Nivalin®
MUTAGENICITY OF NIVALIN
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:
- Oral or subcutaneous doses of 0.5-15.9 mg/kg Nivalin had no
teratogenic effect on pregnant rats and rabbits.
- Oral or subcutaneous Nivalin at doses equal to 1/5 and 1/10 LD50
caused 10-16% foetal lethality in pregnant rats.
- Long-term treatment with Nivalin throughout had non-specific
embryotoxic effect, expressed in increased foetal-placental index (FPI).
- Pos-implantation embryogenesis was more sensitive to Nivalin.
- 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.
Galanthamine 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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