Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No guideline followed. Only few data on test method reported.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1950

Materials and methods

GLP compliance:
no
Type of study:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyanocobalamin
EC Number:
200-680-0
EC Name:
Cyanocobalamin
Cas Number:
68-19-9
Molecular formula:
C63H88CoN14O14P
IUPAC Name:
cyanocobalamin
Test material form:
not specified
Details on test material:
- Name of test material as cited in the study report: Vitamin B12.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 400 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: subcuatenous
Vehicle:
no data
Concentration / amount:
Induction: 5 µg per animal
Challenge: 15 µg per animal
Challengeopen allclose all
Route:
other: intraperitoneal
Vehicle:
no data
Concentration / amount:
Induction: 5 µg per animal
Challenge: 15 µg per animal
No. of animals per dose:
12 animals per one dose.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21.
- Exposure period: 21 days
- Test groups: Only 1 group.
- Site: Subcutaneous.
- Frequency of applications: Once a day.
- Duration: 21 days.
- Concentrations: 5 µg/animal

B. CHALLENGE EXPOSURE
- No. of exposures: One.
- Day(s) of challenge: Day 37 after the last induction exposure.
- Test groups: Only 1 group.
- Site: Intraperitoneal.
- Concentrations: 15 µg/animal
:

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: None.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
In the present study, the intraperitoneal injection of the test substance did not cause an allergic reaction after 21 days induction period of daily subcutaneous injections.
Executive summary:

In the present study, a group of 12 guinea pigs received daily subcutaneous injections of 5 µg of the test substance for 21 days as Induction phase. After an internval of 37 days, the challenge phase was carried out through an intraperitoneal injection of 15 µg the test item.

None of the animals suffered any allergic reactions and therefore the test item can be considered as not sensitizer.

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