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Navigating New Approach Methodologies
In Vitro Testing for Agrochemical and Industrial Chemicals
The global market for new approach methodologies including in vitro testing is expected to rise considerably by 2030. The growing demand for the use of in vitro studies is being driven by guidance from regulatory bodies. Depending on the study, using new approach methodologies like in vitro testing can offer time and cost savings which benefits agrochemical and industrial chemical companies looking to get their chemicals to market as quickly and efficiently as possible.
Benefits of In Vitro Testing
The impact of in vitro testing can be felt in both the development and registration phases of chemicals. For example:
- In vitro studies can help determine what formulation candidate is the best to put forward to regulatory testing
- In vitro models can be used for de-risking, helping chemical companies get mechanistic data faster, allowing them to receive data on potential off target effects or adverse effects for materials
In vitro endocrine disruptor studies allow chemical companies to screen their portfolio, identifying risks within their compounds and thinking about replacements before being prompted to fulfill data requirements for registration
What if in vivo testing is needed?
While there are research benefits to using new approach methodologies, in vivo models are still needed in most instances. For example, the majority of testing required for regulatory registration is based on animal studies because in vitro assays are not yet accepted by regulators due to lack of supporting historical data or limited capability to conclude on (absence of) hazardous properties. So, while some assays are accepted, such as dermal absorption studies for agrochemicals and skin and eye irritation for industrial chemicals, for more complex endpoints regulators are often still asking for data from in vivo work.
If in vivo studies are required, chemical companies will need to navigate through the 3Rs; Replacement, Reduction, and Refinement:
- Replacement: Replacing traditional animal models with non-animal systems like computer models, biochemical or cell-based systems, or one animal species with a less developed one (e.g., replacing a mouse with a worm)
- Reduction: Minimizing the number of animals required for testing while still achieving testing goals.
- Refinement: Removing pain or fear in animals or promoting animal welfare (e.g., using better housing or enrichment)
An advisor, such as our regulatory affairs experts, can help by reviewing your data and identifying any gaps. The data will be used as guidance to determine if additional testing is needed for your compound. Depending on the regulatory framework, in vitro testing data can be used to replace in vivo in support of hazard identification and classification, read-across approaches, or screening and priority setting. Our multidisciplinary team can guide you throughout the entire process.
Global In Vitro Capabilities
Charles River offers global capabilities for new approach methodologies like in vitro testing with multiple sites in Europe and North America. Our regulatory affairs experts has the expertise to help you navigate the regulatory and registration requirements for your chemical compound and keep you ahead of the curve of anticipated legislations and updates involving in vitro testing.