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Reproductive toxicity studies of ademetionine.
D D Cozens1, S J Barton, R Clark
1Huntingdon Research Centre Ltd., Cambridgeshire, England.
Arzneimittel-Forschung
|November 1, 1988
Summary
S-Adenosyl-L-methionine sulphate-p-toluene sulphonate (SAMe) showed no adverse effects on embryo-foetal development or offspring in rats and rabbits. However, high doses in parent rats caused adverse effects, including kidney changes and weight gain retardation.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Pharmacology
Background:
- S-Adenosyl-L-methionine sulphate-p-toluene sulphonate (SAMe) is a methyl group donor.
- Understanding SAMe's reproductive and developmental toxicity is crucial for its safe use.
Purpose of the Study:
- To evaluate the embryofoetal and peri/post-natal toxicity of SAMe in rats and rabbits.
- To determine the safety profile of SAMe during different stages of reproduction.
Main Methods:
- Rats received SAMe (0-400 mg/kg/d) via subcutaneous or intravenous routes, covering premating, pregnancy, and post-natal periods.
- Rabbits received SAMe (0-40 mg/kg/d) intravenously during pregnancy.
- Toxicity endpoints included reproductive parameters, litter parameters, malformations, anomalies, skeletal variants, and parent animal effects.
Main Results:
- SAMe treatment did not adversely affect reproductive parameters or litter characteristics in rats or rabbits.
- No significant malformations, anomalies, or skeletal variants were observed in offspring.
- Parent rats at 400 mg/kg/d showed adverse effects: local tissue reactions, weight gain retardation, kidney histopathology, rigidity, and dyspnoea.
Conclusions:
- SAMe is considered safe regarding embryofoetal and peri/post-natal toxicity at the tested dosages.
- High doses of SAMe can cause adverse effects in adult rats, necessitating careful dose consideration in clinical practice.