Evaluation of the reproductive and developmental toxicity of the D-003, a mixture of long-chain fatty acids, in rats and rabbits.
D-003 is a mixture of long-chain fatty acids isolated and purified from sugar cane wax with cholesterol-lowering properties. D-003 given orally (500 and 1000 mg/kg/day) to female rats for 15 days prior to mating, through mating and gestation to day 21 of lactation and male rats for 4 weeks prior and during mating did not induce toxic effects on reproduction. There were no significant reductions in the number of animals that conceived, in the numbers of pups born to those that did conceive, in the numbers of pups that survived until weaning, and in their body weights at weaning. Drug-treated and control groups' offspring were comparable in growth, physical and behavioral development, spontaneous activity and reproductive performance. Pregnant New Zealand rabbits were given D-003 as oral doses of 500 and 1000 mg/kg/day on days 6 through 18 of gestation without any evidence of embryotoxicity or teratogenicity. The no-observed-effect dose in these two experimental studies was 1000 mg/kg/day. After assessment of the potential of high doses of D-003 to act on developing embryo and reproduction process, no evidence supports the conclusion that D-003 is a reproductive and developmental toxicant/teratogen.
Rodríguez
M D
MD
Centre of Natural Products, National Centre for Scientific Research, Ave 25 and 158, P.O.B 6414, Cubanacán, Havana, Cuba. clinica@enet.cu
González
J E
JE
Alemán
C
C
Rodeiro
I
I
Arango
E
E
Gámez
R
R
Valdés
S
S
García
H
H
Goicochea
E
E
Acosta
C P
CP
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005227:Fatty Acids / Q000633:toxicity*; D005260:Female; D005298:Fertility / Q000187:drug effects; D007774:Lactation / Q000187:drug effects; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects*; D013723:Teratogens; D015430:Weight Gain / Q000187:drug effects
C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids; D013723:Teratogens