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EC number: 939-867-3 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1997-01-23 - 1997-07-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 144538-83-0
- EC Number:
- 604-420-0
- Cas Number:
- 144538-83-0
- IUPAC Name:
- 144538-83-0
- Reference substance name:
- Sodium-iminodisuccinate
- IUPAC Name:
- Sodium-iminodisuccinate
- Reference substance name:
- sodium;(2S)-2-(1,2-dicarboxylatoethylamino)butanedioate
- IUPAC Name:
- sodium;(2S)-2-(1,2-dicarboxylatoethylamino)butanedioate
- Reference substance name:
- IDS, Na-Salz
- IUPAC Name:
- IDS, Na-Salz
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): IDS, Na-Salz = Iminodisuccinate, Na-salt or Sodium-iminodisuccinate
- Molecular formula (if other than submission substance): C8H7NO8Na4
- Molecular weight (if other than submission substance): 337.1 [g/mol]
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: chelate
- Physical state: white powder
- Analytical purity: 67,2 %
- Composition of test material, percentage of components: 67.2% IDS, Na-Salz, 10.1% DL-Asparic acid, Na-salt, 8.3% H20, 7.8% Fumaric acid, Na-salt, 4.2% DL-Malic acid, Na-salt, 1.1% Sodium hydroxide, 0.9% Maleinic acid, Na-salt (analytical result dated February 27, 1997)
- Purity test date: February 27, 1997
- Lot/batch No.: SAV B 0004
- Expiration date of the lot/batch: January 14, 1998
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- his-
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: normal nutrient broth
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
TA 1535 and TA 100 bear the base-pair substitution, his G 46, and TA 100 additionally contains the plasmid pKM 101.
This R factor, also contained in TA 98 and TA 102, codes for an ampicillin resistance and should raise the sensitivity of the strains.
TA 102 carries the ochre Mutation his G 428 on the multicopy plasmid pAQl, which codes in addition for tetracycline resistance.
TA 1537 and TA 98 bear frameshift markers.
TA 1537 exhibits the +1 mutant, his C 3076, while TA 98 bears the +2 type, his D 3052.
With the exception of TA 102, all strains have reduced capability to repair DNA-damage which increases the likelihood that such damage results in mutations.
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: normal nutrient broth
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
TA 1535 and TA 100 bear the base-pair substitution, his G 46, and TA 100 additionally contains the plasmid pKM 101.
This R factor, also contained in TA 98 and TA 102, codes for an ampicillin resistance and should raise the sensitivity of the strains.
TA 102 carries the ochre Mutation his G 428 on the multicopy plasmid pAQl, which codes in addition for tetracycline resistance.
TA 1537 and TA 98 bear frameshift markers.
TA 1537 exhibits the +1 mutant, his C 3076, while TA 98 bears the +2 type, his D 3052.
With the exception of TA 102, all strains have reduced capability to repair DNA-damage which increases the likelihood that such damage results in mutations.
- Metabolic activation:
- with and without
- Metabolic activation system:
- the 9000 g fraction of homogenized mammalian Livers together with co-factors
- Test concentrations with justification for top dose:
- 0, 40, 158, 500, 1581 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionized water (formed a clear colourless solution
- the positive controls were dissolved in DMSO
- Justification for choice of solvent/vehicle: The solvent used was chosen out of the following solvents, in the order given: water, DMSO, methanol, ethanol, acetone, ethylene glycol dimethylether, and DMF according to information given by the internal sponsor. The order of these solvents is based on their bacteriotoxic effects in preincubation experiments.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- sodium azide (10 µg/plate, TA1535), nitrofurantoin (0.2 µg, TA100), 4-nitro-1,2-phenylene diamine (10 µg, TA1537), 4-nitro-1,2-phenylene diamine (0.5 µg/plate TA98), Cumene hydroperoxide (50 µg/plate) and 2-aminoanthracene (3 µg/plate, TA102)
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2 aminoantracene
- Remarks:
- No "untreated" negative control was set up for the used solvent, since sufficient evidence was available ia the literature and from our own experience , indicating that this solvent had no influence on the spontaneous mutant counts of the used strains.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation)
For the mutant count, three 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 three 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 or 5 µL per plate were used as the highest dose. At least four, additional doses were routinely used. 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 obtained in the first experiment.
The first repeat was performed as preincubation in a water bath at 37°C for 20 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, three 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 three plates per strain. In experiments without S9 mix buffer was used as replacement.
The dose of this trial were determined on the basis of the results of the plate incorporation assay. Doses are given as µg/tube for better separation of plate incorporation and preincubation trials, despite the fact that µg/plate and µg/tube could be used synonymously.
The toxicity of the substance was assessed in two ways. The first method was a gross appraisal of background growth on the plates for mutant determination. A reduction in background growth was indicated by the letter "b" after the mutant count and only a single "b", without any other values, is noted for a concentration, this "b" represents three plates with reduced background growth. 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.
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 the bacterial suspensions at a defined density of viable cells per milliliter, 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 of the negative controls with S9 mix.
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 fivefold 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, plates were temporarily stored in a refrigerator. - 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 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.
Only trials which complied with all three of the above criteria were accepted for assessment. Even if the criteria for points (b) and (c) were not met, a trial was accepted if it showed mutagenic activity of the test compound. Furthermore, an unacceptable trial would have been repeated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- other: Due to the results of the first trial, doses ranging from 1000 µg to 5000 µg per tube were chosen for the repeat tests.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The colony number of each plate and mean values of the plate incorporation assay are listed for each dose in the tables 4 to 8, 13 and 14. As may be seen, there was no indication of a bacteriotoxic effect of IDS, Na-Salz at doses of up to and including 1581 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/plate had only a weak, strain-specific bacteriotoxic effect. Therefore this dose could nevertheless be used for assessment purposes.
Salmonella typhimurium TA 102 revealed without S9 mix an in crease in mutant counts of about 80 as compared to the respective negative control (Table 5). This increase could not be confirmed (Tables 11 and 12), and is therefore to be regarded as a random result.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide and 2-amino-anthracene 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.
The colony number of each plate and mean values of the preincubation assay are listed for each dose in Tables 6 to 10. As may be seen, there was no indication of a bacteriotoxic effect of IDS, Na-Salz at doses of up to and including 5000 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.
None of the five strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls (Tables 6 to 10) and thus confirmed the results of the plate incorporation method.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide and 2-amino-anthracene 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.
Table 2: Tabulated Summary of Data | ||||||
Summary of Mean Values Without S9 Mix From Tables 1-12 | ||||||
Table and group | Strain | |||||
TA 1535 | TA 100 | TA 1537 | TA 98 | TA 102 | ||
1-5 | ||||||
µ/plate | ||||||
0 | 6 | 97 | 9 | 22 | 151 | |
50 | 7 | 92 | 8 | 20 | 160 | |
158 | 6 | 90 | 9 | 17 | 149 | |
500 | 5 | 87 | 6 | 17 | 165 | |
1581 | 4 | 88 | 7 | 22 | 191 | |
5000 | 7 | 92 | 6 | 24 | 231 | |
Na-azide | 924 | |||||
NF | 209 | |||||
4-NPDA | 64 | 129 | ||||
Cumene | 242 | |||||
6-10 | ||||||
µg/tube | ||||||
0 | 7 | 127 | 8 | 21 | 315 | |
1000 | 7 | 125 | 9 | 28 | 325 | |
2000 | 6 | 128 | 7 | 29 | 327 | |
3000 | 6 | 98 | 6 | 31 | 304 | |
4000 | 7 | 136 | 4 | 32 | 255 | |
5000 | 6 | 122 | 5 | 18 | 265 | |
Na-azide | 824 | |||||
NF | 216 | |||||
4-NPDA | 69 | 171 | ||||
Cumene | A.. | 599 | ||||
11-12 | ||||||
µg/plate | ||||||
0 | 145 | 113 | ||||
1000 | 142 | 120 | ||||
2000 | 156 | 141 | ||||
3000 | 123 | 160 | ||||
4000 | 133 | 165 | ||||
5000 | 163 | 159 | ||||
Cumene | 223 | 234 |
Table 3: Summary of Mean Values With S9 Mix From Tables 1-12 | ||||||
Table and group | Strain | |||||
TA 1535 | TA 100 | TA 1537 | TA 98 | TA 102 | ||
1-5 | ||||||
µg/plate | ||||||
0 | 11 | 105 | 9 | 30 | 314 | |
50 | 13 | 96 | 14 | 26 | 271 | |
158 | 12 | 111 | 10 | 26 | 243 | |
500 | 9 | 104 | 8 | 33 | 295 | |
1581 | 7 | 122 | 8 | 25 | 265 | |
5000 | 12 | 119 | 8 | 25 | 332 | |
2-AA | 74 | 1675 | 91 | 2083 | 623 | |
6-10 | ||||||
µg/tube | ||||||
0 | 6 | 104 | 6 | 26 | 353 | |
1000 | 5 | 105 | 5 | 24 | 357 | |
2000 | 7 | 98 | 6 | 26 | 384 | |
3000 | 8 | 108 | 5 | 29 | 380 | |
4000 | 5 | 108 | 6 | 22 | 381 | |
5000 | 6 | 95 | 6 | 21 | 404 | |
2-AA | 66 | 1227 | 26 | 1625 | 719 | |
11-12 | ||||||
µg/plate | ||||||
0 | 196 | 159 | ||||
1000 | 174 | 181 | ||||
2000 | 161 | 183 | ||||
3000 | 168 | 151 | ||||
4000 | 188 | 154 | ||||
5000 | 178 | 156 | ||||
2-AA | 361 | 337 |
Bayer A.G. | Table : 4 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 13.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 1535 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 6 | 6 | 1 | 12 | 11 | 2 | 61 | 6.9 | 1.0 | 1.0 |
5 | 8 | 77 | ||||||||
7 | 12 | |||||||||
50 | 8 | 7 | 1 | 11 | 13 | 2 | % | / | 1.2 | 1.3 |
7 | 14 | |||||||||
7 | 15 | |||||||||
158 | 8 | 6 | 2 | 10 | 12 | 2 | % | / | 1.1 | 1.2 |
6 | 14 | |||||||||
5 | 13 | |||||||||
500 | 7 | 5 | 2 | 9 | 9 | 2 | % | / | 0.9 | 0.8 |
4 | 10 | |||||||||
5 | 7 | |||||||||
1581 | 5 | 4 | 1 | 7 | 7 | 1 | % | / | 0.7 | 0.7 |
4 | 7 | |||||||||
4 | 8 | |||||||||
5000 | 8 | 7 | 1 | 13 B | 12 | 1 | % | / | 1.2 | 1.2 |
6 | 11 B | |||||||||
7 | 13 B | |||||||||
Na-azide 10 | 918 | 924 | 23 | % | / | / | % | / | 154. 1* | / |
905 | ||||||||||
950 | ||||||||||
2-AA 3 |
% | / | / | 77 | 74 | 5 | % | / | / | 6.9* |
68 | ||||||||||
77 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 5 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 13.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 100 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 106 | 97 | 9 | 102 | 105 | 3 | 42 | 5.0 | 1.0 | 1.0 |
89 | 106 | 58 | ||||||||
97 | 108 | |||||||||
50 | 86 | 92 | 7 | 90 | 96 | 7 | % | 0.9 | 0.9 | |
91 | 104 | |||||||||
100 | 95 | |||||||||
158 | 80 | 90 | 13 | 123 | 111 | 15 | % | / | 0.9 | 1.1 |
105 | 94 | |||||||||
86 | 116 | |||||||||
500 | 81 | 87 | 11 | 106 | 104 | 15 | % | / | 0.9 | 1.0 |
100 | 117 | |||||||||
81 | 88 | |||||||||
1581 | 99 | 88 | 10 | 126 | 122 | 4 | % | / | 0.9 | 1.2 |
84 | 118 | |||||||||
80 | 122 | |||||||||
5000 | 93 | 92 | 4 | 114 | 119 | 6 | % | / | 0.9 | 1.1 |
88 | 117 | |||||||||
95 | 126 | |||||||||
NF 0.2 |
208 | 209 | 20 | % | / | / | % | / | 2.1* | / |
190 | ||||||||||
229 | ||||||||||
2-AA 3 |
% | / | / | 1785 | 1675 | 238 | % | / | / | 15.9* |
1838 | ||||||||||
1402 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 6 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 13.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 1537 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 8 | 9 | 1 | 7 | 9 | 2 | 88 | 8.9 | 1.0 | 1.0 |
9 | 9 | 89 | ||||||||
9 | 10 | |||||||||
50 | 8 | 8 | 1 | 13 | 14 | 1 | % | / | 0.9 | 1.6 |
7 | 14 | |||||||||
9 | 14 | |||||||||
158 | 8 | 9 | 1 | 12 | 10 | 2 | % | / | 1.0 | 1.2 |
8 | 9 | |||||||||
10 | 10 | |||||||||
500 | 9 | 6 | 3 | 10 | 8 | 2 | % | / | 0.7 | 0.9 |
6 | 7 | |||||||||
4 | 6 | |||||||||
1581 | 8 | 7 | 1 | 10 | 8 | 2 | % | / | 0.8 | 0.9 |
7 | 7 | |||||||||
6 | 6 | |||||||||
5000 | 7 | 6 | 1 | 7 | 8 | 2 | % | / | 0.7 | 0.9 |
6 | 10 | |||||||||
6 | 7 | |||||||||
4-NPDA 10 |
54 | 64 | 8 | % | / | / | % | / | 7.3* | / |
69 | ||||||||||
68 | ||||||||||
2-AA 3 |
% | / | / | 105 | 91 | 12 | % | / | / | 10.5* |
81 | ||||||||||
87 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 7 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 13.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 98 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 27 | 22 | 5 | 31 | 30 | 3 | 209 | 21.2 | 1.0 | 1.0 |
17 | 33 | 215 | ||||||||
23 | 27 | |||||||||
50 | 22 | 20 | 8 | 27 | 26 | 4 | % | / | 0.9 | 0.9 |
12 | 22 | |||||||||
27 | 29 | |||||||||
158 | 24 | 17 | 6 | 26 | 26 | 1 | % | / | 0.8 | 0.9 |
13 | 27 | |||||||||
14 | 26 | |||||||||
500 | 14 | 17 | 5 | 34 | 33 | 3 | % | / | 0.8 | 1.1 |
14 | 29 | |||||||||
23 | 35 | |||||||||
1581 | 19 | 22 | 3 | 25 | 25 | 2 | % | / | 1.0 | 0.8 |
24 | 27 | |||||||||
22 | 23 | |||||||||
5000 | 22 | 24 | 3 | 31 | 25 | 6 | % | / | 1.1 | 0.8 |
23 | 19 | |||||||||
28 | 24 | |||||||||
4-NPDA 0.5 |
138 | 129 | 8 | % | / | / | % | / | 5.8* | / |
127 | ||||||||||
122 | ||||||||||
2-AA 3 |
% | / | / | 1970 | 2083 | 103 | % | / | / | 68.7* |
2108 | ||||||||||
2172 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 8 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 13.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 102 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 151 | 151 | 6 | 302 | 314 | 15 | 68 | 6.0 | 1.0 | 1.0 |
145 | 309 | 52 | ||||||||
156 | 331 | |||||||||
50 | 169 | 160 | 17 | 254 | 271 | 15 | % | / | 1.1 | 0.9 |
140 | 278 | |||||||||
171 | 282 | |||||||||
158 | 168 | 149 | 17 | 247 | 243 | 6 | % | / | 1.0 | 0.8 |
141 | 245 | |||||||||
137 | 236 | |||||||||
500 | 175 | 165 | 9 | 258 | 295 | 35 | % | / | 1.1 | 0.9 |
164 | 301 | |||||||||
157 | 327 | |||||||||
1581 | 180 | 191 | 14 | 307 | 265 | 40 | % | / | 1.3 | 0.8 |
185 | 261 | |||||||||
207 | 228 | |||||||||
5000 | 269 | 231 | 33 | 350 | 332 | 17 | % | / | 1.5² | 1.1 |
211 | 329 | |||||||||
213 | 317 | |||||||||
Cumene 50 |
249 | 242 | 17 | % | / | / | % | / | 1.6* | / |
222 | ||||||||||
254 | ||||||||||
2-AA 3 |
% | / | / | 629 | 623 | 14 | % | / | / | 2.0* |
607 | ||||||||||
634 | ||||||||||
² see Chapter 5.1 | *: Mutagenic effect | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 9 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 20.1997 | ||||||||
AMES Test with IDS Na-salt | Strain: | S.typhimurium TA 1535 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 7 | 7 | 1 | 7 | 6 | 1 | 223 | 23.8 | 1.0 | 1.0 |
7 | 6 | 252 | ||||||||
6 | 6 | |||||||||
1000 | 7 | 7 | 2 | 5 | 5 | 1 | % | / | 1.0 | 0.8 |
8 | 5 | |||||||||
5 | 6 | |||||||||
2000 | 5 | 6 | 1 | 5 | 7 | 2 | % | / | 0.9 | 1.1 |
5 | 7 | |||||||||
7 | 8 | |||||||||
3000 | 6 | 6 | 2 | 7 | 8 | 1 | % | / | 1.0 | 1.2 |
5 | 9 | |||||||||
8 | 7 | |||||||||
4000 | 8 | 7 | 2 | 4 | 5 | 2 | % | / | 1.0 | 0.7 |
5 | 7 | |||||||||
7 | 3 | |||||||||
5000 | 6 | 6 | 0 | 5 | 6 | 2 | % | / | 0.9 | 0.9 |
6 | 5 | |||||||||
6 | 8 | |||||||||
Na-azide 10 | 841 | 824 | 59 | % | / | / | % | / | 123.6* | / |
758 | ||||||||||
872 | ||||||||||
2-AA 3 |
% | / | / | 73 | 66 | 7 | % | / | / | 10.4* |
60 | ||||||||||
65 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Bayer A.G. | Table : 10 | Study Number: | T 5053854 | |||||||
Department of Toxicology | Study Director: | Dr.Herbold | ||||||||
Pharma Research Center | Technician: | Düver | ||||||||
Wuppertal Elberfeld | Date: | Feb. 20.1997 | ||||||||
AMES Test with : IDS Na-salt | Strain: | S.typhimurium TA 100 | ||||||||
Dose/Plate (µg/Plate) | Revertants per plate | Titer | Quotient | |||||||
10% | Dilution per mL | |||||||||
-S9 | M | SD | +S9 | M | SD | 10+6 | 10+8 | -S9 | +S9 | |
Water | 135 | 127 | 7 | 105 | 104 | 2 | 197 | 19.7 | 1.0 | 1.0 |
124 | 102 | 196 | ||||||||
121 | 105 | |||||||||
1000 | 121 | 125 | 4 | 95 | 105 | 10 | % | / | 1.0 | 1.0 |
126 | 107 | |||||||||
128 | 114 | |||||||||
2000 | 138 | 128 | 9 | 108 | 98 | 12 | % | / | 1.0 | 0.9 |
125 | 101 | |||||||||
122 | 85 | |||||||||
3000 | 96 | 98 | 13 | 105 | 108 | 12 | % | / | 0.8 | 1.0 |
86 | 121 | |||||||||
111 | 97 | |||||||||
4000 | 126 | 136 | 17 | 118 | 108 | 12 | % | / | 1.1 | 1.0 |
126 | 110 | |||||||||
155 | 95 | |||||||||
5000 | 123 | 122 | 6 | 103 | 95 | 9 | % | / | 1.0 | 0.9 |
127 | 85 | |||||||||
115 | 97 | |||||||||
NF 0.2 |
218 | 216 | 11 | % | / | / | % | / | 1.7* | / |
204 | ||||||||||
225 | ||||||||||
2-AA 3 |
% | / | / | 1219 | 1227 | 18 | % | / | / | 11.8* |
1248 | ||||||||||
1214 | ||||||||||
*: mutagenic effect | B: Background lawn reduced | |||||||||
%: not tested | SD: Standard-Deviation | |||||||||
M: Mean | +S9: with S9 Mix | |||||||||
-S9: without S9 Mix |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Therefore, IDS, Na-Salz was considered to be non-mutagenic with and without S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. - Executive summary:
IDS, Na-Salz was investigated using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on five Salmonella typhimurium LT2 mutants (Herbold, B, 1997a, OECD 471). These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. In a first experiment, doses up to and including 1581 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect. Due to the weakness of this effect this range could nevertheless be used for assessment purposes. Moreover, IDS, Na-Salz was investigated in an independent repeat using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 µg per tube after preincubation for 20 minutes at 37°C on the same Salmonella typhimurium LT2 mutants. In this experiment, doses up to and including 5000 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed.
In both experiment, evidence of mutagenic activity of IDS, Na-Salz 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, cumene hydroperoxide and 2-amino-anthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls. Therefore, IDS, Na-Salz was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
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