Adopting New Approach Methodologies (NAM) in the next generation risk assessment (NGRA)
The term “new approach methodologies” (NAMs) has been emerged as a descriptive reference to any non-animal-based approaches that can be used to provide information in the context of chemical hazard and risk assessment. These new approaches include integrated approaches to testing and assessment (IATAs), defined approaches for data interpretation, and performance-based evaluation of test methods.
Animal testing has been the gold standard for the hazard assessment of a range of chemicals and products. With advancing science, more efforts are made to develop non-animal-based test systems which mimic or resemble toxicity and disease pathways relevant to the humans. Governments as well as different industries around the world have been investing significant amount of time, money and efforts in NAMs, which lead to significant progress in development and validation efforts in the field of NAMs in the last decade.
A recent publication by Catherine Mahony, discussed about current efforts and collaborations between international regulators, researchers and cosmetic industry for building confidence in using non-animal methods. The publication also outlined the discussion on “application of NAMs in NGRA of cosmetic products”, held at Eurotox 2018 session. Further, the publication has discussed the current practice, progress and future work plans while applying the threshold of toxicological concern (TTC), read across and integrated safety assessment approaches in cosmetic safety assessment.
Recently there have been efforts to update TTC approach by adding more chemicals data into three Cramer class datasets, especially in class II, where there are very limited chemicals. In addition, despite significant challenges, there have been developments to derive route specific TTC values, i.e., inhalation and systemic TTC values. TTC can be a useful tool for exposure based risk assessment and metabolism based read across assessment. While discussing use of read across as NAM in risk assessment, it is also emphasized that apart from chemical similarity, mechanistic similarity is equally important parameter among chemicals. Toxicokinetic data can be a valuable support to prove mechanistic similarity of read across chemicals. Furthermore, the development of exposure and mode of action (MoA) led integrated safety assessment workflow as well as its regulatory acceptance will be a key future work area in NAMs application in NGRA.
Overall, it can be concluded that there will be very interesting and promising developments in NAMs application in NGRA. As regulators, industries as well as researchers are working together and in collaborations to help make toxicity testing paradigm shift in 21st century, despite many challenges, it appears that in coming days more NAMs will be accepted by regulatory authorities around the world.
ToxMinds have extensive scientific as well as regulatory experience in application of TTC (cosmetic and consumer products), read across (chemicals) and MoA-based approaches (skin sensitisation) in hazard and risk assessment. For more details on our expertise in these NAMs and how we can help and support you, kindly contact us at