Concentration variability of potent allergens of p-tert-butylphenol-formaldehyde resin (PTBP-FR) in patch test preparations and commercially available PTBP-FR

• Published in: British journal of dermatology (1951) Vol. 166; no. 4; pp. 761 - 770
• Main Authors: Hamann, C.R., Zimerson, E., Hamann, D., Laugesen, L., Carlsson, B., Nathansen, C., Hamann, C., Bruze, M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-04-2012; Wiley-Blackwell
• Subjects: Adhesives; Adhesives - chemistry; Allergens - analysis; Biological and medical sciences; Chromatography, High Pressure Liquid; Clinical Medicine; Dermatologi och venereologi; Dermatology; Dermatology and Venereal Diseases; Klinisk medicin; Magnetic Resonance Spectroscopy; Medical and Health Sciences; Medical sciences; Medicin och hälsovetenskap; Patch Tests - methods; Phenols - analysis; Reference Standards; Resins, Synthetic - chemistry; Immunopathology; Allergy; Concentration; Dermatology; Patch; Formaldehyde
• ISSN: 0007-0963; 1365-2133; 1365-2133
• DOI: 10.1111/j.1365-2133.2011.10781.x

Summary Background  p‐tert‐Butylphenol‐formaldehyde resin (PTBP‐FR) is a common component of glues used in the manufacturing of many plastic, electronic, rubber, wood and leather products. Two main allergens of PTBP‐FR have been described.
Objectives  To determine the concentrations of the two main allergens of PTBP‐FR in diagnostic patch testing preparations and PTBP‐FR available to glue and adhesive manufacturers.
Methods  Nuclear magnetic resonance spectrometry was used to confirm the identity and determine the purity of reference materials. High‐pressure liquid chromatography was used to analyse patch test preparations and commercially available PTBP‐FR.
Results  In the PTBP‐FR in analysed patch test preparations the highest concentration of the allergenic dimer 4‐tert‐butyl‐2‐(5‐tert‐butyl‐2‐hydroxy‐3‐hydroxymethyl‐benzyloxymethyl)‐6‐hydroxymethylphenol found was 1·79% and the lowest 0·21%. The highest concentration of the allergenic dimer 4‐tert‐butyl‐2‐(5‐tert‐butyl‐2‐hydroxy‐benzyloxymethyl)‐6‐hydroxymethylphenol found in PTBP‐FR of analysed patch test preparations was 0·50% and the lowest concentration found was 0·04%. In commercially available PTBP‐FR the highest concentration of 4‐tert‐butyl‐2‐(5‐tert‐butyl‐2‐hydroxy‐3‐hydroxymethyl‐benzyloxymethyl)‐6‐hydroxymethylphenol found was 3·7% and the highest concentration of 4‐tert‐butyl‐2‐(5‐tert‐butyl‐2‐hydroxy‐benzyloxymethyl)‐6‐hydroxymethylphenol found was 1·1%. In three PTBP‐FR samples neither allergen could be detected.
Conclusions  Our data suggest that reporting resin concentration in petrolatum is not predictive of a consistent concentration of the two main allergens of PTBP‐FR. The 10‐fold difference in allergen concentration between different patch test preparations has significant ramifications for maintaining consistent dose of delivered allergen. The results of this study reinforce the need for patch test product standardization in the contact dermatitis community.