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
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