Commission Regulation (EC) No 761/2009Show full title

INTRODUCTION

Procedures proposed for use under this Test Method should be evaluated to determine their reliability and accuracy using substances representing the full range of Draize irritancy scores. When evaluated using the 20 recommended reference substances (Table 2), the proposed procedure should have reliability and accuracy values which are comparable to that of the validated reference method 1 (Table 3) (1). The accuracy and reliability standards that should be achieved are provided under II and III below. Non-classified and classified (UN GHS category 2) substances, representing relevant chemical classes are included, so that the reliability and performance (sensitivity, specificity, false negative rates, and false positive rates and accuracy) of the proposed test method can be compared to that of the validated reference method 1. The reliability of the test method, as well as its ability to correctly identify UN GHS category 2 irritant substances, should be determined prior to its use for testing new substances.