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Registration Dossier
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EC number: 221-242-5 | CAS number: 3039-83-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- 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:
- 1988-03-15 to 1988-03-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- used dose level too low according to current requirements
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium ethylenesulphonate
- EC Number:
- 221-242-5
- EC Name:
- Sodium ethylenesulphonate
- Cas Number:
- 3039-83-6
- Molecular formula:
- C2H4O3S.Na
- IUPAC Name:
- sodium ethylenesulphonate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- oxidane
- Reference substance name:
- Sodium 2-hydroxyethanesulphonate
- EC Number:
- 216-343-6
- EC Name:
- Sodium 2-hydroxyethanesulphonate
- Cas Number:
- 1562-00-1
- Molecular formula:
- C2H6O4S.Na
- IUPAC Name:
- sodium 2-hydroxyethanesulfonate
- Reference substance name:
- Disodium 1,2-ethanedisulphonate
- EC Number:
- 226-198-0
- EC Name:
- Disodium 1,2-ethanedisulphonate
- Cas Number:
- 5325-43-9
- Molecular formula:
- C2H6O6S2.2Na
- IUPAC Name:
- disodium ethane-1,2-disulfonate
- Reference substance name:
- 2,2'-Oxybis-ethanesulfonic acid disodium salt
- Cas Number:
- 63440-92-6
- Molecular formula:
- C4H8O7S2.2Na
- IUPAC Name:
- 2,2'-Oxybis-ethanesulfonic acid disodium salt
- Reference substance name:
- sodium 2-sulfonatoethyl sulfate
- Molecular formula:
- C2H4Na2O7S2
- IUPAC Name:
- sodium 2-sulfonatoethyl sulfate
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- H2O4S.2Na
- IUPAC Name:
- disodium sulfate
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9
:
microsomal enzyme system (S-9 mix) from Aroclor 1254 induced Sprague-Dawley rat liver
- method of preparation of S9 mix:
Male Sprague Dawley rats (200 - 300 g) received a single intraperitoneal injection of Aroclor 1254 (500 mg/kg bodyweight) 5 days before sacrifice. Preparation was performed at 0 to 4 °C using cold sterile solution and glassware. The livers from at least 5 - 6 animals are removed and pooled, washed in 150 mM KCL (approximately 1 mL/g wet livers). The washed livers are cut into small pieces and homogenized in three volumes of KCL. The homogenate is centrifuged at 9000 g for 10 minutes. The supernatant is the S-9 fraction. It is divided into small portions, rapidly frozen and storage at -80 °C for not longer than three months.
- concentration or volume of S9 mix and S9 in the final culture medium: 10% S9-Mix - Test concentrations with justification for top dose:
- Toxicity test (first and second experiment) and mutagenicity test (first experiment): 0, 4, 20, 100, 500, 2500, 10000 µg/plate of the 30% sodium ethylene sulphonate solution.
Mutagenicity test (second experiment): 0, 4, 20, 100, 500, 2500, 10000 µg/plate of the 30% sodium ethylene sulphonate solution. - Vehicle / solvent:
- aqua bidest
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 Mix (TA 100, TA 1535)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 Mix (TA 1537)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 Mix (TA 98, TA 1538)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 Mix (TA 98, TA 100, TA 1535, TA 1537, TA 1538, WPuvrA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 Mix (TA 98, TA 100, TA 1535, TA 1537, TA 1538, WPuvrA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-Methyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 Mix (WP2uvraA)
- 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:
- Test substance added in medium; in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 to 72 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: thinning of the bacterial lawn - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- 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:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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:
- 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:
- no 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:
- no 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 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no 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:
- 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:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
First experiment
Table 1: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 100
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 100
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
||
0 |
- |
169 |
180 |
178 |
150 |
4 |
- |
178 |
184 |
188 |
163 |
20 |
- |
175 |
176 |
172 |
178 |
100 |
- |
190 |
186 |
204 |
180 |
500 |
- |
202 |
209 |
202 |
194 |
2500 |
- |
185 |
199 |
172 |
185 |
10000 |
- |
182 |
185 |
180 |
180 |
|
|||||
0 |
+ |
180 |
185 |
172 |
182 |
4 |
+ |
175 |
185 |
171 |
171 |
20 |
+ |
175 |
166 |
175 |
183 |
100 |
+ |
196 |
202 |
176 |
210 |
500 |
+ |
191 |
200 |
183 |
189 |
2500 |
+ |
177 |
179 |
182 |
169 |
10000 |
+ |
179 |
183 |
188 |
167 |
Table 2: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1535
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1535
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
||
0 |
- |
12 |
10 |
12 |
14 |
4 |
- |
13 |
15 |
10 |
15 |
20 |
- |
13 |
14 |
15 |
11 |
100 |
- |
13 |
11 |
12 |
17 |
500 |
- |
12 |
15 |
12 |
10 |
2500 |
- |
14 |
11 |
15 |
16 |
10000 |
- |
11 |
11 |
11 |
10 |
|
|||||
0 |
+ |
13 |
15 |
11 |
13 |
4 |
+ |
13 |
14 |
13 |
12 |
20 |
+ |
12 |
13 |
12 |
11 |
100 |
+ |
14 |
17 |
13 |
11 |
500 |
+ |
15 |
11 |
16 |
17 |
2500 |
+ |
14 |
13 |
14 |
15 |
10000 |
+ |
13 |
11 |
15 |
12 |
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
Table 3: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1537
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1537
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
||
0 |
- |
10 |
11 |
8 |
11 |
4 |
- |
10 |
11 |
9 |
11 |
20 |
- |
8 |
9 |
7 |
8 |
100 |
- |
8 |
7 |
9 |
7 |
500 |
- |
9 |
8 |
9 |
9 |
2500 |
- |
8 |
7 |
10 |
7 |
10000 |
- |
8 |
9 |
7 |
8 |
|
|||||
0 |
+ |
10 |
10 |
9 |
11 |
4 |
+ |
10 |
10 |
10 |
11 |
20 |
+ |
11 |
11 |
9 |
12 |
100 |
+ |
11 |
10 |
12 |
12 |
500 |
+ |
12 |
11 |
13 |
11 |
2500 |
+ |
10 |
9 |
13 |
9 |
10000 |
+ |
10 |
10 |
10 |
11 |
Table 4: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1538
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1538
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
|||
0 |
- |
12 |
13 |
11 |
13 |
|
4 |
- |
13 |
14 |
14 |
12 |
|
20 |
- |
13 |
11 |
16 |
12 |
|
100 |
- |
14 |
12 |
14 |
15 |
|
500 |
- |
15 |
15 |
19 |
11 |
|
2500 |
- |
13 |
15 |
14 |
9 |
|
10000 |
- |
12 |
15 |
11 |
10 |
|
|
||||||
0 |
+ |
18 |
18 |
16 |
19 |
|
4 |
+ |
18 |
23 |
16 |
15 |
|
20 |
+ |
15 |
16 |
14 |
14 |
|
100 |
+ |
17 |
18 |
16 |
18 |
|
500 |
+ |
19 |
17 |
20 |
19 |
|
2500 |
+ |
18 |
14 |
16 |
21 |
|
10000 |
+ |
17 |
19 |
14 |
18 |
|
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
Table 5: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 98
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 98
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
||
0 |
- |
25 |
23 |
26 |
25 |
4 |
- |
26 |
21 |
28 |
28 |
20 |
- |
25 |
22 |
24 |
28 |
100 |
- |
23 |
25 |
25 |
20 |
500 |
- |
23 |
23 |
27 |
20 |
2500 |
- |
23 |
20 |
22 |
27 |
10000 |
- |
25 |
25 |
28 |
23 |
|
|||||
0 |
+ |
30 |
29 |
32 |
29 |
4 |
+ |
34 |
34 |
35 |
33 |
20 |
+ |
31 |
33 |
32 |
29 |
100 |
+ |
33 |
30 |
38 |
32 |
500 |
+ |
35 |
34 |
32 |
38 |
2500 |
+ |
35 |
32 |
35 |
37 |
10000 |
+ |
32 |
31 |
34 |
30 |
Table 6: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
WP2uvrA
Number of revertant colonies per plate and mean values using Escherichia coli strain WP2uvrA
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
|||
0 |
- |
40 |
45 |
39 |
35 |
|
4 |
- |
38 |
39 |
40 |
35 |
|
20 |
- |
40 |
40 |
40 |
39 |
|
100 |
- |
37 |
37 |
36 |
37 |
|
500 |
- |
42 |
42 |
43 |
40 |
|
2500 |
- |
41 |
43 |
37 |
42 |
|
10000 |
- |
40 |
42 |
40 |
37 |
|
|
||||||
0 |
+ |
44 |
48 |
36 |
48 |
|
4 |
+ |
42 |
42 |
45 |
39 |
|
20 |
+ |
45 |
42 |
51 |
42 |
|
100 |
+ |
45 |
41 |
48 |
45 |
|
500 |
+ |
39 |
41 |
39 |
38 |
|
2500 |
+ |
42 |
43 |
43 |
39 |
|
10000 |
+ |
43 |
36 |
46 |
46 |
|
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
Second experiment
Table 7: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 100
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 100
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
Surviving fraction |
||
0 |
- |
143 |
152 |
143 |
133 |
1.0 |
4 |
- |
147 |
150 |
136 |
154 |
1.0 |
20 |
- |
142 |
143 |
119 |
164 |
1.0 |
100 |
- |
156 |
161 |
150 |
157 |
1.0 |
500 |
- |
148 |
158 |
119 |
168 |
1.0 |
2500 |
- |
141 |
129 |
127 |
167 |
0.9 |
5000 |
- |
142 |
140 |
126 |
160 |
1.0 |
|
||||||
0 |
+ |
183 |
183 |
195 |
172 |
1.0 |
4 |
+ |
165 |
155 |
158 |
182 |
1.0 |
20 |
+ |
174 |
181 |
158 |
182 |
1.0 |
100 |
+ |
178 |
197 |
163 |
173 |
0.9 |
500 |
+ |
155 |
187 |
155 |
154 |
1.0 |
2500 |
+ |
168 |
191 |
159 |
153 |
0.9 |
5000 |
+ |
172 |
200 |
158 |
159 |
0.9 |
Table 8: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1535
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1535
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
|||
0 |
- |
13 |
13 |
12 |
14 |
|
4 |
- |
13 |
12 |
14 |
14 |
|
20 |
- |
12 |
12 |
10 |
14 |
|
100 |
- |
12 |
14 |
10 |
11 |
|
500 |
- |
14 |
13 |
11 |
17 |
|
2500 |
- |
11 |
10 |
12 |
10 |
|
5000 |
- |
11 |
9 |
14 |
11 |
|
|
||||||
0 |
+ |
12 |
12 |
12 |
13 |
|
4 |
+ |
12 |
10 |
13 |
13 |
|
20 |
+ |
13 |
11 |
11 |
16 |
|
100 |
+ |
13 |
11 |
15 |
14 |
|
500 |
+ |
12 |
10 |
13 |
12 |
|
2500 |
+ |
12 |
13 |
15 |
9 |
|
5000 |
+ |
11 |
12 |
11 |
10 |
|
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
Table 9: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1537
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1537
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
||
0 |
- |
7 |
9 |
7 |
6 |
4 |
- |
8 |
7 |
8 |
8 |
20 |
- |
7 |
5 |
9 |
6 |
100 |
- |
7 |
6 |
8 |
8 |
500 |
- |
7 |
5 |
7 |
8 |
2500 |
- |
7 |
6 |
9 |
6 |
5000 |
- |
7 |
9 |
6 |
7 |
|
|||||
0 |
+ |
9 |
10 |
8 |
8 |
4 |
+ |
9 |
9 |
10 |
7 |
20 |
+ |
10 |
10 |
10 |
11 |
100 |
+ |
10 |
8 |
12 |
11 |
500 |
+ |
8 |
7 |
9 |
9 |
2500 |
+ |
9 |
9 |
9 |
8 |
5000 |
+ |
10 |
10 |
10 |
9 |
Table 10: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 1538
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 1538
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
|||
0 |
- |
12 |
12 |
11 |
13 |
|
4 |
- |
12 |
13 |
12 |
10 |
|
20 |
- |
14 |
15 |
15 |
13 |
|
100 |
- |
12 |
13 |
13 |
12 |
|
500 |
- |
11 |
9 |
11 |
13 |
|
2500 |
- |
14 |
14 |
14 |
15 |
|
5000 |
- |
12 |
10 |
11 |
14 |
|
|
||||||
0 |
+ |
19 |
16 |
21 |
20 |
|
4 |
+ |
17 |
15 |
17 |
19 |
|
20 |
+ |
19 |
17 |
20 |
20 |
|
100 |
+ |
17 |
18 |
19 |
15 |
|
500 |
+ |
17 |
17 |
18 |
15 |
|
2500 |
+ |
19 |
17 |
22 |
17 |
|
5000 |
+ |
17 |
15 |
18 |
18 |
|
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
Table 11: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
TA 98
Number of revertant colonies per plate and mean values using Salmonella typhimurium strain TA 98
Dose µg/plate |
Metabolic activation |
Mean value22 |
Colonies per plate |
||
0 |
- |
22 |
23 |
22 |
22 |
4 |
- |
22 |
20 |
21 |
25 |
20 |
- |
27 |
26 |
27 |
27 |
100 |
- |
23 |
24 |
24 |
20 |
500 |
- |
21 |
24 |
19 |
19 |
2500 |
- |
24 |
30 |
20 |
21 |
5000 |
- |
22 |
21 |
22 |
24 |
|
|||||
0 |
+ |
25 |
23 |
26 |
27 |
4 |
+ |
29 |
28 |
28 |
32 |
20 |
+ |
28 |
30 |
27 |
27 |
100 |
+ |
26 |
30 |
20 |
27 |
500 |
+ |
28 |
31 |
25 |
29 |
2500 |
+ |
27 |
23 |
31 |
27 |
5000 |
+ |
25 |
23 |
28 |
25 |
Table 12: Mutagenicity experiment with Vinylsulfonsaures Natrium 30%ig with and without metabolic activation
WP2uvrA
Number of revertant colonies per plate and mean values using Escherichia coli strain WP2uvrA
Dose µg/plate |
Metabolic activation |
Mean value |
Colonies per plate |
|||
0 |
- |
51 |
52 |
56 |
45 |
|
4 |
- |
50 |
43 |
46 |
60 |
|
20 |
- |
54 |
54 |
56 |
53 |
|
100 |
- |
51 |
52 |
49 |
51 |
|
500 |
- |
52 |
51 |
55 |
50 |
|
2500 |
- |
53 |
51 |
57 |
50 |
|
5000 |
- |
57 |
54 |
61 |
55 |
|
|
||||||
0 |
+ |
56 |
54 |
56 |
59 |
|
4 |
+ |
58 |
52 |
61 |
62 |
|
20 |
+ |
54 |
53 |
54 |
54 |
|
100 |
+ |
56 |
54 |
53 |
60 |
|
500 |
+ |
59 |
59 |
60 |
58 |
|
2500 |
+ |
57 |
56 |
60 |
56 |
|
5000 |
+ |
53 |
52 |
49 |
58 |
|
Compound dissolved in 100 microliter Aqua bidest.
- ' : absence
+ : presence
First experiment
Table 13: mutability (positive controls) and sterility test of the experiment with Vinylsulfonsaures Natrium 30%ig
Number of revertant colonies per plate and mean values using Salmonella typhimurium strains and Escherichia coli
Strain |
Compound |
Dose µg/plate |
Metab. Activ. |
Mean Value |
Colonies per plate |
||
TA100 |
Sodium-azide |
1 |
- |
526 |
456 |
549 |
574 |
TA1535 |
Sodium-azide |
1 |
- |
409 |
410 |
398 |
419 |
TA1537 |
9-Aminoacridine |
50 |
- |
95 |
81 |
102 |
103 |
TA1538 |
2-Nitrofluorene |
2.5 |
- |
462 |
432 |
487 |
467 |
TA98 |
2-Nitrofluorene |
2.5 |
- |
327 |
294 |
355 |
333 |
WP2uvrA |
MNNG |
1.5 |
- |
261 |
285 |
256 |
243 |
- |
Vinylsulfon- saures Natrium 30%ig |
10000 |
- |
0 |
0 |
0 |
0 |
- : absence
Table 13a : mutability (positive controls) and sterility test of the experiment with Vinylsulfonsaures Natrium 30%ig
Number of revertant colonies per plate and mean values using Salmonella typhimurium strains and Escherichia coli
Strain |
Compound |
Dose ug/plate |
Metab. Activ. |
Mean Value |
Colonies per plate |
||
TA100 |
2-Aminoanthracen |
0.5 |
+ |
818 |
874 |
806 |
775 |
TA1535 |
2-Aminoanthracen |
1 |
+ |
140 |
151 |
126 |
142 |
TA1537 |
2-Aminoanthracen |
1 |
+ |
126 |
122 |
130 |
125 |
TA1538 |
2-Aminoanthracen |
0.5 |
+ |
458 |
438 |
463 |
473 |
TA98 |
2-Aminoanthracen |
0.5 |
+ |
426 |
407 |
444 |
426 |
WP2uvrA |
2-Aminoanthracen |
10 |
+ |
440 |
428 |
442 |
451 |
|
|||||||
TA100 |
Benzo[a]pyrene |
10 |
+ |
1311 |
1352 |
1298 |
1283 |
TA1535 |
Benzo[a]pyrene |
10 |
+ |
18 |
15 |
18 |
21 |
TA1537 |
Benzo[a]pyrene |
10 |
+ |
96 |
85 |
100 |
102 |
TA1538 |
Benzo[a]pyrene |
10 |
+ |
176 |
206 |
173 |
149 |
TA98 |
Benzo[a]pyrene |
10 |
+ |
550 |
535 |
585 |
531 |
WP2uvrA |
Benzo[a]pyrene |
10 |
+ |
87 |
97 |
75 |
88 |
- |
S-9 mix |
500 µl |
+ |
0 |
0 |
0 |
0 |
- |
Vinylsulfon- saures Natrium 30%ig |
1000 µg |
+ |
0 |
0 |
0 |
0 |
+ :presence
Second experiment
Table 14: mutability (positive controls) and sterility test of the experiment with Vinylsulfonsaures Natrium 30%ig
Number of revertant colonies per plate and mean values using Salmonella typhimurium strains and Escherichia coli
Strain |
Compound |
Dose µg/plate |
Metab. Activ. |
Mean Value |
Colonies per plate |
||
TA100 |
Sodium-azide |
1 |
- |
293 |
29+2 |
306 |
280 |
TA1535 |
Sodium-azide |
1 |
- |
272 |
277 |
287 |
252 |
TA1537 |
9-Aminoacridine |
50 |
- |
157 |
160 |
163 |
178 |
TA1538 |
2-Nitrofluorene |
2.5 |
- |
459 |
469 |
430 |
478 |
TA98 |
2-Nitrofluorene |
2.5 |
- |
340 |
314 |
379 |
328 |
WP2uvrA |
MNNG |
2.5 |
- |
223 |
206 |
223 |
241 |
- |
Vinylsulfon- saures Natrium 30%ig |
5000 |
- |
0 |
0 |
0 |
0 |
- : absence
Table 14a : mutability (positive controls) and sterility test of the experiment with Vinylsulfonsaures Natrium 30%ig
Number of revertant colonies per plate and mean values using Salmonella typhimurium strains and Escherichia coli
Strain |
Compound |
Dose µg/plate |
Metab. Activ. |
Mean Value |
Colonies per plate |
||
TA100 |
2-Aminoanthracen |
0.5 |
+ |
465 |
399 |
497 |
502 |
TA1535 |
2-Aminoanthracen |
1 |
+ |
88 |
77 |
84 |
103 |
TA1537 |
2-Aminoanthracen |
1 |
+ |
90 |
79 |
108 |
84 |
TA1538 |
2-Aminoanthracen |
0.5 |
+ |
494 |
474 |
549 |
458 |
TA98 |
2-Aminoanthracen |
0.5 |
+ |
577 |
589 |
563 |
579 |
WP2uvrA |
2-Aminoanthracen |
10 |
+ |
481 |
463 |
496 |
483 |
|
|||||||
TA100 |
Benzo[a]pyrene |
10 |
+ |
685 |
746 |
670 |
639 |
TA1535 |
Benzo[a]pyrene |
10 |
+ |
18 |
16 |
15 |
24 |
TA1537 |
Benzo[a]pyrene |
10 |
+ |
86 |
81 |
96 |
80 |
TA1538 |
Benzo[a]pyrene |
10 |
+ |
183 |
176 |
184 |
188 |
TA98 |
Benzo[a]pyrene |
10 |
+ |
551 |
552 |
547 |
583 |
WP2uvrA |
Benzo[a]pyrene |
10 |
+ |
74 |
66 |
79 |
76 |
- |
S-9 mix |
500 ul |
+ |
0 |
0 |
0 |
0 |
- |
Vinylsulfon- saures Natrium 30%ig |
5000 ug |
+ |
0 |
0 |
0 |
0 |
+ :presence
Applicant's summary and conclusion
- Conclusions:
- The test solution, containing 30% sodium ethylene sulphonate, did not demonstrate mutagenic potential. Under the conditions of the present bacterial reverse mutation assay the maximum test concentration of sodium ethylene sulphonate was 3000 µg/plate.
- Executive summary:
Sodium ethylene sulphonate was tested as a 30% aqueous solution in the Salmonella typhimurium reverse mutation assay (Hoechst AG (b), 1988) with the strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA100 and TA98) and in Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA) similar to OECD guideline 471 and GLP. Two independent mutagenicity studies were conducted (plate incorporation method), each in the absence and in the presence of a metabolising system derived from a rat liver homogenate. For both studies each bacterial strain was exposed to 6 dose levels. In the first experiment concentrations ranged from 4 to 10000 µg/plate and in the second experiment from 4 to 5000 µg/plate.Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies. The test solution proved to be not toxic to the bacterial strains. In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the 30% sodium ethylene sulphonate solution did not result in relevant increases in the number of revertant colonies.In conclusion the test solution, containing 30% sodium ethylene sulphonate, did not demonstrate mutagenic potential. Under the conditions of the present bacterial reverse mutation assay the maximum test concentration of sodium ethylene sulphonate was 3000 µg/plate.
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