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Diss Factsheets
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EC number: 807-276-9 | CAS number: 1421695-64-8
- 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
![](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
- GLP compliance:
- yes
Test material
- Details on test material:
- -Purity: 100%
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: 2277 - 2595 g
- Housing: The animals were individually 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.
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 C°C
- Humidity (%): 55-80%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each rabbit remained untreated with the test substance and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Duration of treatment / exposure:
- Single administration
- Observation period (in vivo):
- 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 et al.
TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light. 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
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: one rabbit showed a score of 1 at 1 hour
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: disharge (score of 1 or 2) was observed in all 3 animals at 1 hour
- Irritant / corrosive response data:
- No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 hours.
- Other effects:
- All animals appeared active and healthy and gained weight during the study. No clinical signs were observed.
Any other information on results incl. tables
|
Rabbit No.: 3401 (Female) |
Rabbit No.: 3402 (Female) |
Rabbit No.: 3403 (Female) |
|||||||||
|
Hour |
Hour |
Hour |
|||||||||
|
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 |
II. Iris |
|
|
|
|
|
|
|
|
|
|
|
|
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
A. Redness |
0 |
0 |
0 |
0 |
0 |
0 |
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 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 hours.
- Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation from a single instillation via the ocular route. Initially, one-tenth of a millilitre of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.. Since irritation cleared by 24 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals, as described above.
No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 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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