Registration Dossier
Registration Dossier
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EC number: 200-680-0 | CAS number: 68-19-9
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: No guideline followed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
- GLP compliance:
- no
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 study report): Vitamin B12
Constituent 1
Method
- Type of population:
- other: Vitamin B12 deficient
- Ethical approval:
- not applicable
- Subjects:
- - Number of subjects exposed: 1
- Sex: Female
- Age: 16 years old - Clinical history:
- -Exposure: Intramuscular injection.
First exposition: Pain at the injection site.
Second exposition (2 months later): additional sensation of substernal burning and pleuritic pain.
Third exposition (1 month later): additional pruritus of the arms and legs. - Controls:
- Benzyl alcohol (positive control)
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- The patient demonstrated no reaction to the intranasal exposure.
Applicant's summary and conclusion
- Conclusions:
- A 16-year-old female was skin tested with cyanocobalamin and benzyl alcohol, showing adverse reactions in the last case but any reaction when exposed to 500µg of Cyanocobalamine alone.
- Executive summary:
A 16 -year-old female was referred for assessment of possible anaphylactic reactions following cyanocobalamin injections. After the first intramuscular injection she reported pain at the injection site. In the second exposition, 2 months later, she also reported sensation of subesternal burning and pleuritic pain. In the third exposition, 1 month later, she added pruritus of the arms and legs.
Firstly she was skin tested to three commercial preparations of injectable cyanocobalamin and to the benzyl alcohol (0.9%) preservative found in each. Prick testing was negative, but intradermal testing was positive in all cases.
Then, she was given a 500µg dose of a cyanocobalamin gel (without benzyl alcohol) for intranasal application. The patient did not demonstrated any reaction, and therefore Cyanocobalamin can be considered as non sensitizer under the test conditions.
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