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EC number: 201-708-4 | CAS number: 86-92-0
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:
- other: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methyl-1-p-tolyl-5-pyrazolone
- EC Number:
- 201-708-4
- EC Name:
- 3-methyl-1-p-tolyl-5-pyrazolone
- Cas Number:
- 86-92-0
- Molecular formula:
- C11H12N2O
- IUPAC Name:
- 3-methyl-1-p-tolyl-5-pyrazolone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4 - 3.1 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser system
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiol. saline (37°C)
- Time after start of exposure: 24 after application
SCORING SYSTEM:
cornea: 0-4
iris: 0-2
conjunctivae redness: 0-3
conjunctivae chemosis: 0-4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: fluorescein, ultraviolet light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritation parameter:
- iris score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritant / corrosive response data:
- 1 h after application: yellow discharge (coloured by test item), which was fully reversible within 24 h
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not serious eye damaging and not eye irritating.
Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008. - Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD guideline 405. The test item (0.1 g) was applied to the intact eye of each of three New Zealand White rabbits. 24 h after application the eyes were rinsed with physiol. saline. The scoring of eye reactions (cornea, iris, conjunctivae redness, conjunctivae chemosis) was performed 1, 24, 48 and 72 h after instillation of the test item. Mean scores were calculated for each animal following grading at 24, 48 and 72 h after instillation of the test material.
The individual mean scores calculated across the scoring times (24, 48 and 72 h after instillation of the test material) were 0.0 (three animals) for cornea, iris and conjunctivae chemosis and 0.3 (two animals) or 0.7 (one animal) for conjunctivae redness. All signes of irritation were fully reversible within 48 h.
All scores were below the threshold values for classification.
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