Draft report interim analysis of the estimated potential underclassification rates of the current rabbit test for detecting ocular corrosives and severe irritants (2005).

Content Provider	CiteSeerX
Author	Haseman, Joseph K. Choksi, Neepa Y. Allen, David G. Tice, Raymond R. Stokes, William S.
Abstract	An analysis 1 was conducted to estimate the likelihood of underclassifying ocular corrosives or severe irritants when using the current sequential three animal in vivo rabbit eye test method based on existing protocol guidelines (e.g., OECD 2002) and the United Nations (UN) Globally Harmonized System (GHS) of Classification and Labeling of Chemicals (UN 2003). The analysis was based on a database of 128 substances classified as GHS Category 1 irritants (i.e., corrosives and severe irritants) based on 142 studies using a total of 661 rabbits. To conduct this analysis, individual rabbit responses were first classified according to the GHS classification system (UN 2003). The estimated underclassification rate was then calculated three ways, each using a different assumption. Calculation 1 assumed homogeneity of response for GHS Category 1 irritants; Calculation 2 assumed heterogeneity of response for GHS Category 1 irritants; and Calculation 3 assumed homogeneity of response for three subgroups of GHS Category 1 irritants. The three subgroups were: (1) strong responders, where all treated rabbits expressed a severe response; (2) moderate responders, where the majority but not all treated rabbits expressed a severe response; and (3) weak responders, where the majority of treated rabbits expressed a nonsevere irritant or nonirritant response. Using the three calculation methods, the estimated underclassification rates for the total database
File Format	PDF
Publisher Date	2005-01-01
Access Restriction	Open
Content Type	Text