Registration Dossier

Administrative data

Endpoint:
skin 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.4. 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.4
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:
not specified
Details on test material:
- Name of test material: BIMBIM

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
SPF animals.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: moistened substance
Controls:
not specified
Amount / concentration applied:
500 mg.
Duration of treatment / exposure:
4 h.
Observation period:
72 h.
Number of animals:
3
Details on study design:
SCORING SYSTEM: B.4 scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 72 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 3 days.
Other effects:
During the observation period orange staining occurred on
the treated skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance did not caused skin irritation/corrotion in rabbits when 500 g of moistened substance was applied to rabbits for 4 hours under semiocclusive conditions.
Executive summary:

A skin irritation test was performed according to 92/69/EWG, B.4 under GLP conditions. The test moistened substance was applied to 3 rabbits under semiocclusive conditions for 4 hours. The post-exposure observation perdiod was 72 hours. All scores for erythema and oedema were 0 and the changes observed were fully reversible within 3 days, the only remarcable event was that during observation period orange staining occured on the treated skin.