Differences in contents of organochlorine impurities do not influence responses to patch testing with Majantol®.

ABSTRACT

BACKGROUND: Majantol® [2,2-dimethyl-3-(3-methylphenyl)propan-1-ol; CAS no. 103694-68-4] has been identified as a contact allergen in humans, despite negative animal tests. Hence impurities, specifically organochlorines, in Majantol® might have been the reason for positive patch test reactions in the past. OBJECTIVES: To assess elicitation via patch testing with a standard market-quality version of Majantol® ('normal') with a normal content of organochlorine impurities, as compared with an ultra-purified version of Majantol® ('pure'), without detectable organochlorine impurities. METHODS: Between 1 October 2013 and 31 December 2014, two different Majantol® patch test preparations of the above-mentioned quality were tested 5% pet. in parallel in the 'monitor series', that is, together with the baseline series, in 8005 consecutive patients from 33 departments of dermatology of the Information Network of Departments of Dermatology (IVDK). RESULTS: Fifty-three of 7740 [0.69% (95%CI 0.51-0.87)] patch tested patients reacted to at least one Majantol® preparation. The majority (n = 32) (60.4%) reacted to both preparations, 13 (24.5%) reacted to the 'normal' version only, and 8 (15.1%) reacted to the 'pure' version only. There was good concordance between results [Cohen's kappa 0.75 (95%CI 0.65-0.85)], and there was no significant difference in frequency or intensity between the two preparations. More doubtful or irritant reactions than positive reactions were observed, and> 80% of all positive reactions were weak positive. CONCLUSION: Organochlorine impurities are very probably not the cause of allergic reactions to Majantol®.