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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
other: Test method accoring to 96/54/EG, B.6 (GPMT). 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: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
not specified
Details on test animals and environmental conditions:
SPF animals.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1 % aqueous CMC
Concentration / amount:
Induction: Intradermal: 2% test substance in 1 % aqueous CMC; Epidermal: 50 % test substance in 1 % aqueous CMC.
Challenge: 50 %.
Challengeopen allclose all
Route:
other: not specified.
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1 % aqueous CMC
Concentration / amount:
Induction: Intradermal: 2% test substance in 1 % aqueous CMC; Epidermal: 50 % test substance in 1 % aqueous CMC.
Challenge: 50 %.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS: Maximum concentration not causing irritating effects in preliminary test: 50 %.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 10 animals in test group, 5 animals in negative control.
- Concentrations: Intradermal induction: 2% test substance in 1 % aqueous CMC; Epidermal induction: 50 % test substance in 1 % aqueous CMC.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Concentrations: 50 %.
- Evaluation: 24 and 48 hours
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

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

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:

Intradermal exposure:

In all animals of the treatment group redness (grade 1 -3) was observed, which was enhanced by treatment with SDS.

Epidermal exposure:

2 of 5 control animals showed a slight scab formation.

2 other control animals showed scaliness of the skin.

All treated animals showed substance related brown staining of the skin.

3 of 10 treated animals showed additionally slight scab formation.

In 1 of 10 treated animals a slight erythema.

In 1 other test animal a severe erythema and scab was observed.

Oedema were observed nor in the test animals neither in the control animals.

Evidence of sensitisation of each challenge concentration:

None of the animals showed effects of sensitisation.

Other observations: none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the Guinea Pig Maximisation Test none of the experimental animals showed effects of sensitisation.
Executive summary:

A sensitization study was performed according to 96/54/EG, B.6. (GMPT) under GLP conditions. Guinea pigs were intradermal (test substance in 1% aqueous carboxymethyl cellulose) and epidermal induced (50 % test substance in 1 % aqueous carboxymethyl cellulose). Then guinea pigs were challenged with test substance at 50% and no evidence of sensitization was seen in any of the tested animals.