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EC number: 617-708-6 | CAS number: 85390-94-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Nov 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- EC Number:
- 617-708-6
- Cas Number:
- 85390-94-9
- Molecular formula:
- C29 H44 O6
- IUPAC Name:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 92136
- Batch No.: 21604812
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 and was not flushed out
- 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:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- Single application of ZK 92136 led to slight to moderate reddening and swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) slight conjunctival reddening was seen in two out of four animals and on day 3, all animals were without findings.
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, 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) | 1 | 0 | 0 | 0.3 | |
| 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) | 1 | 0 | 0 | 0.3 | |
| 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 | |
Applicant's summary and conclusion
- Executive summary:
The single administration of Dipivalat into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 51.2 -52.4 mg) results in slight to moderate reddening and swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) slight conjunctival reddening was seen in two out of four animals and on day 3, 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 and conjuntival swelling and 0.2 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
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