Read-across can increase confidence in the Next Generation Risk Assessment for skin sensitisation: A case study with resorcinol.

Historically skin sensitisation risk assessment for cosmetic ingredients was based on animal models, however regulatory demands have led to Next Generation Risk Assessment (NGRA), using data from New Approach Methodologies (NAM) and Defined Approaches (DA). This case study was meant to investigate if the use of resorcinol at 0.2% in a face cream was safe and a maximum use concentration could be defined. The NAM data and DA predictions could not provide sufficient confidence to determine a point of departure (POD). Therefore, the application of read-across was explored to increase the level of confidence. Analogue searches in various tools and databases using "mode of action" and "chemical structural features" retrieved 535 analogues. After refinement by excluding analogues without a defined structure, similar reactivity profile and skin sensitisation data, 39 analogues remained. A final selection was made based on three approaches: expert judgment, chemical similarity or Local Lymph Node Assay data (LLNA). All read-across approaches supported a moderate potency. A POD derived from the LLNA EC3 of 3.6% was determined leading to a favourable NGRA conclusion and a maximum use concentration of 0.36%. This was supported by a traditional risk assessment based on the available animal data for resorcinol.

[Toxicological risk assessment using the example of potential contact sensitization to resorcinol]. / Toxikologische Risikobewertung am Beispiel einer möglichen Kontaktsensibilisierung auf Resorcinol.

Resorcinol is a frequently used hair dye, whose quantitative risk assessment (QRA) for hair color products is presented in this review as an example to assess its skin sensitization risk after topical application. Its purpose is to determine the maximum concentration that can be used without expecting skin sensitization to occur. The focus is to prevent the de novo development of a contact allergy. Epidemiological data which are provided via dermatological surveillance, e.g., by the IVDK (Information Network of Departments of Dermatology) in Germany, are an important source of information that help to assess the quality and the effectivity of the QRA.

Application of hydrolases and probiotic Pediococcus acidilactici BaltBio01 strain for cereal by-products conversion to bioproduct for food/feed.

The aim of this study was to apply the enzymatic treatment and fermentation by Pediococcus acidilactici BaltBio01 strain for industrial cereal by-products conversion to food/feed bioproducts with high amount of probiotic lactic acid bacteria (LAB). LAB propagated in potato media and spray-dried remained viable during 12 months (7.0 log10 cfu/g) of storage and was used as a starter for cereal by-products fermentation. The changes of microbial profile, biogenic amines (BAs), mycotoxins, lactic acid (L+/D-), lignans and alkylresorcinols (ARs) contents in fermented cereal by-product were analysed. Cereal by-products enzymatic hydrolysis before fermentation allows to obtain a higher count of LAB during fermentation. Fermentation with P. acidilactici reduce mycotoxins content in fermented cereal by-products. According to our results, P. acidilactici multiplied in potato juice could be used for cereal by-products fermentation, as a potential source to produce safer food/feed bioproduct with high amount of probiotic LAB for industrial production.

A clinical assessment of a patch test kit marketed to U.K. hairdressers for detecting hair dye allergy.

BACKGROUND: In 2004 a U.K.-based company developed and marketed a patch test kit (Colourstart); Trichocare, Ridgmont, Beds, U.K.) for use by hairdressers. It is intended to assess whether clients have a 'problem with hair dye' and promotes itself as the 'only practical solution to sensitivity testing'. However, a patient presented with a hair dye reaction that had not been detected while using this patch test system. OBJECTIVES: To assess the Colourstart system in the next seven consecutive patients presenting with a history of adverse reactions to hair dyes. METHODS: The Colourstart system was tested in parallel with commercially available hair dye patch test reagents, where applicable. RESULTS: Only three of seven patients allergic to p-phenylenediamine were detected using this system and one patient allergic to toluene-2,5-diamine sulphate was not detected using this system. CONCLUSIONS: The results raise concerns about the sensitivity of this kit for consumer protection, but also wider questions about the regulation, use and interpretation of 'home diagnostic patch test kits' in general.

Toxicology review and risk assessment of resorcinol: thyroid effects.

Resorcinol administered at high doses to rodents can disrupt thyroid hormone synthesis and can produce goitrogenic effects. These effects were not seen in a 2-year bioassay at doses of up to 520 mg/kg/day. There are species-specific differences in synthesis, binding, and transport of thyroid hormone that complicate interpretation of goitrogenesis in rodents. Clinical case reports from patients undergoing resorcinol therapy for dermatological indications reveal thyroid side effects when copious amounts of resorcinol-containing ointments are applied to integrity-compromised skin for months to years. Effect levels were greater than 34 mg/kg/day. Occupational epidemiology studies provide no evidence that exposure to resorcinol at levels greater than found in the general environment causes thyroid dysfunction. Studies investigating the relationship between endemic goiter and exposure to "phenolics," including resorcinol, in drinking water do not fulfill accepted scientific criteria for establishing resorcinol as a cause of thyroid disease. Those reports neither quantify exposure levels nor demonstrate dose-response relationships or rule out confounding by the multiple other chemicals present in water supplies, by bacterial contamination of water, or by nutritional factors. A risk assessment comparing potential worst-case exposures to resorcinol through its use in dermatological preparations supports the conclusion that under real-world conditions, human exposures to resorcinol are not expected to cause adverse effects on thyroid function.