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Diss Factsheets
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EC number: - | CAS number: -
- 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
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- Endpoint summary
- Stability
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nouan-8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity: 92.1%
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 initiation: Young adult.
- Weight at study initiation: 2225, 2383 and 2603 g
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 6 or 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 33-61%
- Air changes (per hr): 12 or 13.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of each rabbit remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 g - Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: High-intensity white light in accordance with Draize, et al. The fluorescein dye evaluation procedure was used in the treated eye at 24 hours to verify the absence of corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- other: range
- Time point:
- other: 1-72 hours
- Score:
- 0 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- other: range
- Time point:
- other: 1-72 hours
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 hours
- Irritant / corrosive response data:
- All animals appeared active and healthy and gained body weight during the study. Apart from the eye irritation noted, there were no other clinical signs observed. There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.
Any other information on results incl. tables
Table 1: Individual Scores for Ocular Irritation |
||||||||||||
|
Rabbit No.: 3401 (Female) |
Rabbit No.: 3402 (Female) |
Rabbit No.: 3403 (Female) |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
||||||||||||
A. Opacity |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
II. Iris |
||||||||||||
A. Values |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||
A. Redness |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Discharge |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
12% ophthalmic fluorescein sodium used to verify the absence of corneal opacity. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance caused slight irritation to the eye.
- Executive summary:
The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.05 mg ( 0.1 mL) of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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