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EC number: 290-690-1 | CAS number: 90218-17-0
- 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
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- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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- Toxic effects on livestock and pets
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- April, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
- Justification for type of information:
- The read across justification is detailed in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- other: REAL DECRETO 363/1995, 10 march
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: authorised supplier
- Weight at study initiation: 2099-2191 g
- Housing: stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorised vendor
- Water: filtered tap water (5 µm), ad libitum
- Acclimation period: 7 days
- Health check: during observation period
ENVIRONMENTAL CONDITIONS
- Temperature: 21± 2 °C
- Humidity:55 ± 25 %
- Air changes: 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod: 12 hour cycle dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- OBSERVATIONS: after 1, 24, 48, 72 hours and 7,14, and 21 days
SCORING SYSTEM: cornea, iris, conjunctiva (similar to OECD 405)
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity .............................................................................................................. 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible ................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ........................................... 2
Nacrous area; no details of iris visible; size of pupil barely discernible ..................................... 3
Opaque cornea; iris not discernible through the opacity ............................................................. 4
Maximum possible: 4
* The area of corneal opacity should be noted Iris
Iris
Normal......................................................................................................................................... 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect.................... 1
Hemorrhage, gross destruction, or no reaction to light ............................................................... 2
Maximum possible: 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) Normal......................................................................................................................................... 0
Some blood vessels hyperaemic (injected) ................................................................................. 1
Diffuse,crimson colour; individual vessels not easily discernible............................................... 2
Diffuse beefy red ......................................................................................................................... 3
Maximum possible: 3
Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal......................................................................................................................................... 0
Some swelling above normal....................................................................................................... 1
Obvious swelling, with partial eversion of lids........................................................................... 2
Swelling, with lids about half closed........................................................................................... 3
Swelling, with lids more than half closed.................................................................................... 4
Maximum possible: 4
TOOL USED TO ASSESS SCORE: fluorescein
To facilitate consideration of the reactions, the operator used a manual lamp. After 24 hours of application, fluorescein was usedto evaluate any lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Table 1: eye irritation scores
1hour | 24 hours | 48 hours | 72 hours | 7 days | 14 days | 21 days | |
animal #1 | |||||||
corneal opacity | - | 1 | 1 | 1 | 0 | 0 | |
iritis | - | 1 | 1 | 1 | 0 | 0 | |
conjunctival redness | - | 3 | 2 | 2 | 1 | 0 | |
conjunctival oedema (chemosis) | 3 | 3 | 2 | 2 | 0 | 0 | |
animal #2 | |||||||
corneal opacity | - | 1 | 1 | 1 | 0 | 0 | |
iritis | - | 1 | 1 | 1 | 0 | 0 | |
conjunctival redness | - | 3 | 2 | 2 | 1 | 0 | |
conjunctival oedema (chemosis) | 3 | 4 | 3 | 3 | 0 | 0 | |
animal #3 | |||||||
corneal opacity | - | 1 | 1 | 1 | 0 | 0 | |
iritis | - | 1 | 1 | 1 | 0 | 0 | |
conjunctival redness | - | 3 | 3 | 2 | 1 | 0 | |
conjunctival oedema (chemosis) | 3 | 4 | 3 | 2 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (eye irritant) according to the CLP Regulation (EC) No. 1272/08
- Conclusions:
- The test item was found to be irritating when applied to the rabbit eye.
- Executive summary:
The potential for the test item to induce eye irritation or serious damage was evaluated in an experimental study, according to a method similar to the OECD Guideline 405. Three male rabbits were administered 100 mg of unchanged test item to one eye for a duration of 24 hours; the untreated eye served as a negative control. Corneal opacity, iritis, conjunctival redness and chemosis were evaluated 1, 24, 48 and 72 hours and 7, 14 and 21 days after application of the test item.
The cornea and iris scores (mean values 24/48/72) were 1 in all animals. The mean values 24/48/72 h for conjunctivae for redness were 2.33 in two animals (#1 and #2) and 2.67 in one animal (#3); for chemosis were 2.33 in animal #1, 3.33 in animal #2 and 3 in animal #3. All effects observed were fully reversible within the 21-day observation period.
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.
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