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EC number: 208-589-8 | CAS number: 534-15-6
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- Endpoint summary
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- Short-term toxicity to fish
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Genetic toxicity in vitro
Description of key information
1,1-Dimethoxyethane (CAS no. 534-15-6) was considered to be non-mutagenic in the tested species under the conditions of the test.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date 17 August 2017 Experimental completion date 08 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Identification: 1,1-Dimethoxyethane (CAS no. 534-15-6)
Physical state/Appearance: Clear colourless liquid
Batch: 1706291650R
Purity: 99.92%
Expiry Date: 29 June 2019
Storage Conditions: Approximately 4 °C in the dark under nitrogen - Target gene:
- Histidine locus in S. typhimurium and tryptophan locus in E.coli.
- 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:
- Phenobarbital/B-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1 - Plate Incorporation Method: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate.
The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate.
Experiment 2 – Pre-Incubation Method: 15, 50, 150, 500, 1500, 5000 μg/plate.
There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the first mutation test (plate incorporation method). Consequently, the same maximum dose level was used as the maximum concentration in the second mutation test. - Vehicle / solvent:
- The test item was miscible but considered viscous enough in sterile distilled water at 50 mg/mL to make dosing the test item difficult, however it was fully miscible in dimethyl sulphoxide at the same concentration in solubility checks performed in-house. Dimethyl sulphoxide was therefore selected as the vehicle.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2 μg/plate for WP2uvrA 3 μg/plate for TA100 5 μg/plate for TA1535
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 80 μg/plate for TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.2 μg/plate for TA98
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1 μg/plate for TA100 2 μg/plate for TA1535 and TA1537 10 μg/plate for WP2uvrA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- presence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 μg/plate for TA98
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- presence of S9-mix
- Details on test system and experimental conditions:
- Test Item Preparation and Analysis
The highest concentration of the test item tested in this study was 50 mg/mL (final plate concentration was 5000 μg/plate). The test item was accurately weighed and diluted in dimethyl sulphoxide by mixing on a vortex mixer on the day of each experiment. The highest concentration in each test was diluted with dimethyl sulphoxide to produce a series of lower concentrations, separated by approximately half-log10 intervals. No correction was made for purity. Prior to use, the solvent (dimethyl sulphoxide) was dried to remove water using molecular sieves i.e. 2 mm sodium alumino-silicate pellets with a nominal pore diameter of 4 x 10^-4 microns.
All formulations were used within four hours of preparation and were assumed to be stable for this period. Analysis for concentration, homogeneity and stability of the test item formulations is not a requirement of the test guidelines and was, therefore, not determined. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Test for Mutagenicity: Experiment 1 - Plate Incorporation Method
Eight concentrations of the test item were assayed in triplicate against each tester strain, using the direct plate incorporation method.
Without Metabolic Activation
0.1 mL of the appropriate concentration of test item, solvent vehicle or appropriate positive control was added to 2 mL of molten, trace amino-acid supplemented media containing 0.1 mL of one of the bacterial strain cultures and 0.5 mL of phosphate buffer. These were then mixed and overlayed onto a Vogel-Bonner agar plate. Negative (untreated) controls were also performed on the same day as the mutation test. Each concentration of the test item, appropriate positive, vehicle and negative controls, and each bacterial strain, was assayed using triplicate plates.
With Metabolic Activation
The procedure was the same as described previously except that following the addition of the test item formulation and bacterial culture, 0.5 mL of S9-mix was added to the molten, trace amino-acid supplemented media instead of phosphate buffer.
Incubation and Scoring
All of the plates were incubated at 37 ± 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). A single manual count was required due to revertant colonies spreading slightly, thus distorting the actual plate count.
Test for Mutagenicity: Experiment 2 – Pre-Incubation Method
As the result of Experiment 1 was deemed negative, Experiment 2 was performed using the pre-incubation method in the presence and absence of metabolic activation.
Dose selection
Six test item concentrations per bacterial strain were selected in Experiment 2 in order to achieve both a minimum of four non-toxic dose levels and the potential toxic limit of the test item following the change in test methodology from plate incorporation to pre-incubation.
Without Metabolic Activation
0.1 mL of the appropriate bacterial strain culture, 0.5 mL of phosphate buffer and 0.1 mL of the test item formulation, solvent vehicle or 0.1 mL of appropriate positive control were incubated at 37 ± 3 °C for 20 minutes (with shaking) prior to addition of 2 mL of molten, trace amino-acid supplemented media and subsequent plating onto Vogel-Bonner plates. Negative (untreated) controls were also performed on the same day as the mutation test employing the plate incorporation method. All testing for this experiment was performed in triplicate.
With Metabolic Activation
The procedure was the same as described previously except that following the addition of the test item formulation and bacterial strain culture, 0.5 mL of S9-mix was added to the tube instead of phosphate buffer, prior to incubation at 37 ± 3 °C for 20 minutes (with shaking) and addition of molten, trace amino-acid supplemented media. All testing for this experiment was performed in triplicate.
Incubation and Scoring
All of the plates were incubated at 37 ± 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). Several manual counts were required due to revertant colonies spreading slightly, thus distorting the actual plate count. - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
- 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 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:
- 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
- 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
- Additional information on results:
- Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). The amino acid supplemented top agar and the S9-mix used in both experiments was shown to be sterile. The test item formulation was also shown to be sterile. These data are not given in the report.
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
This study meets all items listed in the acceptability criteria outlined.
The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate. There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the first mutation test (plate incorporation method). Consequently, the same maximum dose level was used as the maximum concentration in the second mutation test. Similarly, there was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the second mutation test (pre-incubation method).
No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method). Similarly, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method). - Conclusions:
- 1,1-Dimethoxyethane (CAS no. 534-15-6) was considered to be non-mutagenic in the tested species under the conditions of this test.
- Executive summary:
Introduction
The test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF, the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC) number 440/2008 of 30 May 2008 and the USA, EPA OCSPP harmonized guideline - Bacterial Reverse Mutation Test.
Methods
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range for Experiment 1 (plate incorporation method) was predetermined and was 1.5 to 5000 μg/plate. The experiment was repeated on a separate day (Experiment 2, pre-incubation method) using fresh cultures of the bacterial strains and fresh test item formulations. The dose range was amended following the results of Experiment 1 and was 15 to 5000 μg/plate. Six test item concentrations were selected in Experiment 2 in order to achieve both a minimum of four non-toxic dose levels and the potential toxic limit of the test item following the change in test methodology.
Results
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate. There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the first mutation test (plate incorporation method). Consequently, the same maximum dose level was used as the maximum concentration in the second mutation test. Similarly, there was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the second mutation test (pre-incubation method).
No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method). Similarly, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method).
Conclusion
1,1-Dimethoxyethane (CAS no. 534-15-6) was considered to be non-mutagenic in the tested species under the conditions of this test.
Reference
Experiment 1 – Without Metabolic Activation
Test Period |
From: 31 August 2017 |
To: 03 September 2017 |
|||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
67 68 64 |
(66) 2.1# |
26 26 28 |
(27) 1.2 |
18 (20) 21 2.1 22 |
25 20 19 |
(21) 3.2 |
16 14 10 |
(13) 3.1 |
||
1.5 µg |
63 73 64 |
(67) 5.5 |
24 19 20 |
(21) 2.6 |
23 (20) 17 3.1 21 |
22 23 14 |
(20) 4.9 |
11 7 17 |
(12) 5.0 |
||
5 µg |
56 77 73 |
(69) 11.2 |
19 19 23 |
(20) 2.3 |
17 (19) 19 1.5 20 |
22 19 18 |
(20) 2.1 |
12 10 16 |
(13) 3.1 |
||
15 µg |
62 64 65 |
(64) 1.5 |
24 21 20 |
(22) 2.1 |
24 (21) 18 3.0 21 |
19 22 22 |
(21) 1.7 |
16 13 10 |
(13) 3.0 |
||
50 µg |
60 67 71 |
(66) 5.6 |
16 20 17 |
(18) 2.1 |
14 (19) 18 5.0 24 |
22 24 23 |
(23) 1.0 |
12 10 18 |
(13) 4.2 |
||
150 µg |
71 76 60 |
(69) 8.2 |
22 16 15 |
(18) 3.8 |
24 (19) 17 4.0 17 |
25 13 21 |
(20) 6.1 |
12 11 12 |
(12) 0.6 |
||
500 µg |
59 66 66 |
(64) 4.0 |
22 24 21 |
(22) 1.5 |
25 (16) 12 7.8 11 |
26 25 25 |
(25) 0.6 |
15 11 14 |
(13) 2.1 |
||
1500 µg |
82 74 68 |
(75) 7.0 |
24 19 27 |
(23) 4.0 |
19 (17) 18 2.1 15 |
25 24 26 |
(25) 1.0 |
16 14 15 |
(15) 1.0 |
||
5000 µg |
85 67 66 |
(73) 10.7 |
27 19 24 |
(23) 4.0 |
18 (24) 26 5.3 28 |
29 29 28 |
(29) 0.6 |
11 11 17 |
(13) 3.5 |
||
Positive controls S9-Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 µg |
5 µg |
2 µg |
0.2 µg |
80 µg |
|||||||
786 (627) 670 184.8 424 |
2073 (2144) 2186 61.8 2173 |
1347 (1224) 1206 115.1 1119 |
267 (258) 255 7.9 252 |
435 (403) 423 45.4 351 |
Experiment 1 – With Metabolic Activation
Test Period |
From: 31 August 2017 |
To: 03 September 2017 |
|||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
73 72 69 |
(71) 2.1# |
38 33 29 |
(33) 4.5 |
25 (25) 29 4.0 21 |
32 24 23 |
(26) 4.9 |
14 18 22 |
(18) 4.0 |
||
1.5 µg |
68 66 70 |
(68) 2.0 |
34 36 35 |
(35) 1.0 |
25 (27) 26 2.6 30 |
22 21 30 |
(24) 4.9 |
9 14 15 |
(13) 3.2 |
||
5 µg |
62 74 76 |
(71) 7.6 |
33 29 31 |
(31) 2.0 |
21 (25) 26 4.0 29 |
29 23 22 |
(25) 3.8 |
13 8 12 |
(11) 2.6 |
||
15 µg |
56 69 69 |
(65) 7.5 |
32 28 29 |
(30) 2.1 |
34 (27) 22 6.4 24 |
29 23 24 |
(25) 3.2 |
21 17 10 |
(16) 5.6 |
||
50 µg |
57 66 68 |
(64) 5.9 |
37 33 29 |
(33) 4.0 |
19 (25) 29 5.1 26 |
27 27 25 |
(26) 1.2 |
13 20 13 |
(15) 4.0 |
||
150 µg |
71 67 65 |
(68) 3.1 |
30 33 36 |
(33) 3.0 |
27 (20) 11 8.3 23 |
26 28 30 |
(28) 2.0 |
20 15 15 |
(17) 2.9 |
||
500 µg |
67 65 84 |
(72) 10.4 |
38 31 40 |
(36) 4.7 |
22 (27) 29 4.7 31 |
38 23 21 |
(27) 9.3 |
14 18 15 |
(16) 2.1 |
||
1500 µg |
61 62 82 |
(68) 11.8 |
38 31 31 |
(33) 4.0 |
24 (24) 23 0.6 24 |
35 22 30 |
(29) 6.6 |
22 13 15 |
(17) 4.7 |
||
5000 µg |
77 65 56 |
(66) 10.5 |
36 35 37 |
(36) 1.0 |
34 (32) 21 9.7 40 |
22 29 29 |
(27) 4.0 |
11 7 14 |
(11) 3.5 |
||
Positive controls S9-Mix (+) |
Name Dose Level No. of Revertants |
2AA |
|
2AA |
2AA |
|
BP |
2AA |
|||
1 µg |
|
2 µg |
10 µg |
5 µg |
2 µg |
||||||
1005 (1344) 1910 493.6 1116 |
419 505 436 |
(453) 45.5 |
320 (333) 379 41.1 300 |
207 (222) 252 25.7 208 |
540 (527) 537 19.4 505 |
Experiment 2 – Without Metabolic Activation
Test Period |
From: 05 September 2017 |
To: 08 September 2017 |
|||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
80 67 129 |
(92) 32.7# |
21 29 25 |
(25) 4.0 |
31 (30) 30 0.6 30 |
22 24 26 |
(24) 2.0 |
18 17 24 |
(20) 3.8 |
||
15 µg |
79 100 73 |
(84) 14.2 |
18 29 21 |
(23) 5.7 |
28 (33) 37 4.6 34 |
21 34 21 |
(25) 7.5 |
11 18 21 |
(17) 5.1 |
||
50 µg |
121 90 92 |
(101) 17.3 |
27 17 9 |
(18) 9.0 |
39 (35) 29 5.5 38 |
27 31 27 |
(28) 2.3 |
11 13 9 |
(11) 2.0 |
||
150 µg |
101 112 87 |
(100) 12.5 |
24 31 22 |
(26) 4.7 |
28 (27) 25 1.5 27 |
27 26 29 |
(27) 1.5 |
18 8 8 |
(11) 5.8 |
||
500 µg |
69 85 77 |
(77) 8.0 |
23 25 18 |
(22) 3.6 |
36 (31) 30 4.2 28 |
30 29 28 |
(29) 1.0 |
17 15 16 |
(16) 1.0 |
||
1500 µg |
98 83 109 |
(97) 13.1 |
23 22 21 |
(22) 1.0 |
36 (33) 34 4.2 28 |
30 28 29 |
(29) 1.0 |
14 21 7 |
(14) 7.0 |
||
5000 µg |
83 102 99 |
(95) 10.2 |
29 21 17 |
(22) 6.1 |
30 (30) 35 4.5 26 |
23 17 30 |
(23) 6.5 |
25 16 7 |
(16) 9.0 |
||
Positive controls S9-Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 µg |
5 µg |
2 µg |
0.2 µg |
80 µg |
|||||||
1144 (974) 747 204.4 1030 |
1169 (1127) 1080 44.7 1131 |
179 (168) 178 17.6 148 |
365 (370) 367 7.6 379 |
238 (224) 244 29.0 191 |
Experiment 2 - With Metabolic Activation
Test Period |
From: 05 September 2017 |
To: 08 September 2017 |
|||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
Solvent Control (DMSO) |
79 79 82 |
(80) 1.7# |
17 18 20 |
(18) 1.5 |
28 (27) 26 1.2 26 |
37 30 42 |
(36) 6.0 |
25 14 9 |
(16) 8.2 |
||
15 µg |
88 82 85 |
(85) 3.0 |
17 21 17 |
(18) 2.3 |
21 (29) 36 7.5 29 |
27 38 34 |
(33) 5.6 |
11 16 22 |
(16) 5.5 |
||
50 µg |
83 67 78 |
(76) 8.2 |
24 21 28 |
(24) 3.5 |
32 (31) 26 4.2 34 |
42 19 37 |
(33) 12.1 |
24 11 9 |
(15) 8.1 |
||
150 µg |
78 78 76 |
(77) 1.2 |
22 11 30 |
(21) 9.5 |
27 (27) 35 8.0 19 |
23 29 28 |
(27) 3.2 |
10 9 36 |
(18) 15.3 |
||
500 µg |
82 80 62 |
(75) 11.0 |
32 21 26 |
(26) 5.5 |
21 (24) 30 4.9 22 |
35 27 23 |
(28) 6.1 |
12 10 21 |
(14) 5.9 |
||
1500 µg |
65 90 82 |
(79) 12.8 |
19 18 18 |
(18) 0.6 |
29 (28) 22 6.0 34 |
40 28 27 |
(32) 7.2 |
24 23 10 |
(19) 7.8 |
||
5000 µg |
86 96 85 |
(89) 6.1 |
16 18 19 |
(18) 1.5 |
22 (30) 25 11.9 44 |
39 27 30 |
(32) 6.2 |
9 10 9 |
(9) 0.6 |
||
Positive controls S9-Mix (+) |
Name Dose Level No. of Revertants |
2AA |
|
2AA |
2AA |
|
BP |
2AA |
|||
1 µg |
|
2 µg |
10 µg |
5 µg |
2 µg |
||||||
828 (885) 930 51.9 896 |
214 235 250 |
(233) 18.1 |
165 (175) 169 13.4 190 |
156 (150) 123 25.0 172 |
343 (342) 364 22.0 320 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO: 4-Nitroquinoline-1-oxide
9AA: 9 -Aminoacridine
#: Standard deviation
BP: Benzo(a)pyrene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The test substance was considered to be non-mutagenic under the Ames study therefore the substance is not classified for Genetic toxicity.
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