کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5857750 1132029 2012 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies
چکیده انگلیسی

Skin corrosion or irritation refers to the production of irreversible or reversible damage to the skin following the application of a test substance, respectively. Traditionally, hazard assessments are conducted using the in vivo Draize skin test, but recently in vitro tests using reconstructed human epidermis (RhE) models have gained regulatory acceptance. In this study, skin corrosion (SCT) and irritation tests (SIT) using a RhE model were implemented to reduce the number of in vivo tests required by regulatory bodies. One hundred and thirty-four materials were tested from a wide range of substance classes included 46 agrochemical formulations. Results were assessed according to UN GHS, EU-CLP, ANVISA and US EPA classification schemes. There was high correlation between the two in vitro tests. Assessment of the SCT sensitivity was not possible due to the limited number of corrosives in the data set; SCT specificity and accuracy were 89% for all classification systems. Accuracy (63-76%) and sensitivity (53-67%) were low in the SIT. Specificity and concordance for agrochemical formulations alone in both the SCT and SIT were comparable to the values for the complete data set (SCT: 91% vs. 89% specificity, 91% vs. 89% accuracy and SIT: 64-88% vs. 70-85% specificity, 56-75% vs. 63-76% accuracy).

► Skin corrosion/irritation in vitro tests (SCT/SIT) were compared to in vivo data. ► One hundred and thirty-four substances were tested (including 46 agrochemical formulations). ► SCT sensitivity could not be evaluated due the limited number of corrosives tested. ► SIT sensitivity and accuracy were low. ► Predictivities for agrochemical formulations were comparable to other substances.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 64, Issue 3, December 2012, Pages 402-414
نویسندگان
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