Preclinical Safety Studies on IBAL Formulations

Ion Gel ZCM-25 – Dermo Absorbancy Test Rabbits – Chronic Dose 14 Day.

• In Progress 2020 by UNAM – Preclinical Unit – Mexico.
• Blood evaluation of dermo absorption in 3 groups with control.

Ion Gel ZCM-25 Skin Irritability Test Rabbits – Chronic Dose 14 Day

• Completed in 2019 by UNAM – Preclinical Unit – Mexico.
• No Irritability on the test animals at human dosing levels.

Ion Gel ZCM-25 Skin Irritability Test Rabbits – Single Dose

• Completed in 2018 by CIATEJ – Medical and Pharmaceutical Biotechnology Unit, Mexico.
• No irritability on test animal at 5 times human dosing level.

ION-ZCM1 – Cell-Based In Vitro Toxicity Study

• Completed in 2018 by the University of Debrecen, Hungary.
• By a HACAT cell line-based, MTT Cytotoxicity test method established a safety profile for topical use at 25% concentration.

ION-ZC1 – Acute Intravenous Toxicity In Mice

• Completed in 2015 by the University of Debrecen, Hungary.
• Test methods established a safety profile of Intravenously administered ION-ZC1 which is non-toxic at the dose of 667 mg/kg body weight on mice.

ION-ZC1 – Topical Skin Irritation On Humans

• Completed in 2014 by Cencon Labs, Mexico.
• No irritation was detected on 10 human applications of a cream-based formula at a 10% concentration of ION-ZC1.

ION-ZC1 – 6 Pack Safety Study – Biosimilar Product Safety Study At 100% Concentration

• Completed in 2014 by Product Safety Labs, USA.
• Minor irritability in the eye irritation study, No irritability in other studies:
  • Acute Dermal Toxicity in Rats
  • Primary Skin Irritation in Rabbits
  • Dermal Sensitization Test in Guinea Pigs – Buehler Method Study
  • Acute Inhalation Toxicity in Rats
  • Primary Eye Irritation in Rabbits
  • Acute Oral Toxicity – Up and Down Procedure in Rats