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EC number: 217-703-5 | CAS number: 1934-75-4
- 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:
- 1995-09-07 to 1995-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- before 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 92/69/EEC
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium dicyanoamide
- EC Number:
- 217-703-5
- EC Name:
- Sodium dicyanoamide
- Cas Number:
- 1934-75-4
- Molecular formula:
- C2HN3.Na
- IUPAC Name:
- sodium dicyanamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Aggregate State at room temperature: powder
Colour: white to off-white
Storage Conditions: at room temperature
Method
- Target gene:
- histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: sensitive to agents inducing frame-shift mutations
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: sensitive to agents inducing base-pair substitution
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: sensitive to agents inducing base-pair substitution
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: sensitive to agents inducing frame-shift mutations
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: sensitive to agents inducing frame-shift mutations
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from livers of male Sprague-Dawley rats induced with Arochlor 1254
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500 and 5000 µg/plate. Potential toxicity of the test item was determined with tester strain TA100 in a pre-experiment.
- Vehicle / solvent:
- sterile distilled water
Controls
- Untreated negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other:
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: visible reduction in the growth of the bacterial lawn - Evaluation criteria:
- For a substance to be considered positive in this test system, it should have induced a dose-related and statistically significant increase in mutation rate in one or more strains of bacteria in the presence and/or absence of the S9 microsomal enzymes in both experiments at sub-toxic dose levels. If the two experiments give conflicting results or equivocal results are obtained, then a third experiment may be used to confirm the correct response.
To be considered negative the number of induced revertants compared to spontaneous revertants should be less than twofold at each dose level employed, the intervals of which should be between 2 and 5 fold and extend to the limits imposed by toxicity, solubility or up to the maximum recommended dose of 5000 µg/plate. In this case the limiting factor was the maximum recommended dose. - Statistics:
- All data are statistically analysed using the methods recommended by the UKEMS and normally Dunnett's method of linear regression is used to evaluate the result.
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
- 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
- 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
- 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
- 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
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not reported
- Effects of osmolarity: not reported
- Evaporation from medium: not reported
- Water solubility: yes, test item was dissolved in sterile distilled water
- Precipitation: not reported
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determined with tester strain TA 100 in a pre-experiment. Six concentrations were tested: 0, 50, 150, 500, 1500 and 5000 µg/plate. The test material caused no visible reduction in the growth of the bacterial lawn at any of the dose levels in any of the strains of Salmonella tested. The test material was, therefore, tested up to the maximum recommended dose of 5000 µg/plate.
HISTORICAL CONTROL DATA: not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material caused no visible reduction in the growth of the bacterial lawn at any of the dose levels in any of the strains of Salmonella tested.
Any other information on results incl. tables
Preliminary Toxicity Study
The dose range of the test material used in the preliminary toxicity study was 0, 50, 150, 500, 1500 and 5000 µg/plate. The test material was non-toxic in the strain of Salmonella used (TA 100).
The mean numbers of revertant colonies for the toxicity assay were:
Strain |
Dose (µg/plate) |
|||||
0 |
50 |
150 |
500 |
1500 |
5000 |
|
TA 100 |
111 |
110 |
108 |
118 |
114 |
115 |
Mutation study
The results of the checks for characteristics, viability and spontaneous reversion rate for each tester strain were all found to be satisfactory.
No toxicity was exhibited to any of the strains of Salmonella used.
No significant increase in the frequency of revertant colonies of bacteria were recorded for any of the strains of Salmonella used, at any dose level with or without metabolic activation.
All of the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory.
Results for the negative spontaneous mutation rates are presented in Table 1.
The individual plate counts, the mean number of revertant colonies and the standard deviations, for the test material, positive and vehicle controls both with and without metabolic activation are presented in Tables 2 and 3 for experiment 1 and Tables 4 and 5 for experiment 2.
Table 1: spontaneous mutation rates
EXPERIMENT 1 |
||||
Number of revertants (average number of colonies per plate) |
||||
Base-pair Substitution Type |
Frameshift Type |
|||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
115 |
19 |
16 |
13 |
13 |
EXPERIMENT 2 |
||||
103 |
16 |
15 |
16 |
11 |
Table 2: experiment 1 without metabolic activation
S9-mix |
Test substance (µg/plate) |
Number of revertants (average number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
||
- |
0 |
109 |
15 |
14 |
17 |
8 |
- |
50 |
106 |
14 |
6 |
17 |
7 |
- |
150 |
99 |
22 |
9 |
13 |
5 |
- |
500 |
108 |
16 |
12 |
7 |
7 |
- |
1500 |
105 |
14 |
7 |
14 |
3 |
- |
5000 |
97 |
16 |
5 |
13 |
6 |
Positive controls |
without S9-mix |
ENNG |
ENNG |
4NOPD |
4NQO |
9AA |
- |
Concentration (µg/plate) |
3 |
5 |
5 |
0.2 |
80 |
- |
No. colonies per plate |
444 |
220 |
461 |
147 |
289 |
Table 3: experiment 1 with metabolic activation
S9-mix |
Test substance (µg/plate) |
Number of revertants (average number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
||
+ |
0 |
103 |
10 |
20 |
55 |
7 |
+ |
50 |
110 |
8 |
26 |
38 |
7 |
+ |
150 |
97 |
6 |
20 |
39 |
11 |
+ |
500 |
104 |
10 |
21 |
31 |
9 |
+ |
1500 |
102 |
7 |
19 |
31 |
9 |
+ |
5000 |
109 |
8 |
22 |
42 |
9 |
Positive controls |
without S9-mix |
2AA |
2AA |
2AA |
2AA |
2AA |
+ |
Concentration (µg/plate) |
1 |
2 |
0.5 |
0.5 |
2 |
+ |
No. colonies per plate |
389 |
143 |
297 |
308 |
173 |
Table 4: experiment 2 without metabolic activation
S9-mix |
Test substance (µg/plate) |
Number of revertants (average number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
||
- |
0 |
98 |
15 |
11 |
17 |
13 |
- |
50 |
103 |
13 |
10 |
20 |
9 |
- |
150 |
100 |
19 |
11 |
24 |
18 |
- |
500 |
103 |
17 |
12 |
19 |
13 |
- |
1500 |
92 |
15 |
15 |
24 |
10 |
- |
5000 |
104 |
15 |
11 |
17 |
8 |
Positive controls |
without S9-mix |
ENNG |
ENNG |
4NOPD |
4NQO |
9AA |
- |
Concentration (µg/plate) |
3 |
5 |
5 |
0.2 |
80 |
- |
No. colonies per plate |
473 |
172 |
412 |
174 |
374 |
Table 5: experiment 2 with metabolic activation
S9-mix |
Test substance (µg/plate) |
Number of revertants (average number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
||
+ |
0 |
109 |
15 |
19 |
27 |
16 |
+ |
50 |
105 |
12 |
15 |
22 |
16 |
+ |
150 |
122 |
11 |
19 |
27 |
15 |
+ |
500 |
108 |
19 |
21 |
26 |
18 |
+ |
1500 |
103 |
18 |
18 |
27 |
13 |
+ |
5000 |
90 |
16 |
20 |
21 |
15 |
Positive controls |
without S9-mix |
2AA |
2AA |
2AA |
2AA |
2AA |
+ |
Concentration (µg/plate) |
1 |
2 |
0.5 |
0.5 |
2 |
+ |
No. colonies per plate |
494 |
108 |
226 |
194 |
185 |
Applicant's summary and conclusion
- Conclusions:
- No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of this test.
- Executive summary:
In a Bacterial Reverse Mutation Assay according to OECD Guideline 471, 5 strains of Salmonella typhimurium were exposed to sodium dicyanoamide at concentrations of 0, 50, 150, 500, 1500 and 5000 µg per plate in the presence and absence of mammalian metabolic activation (S9-mix). The maximum dose was determined in a pre-experiment.
This study was conducted in 1995 but satisfies the requirements for Test Guideline OECD 471. The results of the checks for characteristics, viability and spontaneous reversion rate for each tester strain were all found to be satisfactory.
No toxicity was observed in any of the strains of Salmonella used.
No significant increase in the frequency of revertant (His+) colonies of bacteria was recorded for any of the strains of Salmonella used at any dose level with or without metabolic activation when tested up to the predetermined maximum concentration of 5000 µg per plate.
All of the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory.
Since there was no evidence of induced mutant colonies over background, sodium dicyanoamide is considered non-mutagenic in this Bacterial Reverse Mutation Assay.
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