Table 9. NOAEL and LOAEL in each study.
| Animal species | Study | Dose (mg/kg bw/day) | NOAEL (mg/kg bw/day) | LOAEL (mg/kg bw/day) | Remarksa) |
|---|---|---|---|---|---|
| Rat | 90-day subacute toxicity study | 0, 20, 200, 2000, 20000 ppm | Male: 122 | Male: 1270 | Male: An increase in relative weight of the liver, centrilobular hepatocellular hypertrophy Female: No toxicological finding |
| Male: 0, 1.22, 12.5, 122, 1,270 | Female: 1500 | Female: — | |||
| Female: 0, 1.46, 14.3, 149, 1500 | |||||
| 2-year combined chronic toxicity/carcinogenicity study | Male: 0, 60, 600, 2000, 6000 ppm | Male: 249 | Male: — | Male and Female: No toxicological finding (Flutianil showed no carcinogenicity.) | |
| Female: 0, 60, 2000, 6000, 20000 ppm | Female: 1130 | Female: — | |||
| Male: 0, 2.45, 25.2, 81.9, 249 Female: 0, 3.15, 111, 334, 1130 | |||||
| Two-generation reproductive study | 0, 200, 2000, 20000 ppm | Parent animals | Parent animals | Parent animals | |
| P male: 0, 13.9, 142, 1470 | P male: 142 | P male: 1470 | Male and Female: Increases in absolute and relative weights of the liver, etc. Offspring Male and female: No toxicological finding (Flutianil showed no effect on reproduction.) | ||
| P female: 0, 16.6, 171, 1750 | P female: 171 | P female: 1750 | |||
| F1 male: 0, 15.2, 155, 1580 | F1 male: 155 | F1 male: 1580 | |||
| F1 female: 0, 17.1, 176, 1770 | F1 female: 176 | F1 female: 1770 | |||
| Offspring | Offspring | ||||
| P male: 1470 | P male: — | ||||
| P female: 1750 | P female: — | ||||
| F1 male: 1580 | F1 male: — | ||||
| F1 female:1770 | F1 female: — | ||||
| Developmental toxicity study | 0, 100, 333, 1000 | Dam: 1000 | Dam: — | Dam: No toxicological finding Fetus: No toxicological finding (Flutianil showed no teratogenicity.) | |
| Fetus: 1000 | Fetus: — | ||||
| Mouse | 90-day subacute toxicity study | 0, 1000, 3000, 10000 ppm | Male: 1390 | Male: — | Male and female: No toxicological finding |
| Male: 0, 138, 409, 1390 | Female: 1560 | Female: — | |||
| Female: 0, 159, 481, 1560 | |||||
| 18-month carcinogenicity study | 0, 1000, 3000, 10000 ppm | Male: 1084 | Male: — | Male and female: No toxicological finding (Flutianil showed no carcinogenicity.) | |
| Male: 0, 106, 321, 1084 | Female: 1063 | Female: — | |||
| Female: 0, 105, 316, 1063 | |||||
| Rabbit | Developmental toxicity study | 0, 100, 300, 1000 | Dam: 1000 | Dam: — | Dam: No toxicological finding Fetus: No toxicological finding (Flutianil showed no teratogenicity.) |
| Fetus: 1000 | Fetus: — | ||||
| Dog | 90-day subacute toxicity study | 0, 30, 300, 1000 | Male: 1000 | Male: — | Male and female: No toxicological finding |
| Female: 1000 | Female: — | ||||
| 1-year chronic toxicity study | 0, 30, 300, 1000 | Male: 1000 | Male: — | Male and female: No toxicological finding | |
| Female: 1000 | Female: — |
—: NOAEL or LOAEL could not be set. a) Summary of the toxicological findings observed at the LOAEL is shown in the remark.