Para garantizar la seguridad de LAE® como conservante de alimentos, VEDEQSA ha encargado una amplia gama de estudios toxicológicos con el objetivo de demostrar que no se asocian efectos adversos con su ingestión en los niveles de uso previstos. Se han realizado estudios adicionales para demostrar la inocuidad de LAE® cuando se usa en preparaciones cosméticas. La siguiente figura resume los resultados toxicológicos:

 

RESUMEN DE RESULTADOS TOXICOLÓGICOS
TOXICITY EXPERIMENT ADMINISTERED DOSE RESULT
Genetic Toxicity Bacteria (Ames test) Lauric arginate: 1.5-150 ug/plate Mirenat®-N: 5-5000 ug/plate Not mutagenic
Genetic Toxicity Mouse lymphoma assay Lauric arginate: 1-50 ug/ml Mirenat®-N: 100-300 ug/ml Not mutagenic
Genetic Toxicity Chromosomal level Lauric arginate: 50-200 ug/ml Mirenat®-N: 125-1000 ug/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 letra-n 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)

(letra-n5883 mg/m3 vehicle letra-n 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.

 

Copyright © VEDEQSA 2020.  All rights reserved.