title: Classification and labeling of industrial products with extreme pH by making use of in vitro methods for the assessment of skin and eye irritation and corrosion in a weight of evidence approach.
abstract: Classification and labeling of products with extreme pH values (≤ 2 or ≥ 11.5) is addressed in chemicals legislation. Following determination of pH and alkaline/acid reserve, additional in vitro tests are needed, especially to substantiate results less than corrosive. However, only limited experience with the practical application of in vitro methods to determine appropriate classifications for pH extreme products is available so far. Expert judgment and weight of evidence are given major roles under the globally harmonized system of classification and labeling of chemicals (GHS) and should be performed on a sound data basis. We have used a tiered testing strategy to assess 20 industrial products (cleaning and metal pretreatment) regarding their corrosive and irritating properties towards human skin models in vitro in the EpiDerm skin corrosion and/or skin irritation test. Nine dilutions of individual compounds were additionally tested. Non-corrosive samples were tested in the Hen's egg test chorioallantoic membrane (HET-CAM). We demonstrate how data is combined in a weight of evidence expert judgment, and give examples of classification decisions. To our knowledge this is the first comprehensive analysis of industrial products with extreme pH values to determine irritating and corrosive properties by making use of in vitro methods in a weight of evidence approach.
authors.affiliation: Henkel AG & Co. KGaA, Düsseldorf, Germany. julia.scheel@henkel.com
authors.forename: Julia
authors.initials: J
authors.lastname: Scheel
authors.forename: Andreas
authors.initials: A
authors.lastname: Heppenheimer
authors.forename: Elke
authors.initials: E
authors.lastname: Lehringer
authors.forename: Juergen
authors.initials: J
authors.lastname: Kreutz
authors.forename: Albrecht
authors.initials: A
authors.lastname: Poth
authors.forename: Holger
authors.initials: H
authors.lastname: Ammann
authors.forename: Kerstin
authors.initials: K
authors.lastname: Reisinger
authors.forename: Norbert
authors.initials: N
authors.lastname: Banduhn
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D002645:Chickens; D049033:Chorioallantoic Membrane / Q000187:drug effects; D005123:Eye / Q000187:drug effects*; D015386:Hazardous Substances / Q000032:analysis / Q000145:classification / Q000633:toxicity*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007509:Irritants / Q000737:chemistry / Q000145:classification / Q000633:toxicity*; D015603:Keratinocytes / Q000187:drug effects*; D008954:Models, Biological; D010063:Ovum; D011356:Product Labeling / Q000592:standards; D012867:Skin / Q000187:drug effects*; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D015386:Hazardous Substances; D007509:Irritants