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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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- no
- 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: 50% (w/w)
Test animals
- Species:
- rat
- Strain:
- other: Alpk:ApfSD (Wistar derived)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Rodent Breeding Unit, Alderley Park, Macclesfield, UK
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: for groups 1-4, 242.5 +/- 9.6 g (males), 190.2 +/- 12.3 g (females); four groups five and six, 300.3 +/- 9.1 g (males), 233.8 +/- 11.0 g (females)
- Fasting period before study:
- Housing: five rats, sexes separately, in stainless steel cages
- Diet (e.g. ad libitum): CT1 supplied by Special Diet Services Ltd, Witham, UK ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 5 days
Environmental conditions
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours darkness
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- not applicable
- Details on inhalation exposure:
- Test atmospheres were generated using a glass concentric-jet atomiser to generate fine aerosol directly into a 3-necked quick-fit round bttomed flask, heated by placing it in a waterbath at 80°C. The test substance was pumped to the atomiser using a peristaltic pump, typically operating at a pump speed giving a flow rate of test material of approximately 1 mL/min. Clean, dry air was passed through the atomiser at nominal flow rates of 2, 10 or 15 L/minute for groups 2, 3 and 4 respectively, and (together with heated generation air at 25 L/minute) carried the atmosphere to the lng term exposure chamber. Diluting air was added directly to the exposure chambers at a flow rate of 500-600 L/min. Air flows were monitored continuously using variable area flowmeters.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test atmospheres were sampled by passing the atmosphere, at a fixed flow rate for a known time period, through a known volume of de-ionised water in a midget impinger. The resulting solutions were analysed by flow injection analysis using a LC Module 1 (Waters) separations module at a flow rate of 5 L/minute, a dilute Cobalt-bicarbonate reagent mobile phase, and a 486 series UV detector (Waters) at 260 nm. The limit of detection of the method was assessed to be approximately 0.1 mg/mL corresponding to an atmosphere concentration of 0.1 ppm.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hours daily, 5 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.03 ppm
- Remarks:
- corresponding to 2.88 mg/m3 (analytical)
- Dose / conc.:
- 10.3 ppm
- Remarks:
- corresponding to 14.6 mg/m3 (analytical)
- Dose / conc.:
- 23.3 ppm
- Remarks:
- corresponding to 33 mg/m3 (analytical)
- Dose / conc.:
- 58.1 ppm
- Remarks:
- corresponding to 82.4 mg/m3 (analytical) further adapted to 27.3 ppm corresponding to 38.7 mg/m3 (analytical)
- No. of animals per sex per dose:
- five males, five females
- Control animals:
- yes
- Details on study design:
- Another group (group 4 of the main test) of animals was exposed to 60 ppm at day 1, 4, 5 and 6. Thereafter, the exposure level was reduced to 30 ppm at day 11 and 12. The treatment was terminated on day 13 and animals were sacrificed due to toxicity. The group treated with a target concentration of 25 ppm was introduced later in the test after termination of the test group 4 (60/30 ppm).
- Positive control:
- -
Examinations
- Observations and examinations performed and frequency:
- Clinical observations: prior to the start of the study, frequently during exposure and at the end of the 6 hour exposure duration, daily before exposure
Body weight: before study initiation, weekly during exposure study
Food consumption: continuously throughout the study
Clinical pathology (haematology, blood clinical chemistry): at termination of study - Sacrifice and pathology:
- Animals were killed by an overdose of halothane vapour followed by exsanguination. Weights of adrenal glands, kidneys, liver, lungs and testes were measured. All animals were subjected to full examination post mortem including external and careful internal examination of all organs and structures. Slides were prepared from various organs and tissues. All submitted tissues from control and high exposure animals together with the lungs, liver, kidney, trachea, nasal passages and abnormal tissues from the low and mid exposure groups were routinely processed, embedded in paraffin wax, sectioned at 5 micrometre and stained with haematoxylin and eosin. Examination by light microscopy was performed for these tissues.
- Other examinations:
- -
- Statistics:
- Body weights were considered by analysis of covariance on initial body weight, separately for males and females. Haematology and blood clinical chemistry were consdired by analysis of variance. Male and female data were analysed together. Organ weights were considered by analysis of variance and of covariance on final body weight, separately for males and females. Analyses were carried separately for main study and additional group 5 and 6 animals. Unbiased estimates of differences from control were provided by the difference between each treatment group least-squares mean and the control group least-squares mean. Differences from control were tested statistically by comparing each treatment group least-squares mean with the contol group least squares mean using a two-sided Student's t-test, based on the error mean square in the analysis.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- Neurobehaviour
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical signs were seen in animals exposed to 10.3 ppm and greater and in general the number and severity of these clinical signs increased with repeated exposure at low doses, whereas the onset of clinical signs was earlier at higher doses but also a certain degree of recovery from symptoms was seen at higher doses. Signs included reddening of the nose, stains around the snout, stains around the mouth, signs of salivation, signs of respiratory tract irritation, irregular breathing, signs of urinary incontinence, piloerection, chomodacryorrhoea, hunched posture, increased response to touch, thin appearance. Some evidence of recovery from these symptoms was seen during periods of non-exposure. Body weights gradually decreased in males exposed to 23.3 ppm and in males and females exposed to 58.1/27.3 ppm. Food consumption was affected in males exposed to 23.3 ppm and in males and females exposed to 58.1/27.3 ppm. Minor effects on haematology were seen at exposure levels of 23.3 ppm, which were considered as not biologically and toxicologically significant. In both sexes there was a minimal decrease in albumin and total protein levels at 23.3 ppm exposure. Kidney weight was increased in females exposed to 23.3 ppm and lung/body weight ratio in males and kidney/body weight ratios in females exposed to 23.3 ppm was increased. Treatment-related findings were seen in the nasal and oral cavities of rats at the necropsy following termination of the study. Staining of the nares was seen at 10 ppm and above and mouth staining was at 25 ppm. In both instances, no dose-response could be found. Increased incidences of findings in exposed animals over controls during the microscopic examinations were seen in the nasal cavity, larynx and lung including necrosis, inflammation and perivascular neutrophil infiltration.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2.9 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- histopathology: non-neoplastic
- mortality
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 14.6 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- histopathology: non-neoplastic
- mortality
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 14.6 mg/m³ air
- System:
- other: respiratory tract (histopatho. non-neopl.), clinical signs, mortality, body and food consumption, clinical biochemistry
- Organ:
- larynx
- lungs
- nasal cavity
- Treatment related:
- yes
- Dose response relationship:
- yes
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the sub-acute inhalation NOAEC of the substance in rats was determined to be 2.03 ppm (corresponding to 2.9 mg/m3).
- Executive summary:
A study was conducted to determine the short term repeated dose: inhalation toxicity of the substance according to OECD Guideline 412, in compliance with GLP. Male and female rats Alpk:APfSD (Wistar-derived) were exposed (whole body) to the test substance at concentrations of 0, 2.03, 10.3, 23.3 and 58.1/27.3 ppm (corresponding to analytical concentrations of 0, 2.88, 14.6, 33 and 82.4/38.7 mg/m3 air) for 28 days (6 hours daily, 5 days per week). Treatment of the 58.1 ppm group exposed initially was subsequently changed to to 27.3 ppm and was terminated before schedule due to the toxicity of the test substance. Clinical observations were consistent with the typical observations of respiratory tract irritation (reddened nose, stains around the nose, abnormal respiratory noise). In general the time to onset, incidence and severity of clinical signs increased with exposure concentration and repeated exposure. Males exposed to 23.3 ppm showed lower food consumption and body weight gain compared to controls. Minimal changes in albumin and total protein blood levels were found in males and females exposed to 23.3 ppm. Histopathological, treatment-related changes were seen in the anterior-most regions of the nasal cavity lined with squamous epithelium, where minimal to slight necrosis (with associated inflammation) and rhinitis were seen in animals exposed to 10.3 and 23.3 ppm test substance. Inflammation and epithelial erosion in the larynx and increased perivascular neutrophil infiltration in the lungs were considered unlikely to be related to treatment in the absence of a clear dose response relationship. Under the study conditions, the sub-acute inhalation NOAEC of the substance in rats was determined to be 2.03 ppm (corresponding to 2.9 mg/m3) (European Chemicals Bureau, 2003).
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