# Safety Evaluation of Lab-Made Clinoptilolite: 90-Day Repeated Dose Toxicity Study in Sprague Dawley Rats and a Battery of In Vitro and In Vivo Genotoxicity Tests

## TL;DR

This study evaluates the safety of lab-made clinoptilolite in rats and finds it non-toxic and non-genotoxic, supporting its potential as a safe food ingredient.

## Contribution

The study provides new evidence on the safety of lab-made clinoptilolite through a comprehensive 90-day toxicity and genotoxicity assessment.

## Key findings

- No adverse systemic or genotoxic effects were observed at any dose in the 90-day toxicity study.
- Genotoxicity tests confirmed no mutagenic or clastogenic potential of the lab-made clinoptilolite.
- Minor clinical variations were found to be incidental and reversible, indicating good tolerance.

## Abstract

Clinoptilolite is a zeolite with a microporous structure that enables ion exchange, molecular sieving, and adsorption, conferring detoxifying, antioxidant, and anti-inflammatory properties. These properties have applications in food, medicine, catalysis, and environmental remediation. This study evaluated the safety of the lab-made Clinoptilolite as a potential food ingredient through a 90-day repeated-dose toxicity study in male and female Sprague Dawley rats. The test substance was administered via oral gavage at doses of 0, 5, 10, and 15 mg/kg bw/day, followed by a 28-day recovery period. In addition, genotoxicity was assessed using the Ames test, in vitro chromosomal aberration assay, and an in vivo micronucleus test. All studies were conducted in accordance with OECD and FDA guidelines. Results showed no adverse systemic, genotoxic, or irreversible effects at any dose, with minor clinical variations being incidental and reversible. Genotoxicity tests confirmed no mutagenic or clastogenic potential. Overall, the lab-made Clinoptilolite evaluated in this investigation was well tolerated, non-toxic, and showed no evidence of treatment-related toxicity at the doses tested. These findings provide supportive evidence for its consideration toward a Generally Recognized as Safe (GRAS) determination.