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Study Title

Institution

Detailed Summary

1

Acute oral toxicity in rats

St. Petersburg Institute of Pharmacy

Rats received single oral doses up to 8000 mg/kg. Lethal Dose 50 (LD₅₀) was over 6000 mg/kg, which places lithium ascorbate in the low-toxicity category (Class 5). Most deaths occurred at doses ≥6000 mg/kg, with symptoms such as lethargy, diarrhea, and cardiac overload. This suggests excellent safety for standard human use, where doses are typically thousands of times lower.

2

Acute oral toxicity in mice

St. Petersburg Institute of Pharmacy

In mice, LD₅₀ was similarly high: 6140–6920 mg/kg. Toxic signs like ruffled fur and decreased activity appeared only at very high doses. No chronic damage observed in surviving animals. This confirms cross-species tolerance and low acute toxicity.

3

Acute IV toxicity in rats

St. Petersburg Institute of Pharmacy

Even when injected directly into the bloodstream, lithium ascorbate showed low toxicity up to 3000 mg/kg. LD₅₀ ranged between 3225–3625 mg/kg. Minor side effects like fatigue or respiratory depression appeared only at near-lethal levels. This supports the compound's systemic safety.

4

Cumulative toxicity with repeated oral dosing

St. Petersburg Institute of Pharmacy

Rats received gradually increasing daily doses for 21 days. Toxicity emerged only after 10+ days of high dosing. All animals died by day 21, confirming the existence of moderate cumulative toxicity (Fcum = 3.74). This is expected for bioactive ions like lithium but indicates long-term safety in clinical microdosing.

5

Pharmacokinetics and tissue distribution

Normopharm internal study

A single 1000 mg/kg oral dose was tracked across 11 tissues. The peak blood level was reached at 1.5 hours (Tmax), and the compound remained in the body for over 140 hours (T½). Lithium concentrated in the brain, aorta, bones, and adrenal glands, indicating a beneficial depot effect for neurological and vascular support.

6

6-month chronic toxicity in rabbits

Institute of Toxicology (FMBA)

Over a 6-month daily regimen, rabbits showed no mortality or organ pathology. Weight gain, behavior, and blood parameters remained normal. This suggests the compound is safe for long-term use, even in higher species.

7

Mutagenicity, reproductive and immunotoxicity in rats

Golikov Center of Toxicology (FMBA)

In a broad toxicological screen, lithium ascorbate did not cause genetic mutations, fertility issues, or immune disruption. Some GI irritation was noted at high doses, but no systemic or teratogenic effects occurred. This validates its safety profile for reproductive and long-term human exposure.

8

Allergenicity (hypersensitivity and anaphylaxis)

House of Pharmacy, Leningrad Region

Tests in guinea pigs and mice found no immediate or delayed allergic reactions. Lithium ascorbate did not act as an allergen or sensitizer, making it suitable for use in sensitive populations.

9

Pharmacological safety: CNS, cardiovascular, respiratory

St. Petersburg Institute of Pharmacy

Rats receiving 10–15× therapeutic doses were tested for neurological, cardiac, and respiratory functions. No adverse effects were found. Open field and Irwin battery tests showed normal behavior and physiology, confirming multi-system safety.