GB 15193.3-2014 PDF English
US$380.00 · In stock · Download in 9 secondsGB 15193.3-2014: National food safety standard - Acute toxicity test Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB 15193.3: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 15193.3-2014 | English | 380 |
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National food safety standard - Acute toxicity test
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| GB 15193.3-2003 | English | 599 |
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Acute toxicity test
| Obsolete |
| GB 15193.3-1994 | English | 559 |
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Acute toxicity test
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GB 15193.3-2014: National food safety standard - Acute toxicity test---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15193.3-2014
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard - Acute toxicity test
Issued on. DECEMBER 24, 2014
Implemented on. MAY 01, 2015
Issued by. Health and Family Planning Commission of PRC
Table of Contents
Foreword... 3
1 Scope... 4
2 Terms and definitions... 4
3 Test purpose and principle... 4
4 Test methods... 5
5 Data processing and result evaluation... 14
6 Report... 14
7 Interpretation of the test... 15
Appendix A Calculation of LD50 value in Horn's method (calculation table for the
determination of LD50 by dose escalation method)... 16
Appendix B Dose gradient table for up-down procedure (UDP) with different slopes
... 21
Appendix C Calculation of LD50 point estimates and confidence limits for formal test
... 23
Appendix D Response rate-probability unit table... 25
Appendix E Probability units equivalent to 0% and 100% response rates... 26
Appendix F Observation items in experimental animal poisoning performance... 27
Appendix G Dose grading of acute toxicity (LD50)... 28
Foreword
This standard replaces GB 15193.3-2003 "Acute toxicity test".
Compared with GB 15193.3-2003, the main changes of this standard are as follows.
- CHANGE the standard name into "National food safety standard - Acute toxicity
test";
- MODIFY the Scope;
- ADD test report and test interpretation;
- MODIFY the experimental animals and test methods;
- DELETE the maximum tolerated dose method; ADD the limit test and the up-down
procedure;
- MODIFY the Appendix.
National food safety standard - Acute toxicity test
1 Scope
This standard specifies the basic test methods and technical requirements, for acute oral
toxicity test.
This standard applies to the evaluation of the acute oral toxicity of the test substance.
2 Terms and definitions
2.1 Acute oral toxicity
The toxic effects on animals, in a short period of time, after one or more oral
administration of the test substance to experimental animals within 24 h.
2.2 The half lethal dose (LD50)
The dose of the test substance, that can cause animal mortality to be 50%, after oral
administration of the test substance once or multiple times within 24 h. It is the
calculated value, which is obtained through statistics.
3 Test purpose and principle
The acute oral toxicity test is the most basic test, for detecting and evaluating the toxic
effects of the test substance, that is, after the test substance is administered orally once
or multiple times within 24 hours, the toxic reactions produced by animals, including
poisoning sign and death, are observed in a short period of time. It is usually expressed
as LD50.
4 Test methods
4.1 Test substance
4.1.1 Preparation of test substances
It shall dissolve or suspend the test substance in a suitable solvent. The preferred solvent
is water.
4.1.2 Administration of test substance
4.1.2.1 Approach
Oral gavage.
4.1.2.2 Fasting before the test
Animals need to fast before the test. Generally, rats need to fast overnight (generally
about 16 h); mice need to fast for 4 h ~ 6 h; BUT they can drink water freely. After
administration of the test substance, rats need to continue fasting for 3 h ~ 4 h; mice
need to continue fasting for 1 h ~ 2 h. If the test substance is administered in batches
multiple times, the animals can be given a certain amount of feed, according to the
length of the exposure interval.
4.1.2.5 Observation period
General observation period is 14 d, which may be extended to 28 d if necessary. It shall
be observed for at least 7 d, in special emergency situations.
4.2 Experimental animals
4.2.1 Animal selection
The selection of experimental animals shall comply with national standards and
relevant regulations (GB 14923, GB 14922.1, GB 14922.2). Choose healthy adult rats
(180 g ~ 220 g) and/or mice (18 g ~ 22 g) of two genders, OR choose other experimental
animals. Females shall be unmated and unpregnant. The difference in body weight,
between animals of the same gender, shall not exceed ±20% of the average body weight.
4.2.2 Animal preparation
Before the test, the experimental animals shall undergo at least 3 d ~ 5 d environmental
adaptation and quarantine observation, in the test environment.
4.3 Design methods for several commonly used acute toxicity tests
4.3.1 Horn's method
4.3.1.1 Pre-test
According to the nature of the test substance and the known data, the following methods
are used. Generally, it uses the dose of 100 mg/kg body weight, 1000 mg/kg body
weight, 10000 mg/kg body weight, each of which uses 2 ~ 3 animals for pretest.
According to the death situation within 24 h, estimate the possible range of LD50.
Determine the dose group of the formal test.
4.3.1.2 Formal test
4.3.1.2.1 Number of animals
Generally, there are 10 animals in each group, half male and half female.
4.3.2 Limit test
4.3.2.1 Scope of application
This method is applicable to the test substance, whose data shows little or no toxicity.
When the animal is administered with a certain dose of the test substance, there is still
no death.
4.3.2.2 Number of animals
It generally selects 20 animals, half male and half male.
4.3.3 Up-down procedure (UDP)
4.3.3.1 Scope of application
This method is mainly applicable to the test substance, which has high purity, high
toxicity, low intake, AND the animal will die, within 1 d ~ 2 d after administration of
the test substance. For the test substance, which causes the animal to die at 5 d and
above, after administration, it is not applicable. The test can be carried out, according
to the dose sequence selected by the tester OR under the guidance of a special software
package; the test results can be counted.
4.3.4 Korbor method
4.3.4.1 Pre-test
Unless otherwise required, the dose, at which all animals die or more than 90% of the
animals die, AND the dose, at which no animals die or less than 10% of the animals die,
shall be obtained in the pre-test, as the highest dose and the lowest dose in the formal
test, respectively.
4.3.6 Acute combined toxicity test
4.3.6.1 Principle
When two or more test substances exist at the same time, three different combined
action modes of antagonism, addition or synergy may occur. These three different
actions can be determined, according to certain formulas and judgement criteria.
4.3.6.2 Procedure
4.3.6.3 Calculation
4.3.6.3.1 Each test substance in the mixture is mixed in an equal toxic ratio, so the
calculated LD50 is multiplied by the ratio of each test substance, to obtain the dose of
each test substance.
4.4 Observation indicators
4.4.1 Clinical observation
Observations include skin, hair, eyes, mucous membranes, respiratory system,
genitourinary system, digestive system, nervous system, etc. Special attention shall be
paid to the presence or absence of tremor, convulsions, salivation, diarrhea,
sluggishness, lethargy, coma (see Appendix F).
4.4.2 Pathological examination
All animals, including those died during the test, humanely sacrificed, sacrificed at the
end of the test, shall undergo gross anatomical examination. Record the gross
pathological changes of each animal. It shall perform histopathological observation,
where there are gross anatomical pathological changes.
5 Data processing and result evaluation
Describe the characteristics of the toxic effects, which are initially suggested by the
poisoning performance. Determine the acute toxicity grading of the test substance,
according to the LD50 value (see Appendix G).
6 Report
6.1 Test name, test organization name, contact information, report number.
6.2 The name and contact information of the test entrusting organization, as well as the
date of sample acceptance.
6.3 The start and end date of the test, the person in charge of the test item, the technical
person in charge of the test organization, the date of issue.
6.4 Test summary.
6.5 Test substance. Name, batch number, dosage form, state (including sensory,
properties, packaging integrity, identification), quantity, pre-treatment method, solvent.
6.8 Test results. Animal growth and activity, body weight, body weight gain, response
of each animal (including signs of toxicity, severity, duration, reversibility, death rate
list, gross anatomy of each animal, histopathological findings, LD50 and 95%
confidence limits, statistical treatment method of the results.
7 Interpretation of the test
The acute oral toxicity test can provide information on health hazards, which are caused
by oral exposure to the test substance, in a short period of time; provide a basis for the
dose selection of further toxicity tests; preliminarily estimate the target organs and
possible mechanisms of toxicity.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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