Registration Dossier
Registration Dossier
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EC number: 207-821-5 | CAS number: 496-46-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Perhydroimidazo[4,5-d]imidazole-2,5-dione
- EC Number:
- 207-821-5
- EC Name:
- Perhydroimidazo[4,5-d]imidazole-2,5-dione
- Cas Number:
- 496-46-8
- Molecular formula:
- C4H6N4O2
- IUPAC Name:
- perhydroimidazo[4,5-d]imidazole-2,5-dione
Constituent 1
- Specific details on test material used for the study:
- Batch number: Zwischenprodukt aus Partie 692.
Date of manufacturing: 27July 1998.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals
Source: Boehringer Ingelheim Pharma KG.
Age: Young Adults.
Housing: Single Housing.
Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130g/day).
Water: Tap water, ~250mL/day.
Acclimatisation period: at least 1 week.
Environmental Conditions
Temperature (C): 20 - 24.
Humidity (%): 30-70.
Air changes (per hour): Not Reported.
Photoperiod (hrs dark/hrs light): 12/12.
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- Amount was 0.1mL bulk volume (about 46mg of the comminuted test substance).
Date of application: Animal 1: 05 October 1998; Animals 2 & 3: 12 October 1998. - Duration of treatment / exposure:
- 24 hours.
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 3 (females).
- Details on study design:
- Both eyes of the animals were assessed for abnormalities which would confound the study prior to application of test material.
The test substance was applied in a single dose to the conjunctival sac of the right eyelid; the test substance was washed out about 24 hours after application (before 24 hours reading).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
24 hour exposure |
|||||||
| Reading | Animal | Cornea (opacity) | Cornea (area) | Iris | Conjunctiva (redness) | Conjuctiva (swelling) | Conjuctiva (discharge) |
| 1 hr | 1 | 0 | 0 | 0 | 2 | 1 | 1 |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 2 | 1 | 0 | |
| 24 hrs | 1 | 0 | 0 | 0 |
1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 48 hrs | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 72 hrs | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mean | 1 | 0 | 0 | 0.3 | 0 | ||
| 2 | 0 | 0 | 0 | 0 | |||
| 3 | 0 | 0 | 0.3 | 0 | |||
| Mean | 0 | 0 | 0.2 | 0 | |||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is a non-irritant to the eye.
- Executive summary:
An in vivo eye irritation test was carried out, according to OECD TG 405 (1999), to assess the eye irritation potential of the test substance. The study was conducted on three rabbits (New Zealand White). The test substance was applied to one eye in a single ocular application of 0.1mL bulk volume (~46mg) while the other was used as a negative control for each rabbit. The rabbits were observed for any sign of eye irritation. The average score (24 -72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris, and chemosis whilst 0.2 for conjunctival redness. These clinical observations were reversible in all animals within 48 hours after the application of the test substance; as such the study was terminated after 72 hours. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the eye and therefore is unclassified under Regulation 1272/2008.
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