RESUMEN DE RESULTADOS TOXICOLÓGICOS
| 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 |
Los resultados de los estudios toxicológicos son consistentes con el rápido metabolismo del arginato láurico que se infiere de los estudios in vivo e in vitro en ratas y los estudios in vitro en humanos.
