Regulatory Frameworks
Evaluate chemicals against 6 regulatory frameworks
FDA CTP
v2024-06
Genotoxicity Hazard Identification & Carcinogenicity Tiering
3 clauses
EPA Cancer
v2005
Guidelines for Carcinogen Risk Assessment (CSF/IUR)
3 clauses
EU CLP/REACH
v2026
Classification, labelling, and chemical safety assessment
3 clauses
ISO 10993 (E&L)
v2023-2020
Medical device extractables & leachables risk characterization
3 clauses
ICH M7
Planned
Mutagenic impurity assessment with 5 classes and TTC intake limits
TTC/Cramer
Planned
Threshold of Toxicological Concern with 33-question decision tree