Background:- Iron deficiency anaemia (IDA) is one of the major disease affecting women from adolescents to elderly persons in our country. PITHA PAANDU MAATHIRAI (PPM) , a siddha medicine used in the treatment of IDA as per literary views. The study was carried out to demonstrate the oral toxicity of PPM in wistar albino rats to prove its safety. Methods: Acute and 28-day repeated oral toxicity studies were performed following OECD test guidelines 423 and 407. In acute oral toxicity study, PPM was administered at 2000mg/kg b.wt./p.o, animals were observed for toxic signs at 30min, 4hrs, 24 hrs and for next 14 days. Gross pathology was performed at the end of the study. In repeated dose, the 28- days oral toxicity study, PPM was administered at 200 and 400 mg/kg b.wt./p.o/day. Animals were observed for mortality, clinical signs, body weight changes, feed and water intake. Haematological, biochemical, gross pathology, relative organ weight, histopathological examination and urine analysis were performed. Results: In acute toxicity study, no treatment related death or toxic signs were observed with PPM administration. In the repeated dose study, slight increase in body weight and eosinophil count was observed. Conclusion: Acute study reveals that the LD50 of PPM is greater than 2000mg/kg, b.wt . 28 days repeated oral toxicity demonstrates that the No Observed Adverse Effect Level of PPM is greater than 400 mg/kg b.wt./day, p.o in rats.

Keywords : acute toxicity, sub acute toxicity, pitha paandu.