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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
- 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
Constituent 1
- Specific details on test material used for the study:
- CAS number: 7722-84-1
Purity: not stated
Test animals
- Species:
- mouse
- Strain:
- other: C57BL/6NCrBR
- Remarks:
- catalase-deficient
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
35% hydrogen peroxide was diluterd with distilled water to 100, 300, 1000 and 3000 ppm solutions. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily, 7/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- control groups
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 300 ppm
- Dose / conc.:
- 1 000 ppm
- Dose / conc.:
- 3 000 ppm
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
- yes, concurrent vehicle
- Details on study design:
- 15 animals/sex/group received hydrogen peroxide solutions for 90 day via drinking water. At term, 10 males and female per group were subjected to examinations.
5 animals/sex/group continued on untreated distilled water for a 6-week recovery period. - Positive control:
- not needed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 10/sex/group
CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: at termination
- Animals fasted: Not specified
- How many animals: 10/sex/group
URINALYSIS: Not specified - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Histological examinations were performed on all gross lesions, on the tongue, esophagus, stomach, duodenum, ileum, jejunum, caecum, colon, and rectum from all animals in all groups, and on all major organs including the sex organs in the high dose and control animals.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3000 ppm group died on study day 43 (no histopathological findings).
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights were significantly reduced only in male and female animals receiving 3000 ppm.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-related reductions in both food and water consumption were observed in female animals receiving 300 ppm and greater, while among the males consistent reductions were observed at the top dose level.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-related reductions in both food and water consumption were observed in female animals receiving 300 ppm and greater, while among the males consistent reductions were observed at the top dose level
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hydrogen peroxide related changes were observed only in the duodenum at terminal sacrifice in the 1000 and 3000 ppm groups of males and females, and in a single 300 ppm group male. Although the general architecture of the affected duodenum was normal, there was an increase in cross sectional diameter and a larger mucosal area with broader, more substantial villi when compared to those of control mice. The change was assessed as mucosal hyperplasia because of the increase in mucosal thickness and size of the villi.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Mucosal hyperplasia in the duodenum in animals at 1000 or 3000 ppm, and in one male at 300 ppm
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- water consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 26 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- water consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 37 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- water consumption and compound intake
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
- Relevant for humans:
- yes
Any other information on results incl. tables
Histological examinations revealed no changes (examined: all gross lesions, tongue, esophagus, stomach, duodenum, ileum, jejunum, caecum, colon, and rectum from all animals in all groups, and on all major organs including the sex organs in the high dose and control animals).
Recovery period:
- The most notable effect was increased water consumption observed among males that had received 3000 ppm, and among females that had received 300, 1000 or 3000 ppm.
- After the recovery period no hyperplasia was seen in any dose group.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively.
- Executive summary:
Reportedly, the sub-chronic toxicity of hydrogen peroxide was examined in a drinking water study (FMC, 1997; dose levels: 0, 100, 300, 1000, and 3000 ppm) using catalase-deficient male and female mice (15/sex/group). At termination after 90 days, 10 animals/sex/group were sacrificed and examined (blood, body weights, gross pathology, histopathology. The latter included all gross lesions, tongue, esophagus, stomach, duodenum, ileum, jejunum, caecum, colon, and rectum from all animals in all groups, and on all major organs including the sex organs in the high dose and control animals). The remaining 5 animals/sex/group continued on distilled water during a 6-week recovery period.
Effects during the treatment period (Days 0-90): There were no treatment-related deaths. Clear treatment-related, dose-dependent effects were noted among both females and males receiving 300, 1000 or 3000 ppm of H2O2. Body weights were significantly reduced only in male and female high-dose animals receiving 3000 ppm. Dose-related reductions in both food and water consumption were observed in female animals receiving 300 ppm and greater, while among the males consistent reductions were observed only at the top dose level. Among females 300 ppm (103 mg/kg/day) was a LOAEL based on significant reduction in water consumption. Histopathology revealed treatment-related effects only in the duodenum of males and females at 1000 and 300 ppm, and in one male at 300 ppm. Although the general architecture of the affected duodenum was normal, there was an increase in cross sectional diameter and a larger mucosal area with broader, more substantial villi when compared to those of control mice. The change was assessed as mucosal hyperplasia because of the increase in mucosal thickness and size of the villi. Mucosal hyperplasia was not found in 100 ppm group mice, neither among controls. No other histopathological changes were noted on the tongue, esophagus, stomach, duodenum, ileum, jejunum, caecum, colon, and rectum from all animals in all groups, and on all major organs including the sex organs in the high dose and control animals.
Recovery period: the most notable effect was increased water consumption observed in males that had received 3000 ppm, and among females that had received 300, 1000, or 3000 ppm. Mucosal hyperplasia was reversible, as no such lesion was seen in any dose group after the recovery period.
The NOAEL was 100 ppm (26 and 37 mg/kg bw/day) in this study for males and females, respectively, based on dose-related reductions in water and food consumption, and on the observation of duodenal mucosal hyperplasia (ECB, 2003).
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