Registration Dossier

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:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

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.