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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 November 2017 - 23 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrogen peroxide-urea
- EC Number:
- 204-701-4
- EC Name:
- Hydrogen peroxide-urea
- Cas Number:
- 124-43-6
- Molecular formula:
- CH4N2O.H2O2
- IUPAC Name:
- carbamimidic acid; peroxol
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
- Characteristics of donor animals: 12 - 60 months old
- Storage, temperature and transport conditions of ocular tissue: transported in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container
- indication of any existing defects or lesions in ocular tissue samples: corneas were examined and only corneas which were free from damages were used
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL of the dissolved test item (150 mg/750 µL 20% HBSS)
- Concentration: 20 %
VEHICLE
- Amount applied: 750 µL
- Concentration: 20 %
- Lot/batch no.: 20171207 - Duration of treatment / exposure:
- 4 h
- Number of animals or in vitro replicates:
- 3 replicates per group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the arrival of the corneas, they were examined and only corneas which were free from damages were used.
NUMBER OF REPLICATES: 3 replicates per group
SOLVENT CONTROL USED: Balanced Salt Solution (HBSS)
POSITIVE CONTROL USED: Imidazole solution (20%)
APPLICATION DOSE AND EXPOSURE TIME:
- application dose: 750 µL of the dissolved test item (150 mg/750 µL 20% HBSS)
- exposure time: 4 h
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD492)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in OECD guideline 437
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1 / Replicate 1
- Value:
- 94.27
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1 / Replicate 2
- Value:
- 94.74
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1 / Replicate 3
- Value:
- 94.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for vehicle control: Yes
- Acceptance criteria met for positive control: Yes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item was determined to be have an eye damaging potential (UN GHS Category 1).
- Executive summary:
The eye damaging potential of the test item was assessed in a Bovine Corneal Opacity and Permeability (BCOP) test according to OECD guideline 437. Bovine corneas were collected from slaughtered cattle that were between 12 and 60 months old. The test item solution (20% in HBSS) was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. HBSS-solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In Vitro Irritancy Score) was 1.81. 20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS was 94.64. Under the conditions of this study, the test item induced serious eye damage on the cornea of the bovine eye. The calculated IVIS was 99.44. According to OECD guideline 437, a substance with an IVIS > 55 induces serious eye damage and should be classified as UN GHS Category 1. Therefore, the test item was determined to have an eye damaging potential and is classified as UN GHS Category 1.
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