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EC number: 234-746-5 | CAS number: 12030-88-5
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- European Union Risk Assessment Report
- Author:
- European Chemicals Bureau
- Year:
- 2 003
- Bibliographic source:
- European Union Risk Assessment Report. Hydrogen peroxide; CAS No: 7782-84-1; EINECS No: 231-765-0. Final report, 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Test material
- Reference substance name:
- Hydrogen peroxide
- EC Number:
- 231-765-0
- EC Name:
- Hydrogen peroxide
- Cas Number:
- 7722-84-1
- Molecular formula:
- H2O2
- IUPAC Name:
- Hydrogen peroxide
- Test material form:
- liquid
- Remarks:
- colourless
Constituent 1
- Specific details on test material used for the study:
- Purity: 35% (w/w)
Test animals
- Species:
- mouse
- Strain:
- other: Swiss OF1/ICO:OF1 (IOPS Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
- Source: Iffa Crédo, L'Arbresle, France
- Age at study initiation: approximately 6 weeks
- Weight at study initiation:
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: five per sex in polycarbonate cages
- Diet (e.g. ad libitum): AO4 C pelleted diet (U.A.R., Villemoisson-sur-Orge, France) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
Environmental conditions:
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours darkness
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Water
- Details on exposure:
- The test substance was administered once by intraperitoneal route using a dose volume of 25 mL/kg, which allowed to test higher doses with less concentrated solutions. The quantitiy of the test substance administered to each animal was adjusted according to the body weight recorded at the time of dosing. The vehicle control animals received the vehicle alone, under the same conditions. The positive control animals received cyclophosphamide, by oral route, at a volume of 10 mL/kg.
- Duration of treatment / exposure:
- Once by intraperitoneal injection
- Frequency of treatment:
- Once
- Post exposure period:
- 24 and 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- first cytogenetic test
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- first cytogenetic test
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- first cytogenetic test
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- first cytogenetic test
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- second cytogenetic test
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- second cytogenetic test
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- second cytogenetic test
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- second cytogenetic test
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide, administered by oral route in 10 mL/kg at a dose of 50 mg/kg body weight.
Examinations
- Tissues and cell types examined:
- For each animal, the micronuclei were counted in 20000 polychromatic erythrocytes; the polychromatic (PE) and normochromatic (NE) erythrocyte ratio was established by scoring a total of 1000 erythrocytes (PE + NE).
- Details of tissue and slide preparation:
- At the time of sacrifce, all the animals were killed after CO2 inhalation in excess. The femurs of the mice were removed and the bone marrow eluted out using fetal calf serum. After centrifugation, the supernatant was removed and the cells in the sediment were suspended by shaking. A drop of this cell suspension was placed and spread on a slide. The slides were air-dried and stained with May-Grünwald-Giemsa. All the slides were coded for scoring.
- Evaluation criteria:
- A positive response was assumed if a statistically significant increase in the number of micronucleated polychromatic erythrocytes (MPE) when compared to the vehicle group occurred, which doubled the number of MPE of the historical control data, i.e. a number greater than 3.6/1000 PE. The results were considered as negative if the above criteria was not fully met.
- Statistics:
- The mean number of MPE and the PE/NE ratio from the treated groups were compared to simultaneous vehicle groups. The inter-group comparison was performed using: for MPE the X-square test, for PE/NE ratio the Student's t-test in which p = 0.05 was used as the lowest level of significance.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The mean values of MPE of all groups treated with the test substance were similar to those of their respective controls. A slight, statistically significant increase in the MPE number of the low-dose group after observed after 24 hours was considered as biologically insignificant, because the MPE value was within the range of historical controls, no dose-effect relationship was noted, and the increase was essentially attributed to one animal which had 13 MPE/2000 PE. The PE/NE ratio was statistically significant lower at the three doses at 24 hours and at 250 and 1000 mg/kg after 48 hours, showing that the test substance effectively affected the bone marrow cells.
Due to the marked mortality in the 2000 mg/kg dose group, a second cytogenetic study was carried out. In this second test, no mortality and no clinical signs were observed in the 250 and 500 mg/kg dose groups of both sexes and in the female 1000 mg/kg dose group. After treatment with 1000 mg/kg, one of sixteen males died, which was replaced by one of the supplementary group. Hypoactivity and piloerection was noted in the other treated males at 1000 mg/kg. No macroscopic abnormalities (abdominal cavity) were seen at necropsy at doses of 250, 500 and 1000 mg/kg except for a discolourated spleen in one male at 1000 mg/kg.
The mean values of micronucleated polychromatic erythrocytes were within the historical range in the two vehicle groups.
Cyclophosphamide induced a highly significant increase (p < 0.001) in the number of MPE. In addition, the PE/NE ratio decreased significantly (p < 0.05) showing the toxic effects of the positive control substance to bone marrow cells.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the substance was not genotoxic in bone marrow erythrocyte micronucleus assay in mice.
- Executive summary:
A study was conducted to determine the in vivo genetic toxicity of the substance, according to OECD Guideline 474, in compliance with GLP. The test substance was tested for its potential to induce cytogenetic damage to the bone marrow cells of Swiss OF1 mice. Following preliminary toxicity testing, animals received one intraperitoneal injection of the test substance at concentrations of 0 to 2000 mg/kg bw (first cytogenicity test) or 0 to 1000 mg/kg bw (second cytogenicity test). The positive control animals received cyclophosphamide, by oral route, at a volume of 10 mL/kg. For each animal, bone marrow smears were prepared and the micronuclei were counted in 2000 polychromatic erythrocytes. The polychromatic (PE) to normochromatic (NE) erythrocyte ratio was established by scoring 1000 erythrocytes (PE + NE). The mean number of micronucleated polychromatic erythrocytes (MPE) and the PE/NE ratio from the treated groups were compared to simultaneous vehicle groups. The mean values of MPE of all groups treated with the test substance were similar to those of their respective controls. The mean values of micronucleated polychromatic erythrocytes were within the historical range in the two vehicle groups. Cyclophosphamide induced a highly significant increase in the number of MPE and a decrease in the PE/NE ratio showing the toxic effects to bone marrow cells. Under the study conditions, the test substance was not genotoxic in bone marrow erythrocyte micronucleus assay in mice (European Chemicals Bureau, 2003).
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