SYSTEMIC TOXICITY TEST- ISO 10993-11, GB/T 16886.11, USP Chapter<88>, EN ISO 10993-11, GB/T 14233.2, YY/T 0127.14, YY/T 0268
The systemic toxicity tests of animals can be divided into four types according to the duration of exposure, namely acute, subacute, subchronic and chronic toxicity tests.
The systemic toxicity tests of animals can be divided into four types according to the duration of exposure, namely acute, subacute, subchronic and chronic toxicity tests.
The latter three may be collectively referred to as repeated exposure toxicity tests.
Acute Systemic Toxicity
Adverse effects occurring at any time after one, multiple or continuous contact with the test sample within 24h.
Subacute Systemic Toxicity
Adverse effects after repeated or continuous exposure to test samples within 24h to 28d. International normative guidelines mostly choose a time period of 14d to 28d. Subacute venous studies generally stipulate exposure time > 24h, but < 14d.
Subchronic Systemic Toxicity
Adverse effects occurring at a certain stage of animal life after repeated or continuous exposure to test samples. Subchronic toxicity in rodents is usually studied for 90 days, and in other species for a period not exceeding 10% of their life span. The duration of subchronic venous study is usually 14d to 28d.
Chronic Systemic Toxicity
Adverse effects that occur after repeated or continuous exposure to test samples during the primary life of an animal. Chronic toxicity studies usually take 6 to 12 months.
STANDARDS：
ISO 10993-11, GB/T 16886.11, USP Chapter<88>, EN ISO 10993-11, GB/T 14233.2, YY/T 0127.14, YY/T 0268
RESULTS OBSERVATION:
Acute Systemic Toxicity
Acute systemic toxicity test is the first step in toxicity study. Both rodents and non-rodents are required. Usually mice or rats are exposed by oral, inhalation, venous, or transdermal routes.
Subacute Systemic Toxicity
Subacute toxicity test is to further examine the effects of the toxicity of the tested substances on the vital organs or physiological functions of the body on the basis of acute toxicity test, and estimate the dose of the effects, so as to prepare for the chronic toxicity test. The content of subacute toxicity test was basically the same as that of chronic toxicity test, but the duration of test was different.
Subchronic Systemic Toxicity
The exact number of days of "many days" of subchronic trial has not been completely unified.
Chronic Systemic Toxicity
Chronic toxicity test is to determine the lower limit of toxicity of foreign compounds, that is, the threshold dose and the inactive dose that can cause harm to the body after long-term exposure to the compounds. To provide the toxicological basis for the risk assessment of the compound and the formulation of the safety limit standard of human exposure to the compound, such as the maximum allowable concentration and daily allowable intake, etc.
PERIOD：
Items
Period
Acute Systemic Toxicity
2 weeks, please contact EPIN for details
Subacute Systemic Toxicity
6-8 weeks, please contact EPIN for details
Subchronic Systemic Toxicity
8-16 weeks, please contact EPIN for details
Chronic Systemic Toxicity
32 weeks, please contact EPIN for details
SAMPLE REQUIREMENTS——SINGLE POLAR：
ISO 10993-11, GB/T 16886.11, EN ISO 10993-11, GB/T 14233.2
