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EC number: 202-086-7 | CAS number: 91-64-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Testing report according to National Act method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Coumarin
- EC Number:
- 202-086-7
- EC Name:
- Coumarin
- Cas Number:
- 91-64-5
- Molecular formula:
- C9H6O2
- IUPAC Name:
- 2H-chromen-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- -Substance type: pure substance
-Storage condition of test material: room tempeature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals
-Age at study intiation: 7-9 weeks
-Weight at study intiation: 1-2 kg
-Other conditions: six rabbits in good general health,are used for testing each material. Only one eye of each rabbit is used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 50mg of powder as supplied.
- Duration of treatment / exposure:
- 96 hours
Test substance are applied to one eye of each of six rabbits by gently pulling he low lid away from the eye ball and placing 50mg in the sac so
formed.
Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured. - Observation period (in vivo):
- Assessment of ocular damage/irritation was made 15min and 2,3,4 days following treatment.
- Number of animals or in vitro replicates:
- six
- Details on study design:
- All animals are inspected before any treatment and those with spontaneous eye lesions are rejected. Fluorescein is applied to the eye to assist in the detection of corneal lesions. Corneal thickness is also measured before the application of test materials.
The lower eyelid is gently pulled away from the globe and 50mg of test substance applied into the cup so formed. The eyelid is then released.
Assessment of reactions. Animals are carefully watched during and immediately after application of test material for sings of discomfort of pain. If this is excessive or persistent then the animals are immediately killed.
Fifteen minutes after application of test material the eyes are inspected for conjunctival reactions. One day after application of test material and then at daily intervals for five days per week for three weeks or until the eye is considered to be of normal appearance, the eyes are inspected for corneal, conjunctival and irridial reactions. Subjective grades are given to the serverity of the reactions, these are described below. est substance are applied to one eye of each of six rabbits by gently pulling he low lid away from the eye ball and placing 50mg in the sac so formed.
Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
Grading of ocular reactions.
Cornea
Normal 0,
Any change from normal, including slight dulling of corneal luster 0.5
Scattered of diffuse areas of opacity, iris clearly visible 1
Easily discernible, grayish, translucent areas, details of iris slightly obscured 2
Grey-white areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible 4
Iris
Normal 0
Any divergence from normal, congestion of iridial vessels, deepening of folds +
Redness
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson red, individual vessels not easily discernible 2
Diffuse, beefy red 3
Chemosis
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of eyelids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritant / corrosive response data:
- See the following "Any other information on results incl.tables
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, Coumarin(50mg) is not eye irritant.
- Executive summary:
Coumarin caused slight conjunctivitis in four animals. Two animals healed within 48hours of treatment, two by day 4. Two animals were unaffected 24 hours after treatment.
However, the test material doesn’t meet the criteria for classification as irritation according to CLP regulation.
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