Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-834-1 | CAS number: 863329-69-5
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:
- 7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
- EC Number:
- 617-834-1
- Cas Number:
- 863329-69-5
- Molecular formula:
- C25H35BrO4
- IUPAC Name:
- 7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 137314
- Batch No.: 21608213
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:
- 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:
- 0.17
- 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:
- 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 | 0 | 0 | 0.33 | |
| 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) | 1 | 0 | 0 | 0.33 | |
| 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 | |
A slight to moderate reddening and swelling of the conjunctivae were seen in all animals on administration day.
Applicant's summary and conclusion
- Executive summary:
The single administration of Bromepoxid into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 43.3 -44.2 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) only slight conjunctival reddening was seen in two out of four animals and from day 3 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 and conjuntival swelling and 0.2 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
