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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Opinion on hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products
- Author:
- SCCP (Scientific Committee on Consumer Products)
- Year:
- 2 007
- Bibliographic source:
- European Commission Directorate C - Public Health and Risk assessment.
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Qualifier:
- no guideline required
- Version / remarks:
- DNA damage (8-OH-2'-deoxyguanosine; mutations in codon 61 of c-Ha-ras gene; epidermal hyperplasia and dermal cellularity changes
- GLP compliance:
- not specified
- Type of assay:
- other: inter alia micronucleus assays (4); unscheduled DNA synthesis (1) ; Drosophila SLRL assay (1)
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
Constituent 1
Test animals
- Species:
- other: mousee, rat, drosophila melanogaster
- Details on species / strain selection:
- see attached background information
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: oral (mouse), injection (drosophila, rat (i.v. and i.p.)), topical (Sencar mouse)
- Vehicle:
- milk or water
Doses / concentrationsopen allclose all
- Dose / conc.:
- 536 mg/kg bw/day (actual dose received)
- Remarks:
- Oral, mouse: H2O2 in drinking water at 0, 200, 1,000, 3,000 or 6,000 ppm for 2 weeks.
Doses males: 0, 42.4, 164, 415 or 536 mg/kg bw/day;
females: 0, 48.5, 198, 485 or 774 mg/kg bw/day.
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Remarks:
- rat: i.v. injection of 0, 25 or 50 mg/kg bw of 0.1 or 0..2% solutions
- Dose / conc.:
- 2 mg/kg bw/day (actual dose received)
- Remarks:
- Topical application, mouse: Hydrogen peroxide 70% was applied to the skin of 10 female Sencar mice per dose group at dose levels of 10, 100, or 200 µmol in 200 µl of ethanol (i.e. 0.2-3.2% solutions) twice weekly for 4 weeks.
- Dose / conc.:
- 3 other: 3% H2O2
- Remarks:
- injection into Drosophila melanogaster
Results and discussion
Test resultsopen allclose all
- Key result
- Sex:
- not specified
- Genotoxicity:
- positive
- Remarks:
- The only study with positive result.
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- other:
- Remarks on result:
- other: Mouse; increased chromatid aberrations (local) following i.p. injection. Local effect; response presumed to depend on the presence or absence of RBCs.
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Remarks:
- negative results in 8 of 9 in-vivo studies
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: species tested: rat, mouse, Drosophila
Applicant's summary and conclusion
- Conclusions:
- Hydrogen peroxide lacks genotoxicity in-vivo.
- Executive summary:
Based on the negative results obtained in 9 in-vivo mutagenicity studies, it is concluded that hydrogen peroxide is a mutagen in-vitro but not in-vivo. In line with this, the SCCP endorsed in their opinion (2007) the conclusions of the European Chemicals Bureau (2003) which are cited below (quoted references contained in the EU RAR on Hydrogen Peroxide (2003)).
"Hydrogen peroxide is a mutagen and genotoxicant in a variety of in vitro test systems. The responses observed were modified by the presence of degrading enzymes (catalase), the extent of formation of hydroxyl radicals by Fenton reaction, and the cells repair abilities.
Hydrogen peroxide has been studied for possible in vivo genotoxicity. Studies employing modern methodologies have explored DNA repair in liver cells of rats administered hydrogen peroxide by intravenous infusion for 30 minutes (CEFIC, 1997), as well as micronucleus formation in mice in the context of a 2-week drinking water exposure (Du Pont, 1995), or after a single intraperitoneal injection (CEFIC, 1995), all with a negative outcome. Intravenous administration of hydrogen peroxide in the in vivo-in vitro unscheduled DNA synthesis study ensured that the substance had a fair chance to reach the target (liver) cells, although the duration of exposure was limited (CEFIC, 1997). In the micronucleus study by oral drinking water exposure (Du Pont, 1995), the systemic fate of hydrogen peroxide was uncertain, and there was no decrease in the ratio of polychromatic/normochromatic erythrocytes in the bone marrow. In the other micronucleus study (CEFIC, 1995), a single intraperitoneal injection of a large dose of hydrogen peroxide somehow affected the bone marrow (because the PE/NE decreased), but the absence of micronucleus formation must be viewed with caution because of the presumably very short lifetime of hydrogen peroxide. With a view to exploring target tissue in vivo genotoxicity and mutagenicity as a pre-screen for carcinogenicity, hydrogen peroxide 0.2-3.2% solutions in ethanol were applied to the skin of Sencar mice twice weekly for 4 weeks (Society for Plastic Industry, 1997). There was no indication of induced DNA damage (increased 8-OH- dG), c-Ha-ras mutations, epidermal hyperplasia and dermal cellularity changes. Thus, at low concentrations, and with a low application frequency, hydrogen peroxide did not induce local mutagenicity in this tissue model.
In conclusion, the available studies are not in support of a significant genotoxicity/mutagenicity for hydrogen peroxide under in vivo conditions. A wider database of genotoxicity and mutagenicity observations on other relevant target tissues in direct contact with hydrogen peroxide is, however, desirable. Mechanistic studies suggest that cells are adapted to repair DNA damage caused by oxidants; on the other hand there is some evidence that hydrogen peroxide may inhibit the repair of DNA lesions inflicted by other types of reactive chemicals (Churg et al., 1995, Pero et al., 1990, Hu et al., 1995).”
The conclusion is that hydrogen peroxide is a mutagen in-vitro but not in-vivo.
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