The ability to perform animal-free risk assessment for a wide range of consumer products and their ingredients is within reach, but significant barriers remain to widespread implementation of these methods globally. At Humane Society International, we partner with collaborative stakeholders to provide solutions at many levels, including legislative and regulatory, scientific and, more recently, in education and training. With ongoing changes to cosmetics and chemicals laws in the EU as part of the Chemicals Strategy for Sustainability, these solutions are more needed and more timely than ever.
Great strides have been made over the past few decades in the science available to assess chemical safety. Cutting-edge science involves advances in cell culture techniques to the point where it is now possible to grow tissues that quite closely resemble organs in a petri dish. Our ability to interrogate complex cellular processes is also advancing through the use of omics technologies (genomics, proteomics, etc.) and high-content imaging. Computer scientists are making extraordinary progress, with ever more data being used to generate accurate predictive models of biological outcomes.
These approaches have the potential to completely revolutionize chemical safety. They provide very different information from what traditional animal testing provides. Not only is the information different, but its application to chemical safety is a relatively new field, with few published examples and few practitioners worldwide. To help familiarize stakeholders with these new types of information and their application to chemical safety, we have assembled a large team of experts to share their knowledge and experience as part of the Safety Assessment Collaboration. animal-free safety. This course will be accessible to all, free of charge, via AFSAcollaboration.org website, from January 2023.
The course focuses on the safety assessment of cosmetic products and ingredients without new animal data and covers all aspects of internal company decision-making and regulatory safety assessment. What makes this course unique is that it focuses on understanding the information generated by these tools and how it is used in decision making. It is designed to complement other courses and training that focus on how to perform or build the individual methods. The ultimate goal is to support capacity building in animal-free risk assessment within regulated and regulatory communities globally.
The basic structure of traditional risk assessment based on animal and non-animal data is quite similar: both rely on measurements or estimates of exposure, as well as estimation of the intrinsic bioactivity of a chemical, to determine the risk associated with a particular use. or exposure. The main differences are in how and when exposure occurs in the process, the types of information used to estimate the hazard and risk of a chemical, and the application of an assessment framework. at several levels. In traditional risk assessment, a set of standard animal tests are performed and the lowest dose causing an effect, or the highest dose causing no effect, in any of these tests is taken. as a biological activity data point to perform the risk assessment. Exposure is generally only considered after or at the same time as the hazard assessment.
In animal-free risk assessment, also known as next-generation risk assessment, exposure is considered from the outset and used either to make early determinations of safety or to inform the design of suitable testing strategies. to create the information needed for risk assessment. Leading with exposure is especially important for consumer products that have high expected consumer exposure. The assessment itself is carried out in stages.
Computational tools are used in the initial chemical characterization and in the potential identification of similar chemicals which can be used to help identify existing safety information. Any new information on biological activity or necessary internal exposure is generated using non-animal assessment methods. Finally, the biological activity results are examined to identify a lowest level of effect. This is then compared to measured or predicted internal concentrations to generate a margin of exposure, which is used to conclude the risk for a given scenario.
Principles and a detailed framework for carrying out next-generation risk assessment have been developed through partnerships between regulators and industry – the development of the framework has also involved academics through the former project of the seventh European framework programme, Safety Evaluation Ultimately Replacing Animal Testing. The AFSA program builds on these principles to cover the entire risk assessment process in eight technical modules, as well as an overview of the global regulatory landscape covering cosmetics and chemicals.
1: After an introductory session on animal-free safety assessment, the program begins with problem formulation, including collecting, compiling and reviewing existing information, generating initial hypotheses and early decision making.
2: The consumer exposure module covers habits and practices, data and where to find it, and different types of exposure modeling covering the main exposure routes: dermal, oral and respiratory.
3: The module on silicone tools covers the variety of different types of computing tools, data, math and thought processes used to build them; and what they can be used for. This module also covers the use of silicone similar chemical identification tools and cross-references.
4: A module on exposure-based waiver explains how it is applied for three routes of exposure: oral, dermal and inhalation.
5: A separate module covers the history of safe use of complex extracts such as herbs.
6: A module on internal exposure – including absorption, distribution, metabolism and excretion – covers the types of models used and what data and considerations go into physiologically based kinetic modeling as well as in vitro-at-live extrapolation.
7: The module on in vitro Data synthesis covers the types of tools used to generate bioactivity data and how the data can be combined to inform hazard identification and characterization.
8: And there is a final module on integrating all information into a risk assessment with case examples for a wide range of decisions, from acute local, endpoint-specific decisions, such as irritation of skin and eye and skin sensitization, to a more complete risk assessment. for repeated dose systemic exposures.
9. A module describing the global regulatory landscape covering cosmetics and chemicals is also included.
Our intention with this course is to meet, at least in part, the needs of regulators, the regulated community, contractors, consultants, and others less familiar or less comfortable with the use of non-animal information. in safety decisions, and to help ensure a future where these methods are a pillar of a more effective and efficient chemical safety paradigm. We look forward to wide participation.