title: Study of the long-term carcinogenicity potential of D-003, a mixture of high molecular weight sugarcane wax acids, in mice.
abstract: 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.
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Cubanacan, Playa, Havana City, Cuba. miriam.noa@cnic.edu.cu
authors.forename: M
authors.initials: M
authors.lastname: Noa
authors.forename: R
authors.initials: R
authors.lastname: Gámez
authors.forename: R
authors.initials: R
authors.lastname: Más
authors.forename: A
authors.initials: A
authors.lastname: Gutiérrez
authors.forename: N
authors.initials: N
authors.lastname: Mendoza
authors.forename: B
authors.initials: B
authors.lastname: Pardo
authors.forename: G
authors.initials: G
authors.lastname: Marrero
authors.forename: D
authors.initials: D
authors.lastname: Curveco
authors.forename: E
authors.initials: E
authors.lastname: Goicochea
authors.forename: H
authors.initials: H
authors.lastname: García
authors.forename: Y
authors.initials: Y
authors.lastname: Pérez
authors.forename: R M
authors.initials: RM
authors.lastname: González
mesh_terms: 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*
chemical_list: C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids