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EC number: 247-728-7 | CAS number: 26479-35-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-12-20 through 2012-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, OECD study performed without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- OECD GLP and UK GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium carbamoylcarbamate
- EC Number:
- 247-728-7
- EC Name:
- Potassium carbamoylcarbamate
- Cas Number:
- 26479-35-6
- Molecular formula:
- C2H4N2O3.K
- IUPAC Name:
- potassium N-carbamoylcarbamate
- Reference substance name:
- potassium allophonate
- IUPAC Name:
- potassium allophonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Potassium Allophonate, CAS No 26479-35-6, Purity: 83.8%
- Storage condition of test material: 15-30 degrees C protected from light
- Synonyms: Potassium Carbamoylcarbamate
- Physical state: powder
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 prepared from Sprague Dawley male rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- 0.32, 1.6, 8, 40, 200, 1000 and 5000 μg/plate, plus negative (vehicle) and positive controls with or without S9 (preliminary study and initial
mutagenicity assay).
156.25, 312.5, 625, 1250, 2500, 5000 μg/plate, plus negative (vehicle) and positive controls with or without S9 (independent repeat/confirmatory
mutagenicity assay). - Vehicle / solvent:
- purified water
Controls
- Untreated negative controls:
- yes
- Remarks:
- vehicle, H2O
- Negative solvent / vehicle controls:
- yes
- Remarks:
- H2O
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene and 4-nitroquinoline 1-oxide
- Details on test system and experimental conditions:
- The test article was tested for mutation (and toxicity) in four strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and one strain of Escherichia coli (WP2 uvrA) in two separate experiments at the concentrations detailed previously, using triplicate plates with and without S-9.
Negative (vehicle) controls were included in quintuplicate, and positive controls were included in triplicate in both assays without and with S-9. These platings were achieved by the following sequence of additions to 2.5 mL molten agar at 46±1 degrees C:
• 0.1 mL bacterial culture
• 0.1 mL test article solution or control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to Vogel-Bonner E agar plates. When set, the plates were inverted and incubated at 37±1 degrees C in the dark for 3 days. Following incubation, these plates were examined for evidence of toxicity to the background lawn, and where possible revertant colonies were counted (see Colony counting).
As the results of the first experiment were negative, treatments in the presence of S-9 in Experiment 2 included a pre-incubation step. Quantities of test article or control solution, bacteria and S-9 mix detailed above, were mixed together and incubated for 1 hour at 37±1 degrees C, with shaking, before the addition of 2.5 mL molten agar at 46±1 degrees C. Plating of these treatments then proceeded as for the normal plate-incorporation procedure. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected in the assay. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. Dunnett's test gave a significant response (p ≤ 0.01) which was concentration related;
2. The positive trends/responses described above were reproducible.
The test article was considered positive in this assay if all of the above criteria were met.
The test article was considered negative in this assay if none of the above criteria were met.
Results which only partially satisfy the above criteria are dealt with on a case-by-case basis. Biological relevance is taken into account, for example,
consistency of response within and between concentrations and (where applicable) between experiments. Further experimental work may be deemed necessary to aid evaluation of these data. - Statistics:
- Dunnett's test
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: S.typhimurium TA98, TA100, TA1535 and TA1537 & E. coli WP2 uvrA
- 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
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of Potassium Allophonate at 0.32, 1.6, 8, 40, 200, 1000 and 5000 μg/plate, plus negative (vehicle) and positive controls. Following these treatments no evidence of toxicity, as would usually be manifest as a diminution of the background bacterial lawn, was observed in any of the tester strains either in the absence or in the presence of S-9.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 μg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 156.25 – 5000 μg/plate, in order to
examine more closely those concentrations of Potassium Allophonate approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments no evidence of toxicity was observed in any of the tester strains either in the absence or in the presence of S-9.
The test article was completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Potassium AllophonateMean number of Revertants per Plate―Experiment 1 Without S-9 |
|
||||||||||||
Compound |
Concentration (ug/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|
||||||
|
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
|
|
Purified Water |
|
18.0 |
2.3 |
106.0 |
12.3 |
16.4 |
3.6 |
12.4 |
3.8 |
13.4 |
2.9 |
|
|
Potassium Allophonate |
0.32 |
23.0 |
8.2 |
113.0 |
20.7 |
17.0 |
3.6 |
11.7 |
3.8 |
14.3 |
3.1 |
|
|
Potassium Allophonate |
1.6 |
11.7 |
0.6 |
112.7 |
10.7 |
18.3 |
3.1 |
10.0 |
4.0 |
13.7 |
9.9 |
|
|
Potassium Allophonate |
8 |
15.3 |
4.0 |
127.0 |
13.9 |
22.3 |
4.2 |
13.3 |
3.1 |
8.0 |
2.6 |
|
|
Potassium Allophonate |
40 |
13.7 |
4.6 |
124.0 |
20.8 |
21.3 |
6.4 |
11.7 |
3.1 |
12.7 |
2.9 |
|
|
Potassium Allophonate |
200 |
16.7 |
2.1 |
117.7 |
14.5 |
17.0 |
4.4 |
7.3 |
2.9 |
12.3 |
3.2 |
|
|
Potassium Allophonate |
1000 |
14.7 |
2.5 |
139.7 |
6.4* |
21.0 |
9.5 |
10.0 |
4.6 |
10.7 |
1.2 |
|
|
Potassium Allophonate |
5000 |
15.0 |
3.6 |
112.3 |
19.5 |
14.0 |
5.0 |
12.0 |
2.0 |
14.3 |
4.9 |
|
|
Positive Control |
|
1263.3 |
134.1 |
502.3 |
24.0 |
670.0 |
70.6 |
379.7 |
125.9 |
652.3 |
74.8 |
|
|
Dunnett’s t-test significance values
* |
p<0.05 |
** |
p<0.01 |
Potassium AllophonateMean number of Revertants per Plate ―Experiment 1 With S-9 |
|
||||||||||||
Compound |
Concentration (ug/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|
||||||
|
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
|
|
Purified Water |
|
29.0 |
7.7 |
127.6 |
9.4 |
19.0 |
1.4 |
18.0 |
3.4 |
19.8 |
4.5 |
|
|
Potassium Allophonate |
0.32 |
30.7 |
4.2 |
134.3 |
19.6 |
22.3 |
5.5 |
10.3 |
4.0 |
24.7 |
2.5 |
|
|
Potassium Allophonate |
1.6 |
35.0 |
3.6 |
130.0 |
8.9 |
19.0 |
3.6 |
16.7 |
3.1 |
16.0 |
2.6 |
|
|
Potassium Allophonate |
8 |
39.7 |
13.8 |
106.3 |
30.9 |
23.3 |
6.0 |
13.7 |
1.5 |
19.0 |
3.0 |
|
|
Potassium Allophonate |
40 |
39.3 |
3.1 |
105.3 |
17.2 |
24.3 |
0.6 |
13.7 |
4.6 |
21.7 |
4.0 |
|
|
Potassium Allophonate |
200 |
30.0 |
8.7 |
111.0 |
7.2 |
19.0 |
4.4 |
13.3 |
2.3 |
16.7 |
7.4 |
|
|
Potassium Allophonate |
1000 |
28.0 |
7.9 |
136.7 |
12.6 |
14.0 |
6.2 |
8.0 |
1.7 |
17.7 |
5.1 |
|
|
Potassium Allophonate |
5000 |
32.3 |
4.7 |
139.0 |
9.8 |
11.0 |
1.0 |
8.7 |
1.5 |
15.0 |
4.0 |
|
|
Positive Control |
|
449.0 |
29.3 |
539.3 |
24.2 |
265.7 |
23.1 |
109.0 |
3.6 |
238.0 |
4.6 |
|
|
Dunnett’s t-test significance values
* |
p<0.05 |
** |
p<0.01 |
Potassium AllophonateMean number of Revertants per Plate―Experiment 2 Without S-9 |
|
||||||||||||
Compound |
Concentration (ug/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|
||||||
|
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
|
|
Purified Water |
|
20.6 |
4.9 |
120.8 |
9.8 |
17.2 |
3.7 |
14.4 |
6.0 |
18.4 |
1.5 |
|
|
Potassium Allophonate |
156.25 |
14.0 |
5.0 |
125.3 |
19.4 |
9.3 |
3.5 |
17.7 |
4.6 |
17.0 |
1.7 |
|
|
Potassium Allophonate |
312.5 |
15.7 |
2.1 |
126.7 |
5.5 |
15.3 |
2.5 |
9.7 |
1.5 |
16.3 |
2.9 |
|
|
Potassium Allophonate |
625 |
18.7 |
0.6 |
115.3 |
6.5 |
10.0 |
4.6 |
13.0 |
3.6 |
15.0 |
4.6 |
|
|
Potassium Allophonate |
1250 |
15.3 |
5.0 |
124.7 |
10.7 |
20.0 |
5.6 |
13.0 |
3.6 |
14.3 |
1.2 |
|
|
Potassium Allophonate |
2500 |
15.3 |
4.6 |
129.0 |
12.8 |
12.0 |
2.6 |
14.0 |
6.6 |
15.0 |
4.6 |
|
|
Potassium Allophonate |
5000 |
12.0 |
3.5 |
121.0 |
9.6 |
10.7 |
2.5 |
15.7 |
4.9 |
18.7 |
7.8 |
|
|
Positive Control |
|
836.3 |
111.0 |
831.7 |
57.2 |
767.7 |
41.6 |
230.0 |
91.3 |
891.0 |
8.7 |
|
|
Dunnett’s t-test significance values
* |
p<0.05 |
** |
p<0.01 |
Potassium AllophonateMean number of Revertants per Plate―Experiment 2 With S-9 |
|
||||||||||||
Compound |
Concentration (mg/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|
||||||
|
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
Mean |
Standard Deviation |
|
|
Purified Water |
|
38.8 |
4.0 |
142.4 |
3.9 |
19.8 |
4.9 |
18.0 |
2.9 |
17.2 |
2.2 |
|
|
Potassium Allophonate |
156.25 |
26.7 |
4.9 |
147.7 |
3.2 |
22.3 |
2.9 |
18.7 |
5.5 |
15.7 |
4.5 |
|
|
Potassium Allophonate |
312.5 |
34.7 |
7.2 |
148.0 |
4.6 |
24.3 |
8.1 |
22.7 |
2.5 |
16.7 |
5.1 |
|
|
Potassium Allophonate |
625 |
32.7 |
7.5 |
137.0 |
7.9 |
27.0 |
1.7 |
21.3 |
2.3 |
20.0 |
4.0 |
|
|
Potassium Allophonate |
1250 |
37.7 |
5.8 |
143.3 |
9.5 |
24.3 |
2.9 |
18.0 |
6.2 |
21.7 |
3.1 |
|
|
Potassium Allophonate |
2500 |
31.3 |
4.0 |
149.3 |
0.6 |
23.0 |
3.0 |
18.7 |
3.2 |
19.7 |
4.2 |
|
|
Potassium Allophonate |
5000 |
30.7 |
6.4 |
139.0 |
17.1 |
20.3 |
5.1 |
17.7 |
2.9 |
15.7 |
4.0 |
|
|
Positive Control |
|
482.0 |
41.9 |
671.0 |
60.7 |
163.0 |
9.5 |
55.7 |
8.0 |
48.3 |
2.5 |
|
|
Dunnett’s t-test significance values
* |
p<0.05 |
** |
p<0.01 |
|
|
Historical negative (vehicle) control values
|
Revertant numbers for individual plates |
|||||||
Strain |
S-9 |
No. of studies |
No. of plates |
Mean |
99% reference range(1) |
99% confidence interval for group mean of: |
||
4 values(2) |
5 values(2) |
6 values(2) |
||||||
TA98 |
- |
51 |
525 |
25 |
9.0-44.0 |
16.0-34.3 |
16.8-33.1 |
17.4-32.3 |
TA98 |
+ |
51 |
538 |
35 |
16.0-58.0 |
25.0-46.6 |
26.0-45.3 |
26.7-44.4 |
|
|
|
|
|
|
|
|
|
TA100 |
- |
51 |
600 |
111 |
73.0-156.5 |
88.7-133.5 |
90.8-130.9 |
92.4-129.0 |
TA100 |
+ |
51 |
604 |
117 |
71.0-168.0 |
91.8-144.3 |
94.3-141.2 |
96.2-139.0 |
|
|
|
|
|
|
|
|
|
TA1535 |
- |
50 |
520 |
17 |
5.0-30.0 |
10.8-24.8 |
11.4-23.9 |
11.8-23.3 |
TA1535 |
+ |
50 |
525 |
17 |
6.0-32.0 |
10.8-24.5 |
11.4-23.6 |
11.8-23.0 |
|
|
|
|
|
|
|
|
|
TA1537 |
- |
51 |
530 |
13 |
3.0-30.0 |
6.3-20.1 |
6.9-19.2 |
7.3-18.5 |
TA1537 |
+ |
51 |
523 |
18 |
4.0-30.0 |
10.4-25.6 |
11.0-24.6 |
11.5-23.9 |
|
|
|
|
|
|
|
|
|
WP2 uvrA |
- |
8 |
80 |
14 |
5.0-24.0 |
8.8-20.0 |
9.3-19.3 |
9.6-18.8 |
WP2 uvrA |
+ |
8 |
80 |
16 |
7.0-39.0 |
9.5-24.2 |
10.1-23.2 |
10.6-22.6 |
(1) Reference ranges are calculated from percentiles of the observed distributions.
(2) Calculated from square-root transformed data.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with or without metabolic activation
All criteria for a valid study were met. It was concluded that Potassium Allophonate did not induce mutation in four histidine-requiring strains of
Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and one tryptophan-requiring strain of Escherichia coli (WP2 uvrA) when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 μg/plate (the maximum recommended
concentration according to current regulatory guidelines) in the absence and in the presence of a rat liver metabolic activation system (S-9).
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