A 90 day chronic toxicity study of Nigerian herbal preparation DAS-77 in rats.
BACKGROUND
The herbal preparation DAS-77, used for the treatment of various ailments in Nigeria, contains the milled bark of Mangifera indica L. and root of Carica papaya L. Toxicological assessment of the preparation was carried out in this study.


METHODS
In the acute toxicity study, DAS-77 was administered to mice p.o. up to 20 g/kg in divided doses and i.p. at 250-3000 mg/kg. Mortality within 24 h was recorded. In the chronic toxicity study, rats were treated p.o. for 90 days at doses of 80, 400 (therapeutic dose, TD) and 2000 mg/kg. By 90 days, animals were sacrificed and blood samples collected for hematological and biochemical analysis. Organs were harvested for weight determination, antioxidants and histopathological assessments.


RESULTS
DAS-77 did not produce any lethality administered p.o. up to 20 g/kg in divided doses but the i.p. LD50 was 1122.0 mg/kg. At TD, DAS-77 produced significant (p < 0.05) reductions in body weight, food intake and K+, and increases in ovary weight, neutrophils and HDL, which were reversible. Histopathological presentations were generally normal. Effects at the other doses were comparable to those at TD except for reversible increases in antioxidants in the liver, kidney and testes, and sperm abnormality, and reductions in liver enzymes, sperm motility and count.


CONCLUSIONS
Findings in this study revealed that DAS-77 is relatively safe with the potential for enhancing in vivo antioxidant activity. However, possibly reversible side-effects include electrolyte imbalance and sterility in males.
Department of Pharmacology, Faculty of Basic Medical Sciences, College of Medicine, University of Lagos, Nigeria.
Saheed O
SO
Afolabi
Abidemi J
AJ
Akindele
Olufunsho
O
Awodele
Chidozie C
CC
Anunobi
Olufunmilayo O
OO
Adeyemi
D000818:Animals; D029441:Carica / Q000009:adverse effects*; D008076:Cholesterol, HDL / Q000097:blood; D004435:Eating / Q000187:drug effects; D002149:Energy Intake / Q000187:drug effects; D005260:Female; D007248:Infertility, Male / Q000209:etiology*; D007668:Kidney / Q000187:drug effects / Q000378:metabolism; D007928:Lethal Dose 50; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D031022:Mangifera / Q000009:adverse effects*; D016488:Medicine, African Traditional; D051379:Mice; D008815:Mice, Inbred Strains; D009504:Neutrophils / Q000378:metabolism; D009929:Organ Size; D010053:Ovary / Q000187:drug effects; D008517:Phytotherapy / Q000009:adverse effects*; D010936:Plant Extracts / Q000009:adverse effects* / Q000494:pharmacology; D011188:Potassium / Q000097:blood; D051381:Rats; D017208:Rats, Wistar; D013094:Spermatozoa / Q000187:drug effects / Q000473:pathology; D013737:Testis / Q000187:drug effects / Q000378:metabolism; D014883:Water-Electrolyte Imbalance / Q000209:etiology*; D015431:Weight Loss / Q000187:drug effects
D008076:Cholesterol, HDL; C581152:DAS-77; D010936:Plant Extracts; D011188:Potassium