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EC number: 239-784-6 | CAS number: 15687-27-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 7 September 2009
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002; for determination of eye irritation/corrosion
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ibuprofen
- EC Number:
- 239-784-6
- EC Name:
- Ibuprofen
- Cas Number:
- 15687-27-1
- Molecular formula:
- C13H18O2
- IUPAC Name:
- 2-(4-isobutylphenyl)propanoic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test substance: Ibuprofen
- Test substance No.: 02/0156-6
- Batch ID: IB1S1290
- Purity: 99.7%
- pH: ca. 4.5 (undiluted test substance, minimally moistened with water); ca. 4 (20% aqueous preparation)
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim
- Characteristics of donor animals: age of animals: minimum 12 months, maximum 60 months
- Species: Bovine (eyes are obtained as a by-product of freshly slaughtered cattle)
Test system
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS & QUALITY CHECK OF THE ISOLATED CORNEAS
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in specially designed corneal holders that consists of anterior and posterior chambers. Both chambers were filled to excess with prewarmed Eagles’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour. After the equilibration period the medium in both chambers was replaced with fresh prewarmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that show macroscopic tissue damage or an opacity value < 566 opacity units were discarded. Corneas with opacity values close to the median value of all corneas were selected as negative (vehicle) control. The remaining corneas were then distributed into treatment and positive control groups. Each corneal holder was uniquely identified with a number written on the chambers with a felt pen.
NUMBER OF REPLICATES
Each treatment group (test substance, vehicle control and positive control) consisted of 3 corneas.
SOLVENT CONTROL USED
Highly deionized water
POSITIVE CONTROL USED
20% (w/v) solution of Imidazole in highly de-ionized water
APPLICATION DOSE AND EXPOSURE TIME
750 μL of the 20% (w/v) test-substance preparation (non-surfactant), vehicle control or positive control was applied using a pipette. The corneas were incubated in a horizontal position at about 32 °C for approximately 4 hours (non-surfactant solids).
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
The vehicle control and positive control were removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red). Because the test substance could not be removed using a syringe, the epithelium was rinsed with the open chamber method.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: visual observations and opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
ACCEPTANCE CRITERIA
In case one of the below given acceptance criteria is not covered, repetition of the test was considered.
- A study is considered acceptable if the positive control gives an IVIS that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the established upper limits.
- Since the IVIS per treatment group is determined from the mean of three single corneas, the variability between the corneas treated per test substance should be acceptably low. If the prediction is not clearly identified in all corneas, the test will be repeated.
DECISION CRITERIA
IVIS > 55: risk of serious damage to eyes
IVIS ≤ 55: no risk of serious damage to eyes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1st
- Value:
- 28.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 2nd
- Value:
- 32.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1st
- Value:
- 1.357
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 2nd
- Value:
- 1.05
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1st
- Value:
- 49
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2nd
- Value:
- 48.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Results of negative and positive controls see "any other information on results incl. tables"
Any other information on results incl. tables
First run
|
Mean Opacity Value |
Mean Permeability Value |
In Vitro Irritancy Score |
Test substance |
28.7 |
1.357 |
49.0 |
Negative Control |
2.2 |
0.020 |
2.5 |
Positive Control |
81.6 |
3.738 |
137.6 |
Second run
|
Mean Opacity Value |
Mean Permeability Value |
In Vitro Irritancy Score |
Test substance |
32.7 |
1.050 |
48.4 |
Negative Control |
4.1 |
-0.005 |
4.0 |
Positive Control |
63.2 |
3.466 |
115.2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive to the eyes
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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