Registration Dossier
Registration Dossier
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EC number: 259-583-7 | CAS number: 55302-96-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: secondary source
Data source
Reference
- Reference Type:
- other: secondary source
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-[(2-hydroxyethyl)amino]-o-cresol
- EC Number:
- 259-583-7
- EC Name:
- 5-[(2-hydroxyethyl)amino]-o-cresol
- Cas Number:
- 55302-96-0
- Molecular formula:
- C9H13NO2
- IUPAC Name:
- 5-[(2-hydroxyethyl)amino]-2-methylphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Op.169/2
- Expiration date of the lot/batch: no data
- Purity: 99%
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: no data
FORM AS APPLIED IN THE TEST (if different from that of starting material): no data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 3 females
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.1 g in conjunctival sac
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A 0.1 g sample of undiluted Imexine OAG was instilled in the conjunctival sac of the left eye of each animal. The eye was not rinsed-off after instillation of the test item, and the untreated right eye served as control. The ocular reactions were assessed 1 hour, 24, 48, and 72 hours after
instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.33
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.33
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Reversibility:
- not specified
- Irritant / corrosive response data:
- A slight swelling and a slight redness of conjunctivae were noted 1 hour after instillation of Imexine OAG. At 24 and 48 hours, animals showed significant swelling with eyelids half or completely closed. At 72 hours, a marked decrease in chemosis was observed. At 24 through 72 hours, significant redness was noted. Grading of the iris was not possible resulting from corneal opacity. From 1 hour after instillation, corneal translucency was easily identifiable. The cumulative mean indices of chemosis, redness, and cornea were 3.33, 2.00, and 2.33, respectively.
Applicant's summary and conclusion
- Conclusions:
- Imexine OAG is an irritant to rabbit eyes when tested undiluted
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