Trial items
| Acute Toxicity Test |
LD50 (Oral): Rats, sexed >5,000mg/kg |
| Human 4 week repeat-dose study |
900mg/day were administered for four weeks, but no abnormalities were found in the general condition of the test subjects, blood, urine, or in morphological observations. |
| Rat 1 year repeat-dose study |
250,500,1000mg/kg/day were administered orally for 52 weeks, but no notable fluctuations were found in the general condition of the test subjects, blood, urine, or in morphological observations. |
| Mutagenicity test (Ames Test) |
Results of reverse mutation test using bacteria (4 strains of salmonella, 1 strain of coli bacteria) were negative. |
| Mutagenicity test (chromosomal aberration test) |
Results of chromosomal aberration test using Chinese Hamster lung cells were negative. |
| Mutagenicity test (micronucleus test) |
Results of micronucleus test in bone marrow cells of Crlj: CD1 mice were negative. |