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ISSN 1561-3011 (Electronic)

2013, Number 3

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Rev Cubana Invest Bioméd 2013; 32 (3)

Carcinogenicity of D-004 in Sprague Dawley rats. A partial report at 18 months

Gutiérrez MA, Gámez MR, Mas FR, Noa PM, Valle CM, Nodal FC

Language: Spanish
References: 46
Page: 254-270
PDF size: 207.88 Kb.


ABSTRACT

Introduction: D-004, a lipid extract from royal palm (Roystonea regia) fruit made up of a reproducible mixture of fatty acids, mainly oleic, palmitic, lauric and myristic, has shown to prevent prostate hyperplasia (PH) induced by T in rodents. It acts through a multifactorial mechanism involving prostatic 5a-reductase inhibition, antagonism of a1-ADR-mediated responses, and antiinflammatory and antioxidant effects.
Objective: the paper is aimed at summarizing the partial results (18 months) of the long-term carcinogenicity study of D-004 in rats, which is set to conclude in the established 24-month period.
Method: Sprague Dawley (SD) rats of both sexes were randomly distributed into four groups (50 rats/sex/group): one group as vehicle control and three treated with D-004 (500, 1 000 and 1 500 mg/kg, respectively). Treatments were administered by gastric intubation. This report presents the results obtained so far concerning body weight, clinical observations, mortality and frequency of appearance of tumors.
Results: mortality rate is low: 8.3% in the treated groups and 9% among controls. No evidence was found of survival time reduction, and daily observations did not reveal any signs of toxicity attributable to the treatment. The time of appearance and the frequency of tumors in treated animals and controls were statistically similar in both sexes.
Conclusions: administration of D-004 (5001 500 mg/kg) to rats during the first 18 months of the study did not show any evidence of early carcinogenicity or toxicity associated with the treatment.


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