Registration Dossier
Registration Dossier
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EC number: 200-680-0 | CAS number: 68-19-9
Skin sensitisation
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:
- 1 950
Materials and methods
- GLP compliance:
- no
- Type of study:
- not specified
Test material
- 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.
Constituent 1
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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