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Assessing the severity of allergic reactions: A regulatory dilemma

机译:评估过敏反应的严重性:监管难题

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The identification of chemicals possessing the intrinsic ability to cause sensitization via skin contact or inhalation, commonly referred to as skin and respiratory sensitizers, is a key endpoint in regulatory toxicology. Predictive assays for this purpose exist only for skin sensitizers, but, for both types of sensitizer, human evidence can be used to determine whether a substance should be classified. Furthermore, the use of human evidence for subcategorization according to sensitization potency is also accommodated within the regulations. Normally, this is based on the prevalence of sensitization in relation to the degree of exposure in the context of the size of the population exposed. However, the regulations also indicate that the severity of (allergic) reactions may be taken into account. In this article, we consider whether this is appropriate and whether there is evidence that reaction severity can inform decisions on classification and/or potency categorization. The conclusion drawn is that the severity of an allergic reaction does not correlate with, or serve as an indicator of, the sensitizing potency of a chemical. In reality, it reflects the overall extent of sensitization that an individual has acquired, in concert with the concentration of the causative allergen to which they have been exposed.
机译:具有调节通过皮肤接触或吸入引起致敏作用的内在能力的化学物质(通常称为皮肤和呼吸敏化剂)的鉴定是调节毒理学的关键终点。为此目的的预测性测定仅针对皮肤敏化剂,但对于两种类型的敏化剂,都可以使用人类证据来确定是否应对物质进行分类。此外,法规中还包含了根据致敏力将人类证据用于子类别的用途。通常,这是基于在暴露人口规模的背景下与暴露程度有关的致敏率。但是,该法规还指出(过敏)反应的严重性可能会被考虑在内。在本文中,我们考虑这是否合适以及是否有证据表明反应的严重性可以为分类和/或效价分类的决策提供依据。得出的结论是,过敏反应的严重性与化学物质的致敏力无关,也不作为其指标。实际上,它反映了一个人获得的总体致敏程度,与他们所接触的致病性致敏原的浓度一致。

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