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EC number: 612-953-5 | CAS number: 6218-29-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Aug to Sep 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Test material
- Reference substance name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- EC Number:
- 612-953-5
- Cas Number:
- 6218-29-7
- Molecular formula:
- C18 H24 O2
- IUPAC Name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 47359
- Batch No.: 54512003
- purity: 100.2%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- test substance remained in the eye - eye was not rinsed
- Observation period (in vivo):
- 5, 7 or 8 days
- 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:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.58
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- The treatment did not result in any effect on body weight.
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 etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 2 | 1 | 1 | 1.33 | |
| Conjunctivae (swelling) | 1 | 1 | 0 | 0.67 | |
| 2 (male) | Corneal (opacity) | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 1 | 1 | 1.0 | |
| Conjunctivae (swelling) | 1 | 1 | 1 | 1.0 | |
| 3 (female) | Corneal (opacity) | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 1 | 1 | 1.33 | |
| Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
| 4 (female) | Corneal (opacity) | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 1 | 1 | 1.0 | |
| Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
On the day of administration slight to severe reddening and moderate to severe swelling of the conjunctivae were observed in all animals. Afterwards slight to moderate reddening of the conjunctivae was noted up to day 4 or 7 and slight swelling was seen until day 2, 3, or 6. All animals were without findings on day 8.
Applicant's summary and conclusion
- Executive summary:
The single administration of Hydroxyestradienon into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 52.9 -64.9 mg) results in slight to severe reddening and moderate to severe swelling of the conjunctivae in all animals on administration day. Afterwards slight to moderate conjunctival reddening was noted up to day 4 or 7 and slight swelling was seen until day 2, 3, or 6. All animals were without findings on day 8.
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, 0.6 for conjuntival swelling and 1.1 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
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