Long-term carcinogenicity of D-003, a mixture of high molecular weight acids from sugarcane wax, in Sprague Dawley rats: a 24 months study.
D-003 is a mixture of high molecular weight sugarcane wax aliphatic primary acids with cholesterol-lowering, anti-platelet and antioxidant effects. This study investigated the long-term oral toxicity and carcinogenicity of D-003 in Sprague Dawley rats of both sexes, randomly distributed into four groups: a control group, treated only with the vehicle, and three treated with D-003 (50, 500 and 1500 mg/kg). All treatments were given orally for 24 months. Mortality (survival analysis), clinical symptoms, weight gain, food consumption, organ weights, time-to-tumour or tumour incidence data were not shown between group differences or trends. With the exception of serum cholesterol levels, lower in D-003-treated groups (500 and 1500 mg/kg) than in the controls, no other difference in blood indicators was found. D-003 did not increase the frequency of neoplastic and non-neoplastic lesions compared with the controls. The occurrence of all malignant and mammary tumours in D-003-treated females was lower than in the controls. The lesions observed were consistent with spontaneous lesions reported in this species. In conclusion, D-003 is not toxic or carcinogenic when given orally to Sprague Dawley rats up to 1500 mg/kg for 2 years, and 1500 mg/kg was a not-observable effect dose.
Gámez
R
R
Centre of Natural Products, National Centre for Scientific Research, Cubanacán, Playa, Havana City, Cuba. rafael.gamez@cnic.edu.cu
Noa
M
M
Mas
R
R
Mendoza
N
N
Pardo
B
B
Menéndez
R
R
Pérez
Y
Y
González
R M
RM
Gutiérrez
A
A
Marrero
G
G
Goicochea
E
E
García
H
H
Curveco
D
D
D000284:Administration, Oral; D000818:Animals; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D015197:Carcinogenicity Tests; D005227:Fatty Acids / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D005260:Female; D008297:Male; D008970:Molecular Weight; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley
D000924:Anticholesteremic Agents; C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids; D010975:Platelet Aggregation Inhibitors