title: Suitability of the isolated chicken eye test for classification of extreme pH detergents and cleaning products.
abstract: A.I.S.E. investigated the suitability of the regulatory adopted ICE in vitro test method (OECD TG 438) with or without histopathology to identify detergent and cleaning formulations having extreme pH that require classification as EU CLP/UN GHS Category 1. To this aim, 18 extreme pH detergent and cleaning formulations were tested covering both alkaline and acidic extreme pHs. The ICE standard test method following OECD Test Guideline 438 showed good concordance with in vivo classification (83%) and good and balanced specificity and sensitivity values (83%) which are in line with the performances of currently adopted in vitro test guidelines, confirming its suitability to identify Category 1 extreme pH detergent and cleaning products. In contrast to previous findings obtained with non-extreme pH formulations, the use of histopathology did not improve the sensitivity of the assay whilst it strongly decreased its specificity for the extreme pH formulations. Furthermore, use of non-testing prediction rules for classification showed poor concordance values (33% for the extreme pH rule and 61% for the EU CLP additivity approach) with high rates of over-prediction (100% for the extreme pH rule and 50% for the additivity approach), indicating that these non-testing prediction rules are not suitable to predict Category 1 hazards of extreme pH detergent and cleaning formulations.
authors.affiliation: A.I.S.E., Brussels, Belgium. Electronic address: elodie.cazelle@aise.eu.
authors.forename: Elodie
authors.initials: E
authors.lastname: Cazelle
authors.affiliation: SeCAM, Magliaso, Switzerland. Electronic address: chantra.eskes@secam-ce.eu.
authors.forename: Chantra
authors.initials: C
authors.lastname: Eskes
authors.affiliation: Henkel AG & Co. KGaA, Duesseldorf, Germany. Electronic address: martina.hermann@henkel.com.
authors.forename: Martina
authors.initials: M
authors.lastname: Hermann
authors.affiliation: Unilever, Colworth Science Park, Sharnbrook, Bedford, UK. Electronic address: penny.jones@unilever.com.
authors.forename: Penny
authors.initials: P
authors.lastname: Jones
authors.affiliation: The Procter & Gamble Company, Egham, Surrey, UK. Electronic address: mcnamee.pm@pg.com.
authors.forename: Pauline
authors.initials: P
authors.lastname: McNamee
authors.affiliation: TNO Triskelion, Zeist, The Netherlands. Electronic address: menk.prinsen@tno.triskelion.nl.
authors.forename: Menk
authors.initials: M
authors.lastname: Prinsen
authors.affiliation: Reckitt Benckiser, Hull, UK. Electronic address: hannah.taylor@reckittbenckiser.com.
authors.forename: Hannah
authors.initials: H
authors.lastname: Taylor
authors.affiliation: TNO Triskelion, Zeist, The Netherlands. Electronic address: marcel.wijnands@tno.triskelion.nl.
authors.forename: Marcel V W
authors.initials: MV
authors.lastname: Wijnands
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D002645:Chickens / Q000502:physiology*; D003902:Detergents / Q000633:toxicity*; D005123:Eye / Q000187:drug effects*; D005189:False Positive Reactions; D006863:Hydrogen-Ion Concentration; D066298:In Vitro Techniques; D007509:Irritants; D015233:Models, Statistical; D015203:Reproducibility of Results
chemical_list: D003902:Detergents; D007509:Irritants
keywords: Detergent and cleaning products; Extreme pH; Eye irritation; Isolated chicken eye test