Test result of safety (3 items)
No abnormality was found in the acute toxicity test and the chronic toxicity test of CTP by using rats. The maximum dose in those tests was 2,000 mg/kg while a dose for human intake was normally about 80 mg/kg. The mutagenicity test by using bacteria was also negative.
| Test Item | Test Subject | Results |
|---|---|---|
| Single oral dose toxicity test | SPF rats (5 male and 5 female rats) | As a result of the single oral dose toxicity test of CTP-containing collagen in SPF rats which were administered the test samples of 1,000 mg/kg or 2,000 mg/kg, no changes were observed in all rats - both male and female. |
| Repeated oral dose toxicity test (4 weeks) | SPF rats (12 male and 12 female rats) | As a result of the repeated oral dose toxicity test of CTP-containing collagen in SPF rats which were administered the test sample of 1,000 mg/kg or 2,000 mg/kg, no changes were observed in all rats - both male and female. Moreover, the test sample didn�t show any effect in various hematological and pathological examinations. |
| Reverse mutation test | 5 strains of bacteria (Salmonella typhimurium x 4, colibacillus x 1) | As a result of the dose finding trial and that test, no mutagenicity was found in all 5 strains. |
