Registration Dossier
Registration Dossier
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EC number: 604-866-6 | CAS number: 152628-02-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to 92/69/EWG, B.5. GLP study.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.5
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-240-7
- EC Name:
- -
- Molecular formula:
- C19H20N4.H2O
- IUPAC Name:
- 1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzimidazole hydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: BIMBIM
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 40 mg.
- Duration of treatment / exposure:
- Eye instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24 h observation.
SCORING SYSTEM: B.5 scoring system.
TOOL USED TO ASSESS SCORE: fluorescein (2%).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 1.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 1.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0.67
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: Overall at 24, 48 and 72 h.
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 15 days.
- Other effects:
- Instillation of approximately 40 mg substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in one animal and within 15 days in the other two animals.
No iridic irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24 h observation.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- When instillated into eyes of rabbits, the test substance caused irritation of conjunctivae, chemosis and discharge but the irritation completely resolved in 15 days and no iridic irritation or corneal opacitiy were observed.
- Executive summary:
A eye irritation test was performed according to 92/69/EWG, B.5. 40 mg of the test substance was instillated into one eye of each three rabbits. The instillationr resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in one animal and within 15 days in the other two animals. No iridic irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.There was no evidence of ocular corrosion.
Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24-h observation.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
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