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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Only available data were used for registration according to REACH article 18. Conducting new tests is not required according to article 18.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
440-240-7
EC Name:
-
Cas Number:
1282554-35-1
Molecular formula:
C19 H20 N4
IUPAC Name:
2-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazole

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan strain
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Challenge
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical observations
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no clinical observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no clinical observations.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical observations
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% test substance concentration
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance concentration. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical observations.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No evidence was obtained that BIBR 2271BIMBIM had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Direct ive 93/211EEC, 27th Apri 1 1993), BIBR 227lBIMBIM does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact.