Bituminous tars (Ichthammol and Ichthyol Pale) are widely used in pharmaceutical, veterinary and cosmetic industries for their anti-microbial, anti-inflammatory and anti-pruritic effects. In contrast to coal tar, no phototoxicity of bituminous tars has been reported in man, although both Ichthammol and Ichthyol Pale exhibit UV absorption which is higher and broader for the former. The validated 3T3 NRU phototoxicity test indicated phototoxic potential of both substances. The phototoxicity test in a 3D human skin model (EpiDerm) only confirmed phototoxicity for Ichthammol. Human data on Ichthammol phototoxicity are missing. A photopatch test in human volunteers was performed in order to clarify the discrepancy between the phototoxicity found in the skin model and the absence of reported human phototoxicity. Following 4h exposure to 5% and 10% aqueous solutions of Ichthammol and Ichthyol Pale the test sites were irradiated with a UVA dose of 5 J/cm(2). Early phototoxic reaction (erythema) within 4-6h after irradiation was only elicited by Ichthammol and not by Ichthyol Pale. These data correspond well with those from the 3D skin model test and suggest the necessity to employ several test systems for final phototoxicity assessment. In addition to the results obtained in 3T3 NRU PT, further testing on 3D skin models may better reflect bioavailability of a given chemical in the skin, relevant to the situation in humans.

译文

沥青焦油 (鱼腥味和鱼腥味) 因其抗微生物,抗炎和止痒作用而广泛用于制药,兽医和化妆品行业。与煤焦油相反,尽管鱼炭和鱼炭都表现出紫外线吸收,但在人类中没有沥青焦油的光毒性,前者的紫外线吸收更高,更宽。经过验证的3T3 NRU光毒性测试表明两种物质的光毒性潜力。3D人类皮肤模型 (表皮) 中的光毒性测试仅证实了鱼酰胺的光毒性。关于鱼腥草素光毒性的人类数据缺失。为了澄清在皮肤模型中发现的光毒性与没有报告的人类光毒性之间的差异,对人类志愿者进行了光测试。暴露于5% 和10% 的鱼腥酚和鱼腥酚水溶液中4小时后,用5 j/cm(2) 的UVA剂量照射测试部位。辐照后4-6小时内的早期光毒性反应 (红斑) 仅由鱼胺酚引起,而不是由鱼鳞苍白引起。这些数据与3D皮肤模型测试中的数据非常吻合,并建议有必要使用几种测试系统进行最终的光毒性评估。除了在3T3 NRU PT中获得的结果外,在3D皮肤模型上进行的进一步测试可能会更好地反映皮肤中给定化学物质的生物利用度,与人类的情况有关。

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