Study of the long-term carcinogenicity potential of D-003, a mixture of high molecular weight sugarcane wax acids, in mice.
D-003, a mixture of high aliphatic primary acids purified from sugar cane wax, has shown cholesterol-lowering, anti-platelet and antioxidant effects. Previous data demonstrated that D-003 was not toxic or carcinogenic when given orally to Sprague-Dawley rats up to 1500 mg/kg. This study investigated the potential long-term oral carcinogenicity of D-003 in a second rodent species. OF1 mice of both sexes were randomized into 4 groups treated for 18 months: a vehicle control group and three groups treated with D-003 at 50, 500 and 1500 mg/kg, respectively, orally gavaged 6 days per week. Mortality, clinical symptoms, weight gain, food consumption, organ weight, blood indicators and tumour incidence did not show significant differences between control and treated groups. D-003 did not increase the frequency of neoplastic or non-neoplastic lesions with respect to the controls. Lesions observed in the study were consistent with spontaneous lesions reported for this specie. It can be concluded that D-003 did not result toxic or carcinogenic when given orally to OF1 mice for 18 months and that the highest dose was a NOAEL, consistent with results of the oral carcinogenicity study of D-003 in rats.
Noa
M
M
Centre of Natural Products, National Centre for Scientific Research, Cubanacan, Playa, Havana City, Cuba. miriam.noa@cnic.edu.cu
Gámez
R
R
Más
R
R
Gutiérrez
A
A
Mendoza
N
N
Pardo
B
B
Marrero
G
G
Curveco
D
D
Goicochea
E
E
García
H
H
Pérez
Y
Y
González
R M
RM
D000230:Adenocarcinoma / Q000139:chemically induced; D000818:Animals; D015197:Carcinogenicity Tests; D005227:Fatty Acids / Q000633:toxicity*; D005260:Female; D008175:Lung Neoplasms / Q000139:chemically induced; D008297:Male; D051379:Mice; D009374:Neoplasms, Experimental / Q000139:chemically induced*
C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids