TOXICOLOGICAL SUMMARY RESULTS
| TOXICITY | EXPERIMENT | ADMINISTERED DOSE | RESULT |
|---|---|---|---|
| Genetic Toxicity | Bacteria (Ames test) | Lauric arginate: 1.5-150 g/plate Mirenat®-N: 5-5000 g/plate | Not mutagenic |
| Genetic Toxicity | Mouse lymphoma assay | Lauric arginate: 1-50 g/ml Mirenat®-N: 100-300 g/ml | Not mutagenic |
| Genetic Toxicity | Chromosomal level | Lauric arginate: 50-200 g/ml Mirenat®-N: 125-1000 g/ml | Not clastogenic |
| Subchronic Toxicity | Rat 13 week | Lauric arginate: 5000, 15000, 50000 ppm | NOAEL: 15000 ppm (1143 male & 1286 female mg/kg bw/day) |
| Subchronic Toxicity | Rat 13 week | Mirenat®-N: 3200, 12800, 50000 ppm in the diet | NOAEL: 50000 ppm (3324 male & 3927 female mg/kg bw/day formulated 718 male & 848 female mg/kg bw/day LAE®) |
| Chronic Toxicity | Rat 52 week | Lauric arginate: 2000, 6000, 18000 ppm in the diet | NOAEL: 18000 ppm (907 male & 1128 female mg/kg bw/day) |
| One-Generation Reproductive Toxicity Study | Rat | Lauric arginate: 200, 600, 2000 mg/kg bw/day | NOAEL: Dams & Foetuses: 2000 mg/kg bw/day |
| One-Generation Reproductive Toxicity Study | Rabbit | Lauric arginate: 100, 300, 1000 mg/kg bw/day | NOAEL: Dams 300 mg/kg bw/day Foetuses 1000 mg/kg bw/day |
| Two-Generations Reproductive and Developmental Toxicity | Rat | Lauric arginate: 2500, 6000, 15000 ppm in the diet | NOAEL reproductive and development performance: 6000 ppm (502 mg/kg bw/day female rats) |
| Acute Toxicity | Rat oral | Lauric arginate: 2000 mg/kg bw | LD50> 2000 mg/kg bw |
| Acute Toxicity | Rat oral | Mirenat®-N: 2000 mg/kg bw | LD50> 2000 mg/kg bw |
| Acute Toxicity | Rat dermal | Lauric arginate: 2000 mg/kg bw | LD50> 2000 mg/kg bw |
| Acute Toxicity | Rat inhalation | Lauric arginate: 0.634% ai. | LC50> 28150 mg/m3 (aerosol) (5883 mg/m3 vehicle 37.3 mg/m3 LAE®) |
| Other Studies | In vitro percutaneous absorption | Lauric arginate: 0.4% Lauric arginate: 0.8% | 2.1 ± 0.9% 0.82 ± 0.78% |
| Other Studies | Rabbit eye irritation | Lauric arginate | Irritant |
| Other Studies | Rabbit eye irritation | Aminat® up to 4% | No irritation |
| Other Studies | Rabbit skin irritation | Lauric arginate: 0.08 g/cm2 | No irritation |
| Other Studies | Guinea pig skin sensitisation | Lauric arginate: 5% | No sensitisation |
| Other Studies | Guinea pig skin sensitisation | Mirenat®-N | No sensitisation |
The results of the toxicological studies are consistent with the rapid metabolism of Lauric arginate that was elucidated from the rat in vivo and in vitro and human in vitro studies.
