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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- 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: crystalline
- Details on test material:
- -Name of test material: coumarin
-Substance type: pure active substance
-Physical state:crystal
-Analytical purity:100%
-Lot/batch No.: not metioned
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 10 New Zealand White rabbits, aged 9-12 weeks are used for each test. The whole dorsal surface is clipped 3-4 days before the test is due to start, and animals in the telogen phase of hair growth are selected.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- Amount applied: 0.2g solid
- Duration of treatment / exposure:
- The test material and appropriate standards are applied to the clipped dorsum of rabbits for 4 hours under individual semi-occlusive patches,
the treated areas are wiped and examined for evidence of irritation. - Observation period:
- 72h
- Number of animals:
- 8
- Details on study design:
- Occlusive patches are prepared by heat-sealing 1”*1” 24 ply gauze pads on to 1.25”*1.25” squares of polythene sheeting which is then attached to 3.5”*1” strips of adhesive tape. Test solids (0.2g) are applied to a moistened patch. Aerosol preparations are applied directly to the skin with two 1-second bursts and the patches are saturated with spray which acts as a reservoir.
The patches are firmly attached to ensure good contact between the skin and test substance. The animals are immobilized in a canvas body sleeve for 4 hours after application of the patch. When the patches are removed, the treatments sites are wiped clean of excess material. The positions of treatment sites are randomized. Experimental detail for this test are in Table I.
Scoring system:
er-erythema
oe-oedema
cr-cracking
sc-scaling
Reaction Grades and Scores
a marginal/very slight =1
b slight=2
c fairly distinct =3
d quite distinct =4
e becoming well developed =6
f well developed =8
g becoming severe =10
h severe =12
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1.33
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.67
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.67
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritant / corrosive response data:
- See talbe I in "any other information on results incl. tables
- Other effects:
- None
Any other information on results incl. tables
Treatment Site No. | 4 Hours | 24 Hours | 48 Hours | 72 Hours | Totals | Total | |||||||||||||||
Score(T) | |||||||||||||||||||||
er | oe | cr | sc | er | oe | cr | sc | er | oe | cr | sc | er | oe | cr | sc | er | oe | cr | sc | ||
2 | a | _ | _ | _ | _ | 1 | _ | 1 | |||||||||||||
3 | a | a | a | a | _ | _ | 2 | 2 | 4 | ||||||||||||
4 | a | a | _ | _ | _ | 1 | 1 | 2 | |||||||||||||
5 | _ | _ | _ | _ | _ | _ | |||||||||||||||
6 | _ | _ | _ | _ | _ | _ | |||||||||||||||
1 | c | 5 | c | 5 | a | _ | _ | 7 | 4 | 11 | |||||||||||
3 | c | c | d | d | d | d | d | c | 15 | 14 | 29 | ||||||||||
4 | a | a | a | _ | _ | _ | 2 | 1 | 3 |
er-erythema oe-oedema cr-cracking sc-scaling
Reaction Grades and Scores
a marginal/very slight =1 b slight=2 c fairly distinct =3 d quite distinct =4
e becoming well developed =6 f well developed =8 g becoming severe =10 h severe =12
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Only one animal shows mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema. According to GHS criterion, at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal. Therefore, it's not classified as irritating.
- Executive summary:
Methods and Results.
Occlusive patches are prepared by heat-sealing 1”*1” 24 ply gauze pads on to 1.25”*1.25” squares of polythene sheeting which is then attached to 3.5”*1” strips of adhesive tape. Test solids (0.2g) are applied to a moistened patch. Aerosol preparations are applied directly to the skin with two 1-second bursts and the patches are saturated with spray which acts as a reservoir.
The patches are firmly attached to ensure good contact between the skin and test substance. The animals are immobilized in a canvas body sleeve for 4 hours after application of the patch. When the patches are removed, the treatments sites are wiped clean of excess material. The positions of treatment sites are randomized. Experimental detail for this test are in Table I. Only one animal shows mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema.
Conclusion. The test substance when administered to rabbits by dermal route, under the experimental conditions adopted, has to be considered as non irritant for the skin.
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