Registration Dossier

Diss Factsheets

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:
2004

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
GLP compliance:
no

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 study report): Vitamin B12

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.