title: Suitability of histopathology as an additional endpoint to the Isolated Chicken Eye Test for classification of non-extreme pH detergent and cleaning products.
abstract: A.I.S.E. investigated the suitability of histopathological evaluations as an additional endpoint to the regulatory adopted ICE in vitro test method (OECD TG 438) to identify non-extreme pH detergent and cleaning products that require classification as EU CLP/UN GHS Category 1 (serious eye damage). To this aim, a total of 30 non-extreme pH products covering the range of in vivo classifications for eye irritation, and representing various product categories were tested. Epithelium vacuolation (mid and lower layers) and erosion (at least moderate) were found to be the most relevant histopathological effects induced by products classified in vivo as Category 1. Histopathology criteria specifically developed for non-extreme pH detergent and cleaning products were shown to correctly identify materials classified as Category 1 based on in vivo persistent effects, and to significantly increase the overall sensitivity of the standard ICE prediction model for Category 1 identification (to 75%) whilst maintaining a good concordance (73%). In contrast, use of EU CLP additivity approach for classification of mixtures was considerably less predictive, with a concordance of only 27%, and 100% over-predictions of non-Category 1 products. As such, use of histopathology as an addition to the ICE test method was found suitable to identify EU CLP/UN GHS Category 1 non-extreme pH detergent and cleaning products and to allow a better discrimination from Category 2 products.
authors: A.I.S.E., Brussels, Belgium. Electronic address: Elodie.cazelle@aise.eu.
authors: Elodie
authors: E
authors: Cazelle
authors: SeCAM, Agno, Switzerland. Electronic address: chantra.eskes@secam-ce.eu.
authors: Chantra
authors: C
authors: Eskes
authors: Henkel AG & Co. KGaA, Duesseldorf, Germany. Electronic address: martina.hermann@henkel.com.
authors: Martina
authors: M
authors: Hermann
authors: Unilever, Colworth Science Park, Sharnbrook, Bedford, UK. Electronic address: Penny.Jones@unilever.com.
authors: Penny
authors: P
authors: Jones
authors: The Procter & Gamble Company, Egham, Surrey, UK. Electronic address: mcnamee.pm@pg.com.
authors: Pauline
authors: P
authors: McNamee
authors: TNO Triskelion, Zeist, The Netherlands. Electronic address: menk.prinsen@tno.triskelion.nl.
authors: Menk
authors: M
authors: Prinsen
authors: Reckitt Benckiser, Hull, UK. Electronic address: Hannah.Taylor@reckittbenckiser.com.
authors: Hannah
authors: H
authors: Taylor
authors: TNO Triskelion, Zeist, The Netherlands. Electronic address: marcel.wijnands@tno.triskelion.nl.
authors: Marcel V W
authors: MV
authors: Wijnands
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D002645:Chickens; D003902:Detergents / Q000633:toxicity*; D005123:Eye / Q000187:drug effects*; D006863:Hydrogen-Ion Concentration; D066298:In Vitro Techniques / Q000379:methods*; D007509:Irritants / Q000633:toxicity; D023382:Toxicity Tests, Acute / Q000379:methods
chemical_list: D003902:Detergents; D007509:Irritants
keywords: Detergent and cleaning products; Eye irritation; Histopathology; Isolated Chicken Eye Test