Maxicuma®
In vivo safety
Maxicuma® was investigated in a single dose and repeated dose acute toxicity studies for 28 days in three different species, in compliance with OECD guidelines and meeting the requirements of 21 CFR (Part 58).
In the absence of any test item-related adverse effects in the above studies, doses up to 220 mg/kg body weight of the rabbits and 440 mg/kg body weight of the Wistar rats, is safe tolerated and is a no-observed-adverse-effect-level (NOAEL) dose. This is equivalent to 4,500 mg/kg body weight/day human dose and hence supports the safe use of Maxicuma® for the general population.
Read more