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EC number: 619-290-0 | CAS number: 97780-06-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid
- Details on test material:
- -Purity: 96.8%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Buckshire Corporation, Perkasie, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2514 to 3229 g
- Housing: housed
singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow® #5322
- Water (e.g. ad libitum): No data on the source of the water
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): No data are available
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit was not treated with the test material and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 90 mg - Duration of treatment / exposure:
- Approximately 10 seconds; after the test material was administered, both eyes of 3 rabbits were rinsed with water for approximately 1 minute with room temperature water. The eyes of the other 6 rabbits were not washed with water
- Observation period (in vivo):
- Approximately 24, 48, and 72 hours after the test substance administered, the rabbits were examined for evidence of eye irritation. Six rabbits were further examined at 7 days, 2 at 10 days, and 1 at 13, 16, 20, and 21 days
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 rabbits were washed with water for 1 minute
- Time after start of exposure: 10 seconds
SCORING SYSTEM: Draize Scale
TOOL USED TO ASSESS SCORE: biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.34
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Post Treatment Evaluation Time |
Conjunctival Chemosis |
Conjunctival Redness |
Iridic Congestion |
Corneal Opacity |
24 hours |
1 |
0.83 |
0 |
1 |
48 hours |
0 |
0 |
0 |
0.67 |
72 hours |
0 |
0 |
0 |
0.67 |
Overall Average (24h + 48h + 72h/3) |
0.33 |
0.28 |
0 |
1.34 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of testing, the test substance produced ocular irritation in the form of corneal opacity, conjunctiva! redness, and chemosis. Epithelial sloughing of the cornea was observed in 3 of the unwashed eyes and in 1 of the washed eyes. The substance is considered to be irritating to the eyes.
- Executive summary:
The test substance was evaluated for acute eye irritation potential in 9 young adult New Zealand White rabbits. Approximately 90 mg (a weight corresponding to a 0.1 mL volume of test material) was administered to one eye of each test animal. The eyes of 6 rabbits remained unwashed following treatment, and the eyes of 3 rabbits were washed (OECD Guideline 405)
The conjunctiva, iris and cornea of each treated eye were evaluated and scored according to a numerical scale, 24, 48, and 72 hours following administration of the test material. Animals were also assessed for reversibility of ocular effects for up to 21 days following treatment.
Mean values were calculated from the quantitative evaluation of ocular lesions observed in rabbits with unwashed eyes at 24, 48, and 72 hours following treatment. Since the substance produced corneal opacity in 5/6 animals at 24 hours with a mean cornea opacity score of ≥1, the substance is considered an eye irritant. These effects were reversible within 10 days. The substance would therefore be considered a Cat 2 eye irritant.
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