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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- 13-Week drinking water toxicity study of hydrogen peroxide with 6-week recovery period in catalase-deficient mice
- Author:
- Weiner M, Freeman C, Trochimowicz H, de Gerlache J, Jacobi S, Malinverno G, Mayr W, Regnier J
- Year:
- 2 000
- Bibliographic source:
- Food Chem. Toxicol. 38:607-615
- Report date:
- 1999
- 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 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
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: C57BL/6NCrlBR
- Details on species / strain selection:
- C57BL/6NCRlBR mice were chosen due to their particular sensitivity to the test substance because of a deficient detoxification pathway.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
- Source: Charles River Laboratories
- Age at study initiation: 5 weeks
- Weight at study initiation:
- Fasting period before study: no data
- Housing: individually in suspended, stainless steel cages with wire bottom
- Diet (e.g. ad libitum): Purina Rodent Chow 5002 (meal) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
Environmental conditions:
- Temperature: 65 to 71 °F
- Humidity (%): 41 to 78
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours darkness
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on route of administration:
- ad libitum
- Vehicle:
- water
- Details on oral exposure:
- The treated (and control) water for this study was prepared twice weekly and administered to the animals on the day of preparation. The drinking water solutions were made by adding preweighed amounts of 35% test substance to distilled water. The solutions were mixed in carboys for at least 15 minutes prior to dispending the animals. Following administration, unused portions of treated water were stored refrigerated. All equipment for water solution preparation and administration was passivated with nitric acid before use.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the 100 ppm test substance stock solution and the 3000 ppm test substance stock solution used to dose mice at the 100 ppm and 3000 ppm levels were taken together with a blank sample and analysed for concentration and homogeneity. A colourimetric analytical method designated Test Method APG No. 332 was applied which uses a ferrus thiocyanate reagent. The colour absorbance was measured with a Perkin Elmer Lambda 18 Spectrophotometer. Subsequently, on each of four date one distilled water blank, one control sample of 100 ppm and 3000 ppm test substance and five samples of 100 ppm and 3000 ppm dose solutions were analysed by the same method. Additionally, the 35% test substance solution was analysed by an iodometric titration at 30 day intervals up to 120 days to test the stability of the solution under the storage conditions (4 °C, vented closed container).
- Duration of treatment / exposure:
- Approximately 90 days
- Frequency of treatment:
- ad libitum
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- nominal in water
- Dose / conc.:
- 100 ppm
- Remarks:
- nominal in water
- Dose / conc.:
- 300 ppm
- Remarks:
- nominal in water
- Dose / conc.:
- 1 000 ppm
- Remarks:
- nominal in water
- Dose / conc.:
- 3 000 ppm
- Remarks:
- nominal in water
- No. of animals per sex per dose:
- 15/sex per treatment group; 10/sex were killed after ceasing the exposure period, whereas 5/sex were submitted to a six week recovery period.
- Control animals:
- yes
- Details on study design:
- C57BL/6NCRlBR mice were chosen due to their particular sensitivity to the test substance because of a deficient detoxification pathway.
Examinations
- Observations and examinations performed and frequency:
- Clinical signs: daily
Mortality: twice daily
Body weight: weekly
Food consumption: weekly
Water consumption: twice weekly
Blood analysis, haematology, clinical chemistry analyses: blood samples were taken immediately before the scheduled necropsy
Ophthalmic examinations: the eyes of all animals were checked for lesions before the study and one week before the study termination and only animals showing no lesions were used in the study - Sacrifice and pathology:
- Animals that died before the study termination underwent a complete necropsy upon dicovery of death. Animals sacrificed at their scheduled termination (days 91-93 of treatment period, days 133-134 of recovery period) were anaesthetised, bled for haematology and clinical chemistry determinations, sacrificed via exsanguination then necropsied. Animals were not fasted prior to sacrifice. The weights were determined of brain, liver, kidneys, spleen, testes, adrenals and heart. Samples from various tissues were saved in 10% buffered formalin. All slides of organs and tissues in the control and high dose groups as well as tissues from mice that died out of schedule were investigated by an experienced pathologist and histological examinations were performed on all gross lesions, the tongue, esophagus, stomach, duodenum, ileum, jejunum, caecum, colon and rectum of all animals from all groups.
- Other examinations:
- -
- Statistics:
- Body weights, food consumption, water consumption, absolute organ weights, organ:brain weight ratios, haematology and clinical chemistry data were analysed using the Ebar-Squared trend test. The test compared data from the high-dose group to control and computed a p-value to indicate whether the measured parameter was significantly different (p < 0.05 for statistically significant difference). Subsequent analyses compared data from the next highest dosage group to control, in the direction of the overall trend, and generated another p-value. These analyses continued in a stepwise manner for successively lower groups until the p-value was greater 0.05. When the trend test returned a value greater than 0.05, no subsequent comparisons of the lower dosage groups were performed.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- Neurobehaviour: no data
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No treatment-related deaths occurred and no treatment-related clinical signs were noted at any time of the study. Male and females exhibited significant reductions in body weight at 3000 ppm. Food and water consumption were significantly reduced at 3000 ppm, 1000 and 300 ppm. Males receiving 3000 ppm displayed significant reductions in total protein and globulin levels in the blood, possibly caused by mucosal hyperplasia occurring in the duodenum of these animals. Necropsy revealed no treatment-related gross lesions. Tissue slides indicated an increase in the cross sectional diameter and wall thickness of the duodenum. Subsequent microscopic evaluations revealed mild mucosal hyperplasia in eight of nine males receiving 3000 ppm and in seven of ten males receiving 1000 ppm. Minimal mucosal hyperplasia was noted in one of ten males receiving 300 ppm. Minimal to mild mucosal hyperplasia was also seen in ten of ten females receiving 3000 ppm and in eight of ten females receiving 1000 ppm. No other areas of the gastrointestinal tract were affected. No evidence of cellular atypia or architectual disruptions nor any other indications of neoplastic changes were observed; therefore, the treatment-related mucosal hyperplasia noted was not considered as a neoplastic lesion.
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- food consumption and compound intake
- histopathology: non-neoplastic
- water consumption and compound intake
- Remarks on result:
- other: 26 and 37 mg/kg bw/day for males and females, respectively
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 ppm
- System:
- gastrointestinal tract
- Organ:
- duodenum
- Treatment related:
- yes
- Dose response relationship:
- yes
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the sub-chronic NOEL of the substance in mice was determined to be 100 ppm (equivalent to 26 and 37 mg/kg/day for males and females, respectively).
- Executive summary:
A study was conducted to determine the repeated dose oral toxicity of the substance according to OECD Guideline 408, in compliance with GLP. This subchronic toxicity study was conducted with a 35% aqueous solution of the test substance dissolved in drinking water to produce concentrations ranging from 100 to 3000 ppm. Groups of 15 male and 15 female C57BL/6NCrlBR mice was administered the test substance dissolved in their drinking water for 90 d. After the 90 -day exposure, 10 animals/sex of each dose group were sacrificed, while the remaining five animals/sex were kept for a six week recovery period. No treatment-related mortality or clinical signs were noted throughout the study. No other treatment-related effects were observed at the 100 ppm dose level. At 300 ppm, the consumption of food and water was reduced. Microscopic examination indicated an increase in the cross sectional diameter and wall thickness of the duodenum which corresponded to mild mucosal hyperplasia in eight of nine males and ten of ten females receiving 3000 ppm and in seven of ten males and eight of ten females receiving 1000 ppm. No other areas of the gastrointestinal tract were affected. During microscopical evaluation no evidence of cellular atypia or architectural disruptions nor any other indications of neoplastic changes were observed. Therefore, the treatment-related mucosal hyperplasia noted in the study was not considered as neoplastic lesion. Clinical pathologic effects (decreased total protein and globulin blood levels) were limited to the 3000 ppm level. All effects noted during the treatment period were reversible; animals sacrificed following the recovery period were considered biologically normal. Under the study conditions, the sub-chronic NOEL of the substance in mice was determined to be 100 ppm (equivalent to 26 and 37 mg/kg bw/day for males and females, respectively) (Weiner, 2000).
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