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EC number: 606-280-6 | CAS number: 192704-54-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Dec 2000
- 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Test material
- Reference substance name:
- 3,3-Ethylenedioxy-17 alpha-hydroxy-5-androstene-17beta-carbonitrile
- IUPAC Name:
- 3,3-Ethylenedioxy-17 alpha-hydroxy-5-androstene-17beta-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): ZK 233744
- Batch No.: 1366
- Purity: 92.3%
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):
- 72 hours
- Number of animals or in vitro replicates:
- 2 (3) 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:
- 0.59
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- 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) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
| 2 (male) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
| 3 (female) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 0 | 0.67 | |
| Conjunctiva (swelling) | 1 | 1 | 0 | 0.67 | |
| 4 (female) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 0 | 0 | 0.33 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
A slight reddening of the conjunctivae were observed in all animals and a slight to moderate swelling of the conjunctivae was observed in both male animals and one female animal on administration day.
Applicant's summary and conclusion
- Executive summary:
The single administration of Diketon into the right eye of 2 (3) males and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 61.5 -65.2 mg) resulted in slight reddening of the conjunctivae observed in all animals on the administration day and on days 2 and 3 (except one female animal only until day 2). Slight to moderate swelling of the conjunctivae was observed in two male animals and one female animaion the administration
day. In one female animal slight swelling was seen until day 3. All animals were without findings on day 4.
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 and iris, 0.17 for conjuntival swelling and 0.59 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
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