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EC number: 234-277-6 | CAS number: 11059-65-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data was generated according to valid testing guidelines.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 40 CFR, Section 163.81-4, Federal Register, August 22,m 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guideline of November, 1982
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Routine Quality Assurance Unit auditing, to assure laboratory compliance with GLP was ongoing during the period of time when this study was conducted.
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc. Douglassville PA
- Housing: Stainless Steel caging with elevated wire mesh flooring, 1 rabbit/ cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.8.
- Humidity (%):55 +/- 25%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 10 March 1986 – 24 March 1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 1 hour and 1, 2, 3, 4, 7, 14 days following instillation of test material into the eyes.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
- Time after start of exposure: not applicable.
SCORING SYSTEM: Interpretation of the results was made in accordance with the modified Draize technique for scoring ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Remarks on result:
- other: 5/6 animals had Dull eyes during the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 14
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study, the test material produced mild to moderate conjunctival irritation in the albino rabbit eyes. At Day 7, very slight irritation was noted for 2/6 animals and no irritation noted for 4/6 animals. At Day 14 no irritation was noted for 2/6 animals exhibiting irritation at day 7. Corneal involvement was observed in 5/6 animals however it was not evident at day 7. No iritis was noted during the 14 day observation period
- Executive summary:
In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the New Zealand White rabbits (6 animals).The test material produced mild to moderate conjunctival irritation in the albino rabbit eyes which fully reversed in all animals by Day 14. Corneal involvement was observed in 5/6 animals however it was not evident at day 7. No iritis was noted during the 14 day observation period.
The test substance is not classified as in irritant in accordance with the classification system of GHS.
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