Toxicity Evaluation, HET-CAM Irritation, and Anti-Irritant Potential of Rice Bran Wax Policosanol Nanoemulsion
Policosanol, a mixture of long-chain alcohols found in animal and plant waxes, has several biological effects. However, it has a bioavailability of less than 10%. One of the ways of improving bioavailability is by nanoemulsion formulation. We developed rice bran wax policosanol nanoemulsion (npol) using high-pressure homogenization. Even though earlier toxicological studies did not show policosanol-related toxicity, it is an essential part of the development of the therapeutic formulation to evaluate its toxicity status. In this study, in vitro, in vivo toxicity, and irritation and anti-irritation potential of the npol were evaluated. 3T3-L1 cells and Sprague Dawley rats were treated with npol in the in vitro and acute oral toxicity tests; while the Hen’s Egg Test Chorio-Allantoic membrane (HET-CAM) was used to test for its irritation and anti-irritation potential. npol at 2mg/mL showed lower toxicity to 3T3-L1 cells by MTT assay compared to the same concentration of policosanol after 24 (60 and 50% viabilities), 48 (62 and 58% viabilities), and 72 (110 and 89% viabilities) hours, respectively. npol was non-irritant and has slightly anti-irritant potential based on the HET-CAM test. There was also no significant toxicity to a limit test dose of 40 ml/Kg body weight of npol (containing 2000 mg/Kg body weight of policosanol) in acute oral toxicity test on Sprague-Dawly rats. The results suggest that policosanol nanoemulsion is a safe formulation devoid of toxicity and irritation potential.