Nivaliln (Galantamine) Mutagenicity!

Test for mutagenic activity of Nivalin on Salmonella typhimurium strains (AMES test)

Tests conducted with working concentrations of Nivalin from 0.0015 to 1.5 mg/ml added to the nutrient medium of Salmonella typhimurium strains TA97, TA98, TA100, and TA102, with or without microsomal induction system, showed no signs of mutation.

Tests for mutagenic activity of Nivalin on DNA synthesis in peripheral human lymphocytes

Tests with Nivalin in concentrations from 0.15 mg/ml to 0.000015 mg/ml on peripheral human lyphocytes caused no unplanned DNA synthesis after incubation for 60 min at 37°C, with or without microsomal activating system 89 mix.

Embryotoxicity and teratogenicity of Nivalin

Tests for embryotoxicity and teratogenicity of Nivalin were conducted in rats and rabbits. The conclusions were as follows:

  1. Oral or subcutaneous doses of 0.5-15.9 mg/kg Nivalin had no teratogenic effect on pregnant rats and rabbits.
  2. Oral or subcutaneous Nivalin at doses equal to 1/5 and 1/10 LD50 caused 10-16% foetal lethality in pregnant rats.
  3. Long-term treatment with Nivalin throughout had non-specific embryotoxic effect, expressed in increased foetal-placental index (FPI).
  4. Pos-implantation embryogenesis was more sensitive to Nivalin.
  5. Oral and subcutaneous doses of Nivalin, equal to the mean therapeutic doses for humans, had no embryotoxic and teratogenic effects in pregnant rats and rabbits.

Galantamine hydrobromide (Nivalin) is a preparation with low toxicity. As a result, it has broader therapeutic index than the other reversible inhibitors of cholinesterase.

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