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GB/T 15670.10-2017 (GBT15670.10-2017)

GB/T 15670.10-2017_English: PDF (GBT 15670.10-2017, GBT15670.10-2017)
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GB/T 15670.10-2017English130 Add to Cart 0--9 seconds. Auto-delivery Toxicological test methods for pesticides registration -- Part 10: Short-term repeated dose 28-day oral toxicity study Valid GB/T 15670.10-2017

BASIC DATA
Standard ID GB/T 15670.10-2017 (GB/T15670.10-2017)
Description (Translated English) Toxicological test methods for pesticides registration -- Part 10: Short-term repeated dose 28-day oral toxicity study
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard B17
Classification of International Standard 65.100
Word Count Estimation 7,739
Date of Issue 2017-07-12
Date of Implementation 2018-02-01
Older Standard (superseded by this standard) GB/T 15670-1995 Partly
Quoted Standard GB 14925
Drafting Organization Ministry of Agriculture Pesticide Testing Institute
Administrative Organization Ministry of Agriculture of the People Republic of China
Proposing organization Ministry of Agriculture of the People Republic of China
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary This standard specifies the basic principles, methods and requirements for short-term repeated oral toxicity (28 days) toxicity test. This standard applies to the short-term repeated oral exposure (28 days) toxicity test for pesticide registration.

Standards related to: GB/T 15670.10-2017

GB/T 15670.10-2017
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
10: Short-term repeated dose 28-day oral toxicity study
ISSUED ON: JULY 12, 2017
IMPLEMENTED ON: FEBRUARY 01, 2018
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of PRC.
Standardization Administration of PRC.
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 ... 11
8 Test report ... 11
Toxicological test methods for pesticides registration - Part
10: Short-term repeated dose 28-day oral toxicity study
1 Scope
This Part of GB/T 15670 specifies the basic principles, methods, requirements for short-
term repeated dose 28-day oral toxicity study.
This Part applies to short-term repeated dose 28-day oral toxicity study, for pesticide
registration.
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
GB 14925 Laboratory animal - Requirements of environment and housing facilities
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Short-term repeated dose oral toxicity
Health-damaging effects, which are caused by repeated oral administration of the
test substance for a period shorter than 10% of the life span of the experimental
animal.
3.2
No observed adverse effect level; NOAEL
Under the specified test conditions, using existing technical means and detection
indicators, the highest dose or concentration of the test substance, at which harmful
effects related to poisoning cannot be observed.
3.3
Lowest observed adverse effect level; LOAEL
Under the specified test conditions, using existing technical means and detection
indicators, the lowest dose or concentration of the test substance, at which harmful
effects related to poisoning are observed.
3.4
Target organ
Organs, in which the test substance causes significant toxic effects in the body.
4 Test purpose
Through short-term repeated dose 28-day oral toxicity study, determine the toxic effects,
which are caused by repeated oral exposure to the test substance in a short period of
time; preliminarily understand the toxicological characteristics, dose-response
relationship and target organs of the test substance; obtain the non-observed adverse
effect dose level (NOAEL) and the lowest observed adverse effect dose level (LOAEL),
so as to provide a basis for the selection of sub-chronic and chronic toxicity test doses
and observation indicators.
5 Test overview
The experimental animals are repeatedly orally exposed to the poison for 28 days, in a
short period of time. Observe the toxic reactions of the animals. Weigh the body weight
and calculate food intake, regularly. Measure the hematological indicators, blood
biochemical indicators, histopathological examination indicators, etc., to evaluate the
short-term repeated intake toxicity of the test substance, thereby initially determining
the dose and target organs of the harmful effects, which are caused by the test substance
in animals.
6 Test methods
6.1 Preparation of test substance
When the test substance is mixed into feed or drinking water, in order to ensure the
uniformity and stability of the preparation of the test substance, it shall measure the
stability, content, uniformity. The concentration fluctuation in the feed or drinking water
shall be within ±15% of the theoretical concentration; it will not affect the nutritional
quality and water balance of the feed. The amount added into the feed shall not exceed
5% of the feed concentration. When the test substance is added to feed or water to affect
the palatability of animals, the test substance shall be administered orally. When
injecting poison into the stomach, the test substance shall be dissolved or suspended in
6.3.3 Limit test
If it is expected that the dose of 1000 mg/kg body weight is unlikely to produce any
toxic effects, OR it is predicted that it will not produce toxicity based on the structure,
there is no need to set three doses.
6.4 Routes of exposure
The test substance can be mixed into feed or drinking water, OR administered by gavage.
Animals shall be exposed to the poison for 7 days per week. If the gavage method is
used, the gavage method shall be administered once a day at the same time and place;
the amount of gavage shall be adjusted regularly, according to the body weight (the
body weight shall be weighed twice a week for adjustment), to maintain the dose of the
exposure constant. The intragastric volume generally does not exceed 10 mL/kg body
weight. The maximum intragastric volume of aqueous solution can reach 20 mL/kg
body weight. The intragastric volume of each group is consistent. The exposure time is
28 days. The animals in the additional group are observed for at least 14 days during
the recovery period.
6.5 Test observation and inspection
6.5.1 Clinical observation
During the test, the general clinical manifestations of the animals are observed at least
once a day. The signs, extent, duration of poisoning and death of the animals are
recorded. Observations include at least the following: changes in skin, hair, eyes,
mucous membranes, respiratory system, circulatory system, nervous system, limb
activities, behavior, etc. Dead animals shall be dissected promptly; dying animals shall
be disposed of promptly.
6.5.2 Body weight, food and water intake records
Record body weight and food intake every week. If the test substance is administered
through drinking water, it shall record the weekly water intake.
6.5.3 Hematology tests
At the end of the experiment, fasting blood samples are collected before the animals are
sacrificed (or when they were sacrificed), for determination of hematological indicators.
Measurement indicators include hemoglobin concentration, red blood cell count,
hematocrit, total white blood cell count and classification, platelet count, coagulation
function (prothrombin time and activated partial thromboplastin time). If it affects the
blood system, it shall add the reticulocyte and bone marrow smear cytology tests.
6.5.4 Blood biochemical tests
At the end of the experiment, before the animals are sacrificed, blood is collected on an
empty stomach, to measure blood biochemical indicators. The measurement indicators
shall at least include alanine aminotransferase (ALT), aspartate aminotransferase (AST),
alkaline phosphatase (ALP), urea nitrogen (BUN), creatinine (Cr), blood glucose
(GLU), Albumin (ALB), total protein (TP), total cholesterol (TCH), potassium, sodium;
if necessary, indicators such as γ-glutamyl transpeptidase (GGT), ornithine
decarboxylase (ODC), triglycerides, bile acid, cholinesterase, hormones, calcium,
phosphorus.
6.5.5 Urine test
Generally, it is not necessary. When relevant toxic effects are suspected or observed,
urine needs to be collected for urine indicator measurement, including appearance,
specific gravity, pH, urine protein, glucose, blood cells.
6.5.6 Pathological examination
6.5.6.1 Gross anatomy examination
At the end of the test, a general examination of all animals shall be conducted, including
body surface, cranial cavity, chest cavity, abdominal cavity and their organs. Dissect
brain, pituitary gland, heart/aorta, thyroid and parathyroid glands, esophagus,
lungs/trachea, thymus, stomach, duodenum, small intestine, large intestine, liver,
kidneys, spleen, pancreas, adrenal glands, ovaries, testicles, epididymis, representative
lymph nodes, spinal cord (cervical, thoracic and lumbar segments), uterus, prostate,
bladder, sciatic nerve, sternum for fixation. If necessary (if there are lesions on gross
observation), dissect the breasts, muscles, femurs, lacrimal glands, salivary glands, skin,
eyeballs, for fixation. Also weigh the brain, heart, thymus, adrenal gland, liver, kidney,
spleen, testis, ovary, to calculate the organ coefficient.
6.5.6.2 Histopathological examination
The principles of histopathological examination are:
a) Gross anatomy examination of all fixed and preserved organs and tissues in the
high-dose group and control group for histopathological examination;
b) After discovering the lesions in the high-dose group, perform histopathological
examination on the corresponding organs and tissues in the medium- and low-
dose groups;
c) Histopathological examination shall be conducted, on other diseased organs and
tissues visible to the naked eye, during gross anatomical examination;
d) If there are abnormal changes in the poisoning treatment group, histopathological
examination shall be conducted, on the corresponding organs and tissues of the
animals in the additional group;
...