GB/T 15670.6-2017 PDF English
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Toxicological test methods for pesticides registration - Part 6: Acute inhalation toxicity test
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GB/T 15670.6-2017: Toxicological test methods for pesticides registration - Part 6: Acute inhalation 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/GBT15670.6-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 65.100
B 17
Partly replacing GB/T 15670-1995
Toxicological test methods for pesticides registration - Part
6.Acute inhalation toxicity test
Issued on: JULY 12, 2017
Implemented on: FEBRUARY 01, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Purpose of the test... 7
5 Overview of the test... 7
6 Test methods... 8
7 Test results and evaluation... 12
8 Test report... 13
Toxicological test methods for pesticides registration - Part
6.Acute inhalation toxicity test
1 Scope
This Part of GB/T 15670 specifies the basic principles, methods and requirements for
acute inhalation toxicity test.
This Part applies to the acute inhalation toxicity test conducted for pesticide registration.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 14925, Laboratory animal - Requirements of environment and housing
facilities
Provisions on Pesticide Registration Information (Order No. 10 of the Ministry
of Agriculture of the People’s Republic of China [2007])
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acute inhalation toxicity
The health-damaging effect that occurs when the test animal inhales a relatively high
concentration of test substance (gas, vapor, aerosol or particulate matter) continuously
for a short period of time (24 hours or within 24 hours, usually 4 hours).
3.2
inhaled dose
The amount of test substance inhaled by the animal per unit body weight, that is.
equal to a certain aerodynamic diameter (for example, 5 μm) account for 50% of the
total mass or total weight of the aerosol sample, the aerodynamic equivalent diameter
of the aerosol particles is the mass median aerodynamic equivalent diameter (5 μm) of
the aerosol sample.
3.7
geometric standard deviation; GSD
A dimensionless number used to describe the size range of aerosol particles. The smaller
the geometric standard deviation, the higher the proportion of particles of similar size,
that is, the better the uniformity of aerosol particles and the lower the dispersion.
Usually, aerosol samples with a geometric standard deviation less than or equal to 2 are
called single-phase dispersing aerosols.
3.8
inhalable diameter
The aerodynamic equivalent diameter of particles that can be inhaled through the mouth
and/or nose of the subject and deposited in any part of the respiratory tract. Aerosol
particles with an aerodynamic equivalent diameter of less than 10 μm are usually called
inhalable particles.
4 Purpose of the test
Through short-term inhalation exposure, a preliminary understanding of the acute
toxicity characteristics and dose-response relationship of the test substance on test
animals can be gained, to provide scientific reference for acute inhalation toxicity
classification, label management and other related toxicological studies, and also to
provide a basis for formulating protective measures during production and application.
5 Overview of the test
According to the physicochemical properties of the test substance, select an appropriate
method to prepare it into a gas, vapor, aerosol or particulate suspension state of specific
concentration, and input it into the dynamic toxicity system; randomly divide the test
animals into control and different toxicity dose groups, and place them in the toxicity
system for 4 hours of exposure. After the toxicity is over, remove the test animals;
carefully observe the manifestations and signs of toxic effects, death, etc. during the
toxicity period and within 14 days, and perform gross autopsy on dead animals in time;
at the end of the observation period, kill the animals for gross autopsy, and if diseased
tissues or organs are found, conduct histopathological examination.
6 Test methods
6.1 Test preparation
6.1.1 Test substance
The test substance shall be a sample with a stable preparation process and in compliance
with the quality standards, with the name, source, batch number, content (or
specification), storage conditions and preparation method, etc., and a test report
attached. The excipients, solvents or other media used shall be marked with the batch
number, specification and manufacturer.
6.1.2 Selection and preparation of test substance vaporization or aerosol
preparation method
6.1.2.1 Gaseous test substance
After mixing it with air to a certain concentration through a flow meter, directly input
it into the toxicity cabinet.
6.1.2.2 Low boiling point volatile liquid test substance
After volatilization through air bubbling or appropriate heating, mix it with air and pass
into the toxicity cabinet.
6.1.2.3 High boiling point non-volatile liquid test substance
According to the physical and chemical properties of the test object, a spray method
can be selected, or an aerosol generating device can be used to prepare a liquid aerosol
that meets the test requirements and then mix it with a certain amount of air and input
it into the toxicity cabinet.
6.1.2.4 Powdered or solid test substances
Prepare the test substance into solid aerosol using an aerosol generator; mix it with a
certain amount of air and introduce it into the toxicity cabinet.
6.1.3 Dynamic inhalation toxicity method
Use mechanical ventilation equipment to continuously and evenly deliver air containing
a certain concentration of the test substance into the toxicity cabinet, with a ventilation
volume of about 12 times/h ~ 15 times/h to maintain a relatively stable toxicity
concentration. Use whole-body exposure or head/nose exposure to conduct acute
inhalation toxicity on animals for 4 hours. During toxicity, keep the distribution of
toxicity gas in the toxicity cabinet balanced, the oxygen content not less than 19%, the
CO2 content not higher than 1%, the temperature at (22±3) ℃, and the relative humidity
at 30% ~ 70% (except for special circumstances, such as steam toxicity). If the toxicity
not to interfere with the individual activities of the animals and the observed reactions.
The animals shall be fed with regular feed and shall have free access to water.
6.1.5.3 Number and gender
Each concentration group shall have at least 10 animals, 5 males and 5 females. Female
animals shall be non-pregnant and nulliparous.
6.1.5.4 Inhaled dose and grouping
At least 3 different concentrations of toxicity groups shall be set up, with appropriate
concentration intervals between groups, so that a certain degree of toxic effect and death
can occur in the test animals in each concentration group. At the same time, blank and/or
corresponding excipient, solvent or other medium control groups shall be set up, and
the data obtained shall be sufficient to draw a concentration-death curve and calculate
the LC50 value.
If the toxicity of the test substance is very low, 20 rats (half male and half female) can
also be used to conduct a single dose acute inhalation toxicity test. The single acute
inhalation toxicity concentration shall be 2×10-2 (gas test substance), 20 mg/L (liquid
test substance vapor), 5 mg/L (solid or liquid test substance aerosol). If the
concentration requirement cannot be reached due to the physical and chemical
properties of the test substance, the test shall also be conducted at the highest
concentration that the test substance can reach. When the test substance is explosive,
care shall be taken to avoid using a concentration that may cause an explosion.
6.2 Test procedure
6.2.1 Implementation of inhalation toxicity
6.2.1.1 Balance and control of toxicity concentration
Various appropriate conditions in the test preparation stage shall be used to control the
toxicity concentration, inhalable diameter, etc.
6.2.1.2 Body weight measurement of toxicity animals and observation during
toxicity
Before the test begins, each animal shall be weighed.
The time for animals to continuously inhale the test substance is 4 hours. During the
toxicity process, the animals are usually in a state of fasting and water deprivation.
During inhalation toxicity, attention shall be paid to observing the effects of the test
substance on the respiratory system, such as respiratory irritation reactions, changes in
respiratory rhythm, and changes in inhalation and exhalation patterns.
6.2.2 Test observation and inspection
6.2.2.1 Observation period
After the inhalation toxicity, the test animals shall be carefully observed at least once a
day for 14 consecutive days. However, the observation period is not fixed and can be
adjusted according to the time of occurrence of toxic reactions and signs, as well as the
length of the recovery period. If the animals show toxicity reactions and delayed death
after exposure, the observation period shall be appropriately extended, and the
maximum period shall not exceed 21 days.
6.2.2.2 Observation content
Observe and record the clinical manifestations and signs of toxicity animals in detail,
including the time of onset and recovery, the time of animal death, etc. The content of
observation includes.
a) Central nervous system and neuromuscular system. abnormal posture, abnormal
voice, restlessness, dullness, tremor, convulsion, paralysis, movement disorder,
hypersensitivity or slowness in external response, abnormal behavior such as
excessive and repeated scratching around the mouth, combing, circling, even
self-mutilation, walking backwards, etc.;
b) Autonomic nervous system. pupil dilation or constriction, salivation or tearing;
c) Respiratory system. nasal discharge, epistaxis, flaring of the nostrils, deep and
slow breathing, tachypnea, wasp waist;
d) Urogenital system. dirty perineum, discharge, vaginal swelling;
e) Skin and coat. skin congestion, cyanosis, fluffy coat or moist dirty;
f) Eyes. proptosis, conjunctival congestion, hemorrhagic secretions, corneal
opacity;
g) Digestive system. diarrhea, anorexia.
Record the appearance and disappearance of toxicity signs and the time of animal death.
In particular, if there is a trend of delayed death, more careful observation and recording
shall be made. Weak or dying animals shall be quickly isolated, humanely killed and
autopsied, and treated as toxicity deaths. If an animal is found dead during the
observation period, it shall be autopsied in time. If it cannot be examined immediately,
it shall be refrigerated and autopsied within 24 hours.
6.2.2.3 Weighing
The body weight shall be measured and recorded in detail before and after toxicity (at
least once a week) and before the animals are killed.
6.2.2.4 Pathological examination
combination with the results of gross anatomy and histopathological examinations. If
relatively clear dose-effect and dose-response curves can be obtained, a preliminary
evaluation can be made on the threshold of the test substance via respiratory inhalation
toxicity. Calculate the LC50 value, to evaluate the acute inhalation toxicity level of the
test substance, which is determined according to the corresponding standards in 3.3.2.8
of the "Provisions on Pesticide Registration Information". Summarize the safety range
of the test substance, the severity of toxicity and recoverability.
The results of acute inhalation toxicity tests can provide a reference for the selection of
doses for related subsequent toxicology tests, and can also indicate some indicators that
need to be observed in subsequent toxicity tests. When referring to or citing these test
results, attention shall be paid to the organic connection between various data and
information. The LC50 value shall be regarded as a relatively rough toxicological
indicator, which is mainly used to identify the inhalation toxicity potency of a test
substance and as a basis for grading its toxicity. When citing or referring to the LC50
value, in addition to combining the toxic effects of the test substance, histopathological
examination results, etc., attention shall also be paid to specific issues such as the
species of animals, the length of exposure time, and the method of calculating the LC50.
8 Test report
The test report shall at least include the following contents.
a) Name of test, name and contact information of test organization, report number;
b) Name and contact information of the test entrusting organization, the date of
sample acceptance and the situation of sample sealing;
c) Start and end date of the test, the person in charge of the test items, the technical
person in charge of the test organization, and the date of issuance;
d) Summary of test;
e) Name of the test substance, the active ingredient American Chemical Abstracts
Service accession number (CAS number) (if known), code (if any), purity (or
content), dosage form, production date (batch number), physicochemical
properties, and solvents and methods used for preparation;
f) Species, strain, grade, quantity, weight, gender, source (supplier name,
laboratory animal quality certificate number, laboratory animal production
license number) of laboratory animals; quarantine; adaptation conditions; and
laboratory animal breeding environment, including temperature, relative
humidity, feed, single cage breeding or group breeding, laboratory animal
facility use permit number;
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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