GB/T 15670.5-2017 English PDF (GB/T15670.5-2017)

GB/T 15670.5-2017: Toxicological test methods for pesticides registration - Part 5: Acute dermal toxicity test
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GB/T 15670.5-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.100
B 17
Partially replacing GB/T 15670-1995
Toxicological Test Methods for Pesticides Registration - Part
5.Acute Dermal Toxicity Test
ISSUED ON. JULY 12, 2017
IMPLEMENTED ON. FEBRUARY 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 6
4 Test Purpose... 7
5 Test Overview... 7
6 Test Methods... 7
7 Test Results and Evaluation... 10
8 Test Report... 11
Appendix A (normative) Method for Estimating Body Surface Area of Experimental
Animals... 13
Toxicological Test Methods for Pesticides Registration - Part
5.Acute Dermal Toxicity Test
1 Scope
This Part of GB/T 15670 specifies the basic principles, methods and requirements for acute
dermal toxicity test.
This Part is applicable to acute dermal toxicity test for pesticides registration.
2 Normative References
The following documents are indispensable to the application of this document. In terms of
references with a specified date, only versions with a specified date are applicable to this
document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this document.
GB 14925 Laboratory Animal - Requirements of Environment and Housing Facilities
Regulations on Pesticides Registration Information (Decree of Ministry of Agriculture of the
People’s Republic of China [2007] No. 10)
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 acute dermal toxicity
The health-damaging effect of skin exposure to the test substance resulting from continuous
exposure for 24 hours.
3.2 dose
The amount of the test substance provided, which is expressed in terms of 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
After the test substance is administered to the experimental animals once or multiple times
within 24 hours, the statistical dose of toxicant that causes the death of half of the experimental
animals. It is expressed in terms of the mass of the test substance received per unit body weight
of the experimental animal (mg/kg body weight).
3.4 dose-response relationship
The relationship between dose and the occurrence of a specific effect.
4 Test Purpose
By continuously injecting the test substance through the intact skin within 24 hours, observe
the toxic effects of the test substance on the experimental animals, and preliminarily understand
whether the test substance can be absorbed through the skin and its toxic effect mode, which
provides a basis for acute toxicity classification, label management and other toxicological test
dose selection.
5 Test Overview
Before the test, remove the clothing hair of the test parts of the experimental animals, divide
the experimental animals into several dose groups (at least 3 groups), apply different doses of
test substance to each group, then, observe the poisoning reaction and death of the experimental
animals, and conduct gross anatomy on animals that died during the test and were put to death
at the end of the test, and calculate LD50 and 95% confidence interval.
6 Test Methods
6.1 Preparation of Test Substances
Liquid test substances generally use the original solution. Solid test substances shall be ground
into powder and pass through a 100-mesh sieve, and thoroughly moistened with water or other
non-toxic, non-irritating media that do not affect skin permeability and do not react with the
test substance, so as to ensure good contact between the test substance and the skin.
6.2 Experimental Animals
6.2.1 Species and weight
Rats are preferred, but white rabbits, white guinea pigs or non-rodent animals can also be
selected. Reasons for selecting experimental animals other than rats shall be explained. The
required weight ranges for experimental animals are respectively. rats 200 g ~ 300 g, white
rabbits 2.0 kg ~ 3.0 kg, and guinea pigs 350 g ~ 450 g. Common domestic strains can also be
selected. Female animals shall be non-pregnant and nulliparous.
6.2.2 Animal gender
Select animals of the most sensitive gender for test. When uncertain, the test results of animals
of both genders can be provided; or after testing on animals of one gender first, then, select at
e) Skin and clothing hair. dermohemia, cyanosis, fluffy or moist clothing hair, dirty;
f) Eyes. proptosis, conjunctival congestion, hemorrhagic discharge, and corneal opacity;
g) Digestive system. diarrhea and anorexia.
Special attention shall be paid to the reaction of the skin in the exposed area. If an animal is
found to be dead or in a weak or dying state, it shall be separated from other animals in time,
and the time of occurrence shall be recorded, the animal shall be weighed and dissected for
autopsy, so as to reduce animal cannibalism and postmortem tissue autolysis, and to avoid the
loss of animal information. If the dead animal cannot be immediately subjected to gross
anatomy, it shall be kept in a low-temperature environment that can reduce autolysis
(refrigerated, not frozen), and an autopsy shall be performed within 24 hours.
6.5.2.2 Weighing
Animal weights shall be weighed and recorded before exposure, after exposure (at least once a
week) and before execution.
6.5.3 Pathological examination
During the test period, animals that died of poisoning and humanely killed animals shall be
grossly dissected, and the gross pathological changes of each animal shall be recorded. If the
organs of animals that survive for 24 hours or more after exposure show gross pathological
changes, then, histopathological examination is required to obtain information regarding the
toxic effects. If necessary, conduct histological examination of the skin in the poisoned area and
adjacent non-infected areas.
7 Test Results and Evaluation
7.1 Result Processing
7.1.1 Utilize a table to list all the original data of each group (two genders or single gender) of
animals obtained in the test. The content shall include animal No., gender, dose of poison,
weight, presence and extent of various physical signs, death or survival status, presence and
extent of each lesion during gross anatomy and histopathological examination.
7.1.2 Respectively count the number of animals in each group and of different genders, the
occurrence of physical signs, death, survival, and the frequency of various lesions in gross
anatomy and histopathological examination. Calculate the occurrence of the above-mentioned
items in different groups and different genders of animals, and the average body weight at
different times.
7.1.3 Use appropriate statistical methods to conduct statistical analysis on the above-mentioned
data.
7.1.4 Use appropriate methods to calculate LD50 and 95% confidence interval.
7.2 Result Evaluation
7.2.1 Make a preliminary evaluation of whether the test substance can be absorbed through the
skin and its toxic effects.
7.2.2 For the toxic effect level of the test substance, if the dose-reaction relation curve can be
obtained, a preliminary evaluation of the acute dermal toxic effect threshold can be made.
7.2.3 Specify the gender of the animals and the exposure time for which the toxicity parameters
are obtained.
7.2.4 The acute dermal toxicity level is determined in accordance with the corresponding
standards in 3.3.2.8 of Regulations on Pesticides Registration Information.
8 Test Report
The test report shall at least include the following content.
a) Test name, name and contact information of test organization, and report NO.;
b) Name and contact information of test entrusting organization, sample acceptance date
and sample sealing status;
c) Start and end dates of test, person in charge of test project, technical director of test
organization, and date of issuance;
d) Test summary;
e) Name and active ingredient of test substance, US Chemical Abstracts Service No.
(CAS No.) (if known), code (if any), purity (or content), dosage form, production date
(batch No.), physical and chemical properties, solvents and methods used for
preparation;
f) Species, strains, levels, quantity, weights, genders, sources (supplier name,
experimental animal quality certificate No., experimental animal production license
No.), quarantine and adaptation conditions of experimental animals; breeding
environment of experimental animals, including temperature, relative humidity, feed,
single cage or group feeding, experimental animal facility use license No.;
g) Dose and grouping, including the principle or basis for dose selection, dose and
grouping, animal grouping mode and number of animals of each gender in each group;
h) Test conditions and methods, including main instruments and equipment, exposure
routes, exposure schemes, test cycles and observation indicators, etc.;
i) Test results. summarized item by item in text descriptions and tables, including
clinical symptoms of poisoning, emergence, duration and recovery time of poisoning
GB/T 15670.5-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.100
B 17
Partially replacing GB/T 15670-1995
Toxicological Test Methods for Pesticides Registration - Part
5.Acute Dermal Toxicity Test
ISSUED ON. JULY 12, 2017
IMPLEMENTED ON. FEBRUARY 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 6
4 Test Purpose... 7
5 Test Overview... 7
6 Test Methods... 7
7 Test Results and Evaluation... 10
8 Test Report... 11
Appendix A (normative) Method for Estimating Body Surface Area of Experimental
Animals... 13
Toxicological Test Methods for Pesticides Registration - Part
5.Acute Dermal Toxicity Test
1 Scope
This Part of GB/T 15670 specifies the basic principles, methods and requirements for acute
dermal toxicity test.
This Part is applicable to acute dermal toxicity test for pesticides registration.
2 Normative References
The following documents are indispensable to the application of this document. In terms of
references with a specified date, only versions with a specified date are applicable to this
document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this document.
GB 14925 Laboratory Animal - Requirements of Environment and Housing Facilities
Regulations on Pesticides Registration Information (Decree of Ministry of Agriculture of the
People’s Republic of China [2007] No. 10)
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 acute dermal toxicity
The health-damaging effect of skin exposure to the test substance resulting from continuous
exposure for 24 hours.
3.2 dose
The amount of the test substance provided, which is expressed in terms of 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
After the test substance is administered to the experimental animals once or multiple times
within 24 hours, the statistical dose of toxicant that causes the death of half of the experimental
animals. It is expressed in terms of the mass of the test substance received per unit body weight
of the experimental animal (mg/kg body weight).
3.4 dose-response relationship
The relationship between dose and the occurrence of a specific effect.
4 Test Purpose
By continuously injecting the test substance through the intact skin within 24 hours, observe
the toxic effects of the test substance on the experimental animals, and preliminarily understand
whether the test substance can be absorbed through the skin and its toxic effect mode, which
provides a basis for acute toxicity classification, label management and other toxicological test
dose selection.
5 Test Overview
Before the test, remove the clothing hair of the test parts of the experimental animals, divide
the experimental animals into several dose groups (at least 3 groups), apply different doses of
test substance to each group, then, observe the poisoning reaction and death of the experimental
animals, and conduct gross anatomy on animals that died during the test and were put to death
at the end of the test, and calculate LD50 and 95% confidence interval.
6 Test Methods
6.1 Preparation of Test Substances
Liquid test substances generally use the original solution. Solid test substances shall be ground
into powder and pass through a 100-mesh sieve, and thoroughly moistened with water or other
non-toxic, non-irritating media that do not affect skin permeability and do not react with the
test substance, so as to ensure good contact between the test substance and the skin.
6.2 Experimental Animals
6.2.1 Species and weight
Rats are preferred, but white rabbits, white guinea pigs or non-rodent animals can also be
selected. Reasons for selecting experimental animals other than rats shall be explained. The
required weight ranges for experimental animals are respectively. rats 200 g ~ 300 g, white
rabbits 2.0 kg ~ 3.0 kg, and guinea pigs 350 g ~ 450 g. Common domestic strains can also be
selected. Female animals shall be non-pregnant and nulliparous.
6.2.2 Animal gender
Select animals of the most sensitive gender for test. When uncertain, the test results of animals
of both genders can be provided; or after testing on animals of one gender first, then, select at
e) Skin and clothing hair. dermohemia, cyanosis, fluffy or moist clothing hair, dirty;
...