Registration Dossier
Registration Dossier
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EC number: 701-365-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 to 20 March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Principles of method if other than guideline:
- Federal Register 38, No 187
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (e.g. ad libitum): Standard food ERKA 8300
- Water (e.g. ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 17. March To: 20. March 1980
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg pasted with 1 drop physiological saline solution
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: conjunctiva discharge
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Other effects:
- no effects
Any other information on results incl. tables
Classification Index
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is determined to be not irritating to rabbit eye. Classification according to EC: not irritating
- Executive summary:
Acute eye irritation/corrosion study in the rabbits was performed following procedure mentioned in Federal Register 38, No.178. Six rabbits were treated with the test substance for 24 h and observation upto 72 h.The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
Maximum mean total score (MMTS) after 72 h was observed to be 1 on a scale of 110.
Based on the score, the test substance is determined to be not irritating to rabbit eye.
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