Session 18

New approaches to skin sensitisation safety assessment

Programme of the Session

S18-01
Progress in the validation and regulatory adoption of alternative approaches for skin sensitisation assessment
Silvia Casati
European Commission, Joint Research Centre, Ispra, Italy
S18-02
Impact of Cutaneous Bioavailability in Local Skin Toxicity: Preliminary results from Cosmetics Europe Skin Bioavailability and Metabolism Task Force
Sebastien Gregoire¹, Richard Cubberley², Helene Duplan³, Joan Eilstein¹, Corie Ellison⁴, Nicky Hewitt⁵, Carine Jacques-Jamin³, Daniela Lange⁶, Martina Klaric⁵, Helga Rothe⁷, Andreas Schepky⁶, Amy Roe⁴
¹L'Oreal Research & Innovation, Aulnay sous Bois, France; ²Unilever, Sharnbrook, United Kingdom; ³Pierre Fabre Dermo-Cosmetique, Toulouse, France; ⁴Procter & Gamble Inc, Mason, United States; ⁵Cosmetics Europe, Brussels, Belgium; ⁶Beiersdorf AG, Hamburg, Germany; ⁷Coty, Darmstatd, Germany
S18-03
Skin penetration in silico modeling-improvement by using in vitro data
Helga Rothe^1,2, Sebastien Grégoire³, Cindy Obringer⁴, John Manwaring⁴, Joan Eilstein³, Daniela Lange⁵, Richard Cubberley⁶, Helen Duplan⁷, Carine Jacques-Jamin⁷, Corie Ellison⁴, Martina Klaric⁸, Nicky Hewitt⁸, Andreas Schepky⁵
1Coty, Darmstadt, Germany; 2Procter and Gambel, Darmstadt, Germany; 3L'Oreal Research & Innovation, Aulnay-sous-Bois, France; 4)Procter & Gamble Inc, Mason, United States; 5)Beiersdorf, Hamburg, Germany; 6)Unilever, Bedford, United Kingdom; 7)Pierre Fabre Dermo-Cosmétique, Toulouse, France
8)Cosmetics Europe, Brusells, Belgium
S18-04
Cosmetics Europe’s skin sensitisation database
Sebastian Hoffmann¹, Nathalie Alépée², Takao Ashikaga³, Elodie Clouet⁴, Magalie Cluzel⁵, Aurelie Del Bufalo², Nicola Gilmour⁶, Carsten Goebel⁷, Jalila Hibatallah⁸, Lauren Hutchison⁹, Petra Kern¹⁰, Jochen Kühnl¹¹, Karsten Mewes¹², Masaaki Miyazawa¹³, Erwin van Vliet¹⁴, Martina Klaric¹⁵, Dirk Petersohn¹²
¹SEH consulting + services, Paderborn, Germany; ²L'Oréal, Paris, France; ³Shiseido, Kanagawa, Japan; ⁴Pierre Fabre, Toulouse, France; ⁵LVMH, St Jean de Braye, France; ⁶Unilever, Bradford, United Kingdom; ⁷Coty, Darmstadt, Germany; ⁸Chanel, Neuilly sur Seine, France; ⁹Colgate-Palmolive, Piscataway, United States; ¹⁰Procter & Gamble, Strombeeg-Bever, Belgium; ¹¹Beiersdorf, Hamburg, Germany; ¹²Henkel, Düsseldorf, Germany; ¹³Kao, Tochigi, Japan; ¹⁴SeCAM, Magliaso, Switzerland; ¹⁵Cosmetics Europe, Brussels, Belgium
S18-05
Skin sensitization testing strategy and safety assessment of topical ingredients: A case study
Dirk Petersohn¹, Alépée Nathalie², Takao Ashikaga³, Elodie Clouet⁴, Magalie Cluzel⁵, Aurelie Del Bufalo², Nicola Gilmour⁶, Carsten Goebel⁷, Jalila Hibatallah⁸, Sebastian Hoffmann⁹, Lauren Hutchison¹⁰, Petra Kern¹¹, Jochen Kuehnl¹², Karsten Mewes¹, Masaaki Miyazawa¹³, Erwin Van Vliet¹⁴, Martina Klaric¹⁵
¹Henkel, Duesseldorf, Germany; ²L'Oréal, Paris, France; ³Shiseido, Kanagawa, Japan; ⁴Pierre Fabre, Toulouse, France; ⁵LVMH, St Jean de Braye, France; ⁶Unilever, Bedford, United Kingdom; ⁷Coty, Darmstadt, Germany; ⁸Chanel, Neuilly sur Seine, France; ⁹SEH Consulting Services, Paderborn, Germany; ¹⁰Colgate-Palmolive, Piscataway, United States; ¹¹Procter & Gable, Strombeeg-Bever, Belgium; ¹²Beiersdorf, Hamburg, Germany; ¹³Kao, Tochigi, Japan; ¹⁴SeCAM, Services & Consultation on Alternative Methods, Magliaso, Switzerland; ¹⁵Cosmetics Europe, Brussels, Belgium

Session Abstract

The 7^th Amendment to the Cosmetics Directive bans animal testing, therefore, the safety assessment of cosmetic ingredients has now to rely on the use of non-animal approaches.

This session provides an overview of projects run by the Cosmetics Europe Skin Bioavailability and Metabolism (Skin BM) Task Force (TF) and the Skin Tolerance (ST) TF. Results from these projects exemplify how safety assessment for skin sensitization and identification of possible systemic effects of topically applied chemicals can be performed in line with the 21st century vision for toxicity testing. The session will start with an illustration of the progress made in the development and regulatory adoption of non-animal methods for skin sensitization. The session will then delineate how data generated under the Skin BM project, using standardized dermal-based assays for a set of physicochemically diverse chemicals relevant to cosmetics and with potential dermal and/or systemic toxicity, can improve the predictivity of an in silico dermal penetration model. In addition it will be shown how bioavailability information (dermal absorption and metabolism) can be used in conjunction with readouts from skin sensitization in chemico and in vitro assays. Within the ST TF's project, a panel of non-animal skin sensitization methods have been evaluated and prioritised and data for more than 100 chemicals generated with the prioritised methods and incorporated into a database that will be made publically available in 2017. A case study will be presented to demonstrate how data from in vitro methods and in silico predictions can be integrated within defined approaches to testing and assessment and used together with exposure considerations to support risk assessment. Work undertaken by these Task Forces will ultimately lead to testing strategies that would enable cosmetic industries to conduct the safety assessment of cosmetic ingredients without the use of animals.