Registration Dossier
Registration Dossier
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EC number: 617-351-6 | CAS number: 82544-13-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Version / remarks:
- 1987-02-24
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one
- EC Number:
- 617-351-6
- Cas Number:
- 82544-13-6
- Molecular formula:
- C25 H36 O5
- IUPAC Name:
- 5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one
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 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:
- 0.42
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 1
- 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) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 1 | 0 | 0.67 | |
| Conjunctivae (swelling) | 1 | 1 | 0 | 0.67 | |
| 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 | 0.33 | |
| 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 | 0.33 | |
| Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
| 4 (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 | 0.33 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
A slight to moderate reddening and slight to severe swelling of the conjunctivae were seen in all animals on administration day.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item was not irritating to eyes.
- Executive summary:
The single administration of Methylenepoxidpivalat into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 57.8 -66.0 mg) results in slight to moderate reddening and slight to severe swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening and swelling were seen in all animals, while slight reddening and swelling were also seen in one animal on day 3. Three out of 4 animals were without findings from day 3 onwards, all animals were without findings by 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, 0.3 for conjuntival swelling and 0.4 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
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