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  • 1
    Electronic Resource
    Electronic Resource
    Oxford, UK; Malden, USA : Blackwell Science Ltd/Inc.
    Contact dermatitis 50 (2004), S. 0 
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Germall 115 and Germall II are well known cosmetic preservatives, widely used as such since the early 1970’s and 1980’s, respectively. This investigation reveals that they have mistakenly been regarded as pure chemical entities with specific structures by the majority of the chemical society. In fact Germall 115 and Germall II both consist of complex mixtures of numerous and fast degradable allantoin-formaldehyde condensation products and may not even contain the conventionally assigned chemical structures of imidazolidinyl urea (Germall 115) and diazolidinyl urea (Germall II). Equilibrium between different structures may be formed in different cosmetic formulations/test materials. This may have led to the discrepancies in the literature: Are the Germalls themselves sensitizers or are the allergic reactions caused by formaldehyde release? The identification and structure assignment of (4-hydroxymethyl-2,5-dioxo-imidazolidin-4-yl)-urea (HU) will be presented, as it is the major and chemically stable degradation product of both Diazolidinyl urea and Imidazolidinyl urea. A guinea pig maximization test has been performed to determine the potential of HU to induce delayed contact hypersensibility in guinea pigs. Separate chemically stable TRUE Test patches containing the mixtures have shown clinical efficacy.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1600-0536
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: The preservatives imidazolidinyl urea (IMID, Germall 115) and diazolidinyl urea (DU, Germall II) are commonly used in cosmetic products and are well-known sensitizers. The aim of the present study was to establish the optimal patch test concentration in hydrophilic dried-in vehicle (TRUE Test) for IMID and DU. 181 patients were included in the study. Of these, 150 were patients referred for patch testing, 12 were patients with known allergy to IMID and 19 were patients with known allergy to DU. 76 consecutive patients and the 12 IMID-allergic patients were patch tested with a dilution series IMID (0 to 600 μg/cm2), formaldehyde (180 μg/cm2) and DU (200 μg/cm2). 74 consecutive patients and the 19 DU-allergic patients were patch tested with a dilution series of DU (0 to 600 μg/cm2), formaldehyde (180 μg/cm) and IMID (200 μg/cm2). A positive dose-response relationship was found. The number of doubtful reactions decreased with increasing test concentrations. No late reactions were observed. A patch test concentration in hydrophilic dried-in vehicle (TRUE Test) of 600 μg/cm2 was found to be adequate and safe for both IMID and DU.
    Type of Medium: Electronic Resource
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