Suitability of histopathology as an additional endpoint to the Isolated Chicken Eye Test for classification of non-extreme pH detergent and cleaning products

Suitability of the isolated chicken eye test for classification of extreme pH detergents and cleaning products

“…In general, the directions given in the manual AFIP Laboratory Methods in Histotechnology (Prophet et al, 1992) were followed using the Periodic Acid-Schiff (PAS) staining as described previously (Prinsen et al, 2011). Routine semi-quantitative microscopic evaluation of PAS stained corneas was performed by a TNO pathologist according to previously described criteria (Cazelle et al, 2014). Furthermore, the histopathology criteria developed by Cazelle and co-authors (Cazelle et al, 2014) to identify serious eye damage of non-extreme pH formulations (EU CLP/UN GHS Cat.…”

“…Routine semi-quantitative microscopic evaluation of PAS stained corneas was performed by a TNO pathologist according to previously described criteria (Cazelle et al, 2014). Furthermore, the histopathology criteria developed by Cazelle and co-authors (Cazelle et al, 2014) to identify serious eye damage of non-extreme pH formulations (EU CLP/UN GHS Cat. 1) were used in addition to the standard ICE prediction model to evaluate its possible suitability for classification of extreme pH formulations (see Table 2).…”

“…Table 5 shows the results obtained with the ICE test method according to the standard protocol and prediction model prescribed within the OECD TG 438 (OECD, 2013a) with the 18 tested extreme pH detergent and cleaning formulations. Table 6 shows the results obtained with the histopathological observations and possible re-classification based on the histopathology criteria developed by Cazelle and co-workers for non-extreme pH detergent and cleaning formulations (Cazelle et al, 2014). Finally, Table 7 shows an overview of the in vivo classifications of the 18 extreme pH detergent and cleaning formulations compared to the in vitro classifications obtained with the ICE standard test method alone or in combination with the histopathology, as well as to the classifications obtained with the default extreme pH rule (OECD, 2012a) and the additivity approach (EC, 2008).…”

“…In contrast, most of the non-extreme pH formulations under-predicted with the standard ICE test method (6 out of 8) were classified EU CLP/ UN GHS Cat. 1 based on in vivo persistence of effects only, i.e., having tissue effects that did not reverse 21 days after treatment and not on severity of effects (see Cazelle et al, 2014). For these nonextreme pH formulations, use of histopathology significantly improved the sensitivity of the ICE (from 0 to 6 correct identifications out of 8 EU CLP/UN GHS Cat.…”

“…in vitro testing program on the suitability of the Isolated Chicken Eye (ICE) test method to classify non-extreme pH formulations (Cazelle et al, 2014). The ICE test method was selected following an extensive review of public domain literature and A.I.S.E.…”