GB 15193.3-2014 National food safety standard Acute oral toxicity test
1 Scope
This standard specifies the basic test methods and technical requirements for acute oral toxicity tests.
This standard is applicable to evaluate the acute oral toxic effects of test substances.
2 Terms and definitions
2.1 acute oral toxicity
toxic effect of laboratory animal in a short time after oral administration of test substance once or several times within 24h
2.2 median lethal dose (LD50)
dose of the test substance which can cause the animal mortality rate of 50% after oral administration of test substance once or several times within 24 h, which is the calculated value obtained through statistics. The dose unit is milligrams (or grams) of the test substance ingested per kilogram of body weight, that is, mg/kg of body weight or g/kg of body weight
3 Test objective and principle
Acute oral toxicity test is the most basic test to detect and evaluate the toxic effect of the test substance, i.e., observation of toxic effect of animal in a short time after oral administration of test substance once or several times within 24 h, including toxication signs and death, which is usually expressed as LD50.
The test can provide information on health hazards caused by oral administration of the test substance in a short time; be used as the basis for acute toxicity grade; provide the basis of dose selection and observation index for further toxicity test; preliminarily estimate the target organ and possible mechanism of toxic effect.
4 Test methods
4.1 Test substance
4.1.1 Test substance preparation
The test substance shall be dissolved or suspended in a suitable solvent. The preferred solvent is water; vegetable oil (such as olive oil, corn oil, etc.) can be used for test substance insoluble in water; and test substance insoluble in water or oil can also be prepared into suspension or paste with carboxymethyl cellulose, starch, etc. The test substance shall be prepared freshly, except for those whose solution or suspension is stored stably.
4.1.2 Test substance administration
4.1.2.1 Pathway
Oral intragastric administration.
4.1.2.2 Fasting before test
Foreword i
1 Scope
2 Terms and definitions
3 Test objective and principle
4 Test methods
5 Data processing and results evaluation
6 Test report
7 Interpretation of test
Annex A LD50 value calculation by Horn method (Table for calculation of LD50 by dose increment method)
Annex B Dose gradient for different slopes in up-down procedure (UDP)
Annex C Calculation of LD50 point estimates and confidence intervals in formal tests
Annex D Response rate-probability unit form
Annex E Probability units equivalent to 0% and 100% response rates
Annex F Observation items of toxication performance of laboratory animals
Annex G Acute toxicity (LD50) dose classification
Standard
GB 15193.3-2014 National Food Safety Standard - Acute Oral Toxicity Test (English Version)
Standard No.
GB 15193.3-2014
Status
valid
Language
English
File Format
PDF
Word Count
12500 words
Price(USD)
370.0
Implemented on
2015-5-1
Delivery
via email in 1 business day
Detail of GB 15193.3-2014
Standard No.
GB 15193.3-2014
English Name
National Food Safety Standard - Acute Oral Toxicity Test
GB 15193.3-2014 National food safety standard Acute oral toxicity test
1 Scope
This standard specifies the basic test methods and technical requirements for acute oral toxicity tests.
This standard is applicable to evaluate the acute oral toxic effects of test substances.
2 Terms and definitions
2.1 acute oral toxicity
toxic effect of laboratory animal in a short time after oral administration of test substance once or several times within 24h
2.2 median lethal dose (LD50)
dose of the test substance which can cause the animal mortality rate of 50% after oral administration of test substance once or several times within 24 h, which is the calculated value obtained through statistics. The dose unit is milligrams (or grams) of the test substance ingested per kilogram of body weight, that is, mg/kg of body weight or g/kg of body weight
3 Test objective and principle
Acute oral toxicity test is the most basic test to detect and evaluate the toxic effect of the test substance, i.e., observation of toxic effect of animal in a short time after oral administration of test substance once or several times within 24 h, including toxication signs and death, which is usually expressed as LD50.
The test can provide information on health hazards caused by oral administration of the test substance in a short time; be used as the basis for acute toxicity grade; provide the basis of dose selection and observation index for further toxicity test; preliminarily estimate the target organ and possible mechanism of toxic effect.
4 Test methods
4.1 Test substance
4.1.1 Test substance preparation
The test substance shall be dissolved or suspended in a suitable solvent. The preferred solvent is water; vegetable oil (such as olive oil, corn oil, etc.) can be used for test substance insoluble in water; and test substance insoluble in water or oil can also be prepared into suspension or paste with carboxymethyl cellulose, starch, etc. The test substance shall be prepared freshly, except for those whose solution or suspension is stored stably.
4.1.2 Test substance administration
4.1.2.1 Pathway
Oral intragastric administration.
4.1.2.2 Fasting before test
Contents of GB 15193.3-2014
Foreword i
1 Scope
2 Terms and definitions
3 Test objective and principle
4 Test methods
5 Data processing and results evaluation
6 Test report
7 Interpretation of test
Annex A LD50 value calculation by Horn method (Table for calculation of LD50 by dose increment method)
Annex B Dose gradient for different slopes in up-down procedure (UDP)
Annex C Calculation of LD50 point estimates and confidence intervals in formal tests
Annex D Response rate-probability unit form
Annex E Probability units equivalent to 0% and 100% response rates
Annex F Observation items of toxication performance of laboratory animals
Annex G Acute toxicity (LD50) dose classification
