Lack of toxicity or carcinogenicity of S-170, a sucrose fatty acid ester, in F344 rats.
A chronic combined toxicity and carcinogenicity study of S-170, a sucrose fatty acid ester, was performed in male and female F344 rats. S-170 was given ad libitum in the diet at levels of 0, 1.25, 2.5 or 5% to 10 rats/sex/group for 12 months to determine chronic toxicity and 0, 2.5 or 5% to 50 rats/sex/group for two years in the carcinogenicity study. Treatment with S-170 exerted no effect on survival in either sex. In the 12-month chronic toxicity study, no treatment-related effects on body weights, or hematological, blood biochemical, urinary and pathological parameters were demonstrated in any of the treated groups. In the carcinogenicity study, S-170 did not cause any dose-related significant increase in the incidences of tumors in any organs or tissues. Taken together, the results clearly demonstrate that S-170 has neither toxic nor carcinogenic activity in F344 rats under the conditions of the study. No observed adverse effect levels (NOAELs) calculated from the 12-month chronic toxicity and carcinogenicity study were 2.37 g/kg/day in males and 2.80 g/kg/day in females, and 2.12 g/kg/day in males and 2.42 g/kg/day in females, respectively.
Yoshida
Midori
M
Department of Pathology, Sasaki Institute, 2-2 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan. midoriy@sasaki.or.jp
Katsuda
Shin-Ichi
S
Nakae
Dai
D
Maekawa
Akihiko
A
D000818:Animals; D015197:Carcinogenicity Tests; D002273:Carcinogens / Q000008:administration & dosage / Q000633:toxicity*; D004032:Diet; D004305:Dose-Response Relationship, Drug; D005227:Fatty Acids / Q000008:administration & dosage / Q000633:toxicity*; D005260:Female; D005503:Food Additives / Q000008:administration & dosage / Q000633:toxicity*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D011916:Rats, Inbred F344; D013047:Specific Pathogen-Free Organisms; D013395:Sucrose / Q000031:analogs & derivatives*; D036401:Toxicity Tests, Chronic
D002273:Carcinogens; D005227:Fatty Acids; D005503:Food Additives; D013395:Sucrose