 10 µg/plate were examined in the Preliminary Concentration Range Finding Test in 2 tester strains of S. typhimurium (TA98 and TA100) using the plate incorporation method.
In this preliminary experiment, the numbers of revertant colonies were mostly in the normal range (minor differences were detected in some sporadic cases, but they were without biological significance and considered as biological variability of the test system).
No precipitate and no inhibitory, cytotoxic effect of the test item was observed in the Preliminary Concentration Range Finding Test.
COMPARISON WITH HISTORICAL CONTROL DATA: Some relative high number of colonies were observed with the test substance at some concentrations but they were not dose-related, they were within the historical control range and below the biologically relevant threshold limit. Therefore, they were considered as biological variability of the test system.
Untreated, solvent and positive controls were within the historical range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Inhibitory, cytotoxic effect of the test item (absent/reduced/slightly reduced background lawn development) was observed in the Confirmatory Mutation Test in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA strains with and without metabolic activation at 5000 μg/plate. The inhibitory, cytotoxic effect of the test item was also observed in Salmonella typhimurium TA1535 strain without metabolic activation at 5000 μg/plate. - Remarks on result:
- other: Initial mutation test
Any other information on results incl. tables
Table 2. Summary Table of the Range Finding Test
Concentrations
|
Mean values of revertants / Mutation factor (MF) |
Salmonella typhimuriumtester strains |
||||
TA 98 |
TA 100 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
|||
Untreated control |
Mean |
24.7 |
25.3 |
93.0 |
86.3 |
|
MF |
1.76 |
1.27 |
1.04 |
0.95 |
||
DMSO control |
Mean |
14.0 |
20.0 |
89.0 |
90.7 |
|
MF |
1.00 |
1.00 |
1.00 |
1.00 |
||
Distilled water control |
Mean |
-- |
-- |
87.3 |
-- |
|
MF |
-- |
-- |
0.98 |
-- |
||
5000 |
Mean |
19.7 |
22.7 |
109.7 |
96.0 |
|
MF |
1.40 |
1.13 |
1.23 |
1.06 |
||
2500 |
Mean |
21.7 |
21.0 |
99.0 |
97.0 |
|
MF |
1.55 |
1.05 |
1.11 |
1.07 |
||
1000 |
Mean |
16.3 |
22.7 |
98.7 |
95.7 |
|
MF |
1.17 |
1.13 |
1.11 |
1.06 |
||
316 |
Mean |
20.3 |
24.0 |
98.3 |
95.0 |
|
MF |
1.45 |
1.20 |
1.10 |
1.05 |
||
100 |
Mean |
19.3 |
19.7 |
95.3 |
80.3 |
|
MF |
1.38 |
0.98 |
1.07 |
0.89 |
||
31.6 |
Mean |
18.0 |
24.0 |
88.0 |
87.3 |
|
MF |
1.29 |
1.20 |
0.99 |
0.96 |
||
10 |
Mean |
19.3 |
26.0 |
103.0 |
95.0 |
|
MF |
1.38 |
1.30 |
1.16 |
1.05 |
||
NPD (4mg) |
Mean |
372.0 |
-- |
-- |
-- |
|
MF |
26.57 |
-- |
-- |
-- |
||
2AA (2mg) |
Mean |
-- |
2277.3 |
-- |
2272.0 |
|
MF |
-- |
113.87 |
-- |
25.06 |
||
SAZ (2mg) |
Mean |
-- |
-- |
1146.7 |
-- |
|
MF |
-- |
-- |
13.13 |
-- |
||
Table 3. Summary Table of the Initial Mutation Test
Concentrations
|
Mean values of revertants / Mutation factor (MF) |
Salmonella thyphimuriumtester strains |
Escherichia coli |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||
Untreated control |
Mean |
24.0 |
25.3 |
85.0 |
84.3 |
13.0 |
14.3 |
8.3 |
7.3 |
32.7 |
28.7 |
|
MF |
1.16 |
1.09 |
1.04 |
0.90 |
0.66 |
0.73 |
1.79 |
0.92 |
1.04 |
1.02 |
||
DMSO control |
Mean |
20.7 |
23.3 |
82.0 |
93.3 |
19.7 |
19.7 |
4.7 |
8.0 |
31.3 |
28.0 |
|
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
||
Distilled water control |
Mean |
-- |
-- |
91.0 |
-- |
17.0 |
-- |
-- |
-- |
30.0 |
-- |
|
MF |
-- |
-- |
1.11 |
-- |
0.86 |
-- |
-- |
-- |
0.96 |
-- |
||
5000 |
Mean |
21.7 |
20.7 |
122.0 |
107.3 |
51.3 |
65.0 |
7.3 |
6.7 |
37.7 |
40.0 |
|
MF |
1.05 |
0.89 |
1.49 |
1.15 |
2.61 |
3.31 |
1.57 |
0.83 |
1.20 |
1.43 |
||
1581 |
Mean |
21.3 |
30.0 |
99.7 |
89.3 |
34.7 |
29.7 |
8.0 |
5.3 |
30.7 |
39.3 |
|
MF |
1.03 |
1.29 |
1.22 |
0.96 |
1.76 |
1.51 |
1.71 |
0.67 |
0.98 |
1.40 |
||
500 |
Mean |
23.0 |
24.0 |
85.0 |
85.0 |
29.7 |
28.7 |
10.3 |
6.3 |
26.7 |
33.3 |
|
MF |
1.11 |
1.03 |
1.04 |
0.91 |
1.51 |
1.46 |
2.21 |
0.79 |
0.85 |
1.19 |
||
158.1 |
Mean |
19.3 |
28.7 |
86.3 |
72.7 |
22.7 |
26.0 |
4.7 |
7.3 |
29.0 |
33.3 |
|
MF |
0.94 |
1.23 |
1.05 |
0.78 |
1.15 |
1.32 |
1.00 |
0.92 |
0.93 |
1.19 |
||
50 |
Mean |
20.7 |
28.7 |
77.3 |
83.7 |
24.7 |
24.3 |
8.7 |
9.0 |
27.0 |
31.0 |
|
MF |
1.00 |
1.23 |
0.94 |
0.90 |
1.25 |
1.24 |
1.86 |
1.13 |
0.86 |
1.11 |
||
15.81 |
Mean |
21.3 |
20.7 |
69.7 |
65.3 |
21.3 |
21.7 |
6.7 |
7.7 |
30.7 |
29.3 |
|
MF |
1.03 |
0.89 |
0.85 |
0.70 |
1.08 |
1.10 |
1.43 |
0.96 |
0.98 |
1.05 |
||
NPD (4mg) |
Mean |
394.7 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
|
MF |
19.10 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
||
2AA (2mg) |
Mean |
-- |
2288.0 |
-- |
2221.3 |
-- |
225.3 |
-- |
213.3 |
-- |
-- |
|
MF |
-- |
98.06 |
-- |
23.80 |
-- |
11.46 |
-- |
26.67 |
-- |
-- |
||
2AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
149.3 |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
5.33 |
||
SAZ (2mg) |
Mean |
-- |
-- |
1073.3 |
-- |
1184.0 |
-- |
-- |
-- |
-- |
-- |
|
MF |
-- |
-- |
11.79 |
-- |
69.65 |
-- |
-- |
-- |
-- |
-- |
||
9AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
381.7 |
-- |
-- |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
81.79 |
-- |
-- |
-- |
||
MMS (2mL) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
926.7 |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
30.89 |
-- |
||
Table 4.Summary Table of the Confirmatory Mutation Test
Concentrations
|
Mean values of revertants / Mutation factor (MF) |
Salmonella thyphimuriumtester strains |
Escherichia coli |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||
Untreated control |
Mean |
28.3 |
33.7 |
105.7 |
119.7 |
18.3 |
20.3 |
6.7 |
5.0 |
38.0 |
37.0 |
|
MF |
1.25 |
1.38 |
1.09 |
1.20 |
1.15 |
1.22 |
1.11 |
1.25 |
1.01 |
1.10 |
||
DMSO control |
Mean |
22.7 |
24.3 |
96.7 |
99.7 |
16.0 |
16.7 |
6.0 |
4.0 |
37.7 |
33.7 |
|
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
||
Distilled water control |
Mean |
-- |
-- |
109.3 |
-- |
14.0 |
-- |
-- |
-- |
37.3 |
-- |
|
MF |
-- |
-- |
1.13 |
-- |
0.88 |
-- |
-- |
-- |
0.99 |
-- |
||
5000 |
Mean |
2.7 |
16.3 |
0.7 |
65.7 |
31.0 |
70.7 |
1.3 |
4.0 |
30.3 |
30.3 |
|
MF |
0.12 |
0.67 |
0.01 |
0.66 |
1.94 |
4.24 |
0.22 |
1.00 |
0.81 |
0.90 |
||
1581 |
Mean |
25.0 |
27.0 |
115.0 |
125.3 |
36.7 |
55.0 |
5.7 |
6.0 |
55.0 |
47.7 |
|
MF |
1.10 |
1.11 |
1.19 |
1.26 |
2.29 |
3.30 |
0.94 |
1.50 |
1.46 |
1.42 |
||
500 |
Mean |
23.0 |
30.0 |
106.3 |
116.3 |
26.7 |
27.3 |
6.3 |
7.7 |
30.0 |
44.7 |
|
MF |
1.01 |
1.23 |
1.10 |
1.17 |
1.67 |
1.64 |
1.06 |
1.92 |
0.80 |
1.33 |
||
158.1 |
Mean |
18.7 |
23.0 |
92.7 |
113.7 |
22.7 |
20.3 |
6.7 |
8.0 |
38.7 |
33.7 |
|
MF |
0.82 |
0.95 |
0.96 |
1.14 |
1.42 |
1.22 |
1.11 |
2.00 |
1.03 |
1.00 |
||
50 |
Mean |
16.7 |
23.3 |
95.0 |
115.3 |
27.3 |
27.0 |
5.0 |
9.7 |
36.0 |
31.0 |
|
MF |
0.74 |
0.96 |
0.98 |
1.16 |
1.71 |
1.62 |
0.83 |
2.42 |
0.96 |
0.92 |
||
15.81 |
Mean |
19.7 |
21.0 |
96.7 |
106.7 |
24.7 |
21.7 |
6.7 |
5.7 |
32.0 |
35.7 |
|
MF |
0.87 |
0.86 |
1.00 |
1.07 |
1.54 |
1.30 |
1.11 |
1.42 |
0.85 |
1.06 |
||
5 |
Mean |
24.0 |
25.3 |
103.0 |
106.3 |
19.0 |
19.0 |
5.7 |
5.7 |
32.3 |
29.0 |
|
MF |
1.06 |
1.04 |
1.07 |
1.07 |
1.19 |
1.14 |
0.94 |
1.42 |
0.86 |
0.86 |
||
1.581 |
Mean |
24.0 |
26.7 |
102.7 |
93.7 |
23.3 |
20.7 |
6.0 |
8.7 |
32.0 |
29.3 |
|
MF |
1.06 |
1.10 |
1.06 |
0.94 |
1.46 |
1.24 |
1.00 |
2.17 |
0.85 |
0.87 |
||
NPD (4mg) |
Mean |
374.0 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
|
MF |
16.50 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
||
2AA (2mg) |
Mean |
-- |
2234.7 |
-- |
2437.3 |
-- |
206.7 |
-- |
205.3 |
-- |
-- |
|
MF |
-- |
91.84 |
-- |
24.45 |
-- |
12.40 |
-- |
51.33 |
-- |
-- |
||
2AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
196.0 |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
5.82 |
||
SAZ (2mg) |
Mean |
-- |
-- |
1100.0 |
-- |
1158.7 |
-- |
-- |
-- |
-- |
-- |
|
MF |
-- |
-- |
10.06 |
-- |
82.76 |
-- |
-- |
-- |
-- |
-- |
||
9AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
392.0 |
-- |
-- |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
65.33 |
-- |
-- |
-- |
||
MMS (2mL) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
997.3 |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
26.71 |
-- |
||
Applicant's summary and conclusion
- Conclusions:
- The test item was found to be mutagenic for strain TA1535 with metabolic activation using the plate incorporation method.
- Executive summary:
A bacterial reverse mutation test was conducted on the test substance according to OECD guideline 471 under GLP conditions. Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as Escherichia coli WP2 uvrA were exposed to concentrations of the test substance ranging from 1.581 to 5000 µg/plate according to a preliminary range-finding assay. An initial mutation test and a confirmatory mutation test were carried out. The preliminary range finding and the initial mutation test employed the plate incorporation method and the confirmatory mutation test used the pre-incubation method, except for the TA1535 strain which was tested with the plate incorporation method based on the results of the initial test. DMSO and distilled water were used as solvents. Untreated, solvent controls and strain specific positive controls were included in the assays and were within the historical control range in all strains. In the Initial Mutation Test and Confirmatory Mutation Test, a positive effect was obtained in TA1535 strain with metabolic activation using the plate incorporation method. Inhibitory, cytotoxic effect of the test item was observed in the Confirmatory Mutation Test in TA98, TA100, TA1537 and E. coli WP2 uvrA strains with and without metabolic activation at 5000 μg/plate, and in TA1535 strain without metabolic activation at 5000 μg/plate. Based on the result of the study, the test item was found to have mutagenic activity in one (TA1535) of the applied bacterial tester strains with metabolic activation.
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