Quantitative repeated open application testing with a rinse-off product in methyldibromo glutaronitrile-sensitive patients: results of the IVDK.
BACKGROUND
While the use of methyldibromo glutaronitrile (MDBGN) in leave-on products is clearly associated with high sensitization or elicitation risk, such a clear-cut relation could be questioned with regard to rinse-off products.


OBJECTIVE
The objective of this study was to find a maximum non-eliciting concentration for rinse-off products in MDBGN patch test-positive patients.


METHODS
We performed a use-related test [repeated open application test (ROAT)] in patients sensitized to MDBGN with a liquid soap containing three concentrations of MDBGN (50, 200, and 400 p.p.m. MDBGN, respectively). The soap at 50 p.p.m. was used twice daily for 4 weeks. If no reaction of the skin was observed, the product with the next higher concentration was used for another 4 weeks, etc.


RESULTS
In total, 32/37 evaluated cases [86.5%; lower exact one-sided 95% confidence limit (CL): 73.7%] did not react to any of the preparations. The remaining reacted as follows: 1/37 reacted to 50 p.p.m., 3/37 to 200 p.p.m., and 1/37 to 400 p.p.m. The cumulative non-response to 50 p.p.m. was 97.3% (lower CL: 87.8%).


CONCLUSIONS
The majority of subjects sensitized to MDBGN-tolerated rinse-off products containing a maximum concentration of 400 p.p.m. A concentration in rinse-off products in the range of 50 p.p.m. could be regarded as safe for most individuals already sensitized. These concentrations will presumably prevent induction (sensitization) also.
Heratizadeh
Annice
A
Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hanover, Germany. heratizadeh.annice@mh-hannover.de
Killig
Claudia
C
Worm
Margitta
M
Soost
Stephanie
S
Simon
Dagmar
D
Bauer
Andrea
A
Mahler
Vera
V
Schuster
Christian
C
Szliska
Christiane
C
Frambach
Yvonne
Y
Eben
Ricarda
R
Werfel
Thomas
T
Uter
Wolfgang
W
Schnuch
Axel
A
D000328:Adult; D000368:Aged; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects*; D010328:Patch Tests / Q000009:adverse effects*; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects*; D012867:Skin / Q000187:drug effects; D012915:Soaps / Q000009:adverse effects*; D055815:Young Adult
D009570:Nitriles; D011310:Preservatives, Pharmaceutical; D012915:Soaps; C039411:1,2-dibromo-2,4-dicyanobutane