Bacosane® safety profile
In the reported animal safety studies, Bacosane® produced no mortality or apparent toxicity at the tested doses. No significant therapy-related changes were observed in body weight, relative organ weight, hematological parameters, clinical biochemistry or gross organ findings.
Single oral dose in albino rats demonstrated an exceptionally high safety threshold with no mortality or apparent signs of toxicity reported. Haematology (RBC, WBC, hemoglobin, platelets, differentials) and clinical biochemistry (AST, ALT, ALP, creatinine, urea, sodium, potassium, albumin, total protein) were fully comparable with the control group.
Repeat-dose study at 250, 500 and 1,000 mg/kg/day. No mortality or apparent toxicity during therapy. No remarkable changes in liver, kidneys, spleen, lungs or heart. Haematology and clinical chemistry not significantly different from control. No adverse findings at the highest repeat dose tested.
Preclinical Safety & Toxicological Evaluation
Toxicological screening in albino rats demonstrated no mortality or observable adverse physiological effects across tested dose ranges (5,000 mg/kg acute and up to 1,000 mg/kg/day 28-day repeat dose), establishing a wide margin of safety for dietary supplement and functional nutrition formulations.
No significant differences (p > 0.05) in relative organ weights, body weights, or clinical biochemistry vs control.
View experimental methodology & data →Quality standards & batch verification
Batch-Specific Certificate of Analysis
Every commercial batch of Bacosane® is released with a comprehensive, batch-specific Certificate of Analysis verifying standardized bioactive content, physical properties, heavy metal limits, pesticide residue compliance, and microbiological purity.
Dietary and Allergen Compliance
Bacosane® meets strict quality declarations for Allergen-Free, Gluten-Free, Vegan, Non-GMO, Kosher, and Halal dietary standards, fully supported by current QA documentation and valid certifications.
Clinical Progression
Preclinical safety evaluations have established a well-defined safety window, providing a robust scientific foundation for the human clinical studies currently in progress.
Preclinical safety validation
Preclinical safety data confirm that Bacosane® produces no mortality or significant toxicological findings at an acute oral dose of 5,000 mg/kg and during 28 days of repeat administration at doses up to 1,000 mg/kg/day in albino rats, demonstrating an exceptionally high margin of safety for finished product development.
Frequently asked questions
Is Bacosane® safe?+
Acute (5,000 mg/kg) and 28-day subacute (up to 1,000 mg/kg/day) oral-toxicity assessments in albino rats reported no mortality, apparent toxicity or significant therapy-related differences vs controls.
What was the highest Bacosane® dose tested?+
The acute study tested 5,000 mg/kg as a single oral dose. The 28-day repeat-dose study tested up to 1,000 mg/kg/day.