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Registration Dossier
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EC number: 943-403-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Study period:
- April 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: REAL DECRETO 363/1995, 10 march
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: authorized 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 authorized vendor
- Water: filtered tap water (5 µm , ad libitum
- Acclimation period: 7 days
- Health check: during observation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity(%) :55 ± 25%
- Air changes (per hr): 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
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- 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)
TOOL USED TO ASSESS SCORE: fluorescein
To facilitate consideration of the reactions, the operator had used a manual lamp and after 24 hours of application have used fiuorescein to evaluate any lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 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:
- other: mean 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:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Given the lesions observed during the experiment, the substance is classified as irritant.
- Executive summary:
The substance has been tested on rabbit eye for 24 hours. Given the lesions observed during the experiment the substance is classified as eye irritant.
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