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EC number: 617-349-5 | CAS number: 82543-17-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- GLP compliance:
- yes
Test material
- Reference substance name:
- 21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol
- EC Number:
- 617-349-5
- Cas Number:
- 82543-17-7
- Molecular formula:
- C24 H34 O4
- IUPAC Name:
- 21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- test substance remained in the eye and eye was not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results of the study
| Irritant Effects (Score) | |||||
| Animal | 24 h | 48 h | 72 h | Mean scores | |
| 1 (male) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
| 2 (male) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
| 3 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
| 4 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
Slight reactions of the conjunctivae and iris were observed on the day of application. The cornea was not affected. However, all animals were without findings 24 hours after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the eye.
- Executive summary:
The single administration of Trihydroxypropinol into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 34.8 -45.0 mg) results in slight reactions of the conjunctivae and iris on administration day. From day 2 (24 h after administration) onwards all animals were without findings.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris, conjunctival reddening and conjuntival swelling. Therefore, according to EU classification criteria the test substance is not eye irritating.
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