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GB/T 15670.3-2017 English PDF (GBT15670.3-2017)
GB/T 15670.3-2017 English PDF (GBT15670.3-2017)
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GB/T 15670.3-2017: Toxicological test methods for pesticides registration -- Part 3: Acute oral toxicity test -- Up-and-down-procedure
GB/T 15670.3-2017
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 65.100
B 17
Toxicological test methods for pesticides registration - Part
3.Acute oral toxicity test - Up-and-down-procedure
ISSUED ON. JULY 12, 2017
IMPLEMENTED ON. FEBRUARY 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Purpose of the test... 6
5 Experimental overview... 6
6 Test methods... 6
7 Test results and evaluation... 10
8 Test report... 11
Appendix A (Normative) Table of dose levels (mg/kg body weight) with a starting dose
of 175 mg/kg body weight and a slope of 1~8... 12
Appendix B (Normative) Calculation of LD50 in formal tests... 13
Toxicological test methods for pesticides registration - Part
3.Acute oral toxicity test - Up-and-down-procedure
1 Scope
This part of GB/T 15670 specifies the basic principles, methods and requirements for
the up-and-down-procedure of acute oral toxicity testing.
This part applies to acute oral toxicity tests conducted for pesticide registration.
2 Normative references
The following documents are essential for the application of this document. For any
dated referenced document, only the dated version applies to this document. For any
undated referenced document, the latest version (including all amendments) applies to
this document.
GB 14925 Laboratory animal - Environment and housing facilities
Regulations on Pesticide Registration Information (Order No. 10 of the Ministry
of Agriculture of the People's Republic of China [2007])
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 acute oral toxicity
The health-damaging effects that occur in animals in the short term after the test
substance is orally administered to experimental animals once or multiple times within
24 hours.
3.2 dose
The amount of the test substance administered, which is expressed as the mass of the
test substance received per unit body weight of the experimental animal (mg/kg body
weight).
3.3 median lethal dose
LD50
The statistical dose of a toxicant that causes half of the total number of animals to die
after the test substance is given to the experimental animals once or multiple times
within 24 hours. It is expressed as the mass of the test substance received by the
experimental animals per unit body weight (mg/kg body weight).
3.4 dose-response relationship
The relationship between the dose and the incidence of a specific effect.
4 Purpose of the test
Acute oral toxicity test is the first step to evaluate the toxicity of the test substance.
Through short-term administration of toxicant by oral, the toxicity characteristics and
dose-response relationship of the test substance are preliminarily understood, which
provides a basis for acute toxicity classification, label management and other
toxicology test dose selection.
5 Experimental overview
The up-and-down procedure (UDP) is a step-by-step administration procedure. Animals
of the same sex are tested, and one animal is administered at a time. The first animal is
administered a dose that is preferably lower than the estimated LD50.The increase or
decrease in the subsequent dose of administration depends on the administration result
(survival or death) of the previous animal. When the preliminary estimate of the LD50
of the test substance and the slope of the dose-response curve are not available, the
computer simulation result suggests that the starting dose can be 175 mg/kg body
weight, and the dose interval is calculated using the antilogarithm of 0.5 (corresponding
to a default dose progression factor of 3.2). The point estimate value and 95%
confidence interval of LD50 are calculated by the maximum likelihood method.
NOTE. The dose progression factor is determined by the antilogarithm of the reciprocal of the slope of
the dose-response curve (3.2 is the progression factor for a slope of 2).
The number of animals used in the formal test is about 6~9.The number of animals
used in the limit test is no more than 5.This method is only applicable to test substances
that cause death within 1~2 days after administration, and is not applicable to test
substances that are expected to cause death to happen more than 5 days (including 5
days) after administration.
6 Test methods
6.1 Test substances
6.4.1.2 If 3 of the 5 administered animals die within 48 hours or their death is within
the 14-day observation period, the administration is terminated and the formal test
begins.
6.4.2 Formal test
6.4.2.1 Before the experiment, the rats were fasted overnight but had unlimited access
to water.
6.4.2.2 Selection of starting dose and dose progression factor. When an estimate of the
lethal dose of the test substance is not available, the default starting dose is 175 mg/kg
body weight. The dose sequence set corresponding to the progression factor 3.2 of a
dose-response slope of 2 is 1.75 mg/kg body weight, 5.5 mg/kg body weight, 17.5
mg/kg body weight, 55 mg/kg body weight, 175 mg/kg body weight, 555 mg/kg body
weight and 2000 mg/kg body weight; or 1.75 mg/kg body weight, 5.5 mg/kg body
weight, 17.5 mg/kg body weight, 55 mg/kg body weight, 175 mg/kg body weight, 555
mg/kg body weight, 1750 mg/kg body weight and 5000 mg/kg body weight. If the slope
of the dose-response curve of the test substance is known to be relatively steep or
relatively flat, the dose progression factor can be reduced or increased. Appendix A lists
the dose levels available with a starting dose of 175 mg/kg body weight and a slope of
1~8.
6.4.2.3 At the beginning of the test, weigh the fasted animals and administer the test
substance orally using a gavage needle, one animal at a time, with an interval of 48
hours between each animal. The administration dose for the second animal depends on
the result of the first animal's administration. If the animal dies or is in a dying state,
the dose is adjusted down by one level according to the progression factor; if the animal
survives, the dose is adjusted up by one level. When the subsequent doses show the
opposite result to the starting dose, add 4 more animals to be administered the test
substance sequentially and then terminate the test, or when any of the termination
requirements (see 6.4.2.6) are reached, the test can be terminated. After administration,
the rats shall continue to fast for 3 h~4 h. The observation period for each animal is 14
d.
6.4.2.4 If animals survive within 48 hours after administration but die later in the
subsequent observation period, it indicates that the dose selection is inappropriate and
consideration may be given to giving 2 more animals a dose lower than the dose that
causes death, restarting the test and extending the observation period.
6.4.2.5 The test results are used to calculate the LD50 and 95% confidence interval of
the test substance using the maximum likelihood method (see Appendix B).
6.4.2.6 The test can be terminated if any of the following conditions are met.
a) When three animals survive the sequential administration at the upper dose
range;
b) When 5 opposite results occur among 6 animals randomly selected and
sequentially administered;
c) At least 4 animals are sequentially administered after the first adverse result
...
Get QUOTATION in 1-minute: Click GB/T 15670.3-2017
Historical versions: GB/T 15670.3-2017
Preview True-PDF (Reload/Scroll if blank)
GB/T 15670.3-2017: Toxicological test methods for pesticides registration -- Part 3: Acute oral toxicity test -- Up-and-down-procedure
GB/T 15670.3-2017
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 65.100
B 17
Toxicological test methods for pesticides registration - Part
3.Acute oral toxicity test - Up-and-down-procedure
ISSUED ON. JULY 12, 2017
IMPLEMENTED ON. FEBRUARY 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Purpose of the test... 6
5 Experimental overview... 6
6 Test methods... 6
7 Test results and evaluation... 10
8 Test report... 11
Appendix A (Normative) Table of dose levels (mg/kg body weight) with a starting dose
of 175 mg/kg body weight and a slope of 1~8... 12
Appendix B (Normative) Calculation of LD50 in formal tests... 13
Toxicological test methods for pesticides registration - Part
3.Acute oral toxicity test - Up-and-down-procedure
1 Scope
This part of GB/T 15670 specifies the basic principles, methods and requirements for
the up-and-down-procedure of acute oral toxicity testing.
This part applies to acute oral toxicity tests conducted for pesticide registration.
2 Normative references
The following documents are essential for the application of this document. For any
dated referenced document, only the dated version applies to this document. For any
undated referenced document, the latest version (including all amendments) applies to
this document.
GB 14925 Laboratory animal - Environment and housing facilities
Regulations on Pesticide Registration Information (Order No. 10 of the Ministry
of Agriculture of the People's Republic of China [2007])
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 acute oral toxicity
The health-damaging effects that occur in animals in the short term after the test
substance is orally administered to experimental animals once or multiple times within
24 hours.
3.2 dose
The amount of the test substance administered, which is expressed as the mass of the
test substance received per unit body weight of the experimental animal (mg/kg body
weight).
3.3 median lethal dose
LD50
The statistical dose of a toxicant that causes half of the total number of animals to die
after the test substance is given to the experimental animals once or multiple times
within 24 hours. It is expressed as the mass of the test substance received by the
experimental animals per unit body weight (mg/kg body weight).
3.4 dose-response relationship
The relationship between the dose and the incidence of a specific effect.
4 Purpose of the test
Acute oral toxicity test is the first step to evaluate the toxicity of the test substance.
Through short-term administration of toxicant by oral, the toxicity characteristics and
dose-response relationship of the test substance are preliminarily understood, which
provides a basis for acute toxicity classification, label management and other
toxicology test dose selection.
5 Experimental overview
The up-and-down procedure (UDP) is a step-by-step administration procedure. Animals
of the same sex are tested, and one animal is administered at a time. The first animal is
administered a dose that is preferably lower than the estimated LD50.The increase or
decrease in the subsequent dose of administration depends on the administration result
(survival or death) of the previous animal. When the preliminary estimate of the LD50
of the test substance and the slope of the dose-response curve are not available, the
computer simulation result suggests that the starting dose can be 175 mg/kg body
weight, and the dose interval is calculated using the antilogarithm of 0.5 (corresponding
to a default dose progression factor of 3.2). The point estimate value and 95%
confidence interval of LD50 are calculated by the maximum likelihood method.
NOTE. The dose progression factor is determined by the antilogarithm of the reciprocal of the slope of
the dose-response curve (3.2 is the progression factor for a slope of 2).
The number of animals used in the formal test is about 6~9.The number of animals
used in the limit test is no more than 5.This method is only applicable to test substances
that cause death within 1~2 days after administration, and is not applicable to test
substances that are expected to cause death to happen more than 5 days (including 5
days) after administration.
6 Test methods
6.1 Test substances
6.4.1.2 If 3 of the 5 administered animals die within 48 hours or their death is within
the 14-day observation period, the administration is terminated and the formal test
begins.
6.4.2 Formal test
6.4.2.1 Before the experiment, the rats were fasted overnight but had unlimited access
to water.
6.4.2.2 Selection of starting dose and dose progression factor. When an estimate of the
lethal dose of the test substance is not available, the default starting dose is 175 mg/kg
body weight. The dose sequence set corresponding to the progression factor 3.2 of a
dose-response slope of 2 is 1.75 mg/kg body weight, 5.5 mg/kg body weight, 17.5
mg/kg body weight, 55 mg/kg body weight, 175 mg/kg body weight, 555 mg/kg body
weight and 2000 mg/kg body weight; or 1.75 mg/kg body weight, 5.5 mg/kg body
weight, 17.5 mg/kg body weight, 55 mg/kg body weight, 175 mg/kg body weight, 555
mg/kg body weight, 1750 mg/kg body weight and 5000 mg/kg body weight. If the slope
of the dose-response curve of the test substance is known to be relatively steep or
relatively flat, the dose progression factor can be reduced or increased. Appendix A lists
the dose levels available with a starting dose of 175 mg/kg body weight and a slope of
1~8.
6.4.2.3 At the beginning of the test, weigh the fasted animals and administer the test
substance orally using a gavage needle, one animal at a time, with an interval of 48
hours between each animal. The administration dose for the second animal depends on
the result of the first animal's administration. If the animal dies or is in a dying state,
the dose is adjusted down by one level according to the progression factor; if the animal
survives, the dose is adjusted up by one level. When the subsequent doses show the
opposite result to the starting dose, add 4 more animals to be administered the test
substance sequentially and then terminate the test, or when any of the termination
requirements (see 6.4.2.6) are reached, the test can be terminated. After administration,
the rats shall continue to fast for 3 h~4 h. The observation period for each animal is 14
d.
6.4.2.4 If animals survive within 48 hours after administration but die later in the
subsequent observation period, it indicates that the dose selection is inappropriate and
consideration may be given to giving 2 more animals a dose lower than the dose that
causes death, restarting the test and extending the observation period.
6.4.2.5 The test results are used to calculate the LD50 and 95% confidence interval of
the test substance using the maximum likelihood method (see Appendix B).
6.4.2.6 The test can be terminated if any of the following conditions are met.
a) When three animals survive the sequential administration at the upper dose
range;
b) When 5 opposite results occur among 6 animals randomly selected and
sequentially administered;
c) At least 4 animals are sequentially administered after the first adverse result
...
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