Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Reference
Reference Type:
publication
Title:
Patch test reactions to Biobans in metalworkers are often weak and not reproducible.
Author:
Brinkmeier, T., Geier, J., Lepoittevin, J.P., and Frosch, P.J.
Year:
2002
Bibliographic source:
Contact Dermatitis, 47, 27-31.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Route of administration:
dermal

Results and discussion

Results of examinations:
In 408 metalworkers, 14 (3.4%) showed positive reactions to Biobans (2% to CS-1246). Upon retesting, the reactions were confirmed in only 2 cases (P1487 and CS1135). Four patients showed reactions to 3 Biobans (P1487, CS1246, and CS1135), while 9 patients had only solitary sensitizations.
Concomitant sensitizations to formaldehyde were present in 5/10 patients, being reproducible in only 3. In the IVDK data, sensitization prevalence in 3400 patients ranged fro 1.8% (P1487) to 0.8% (CS-1246). A high proportion of doubtful or weak reactions were observed.

Low cross-reactivity between Biobans was low, moderate agreement being calculated for CS1135 and CS1246 (kappa coefficient of 0.43). The consensus pattern between Biobans and formaldehyde was even lower.

Patch test reactions to Biobans are not rare among metalworkers, but are often weak and/or not reproducible.

Applicant's summary and conclusion