Introduction to safety research
The safety of Asaigermanium has been repeatedly confirmed in accordance with the guidelines of each era. In particular, as a third phase of safety testing since 1990, Asai Germanium Research Institute conducted tests on acute, subacute, chronic, teratogenicity, and other toxicities applying GLP standards as follows.
| Acute toxicity (single dose toxicity test) | A study to examine acute toxicity and approximate lethal dose when a high dose of test substance is administered once |
| Subacute / chronic toxicity test (repeated dose toxicity test) (1-12 months) | Study to examine toxicity when test substance is repeatedly administered from 4 weeks to 6 months or more (in the case of subacute, 1 month [28 days, 4 weeks] or 3 months [90 days, 13 weeks]) |
| Teratogenicity / Reproductive and developmental toxicity studies | Examination of effects on reproductive function, fetal development, and growth after birth |
| Genotoxicity test / 3 mutagenicity tests | Tests that examine the toxicity of the test substance gene (DNA) to the structure and function |
| Antigenicity test*1 | A test to determine whether a test substance acts as an antigen and causes an abnormal immune response |
| Skin sensitization test | A test that examines specific skin immune reactions such as erythema, edema, and desquamation caused by contacting the test substance several times with the skin and then contacting the test substance once after a certain period of time. |
| Skin photosensitization test | Test to investigate photosensitivity reaction caused by combined action of test substance and sunlight |
| Skin irritation / primary skin irritation test, continuous skin irritation test |
Test to examine changes in erythema, edema, desquamation, etc. caused by single or repeated application of test substance with skin |
| Eye irritation / ocular mucosal irritation test | A test in which the test substance is place in the eyes of a test animals and harmful effect is examined |
| Phototoxicity / phototoxicity test | Test to examine skin irritation reaction caused by light irradiation when a test substance is administered |
| Human patch test*2 | Test to evaluate the irritation 1 hour after peeling and 24 hours after taking off the test substance for 24 hours |
*1：Non-GLP application test
*2：GCP compliance test
