Regulatory toxicology platform delivers submission-ready reports in hours, addressing industry capacity crisis

BETHESDA, Md., March 9, 2026 /PRNewswire/ -- Insilica today announced the commercial launch of ToxIndex, an agentic platform that generates regulatory-grade chemical safety reports in hours instead of months. Built on a foundation of over 2,000 curated datasets and hundreds of computational tools, ToxIndex addresses the toxicology industry's capacity crisis where demand vastly outpaces the available toxicologists. Over 88% of EPA chemical assessments are overdue and there are only 9,000 toxicologists in North America.

ToxIndex employs specialized AI agents that each perform single, constrained tasks such as querying databases, running predictions, and extracting literature. These agents combine their outputs into complete regulatory submissions. Every claim in the final report traces directly to its source, whether a database query, computational model, or published study. This provenance-by-design architecture delivers the auditability regulators require.

The platform supports critical regulatory frameworks including REACH chemical safety reports, FDA safety assessments, and more. For companies managing hundreds of substances under evolving regulations, ToxIndex multiplies expert capacity by automating evidence gathering and synthesis while keeping toxicologists in control of scientific judgment.

"The toxicology industry faces a structural capacity problem," said Dr. Tom Luechtefeld, CEO of Insilica. "With tens of thousands of chemicals requiring assessment and a fixed pool of qualified experts, the traditional manual approach cannot scale. ToxIndex provides the infrastructure to automate evidence synthesis while maintaining the rigorous standards regulators demand. Our platform doesn't replace toxicologist expertise. It amplifies it by handling the time-consuming data work so experts can focus on scientific judgment."

The platform's comprehensive data foundation includes over 2,000 datasets spanning environmental fate, toxicity endpoints, and regulatory precedents, with access to over 60 billion knowledge graph triples. More than 300 production computational tools predict properties from molecular structure, while over one hundred thousand extracted literature claims provide regulatory-relevant evidence. This breadth ensures ToxIndex can address data-poor substances through read-across, structural analogs, reactions, and metabolism, not just well-studied chemicals.

ToxIndex supports complete regulatory workflows through an orchestrated ecosystem of specialized applications. For REACH compliance, companies can progress from structural profiling through hazard assessment to exposure modeling and dossier export, all within a single platform with automated data handoffs between tools. This orchestration approach delivers complete submissions, not just individual predictions.

The platform produces agency-grade documentation and is under evaluation by regulatory agencies, as well as energy, agrochemical, cosmetic, personal care, and chemical manufacturers. With active pilots underway, ToxIndex is production ready for enterprise customers managing large chemical portfolios.

See ToxIndex at SOT 2026

Insilica will demonstrate the ToxIndex platform at the Society of Toxicology Annual Meeting, March 22-25, 2026, in San Diego. Visit Booth 1348 for live demonstrations of regulatory workflow automation. Dr. Tom Luechtefeld will present "Agentic AI for Chemical Risk Assessment: Architecture, Workflows, and Output" on Wednesday, March 25 at 1:45 PM in Room 23A during the Environmental Health Sciences specialty section.

About Insilica

Insilica is the full-service AI toxicology company. Combining proprietary AI, expert toxicologists, and the world's largest chemical safety data infrastructure, Insilica delivers turnkey safety assessments that empower CROs, consultancies, and internal teams to scale beyond what traditional approaches allow. The company's platform is powered by Google Cloud and serves customers across pharma, energy, agriculture, cosmetics, and consumer products. Founded in 2017, Insilica is based in Rockville, Maryland.

View original content to download multimedia:https://www.prnewswire.com/news-releases/insilica-launches-toxindex-agentic-platform-transforms-chemical-safety-assessment-from-months-to-hours-302708156.html

SOURCE Insilica