Cyanocobalamin

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:

2004

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

GLP compliance:

no

Test material

Test material information

Constituent 1

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.