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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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.