Alternative approaches for identifying acute systemic toxicity: Moving from research to regulatory testing

Area of Science:

• Toxicology
• Chemical Safety Assessment

Background:

• Acute systemic toxicity testing is crucial for chemical hazard labeling and risk management.
• Current methods rely heavily on animal testing, prompting international efforts to find alternatives.

Purpose of the Study:

• To review the state-of-the-science for non-animal alternatives in acute systemic toxicity testing.
• To explore strategies for facilitating the regulatory implementation of these alternative methods.

Main Methods:

• A workshop convened international experts from regulatory agencies, academia, NGOs, and industry.
• Breakout groups developed roadmaps and strategies for reducing and replacing animal use in toxicity testing.

Main Results:

• Key resources for progress include high-quality reference data, training on in vitro/in silico methods, and global harmonization of requirements.
• Characterizing reference data variability and understanding toxicity mechanisms (e.g., via adverse outcome pathways) are critical.
• Workshop participants outlined actionable strategies for near-term advancements.

Conclusions:

• The workshop identified essential components for implementing non-animal alternatives in regulatory toxicology.
• A coordinated effort is underway to implement the workshop's recommendations for advancing alternative testing strategies.