Acute and repeated dose toxicity studies of different β-cyclodextrin-based nanosponge formulations

Area of Science:

• Materials Science
• Toxicology
• Biotechnology

Background:

• Nanosponges (NS) are versatile nanomaterials with applications in medicine, agriculture, and environmental remediation.
• Different cross-linking agents and preparation methods influence NS properties and potential applications.
• Evaluating the toxicological profile of novel NS formulations is crucial for their safe development and deployment.

Purpose of the Study:

• To evaluate the acute and repeated dose toxicity of six different nanosponges (NS) formulations (S1-S6) in experimental animals.
• To determine the maximally tolerated dose (MTD) and identify any adverse effects associated with NS administration.
• To assess the safety of NS formulations synthesized using various cross-linking agents and preparation methods.

Main Methods:

• Acute oral toxicity studies were performed on female rats according to OECD guideline 423 (300 and 2000 mg/kg).
• Repeated dose oral toxicity studies were conducted on rats (either sex) at 300 mg/kg/day for 28 days as per OECD guideline 407.
• Animals were monitored for clinical signs, body weight changes, and subjected to necropsy. Haematological and biochemical parameters were analyzed.

Main Results:

• The maximally tolerated dose for all tested nanosponges formulations was found to be 2000 mg/kg.
• No significant changes in general behavior, haematological, or biochemical parameters were observed during acute and repeated dose toxicity studies.
• Repeated administration of nanosponges for 28 days did not induce any notable adverse effects in the experimental animals.

Conclusions:

• The evaluated nanosponges formulations (S1-S6) demonstrate a favorable safety profile in experimental animals.
• These findings suggest that nanosponges are safe for use, supporting their further investigation and application in various fields.
• The study provides essential toxicological data for the safe development and utilization of nanosponges technology.