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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
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:
- Supplier: Degussa
CAS number: 124-43-6
Name in teh study report: carbamide-peroxide
Purity: not specified
Batch number: 073590600
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks at the time of administration
- Weight at study initiation: Group 1: 188 ± 8.1 g; Group 2: 178.3 ± 3.2 g
- Fasting period before study: yes, overnight
- Housing:
- Diet: ad libitum, starting at 3 hours after dosing
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22.1 °C
- Humidity (%): average 66.1 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: water is the preferred vehicle according to the OECD TG 423; test substance is water soluble
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: aqcute toxicity expected to be low - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Statistics:
- calculation of means ± SD
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none (0/6 animals)
- Clinical signs:
- other: yes, shortly after administration and lasting up tp 6 hours. Fully reversible. Signs of reduced well-being encompasses unspecific alterations, like sedation, apathy, piloerection, hunched posture or closed eyes, in síngle or multiple occurrence.
- Gross pathology:
- No necropsy findings at termination 14 days after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value is > 2000 mg/kg bw
- Executive summary:
The acute oral toxicity of hydrogen peroxide-urea (carbamide peroxide) was determined in the female rat, according to the OECD TG 423 and under GLP conditions. Animals (two groups of 3 rats each) received the test material by oral gavage at 2000 mg/kg bw. Clinical signs were seen during the first 6 hours after dosing. The animals gained body weight after 7 and 14 days post treatment. No mortalities occurred, and there were no necropsy findings at termination on day 14 post treatment. Hence, the oral LD50 is > 2000 mg/kg bw in the rat.
This study is considered to be valid and suitable for assessment.
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