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EC number: 244-343-6 | CAS number: 21351-39-3
- 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
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- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 22-SEP-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Uronium hydrogen sulphate
- EC Number:
- 244-343-6
- EC Name:
- Uronium hydrogen sulphate
- Cas Number:
- 21351-39-3
- Molecular formula:
- CH4N2O.H2O4S
- IUPAC Name:
- hydrogen [amino(hydroxy)methylidene]azanium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Aduct Urea-Sulfuric
- Physical state: not indicated
- Stability under test conditions: no data
- Storage condition of test material: At room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- - pre-experiment (experiment I): 3 – 5000 μg/plate
- experiment II: 33; 100; 333; 1000; 2500; and 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9-mix: sodium azide (TA1535, TA100: 10μg/pl); 4-nitro-o-phenylene-diamine (TA1537, TA98: 10-50µg/pl); methyl methane sulfonate (TA102: 3μL/pl) - With S9-mix: 2-aminoanthracene (all strains: 2.5-10µg/pl)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test (experiment I) and pre-incubation test (experiment II)
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: at least 48 hours at 37 °C in the dark
NUMBER OF REPLICATES: for each strain and dose level, including the controls three plates were used.
DETERMINATION OF CYTOTOXICITY
- Method: background growth - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Aduct Urea-Sulfuric at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct in-crease in induced revertant colonies.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH, effects of osmolality, evaporation from medium, water solubility: no data.
- Precipitation: no precipitation of the test item occurred up to the highest investigated dose.
RANGE-FINDING/SCREENING STUDIES: reported as experiment I
COMPARISON WITH HISTORICAL CONTROL DATA:
In experiment II, the data in the untreated control with metabolic activation of strain TA 102 were slightly above our historical control range. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: result of pre-experiment (experiment I)
Metabolic activation |
Test group |
Dose level (per plate) |
Revertant colony counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without Activation |
water |
|
14 ± 5 |
7 ± 1 |
32 ± 3 |
145 ± 9 |
437 ± 36 |
untreated |
|
17 ± 7 |
8 ± 2 |
35 ± 7 |
137 ± 3 |
420 ± 13 |
|
Aduct Urea-Sulfuric |
3 µg |
15 ± 2 |
7 ± 1 |
30 ± 7 |
143 ± 6 |
416 ± 6 |
|
10 µg |
14 ± 4 |
7 ± 2 |
34 ± 3 |
136 ± 13 |
424 ± 14 |
||
33 µg |
12 ± 4 |
9 ± 3 |
32 ± 10 |
125 ± 6 |
425 ± 30 |
||
100 µg |
10 ± 2 |
6 ± 1 |
31 ± 5 |
135 ± 20 |
445 ± 6 |
||
333 µg |
13 ± 3 |
6 ± 1 |
29 ± 6 |
131 ± 19 |
396 ± 38 |
||
1000 µg |
15 ± 2 |
6 ± 1 |
29 ± 9 |
125 ± 7 |
410 ± 37 |
||
2500 µg |
13 ± 0 |
9 ± 1 |
29 ± 3 |
134 ± 6 |
407 ± 15 |
||
5000 µg |
14 ± 3 |
9 ± 1 |
32 ± 6 |
135 ± 13 |
415 ± 18 |
||
NaN3 |
10 µg |
1606 ± 83 |
|
|
1790 ± 162 |
|
|
4-NOPD |
10 µg |
|
|
298 ± 8 |
|
|
|
4-NOPD |
50 µg |
|
65 ± 8 |
|
|
|
|
MMS |
3 µL |
|
|
|
|
2268 ± 290 |
|
With Activation |
water |
|
20 ± 1 |
16 ± 5 |
42 ± 12 |
166 ± 10 |
561 ± 38 |
untreated |
|
21 ± 5 |
12 ± 4 |
31 ± 3 |
161 ± 13 |
539 ± 61 |
|
Aduct Urea-Sulfuric |
3 µg |
21 ± 5 |
13 ± 1 |
46 ± 5 |
152 ± 3 |
574 ± 26 |
|
10 µg |
21 ± 3 |
13 ± 3 |
46 ± 10 |
147 ± 14 |
571 ± 14 |
||
33 µg |
17 ± 2 |
14 ± 4 |
41 ± 6 |
158 ± 22 |
569 ± 96 |
||
100 µg |
23 ± 5 |
18 ± 2 |
36 ± 12 |
151 ± 7 |
624 ± 27 |
||
333 µg |
25 ± 2 |
15 ± 5 |
43 ± 5 |
141 ± 13 |
615 ± 34 |
||
1000 µg |
21 ± 6 |
13 ± 3 |
30 ± 4 |
150 ± 8 |
594 ± 25 |
||
2500 µg |
20 ± 1 |
18 ± 3 |
42 ± 1 |
155 ± 17 |
627 ± 8 |
||
5000 µg |
24 ± 2 |
16 ± 2 |
38 ± 3 |
155 ± 20 |
625 ± 11 |
||
2-AA |
2.5 µg |
473 ± 43 |
511 ± 45 |
2491 ± 156 |
4053 ± 143 |
|
|
2-AA |
10 µg |
|
|
|
|
2304 ± 92 |
Table 2: result of experiment II
Metabolic activation |
Test group |
Dose level (per plate) |
Revertant colony counts (Mean ± SD) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without Activation |
water |
|
17 ± 4 |
16 ± 3 |
37 ± 13 |
168 ± 24 |
418 ± 37 |
untreated |
|
17 ± 4 |
15 ± 8 |
31 ± 5 |
157 ± 28 |
436 ± 24 |
|
Aduct Urea-Sulfuric |
33 µg |
17 ± 5 |
24 ± 8 |
34 ± 3 |
148 ± 11 |
449 ± 29 |
|
100 µg |
16 ± 1 |
17 ± 4 |
34 ± 8 |
160 ± 23 |
450 ± 24 |
||
333 µg |
17 ± 4 |
16 ± 3 |
41 ± 3 |
161 ± 9 |
460 ± 10 |
||
1000 µg |
19 ± 4 |
20 ± 6 |
35 ± 9 |
145 ± 11 |
418 ± 56 |
||
2500 µg |
13 ± 4 |
13 ± 4 |
34 ± 3 |
143 ± 18 |
444 ± 4 |
||
5000 µg |
17 ± 8 |
19 ± 2 |
31 ± 3 |
145 ± 5 |
442 ± 39 |
||
NaN3 |
10 µg |
1780 ± 54 |
|
|
1244 ± 225 |
|
|
4-NOPD |
10 µg |
|
|
369 ± 14 |
|
|
|
4-NOPD |
50 µg |
|
78 ± 6 |
|
|
|
|
MMS |
3 µL |
|
|
|
|
2472 ± 404 |
|
With Activation |
water |
|
24 ± 6 |
26 ± 3 |
37 ± 9 |
195 ± 8 |
585 ± 77 |
untreated |
|
34 ± 12 |
26 ± 6 |
44 ± 8 |
185 ± 4 |
659 ± 21 |
|
Aduct Urea-Sulfuric |
33 µg |
26 ± 7 |
27 ± 3 |
36 ± 2 |
211 ± 17 |
686 ± 25 |
|
100 µg |
22 ± 2 |
28 ± 5 |
33 ± 6 |
193 ± 14 |
634 ± 15 |
||
333 µg |
25 ± 1 |
22 ± 7 |
35 ± 11 |
200 ± 8 |
686 ± 3 |
||
1000 µg |
19 ± 5 |
30 ± 1 |
45 ± 6 |
183 ± 8 |
644 ± 12 |
||
2500 µg |
28 ± 5 |
22 ± 5 |
42 ± 8 |
190 ± 5 |
593 ± 36 |
||
5000 µg |
25 ± 10 |
24 ± 9 |
39 ± 4 |
171 ± 16 |
554 ± 20 |
||
2-AA |
2.5 µg |
400 ± 63 |
357 ± 13 |
1950 ± 96 |
2862 ± 128 |
|
|
2-AA |
10 µg |
|
|
|
|
2361 ± 277 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
In a reverse gene mutation assay in bacteria (OECD 471, GLP), strains TA 1535, TA 1537, TA 98, TA 100, and TA 102 of S. typhimurium were exposed to Aduct Urea-Sulfuric (Uronium hydrogen sulphate) at concentrations of 33; 100; 333; 1000; 2500; and 5000 μg/plate (experiment II) in the presence and absence of mammalian metabolic activation (pre-incubation).
Aduct Urea-Sulfuric was tested up to limit concentration (5000 µg/plate) and no precipitation was observed.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Aduct Urea-Sulfuric at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
The positive controls induced the appropriate responses in the corresponding strains.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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