Session 25

Hazard assessment of chemical respiratory sensitizers: regulatory needs, scientific progress and industry perspective

Programme of the Session

S25-01
Regulatory needs for the assessment of respiratory sensitisation under REACH and CLP
Fabrice Broeckaert, Laura H Rossi
Risk Management Directorate, Classification and Prioritisation Unit, European Chemicals Agency, Helsinki, Finland
S25-02
An adverse outcome pathway for respiratory sensitization by chemicals: The way forward?
Janine Ezendam¹, Stella Cochrane², Steve Enoch³, Grace Patlewicz⁴, Erwin Roggen⁵, Katherina Sewald⁶, Kristie Sullivan⁷
¹National Institute for Public Health and the Environment, Bilthoven, Netherlands; ²Unilever Safety and Environmental Assurance Centre, Sharnbrook, United Kingdom; ³School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, United Kingdom; ⁴National Center for Computational Toxicology, US Environmental Protection Agency, Durham, United States; ⁵3Rs Management and Consultancy, Copenhagen, Denmark; ⁶Immunotoxicology, Fraunhofer Institut für Toxikologie und Experimentelle Medizin, Hannover, Germany; ⁷Toxicology and Regulatory Testing, Physicians Committee for Responsible Medicine, Washington, United States
S25-03
In Silico and In Chemico Approaches to Identify Respiratory Sensitisers
Steve Enoch
School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, United Kingdom
S25-04
Advances in the development of in vitro airway models as innovative tools to identify chemical respiratory sensitizers
Erwin L Roggen
3Rs Management and Consulting ApS, Lyngby, Denmark
S25-05
Risk assessment and management of respiratory sensitisers, the industry perspective
Ruth Danzeisen
Cobalt Development Institut, Guildford, United Kingdom

Session Abstract

Occupational asthma caused by low-molecular-weight chemicals is an important public health issue with potentially severe consequences for affected individuals. In Europe, respiratory sensitisation is not a standard information requirement under REACH, but during the substance evaluation process information on respiratory sensitisation can be requested. A few known respiratory sensitisers have been classified as substances of an equivalent level of concern to Substances of Very High Concern (SVHC), such as carcinogenic or reproduction toxic substances. Important considerations are that the health effects are irreversible, without a threshold and of an equivalent seriousness in nature. The hazard assessment of this class of chemicals has already for a long time been challenging to toxicologists and regulators given that;

1) Currently no validated and internationally accepted models for the identification of respiratory sensitisers exist.
2) Thresholds for respiratory allergens rely mainly on occupational exposure studies where exposure is often variable and poorly characterised, leading to difficulty in deriving appropriate Occupational Exposure Limits
3) Mechanisms involved in respiratory sensitisation are not completely understood.
The focus of this workshop will be on recent advancements in our knowledge and understanding of respiratory allergy and including the development of an adverse outcome pathway (AOP) for respiratory sensitizers under auspices of the OECD (expected to be published in 2016). Workshop speakers will describe current and promising in silico/in chemico/in vitro/in vivo methodologies that may be used to develop a testing strategy for respiratory sensitizers. Furthermore, both the regulatory needs and industry perspective will be addressed in this workshop. This workshop will provide a forum for dialogue between the scientific, industry and regulatory communities which may foster a better understanding of key public health and occupational safety concerns and the best approaches to identify and protect against the adverse health outcomes of respiratory sensitizers