Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-701-4 | CAS number: 124-43-6
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrogen peroxide-urea
- EC Number:
- 204-701-4
- EC Name:
- Hydrogen peroxide-urea
- Cas Number:
- 124-43-6
- Molecular formula:
- CH4N2O.H2O2
- IUPAC Name:
- carbamimidic acid; peroxol
Constituent 1
- Specific details on test material used for the study:
- Test substance: Carbamide peroxide, i.e hydrogen peroxide - urea (1:1)
CAS number: 124.43-6
Purity: not staterd
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- 30% S9 from induced both rat and hamster liver
- Test concentrations with justification for top dose:
- according to guideline
- Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: positive without metabolic activation
Any other information on results incl. tables
Strain: TA100 |
||||||||||
Dose |
No Activation |
No Activation |
No Activation |
30% RLI |
30% HLI |
|||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
|||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
131 |
3.8 |
177 |
7.8 |
164 |
.9 |
137 |
8.4 |
134 |
.6 |
10 |
166 |
6.1 |
217 |
17.6 |
172 |
11.3 |
||||
33 |
145 |
8.7 |
181 |
4.5 |
211 |
5 |
||||
100 |
162 |
9 |
149 s |
8.5 |
267 |
3.2 |
138 |
9.5 |
144 |
7 |
150 |
105 s |
19.8 |
248 |
10.4 |
||||||
200 |
100 s |
21.9 |
165 s |
11.1 |
||||||
333 |
66 s |
5.8 |
149 |
3.5 |
141 |
5.7 |
||||
1000 |
t |
141 |
2 |
152 |
4.9 |
|||||
3333 |
147 |
6.1 |
162 |
6.3 |
||||||
10000 |
142 |
3.2 |
165 |
3.7 |
||||||
Positive Control |
433 |
12.1 |
554 |
2.1 |
383 |
9 |
796 |
10.4 |
393 |
9.8 |
Strain: TA102 |
||||||||
Dose |
No Activation |
No Activation |
30% RLI |
30% HLI |
||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
283 |
11.7 |
239 |
11.1 |
389 |
5.6 |
391 |
7.9 |
10 |
281 |
12.4 |
||||||
33 |
357 |
13.4 |
282 |
7.7 |
||||
100 |
409 |
3.5 |
408 |
18.7 |
379 |
6.4 |
393 |
9.5 |
150 |
424 |
11.9 |
||||||
200 |
522 |
9.4 |
433 |
9.3 |
||||
333 |
635 |
7.5 |
429 |
25.2 |
348 |
34.2 |
||
1000 |
789 |
15.7 |
430 |
14.8 |
396 |
9.5 |
||
3333 |
435 |
4.7 |
389 |
12.4 |
||||
10000 |
441 |
8.6 |
424 |
7.7 |
||||
Positive Control |
1008 |
168.7 |
546 |
2.3 |
1254 |
215.7 |
2412 |
36.5 |
Strain: TA1535 |
||
Dose |
No Activation |
|
Protocol |
Preincubation |
|
ug/Plate |
Mean |
±SEM |
0 |
11 |
3.4 |
10 |
14 |
1.5 |
33 |
15 |
.7 |
100 |
15 |
2.6 |
150 |
11 s |
3 |
200 |
9 s |
.6 |
Positive Control |
263 |
4 |
Strain: TA1538 |
||
Dose |
No Activation |
|
Protocol |
Preincubation |
|
ug/Plate |
Mean |
±SEM |
0 |
5 |
.3 |
10 |
3 |
.9 |
33 |
6 |
.9 |
100 |
6 |
1.5 |
150 |
6 |
1.5 |
200 |
3 s |
0 |
Positive Control |
292 |
9.9 |
Strain: TA98 |
||||||||||||
Dose |
No Activation |
No Activation |
No Activation |
No Activation |
30% RLI |
30% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
15 |
2.3 |
13 |
.3 |
17 |
2.2 |
25 |
3.8 |
23 |
1.2 |
19 |
1.5 |
10 |
18 |
.9 |
23 |
.9 |
20 |
3.4 |
30 |
4.5 |
||||
33 |
17 |
3.8 |
20 |
3.5 |
24 |
0 |
38 |
3.5 |
||||
100 |
26 |
1.2 |
42 |
4.4 |
35 |
2.6 |
50 |
6.7 |
20 |
1.5 |
23 |
1.5 |
150 |
25 |
3 |
52 |
2.6 |
27 |
7.3 |
||||||
200 |
13 s |
1.2 |
37 |
6.7 |
4 s |
1.2 |
||||||
333 |
6 s |
1.9 |
27 |
3.3 |
25 |
1.8 |
||||||
1000 |
t |
27 |
1.5 |
27 |
4 |
|||||||
3333 |
19 |
1.5 |
25 |
1.8 |
||||||||
10000 |
25 |
1.2 |
28 |
1.5 |
||||||||
Positive Control |
229 |
11 |
297 |
9.3 |
268 |
6.7 |
246 |
2 |
335 |
22.7 |
410 |
16 |
Abbreviations:
RLI
= induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and
Precipitate; t = Toxic;
Applicant's summary and conclusion
- Conclusions:
- Positive results were obtained in TA98 and TA102 in the absence of metabolic activation.
- Executive summary:
Hydrogen peroxide-urea (1:1) (name in test report: carbamide peroxide) was tested in the AMES test using S. typhimurium strains TA98, TA100, TA102, TA1535, and TA1538 according to the OECD 471 test guideline both without and with metabolic activation (30% S9 supernatant from induced rat and hamster liver, respectively). Positive results were obtained in TA98 and TA102 in the absence of metabolic activation.
The study is considered to be fully reliable and suitable for assessment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.