Proposed Safety Classification of Extractables/Leachables
| Class | Threshold | |
|---|---|---|
| μg/day | μg/kg/day, Adult | |
| Initial PQRI Classification for PODP | ||
| 1 (low toxicity) | 150 | 3 |
| 2 (moderate toxicity) | 50 | 1 |
| 3 (marked toxicity) | 5 | 0.1 |
| 4 (genotoxicant) | 0.15 | 0.003 |
| Current PQRI Classification of PODP | ||
| 1 (general toxicity, QT) | 150 | 3 |
| 2 (sensitizers) | 5 | 0.1 |
| 3 (genotoxicant, SCT) | 1.5 | 0.003 |