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EC number: 286-839-5 | CAS number: 85391-83-9
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
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- Additional toxicological data

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:
- March 11, 1992 to March 30, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals "Genetic Toxicology: Salmonella typhimurium, Reverse Mutation Assay" Adopted: 26 May 83, No. 471
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- EEC Directive 84/449/EEC B.14. Other Effects – Mutagenicity Salmonella typhimurium Reverse Mutation Test
- Qualifier:
- according to guideline
- Guideline:
- other: M. J. Prival, V. D; Mitchell
- Version / remarks:
- M. J. Prival, V. D; Mitchell: Analysis of a method for testing azo dyes for mutagenicity in Sallmonella typhimurium in the presence of flavin mononucleo tide and hamster liver S-9. Mut. Res.,103- 116 (1982).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 286-839-5
- EC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85391-83-9
- Molecular formula:
- C21H14ClF2N5O8S2.xNa
- IUPAC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red 123
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- The doses for the first trial were routinely determined on the basis of a standard protocol: if not limited by solubility 5000 μg /plate was used as the highest dose.
The following doses per pate were evaluated in the first test:
0, 8, 40, 200, 1000, 5000 μg/plate
Due to the substance's weak toxicity, doses ranging from 8 μg to 5000 μg per tube were chosen for the repeat tests.
The following doses per plate were evaluated in repeat tests:
0, 8, 40, 200, 1000, 5000 μg/plate - Vehicle / solvent:
- Levafix Scharlach E-2GA was dissolved in deionized water.
The solvent used was chosen out of the following solvents, in the order given: water, methanol, ethanol, acetone &, DMSO, DMF, and ethylene glycol dimethylether according to information given by the internal sponsor.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- congo red
- other: Nitrofurantoin (NF); 4-nitro-1,2-phenylene diamine (4-NPDA); 2-Aminoanthracene (2-AA); Benzidine
- Details on test system and experimental conditions:
- Test Design
For the mutant count, four plates were used, both with and without S9 mix, for each strain and dose. An equal number of plates, filled with the solvent minus the test substance, comprised the negative control. Each positive control also contained four plates per strain. The amount of solvent for the test substance and for the controls was 0.1 ml/plate.
The doses for the first trial were routinely determined on the basis of a standard protocol: if not limited by solubility 5000 μg /plate was used as the highest dose. At least four additional doses were routinely used as progressive dilutions of the top dose. If less than three doses were used for assessment, at least two repeats were performed. The results of the first experiment were then considered as a pre-test for toxicity. However, in case of a positive response or if at least three doses could be used for assessment, the first trial was included in the assessment. If the second test confirmed the results of the first, no additional repeat was performed. Doses of repeats were chosen on the basis of the results obtain in the first experiment.
Because the first assessable trial showed no mutagenic effects of the test substance, the repeat was performed according to Prival and Mitchell (1982) due to the chemical structure of the compound. Preincubation was performed in a water bath at 30 °C for 30 minutes. At the end of the preincubation period 2 ml of molten soft agar were added to the tubes, the content mixed and plated.
For the mutant count, four plates were used for each strain and dose. An equal-number of plates, filled with the solvent minus the test substance, comprised the negative control.
Each positive control also contained four plates per strain. In experiments without S9 mix buffer was used as replacement.
The doses of this trial were determined on the basis of the results of the plate incorporation assay.
The toxicity of the substance was assessed in three ways.
The first method was a gross appraisal of background growth on the plates for mutant determination. If a reduction in background growth was observed, it was indicated in the tables by the letter "b" after the mutant count. Where only a single "b", without any other values, is noted for a concentration, this "b" represents four plates with reduced background growth. (The same applies to the signs "c", "v", "p", "n" or "%", which may also be used in the tables.) Secondly, a toxic effect of the substance was assumed when there was a marked and dose-dependent reduction in the mutant count per plate, compared to the negative controls. Thirdly, the titer, was determined. Total bacterial counts were taken on two plates for each concentration studied with S9 mix. However, if an evaluation was performed only without S9 mix, the bacterial count was taken without S9 mix.
The bacterial suspensions were obtained from 17-hour cultures in nutrient broth, which had been incubated at 37 °C and 90 rpm. These suspensions were used for the determination of mutant counts. No standardized procedure was employed to set S the bacterial suspensions at a defined density of viable cells per millilitre, since the chosen method of incubation normally produces the desired density. However, the numbers of viable cells were established in a parallel procedure by determining the titers.
The dilution of bacterial suspensions used for the determination of titers was 1:1,000,000. Titers were determined under the same conditions as were the mutations, except that the histidine concentration in the soft agar was increased from 0.5 mM to 2.5 mM to permit the complete growth of bacteria.
The tests were performed both with and without S9 mix.
The count was made after the plates had been incubated for 48 hours at 37 °C. If no immediate count was possible, plate were temporarily stored in a refrigerator. - Rationale for test conditions:
- The initial plate incorporation test followed the directions of Ames et al. (1973a, 1975) and Maron and Ames (1983).
Because the first assessable trial showed no mutagenic effects of the test substance, the repeat was performed according to Prival and Mitchell (1982) due to the chemical structure of the compound. - Evaluation criteria:
- The following criteria determined the acceptance of an assay:
a) The negative controls had to be within the expected range, as defined by published data (e.g. Maron and Ames, 1983) and/or the laboratories' own historical data.
b) The positive controls had to show sufficient effects, as defined by the laboratories' experience.
c) Titer determinations had to demonstrate sufficient bacterial density in the suspension.
An assay which did not comply with at least one of the above criteria was not used for assessment. Furthermore, the data generated in this assay needed to be confirmed by two additional independent experiments. Even if the criteria for points (a), (b) and (c) were it met, an assay was accepted if it showed mutagenic activity of the test compound.
A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result.
For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgement.
In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
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
- Remarks:
- bacteriotoxic effects at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- bacteriotoxic effects at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- bacteriotoxic effects at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- bacteriotoxic effects at 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Plate Incorporation Method
There was no indication of a bacteriotoxic effect of Levafix Scharlach E-2GA at doses of up to and including 1000 μg per plate. The total bacteria counts consistently produced results comparable to the negative controls, or differed only insignificantly. No inhibition of growth was noted as well. 5000 μg per plate had a weak, strain-specific bacteriotoxic effect, but could nevertheless be used for assessment.
None of the four strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix.
Prival Assay
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.
There was no indication of a bacteriotoxic effect of Levafix Scharlach E-2GA at doses of up to and including 1000 μg per tube. The total bacteria counts consistently produced results comparable to the negative controls, or differed only insignificantly. No inhibition of growth was noted as well. 5000 μg per plate, a weak, strain-specific bacteriotoxic effect, but could nevertheless be used for assessment.
None of the four strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls and thus confirmed the results of the plate incorporation method.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, benzidine, Congo red and 2-aminoanthracene increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.
Any other information on results incl. tables
Summary of the Results with Levafix Scharlach E-2GA in the Salmonella/Microsome Test
Plate Incorporation Method
S9 mix |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
Without |
-ve |
-ve |
-ve |
-ve |
With |
-ve |
-ve |
-ve |
-ve |
-ve = negative
Summary of the Results with Levafix Scharlach E-2GA in the Salmonella/Microsome Test
Prival Assay
S9 mix |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
Without |
-ve |
-ve |
-ve |
-ve |
With |
-ve |
-ve |
-ve |
-ve |
-ve = negative
Summary of Mean Values Without S9 Mix
Group |
Strain |
|||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
|
μg/plate 0 8 40 200 1000 5000 Na-azide NF 4-NPDA |
19 23 18 21 17 17 875 |
107 124 124 105 106 82
388 |
5 7 6 6 4 4
62 |
19 17 23 17 20 10
82 |
μg/tube 0 8 40 200 1000 5000 Na-azide NF 4-NPDA |
11 12 10 11 10 10 883 |
82 103 109 115 94 86
316 |
13 13 13 14 13 11
44 |
37 32 30 30 27 28
75 |
Summary of Mean Values With S9 Mix
Group |
Strain |
|||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
|
μg/plate 0 8 40 200 1000 5000 2-AA |
26 20 28 27 24 17 140 |
150 140 156 155 140 102 865 |
6 5 6 9 7 5 47 |
28 27 27 33 22 15 245 |
μg/tube 0 8 40 200 1000 5000 Benzidine Congo red 2-AA |
17 22 21 23 20 15
166 |
150 168 176 180 164 137
1392 |
24 21 22 19 23 17
251 |
55 56 47 53 53 42 119 85 |
Historical Controls of Plate Incorporation Method
Summary of historical negative and positive controls of experiments performed from January to June 1988 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Ethanol Acetone EGDME2 |
- - - - - - |
14 13 12 15 10 18 |
2 2 2 3 2 |
97 94 87 69 85 117 |
9 15 11 7 10 |
8 8 8 7 7 10 |
1 1 1 1 1 |
17 17 19 22 18 21 |
2 2 3 3 2 |
Na-azide NF 4-NPDA |
- - - |
839 |
115 |
382 |
46 |
90 |
13 |
109 |
20 |
30% Water DMSO DMF Ethanol Acetone EGDME2 |
+ + + + + + |
14 15 14 20 14 18 |
3 3 3 2 1 |
134 124 113 105 134 159 |
10 14 9 6 25 |
8 9 9 6 11 9 |
2 2 2 1 2 |
29 29 31 30 34 35 |
3 3 5 3 3 |
2-AA |
+ |
282 |
63 |
601 |
164 |
66 |
17 |
532 |
160 |
10% Water DMSO DMF Ethanol Acetone |
+ + + + + |
147 14 -- 23 13 |
4 2 |
123 111 72 87 85 |
4 13
6 |
9 8 9 8 7 |
1 |
33 33 27 38 29 |
5 |
2-AA |
+ |
357 |
67 |
1422 |
428 |
298 |
65 |
1323 |
323 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from July to December 1988 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Ethanol Acetone |
- - - - - |
14 14 12 10 15 |
3 2 2 2 2 |
97 93 70 71 138 |
9 25 4 2 10 |
8 8 7 7 8 |
2 1 1 1 3 |
20 19 13 21 39 |
5 10 1 3 6 |
Na-azide NF 4-NPDA |
- - - |
822 |
137 |
412 |
42 |
88 |
19 |
124 |
25 |
30% Water DMSO DMF Ethanol Acetone |
+ + + + + |
12 16 14 17 13 |
2 2 3 3 4 |
144 124 117 90 177 |
15 15 14 4 35 |
10 10 9 8 9 |
2 2 2 1 2 |
35 32 31 39 43 |
6 5 6 2 8 |
2-AA |
+ |
261 |
69 |
755 |
196 |
93 |
21 |
583 |
171 |
10% DMSO DMF |
+ + |
7 11 |
1 |
110 121 |
12 |
9 6 |
1 |
32 26 |
5 |
2-AA |
+ |
348 |
70 |
1544 |
572 |
416 |
75 |
1499 |
423 |
Summary of historical negative and positive controls of experiments performed from January to June 1989 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Ethanol Acetone EGDE2 |
- - - - - - |
10 9 7 10 9 8 |
3 3 1 2 - 2 |
91 84 60 73 100 69 |
11 16 4 12 -- 16 |
7 7 6 7 7 6 |
1 2 1 2 - 2 |
18 16 14 18 18 17 |
3 2 2 4 - 4 |
Na-azide NF 4-NPDA |
- - - |
721 |
110 |
359 |
61 |
75 |
13 |
119 |
35 |
30% Water DMSO DMF Ethanol Acetone EGDE2 |
+ + + + + + |
14 14 14 17 15 14 |
2 3 2 3 - 2 |
133 114 100 118 138 115 |
12 18 9 12 -- 25 |
9 9 8 10 13 11 |
2 1 2 2 - 2 |
32 28 25 37 32 27 |
8 4 4 8 - 8 |
2-AA |
+ |
195 |
33 |
633 |
127 |
63 |
28 |
392 |
133 |
10% DMSO DMF |
+ + |
12 -- |
2 - |
105 -- |
28 -- |
7 7 |
2 - |
25 31 |
4 - |
2-AA |
+ |
267 |
27 |
1455 |
348 |
283 |
64 |
1547 |
289 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from July to December 1989 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
DMSO DMF Ethanol Acetone EGDE2 |
- - - - - |
10 9 8 15 8 |
4 4 3 - - |
72 57 57 96 63 |
6 15 12 -- -- |
7 8 6 6 6 |
4 2 1 - - |
16 17 14 13 21 |
5 5 6 - - |
Na-azide NF 4-NPDA |
- - - |
853 |
147 |
326 |
47 |
91 |
26 |
87 |
25 |
30% DMSO DMF Ethanol Acetone EGDE2 |
+ + + + + |
14 15 11 21 13 |
2 3 6 - - |
89 87 79 96 87 |
7 6 13 -- -- |
11 11 |
2 4 2 - - |
23 26 23 20 26 |
2 4 5 - - |
2-AA |
+ |
157 |
42 |
500 |
83 |
73 |
22 |
498 |
101 |
10% DMSO Ethanol |
+ + |
14 11 |
5 - |
91 53 |
7 - |
10 4 |
1 - |
24 18 |
4 - |
2-AA |
+ |
158 |
54 |
1464 |
152 |
289 |
117 |
1294 |
113 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from January to June 1990 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
- - - - - - - |
15 12 10 17 13 10 14 |
3 2 4
3 1 4 |
74 72 65 87 77 69 95 |
10 13 10
11 4 14 |
7 8 7 7 8 6 8 |
1 2 2
2 1 1 |
22 17 10 19 19 11 18 |
5 3 6
2 2 5 |
Na-azide NF 4-NPDA |
- - - |
799 |
108 |
268 |
48 |
52 |
12 |
81 |
14 |
30% Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
+ + + + + + + |
18 18 13 22 19 13 15 |
2 3 3
3 1 2 |
108 86 97 121 98 104 97 |
17 11 17
15 8 9 |
9 9 7 11 8 7 9 |
2 2 3
2 3 3 |
27 27 20 28 29 22 28 |
5 3 5
4 3 8 |
2-AA |
+ |
161 |
39 |
509 |
130 |
48 |
15 |
379 |
54 |
10% DMSO Ethanol Acetone |
+ + + |
18 16 |
2 |
89 85 107 |
20 |
11 8 |
4 |
30 29 17 |
6 |
2-AA |
+ |
214 |
49 |
1196 |
181 |
235 |
38 |
1140 |
284 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from July to December 1990 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
- - - - - - - |
13 14 13 13 12 12 13 |
2 2 2 1 3 2 2 |
105 105 82 105 93 116 112 |
16 7 16 16 14 2 15 |
9 8 6 8 9 6 8 |
1 1 2 1 1 1 2 |
21 21 12 21 22 23 18 |
4 3 4 4 3 1 3 |
Na-azide NF 4-NPDA |
- - - |
882 |
114 |
380 |
60 |
48 |
9 |
71 |
15 |
30% Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
+ + + + + + + |
18 17 15 22 19 13 18 |
3 2 3 2 3 1 3 |
143 137 109 144 118 131 135 |
15 5 14 16 18 4 14 |
11 10 10 11 10 9 11 |
2 2 1 2 1 1 2 |
29 28 23 33 39 26 32 |
3 4 3 3 7 1 5 |
2-AA |
+ |
175 |
41 |
800 |
243 |
84 |
17 |
485 |
93 |
10% DMSO Acetone EGDE2 |
+ + + |
16 12 |
2 |
127 124 140 |
19 |
9 10 |
3 |
32 26 |
5 |
2-AA |
+ |
179 |
69 |
1321 |
148 |
298 |
39 |
1206 |
168 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from January to June 1990 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
- - - - - - - |
12 13 9 11 12 10 11 |
3 2 - 2 1 - 3 |
111 113 80 105 96 55 108 |
10 14 -- 14 15 -- 5 |
9 10 7 8 9 5 8 |
2 2 - 2 2 - 1 |
28 30 23 29 31 21 23 |
5 3 - 5 5 - 8 |
Na-azide NF 4-NPDA |
- - - |
623 |
102 |
398 |
56 |
49 |
10 |
89 |
20 |
30% Water DMSO DMF Methanol Ethanol Acetone EGDE2 |
+ + + + + + + |
16 18 11 23 19 14 15 |
3 3 - 5 3 - 4 |
152 154 84 152 127 84 132 |
15 11 -- 7 17 -- 6 |
12 12 9 10 10 14 8 |
2 2 - 3 3 - 1 |
38 40 29 48 43 18 40 |
7 7 - 10 6 - 9 |
2-AA |
+ |
182 |
33 |
800 |
163 |
86 |
24 |
472 |
105 |
10% Water DMSO Methanol |
+ + + |
15 16 -- |
- 3 - |
102 132 150 |
- 5 - |
5 10 -- |
- 1 - |
46 39 -- |
- 4 - |
2-AA |
+ |
208 |
48 |
1408 |
216 |
314 |
147 |
754 |
369 |
2) Ethylene glycol dimethylether
Summary of historical negative and positive controls of experiments performed from July to December 1991 using mean values presented as medians (Z) and semi-Q range (QR)
Compound and S9 Mix |
Strain |
||||||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
||||||
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
||
Water Buffer DMSO DMF Methanol Ethanol Acetone EGDE2 |
- - - - - - - - |
12 13 12 7 10 12 12 14 |
3 2 3
1 4 2 3 |
89 97 92 75 84 80 87 108 |
10 10 15
11 8 6 22 |
9 8 9 7 8 8 8 8 |
3 1 1
1 3 1 1 |
27 25 24 17 25 23 26 26 |
4 2 4
3 4 4 5 |
Na-azide NF 4-NPDA |
- - - |
605 |
122 |
339 |
52 |
53 |
9 |
71 |
17 |
30% Water Buffer DMSO DMF Methanol Ethanol Acetone EGDE2 |
+ + + + + + + + |
19 17 19 11 25 18 18 22 |
4
3
5 2 4 |
138 159 130 142 134 119 111 144 |
21
11
19 9 11 |
13 13 10 9 12 11 13 13 |
2
2
2
3 |
33 38 33 32 37 37 28 32 |
4
4
2 11 3 |
2-AA |
+ |
164 |
38 |
727 |
139 |
91 |
32 |
520 |
161 |
10% Water Buffer DMSO DMF Methanol Ethanol Acetone EGDE2 |
+ + + + + + + + |
16 14 16 15 16 19 17 20 |
4
2
3
2 |
113 94 118 114 111 94 112 153 |
18
14 6
6
11 |
10 10 10 11 9 12 11 11 |
3
3
2
1 |
33 34 31 21 29 32 32 34 |
5
3
2
5 |
2-AA |
+ |
197 |
50 |
1431 |
260 |
304 |
116 |
1097 |
207 |
2) Ethylene glycol dimethylether
Applicant's summary and conclusion
- Conclusions:
- Due to the results, the test item has to be regarded as non-mutagenic. The substance is not classifiable according to CLP criteria.
- Executive summary:
Levafix Scharlach E-2GA was initially investigated using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of up to 5000 μg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.
In the plate incorporation assay doses of up to and including 1000 μg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At 5000 μg per plate, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.
In the plate incorporation assay evidence of mutagenic activity of Levafix Scharlach E-2GA was not seen. No biologically relevant increase in the mutant count, in comparison with the negative, controls, was observed.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Levafix Scharlach E-2GA was investigated in an independent repeat using the Salmonella/microsome test, modified with S9 mix according to Prival and Mitchell, for point mutagenic effects in doses of up to 5000 μg per tube on the same strains. Without S9 mix preincubation was used.
Doses of up to and including 1000 μg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At 5000 μg per plate, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.
Evidence of mutagenic activity of Levafix Scharlach E-2CA was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.
The positive controls sodium azide, nitrofurantoin, 4-nitro--1,2-phenylene diamine, benzidine, Congo red and 2-aminoanthracene had a marked mutagenic effect, as was see by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Therefore, Levafix Scharlach E-2GA was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the Prival modification of the Salmonella/microsome test.
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