Chemicals—Test method of acute inhalation toxicity—Fixed concentration procedure
Some standard content:
JCS 13. 300; 11. 100
National Standard of the People's Republic of China
GB/T 27824—2011
Chemicals
Acute inhalation toxicity
Fixed concentration test method
Chemicals--Test metbod of acute inhalation toxicityFixed concentrationprocedare
Issued on December 30, 2011
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of China
Implementation on August 1, 2012
Terms, definitions and abbreviations
3 Test principles
Test methods
Data and report
Appendix A (Normative Appendix)
References
Test Flow Chart
Figure A.1 Steam Pre-test Trace Chart
Figure A.2 Steam Formal Test Flow Chart
Figure A.3 Dust/Mist Pre-test Flow Chart
Figure A.4 Dust/Mist Formal Test Flow Chart
Figure A.5 Gas Pre-test Flow Chart
Gas Formal Test Flow Chart
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GB/T 27824—2011
This standard was drafted in accordance with the rules given in GB/T1.1—2009. GB/T 27824—2011
This standard is consistent with the technical content of the Organization for Economic Cooperation and Development (OECD) Chemical Crystal Test Guide No. 433 (2004) Acute Human Toxicity Test (Solid
Concentration Method English Version). This standard has made the following structural and editorial changes: A new chapter on scope has been added:
- The "Introduction" section of OECD No. 433: 2004 has been incorporated into the "Introduction" section of this standard; the "Preliminary Considerations" section of OECD No. 433: 2004 has been incorporated into the "4.3 Test Procedures" section of this standard; the "Definition" section of the "Appendix of OECD No. 433+2004" has been incorporated into the "Terms, Definitions and Abbreviations" of this standard; - The measurement list has become the legal measurement list of my country. This standard was proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). The drafting units of this standard are: Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention, Ningbo Institute of Inspection and Quarantine Science and Technology, Jiangsu Coal Chemical Engineering Research and Design Institute Co., Ltd. The main drafters of this standard are Mo Fenxia, Li Chaolin, Ma Zhongchun, Guo Xinyu, Chen Xiaoqing, Long Zaihao, and Lin Zhenxing.日
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GB/T27824—2011
Based on scientific development and animal welfare requirements, the OECD chemical testing guidelines need to be revised regularly. The original acute inhalation toxicity test guidelines (OECD403) were adopted in 1981. The revised acute oral toxicity test: Fixed Dose Procedure (FDP) (OECD420) has been implemented since December 2001, and the Fixed Concentration Procedure (FCP) for acute inhalation toxicity test has been considered. This method mainly adopts several fixed toxic concentrations and uses single-sex animals (generally female animals) to detect acute inhalation toxicity. The traditional method of evaluating acute toxicity is to use animal death as the only observation endpoint. In 1984, the British Toxicology Society (BTS) proposed a new acute toxicity test method, that is, to select a fixed dose for test substance exposure! !]. This method avoids animal death as the observation endpoint, but takes the appearance of obvious poisoning symptoms at a dose among several fixed doses as the observation endpoint. This dose is also the basis for the toxicity classification of the test substance. This test also uses the above method. In order to meet the humane requirements for observation endpoints in OECD Guidance Document 3, it is recommended to optimize the test method to minimize the suffering of animals and reduce the use of animals as much as possible. After evaluation by mathematical model, the FCP test is statistically reasonable: door. For the standard requirements on the test procedures and result interpretation of FCP inhalation toxicity test, please refer to the Guidance Document 1 for Acute Inhalation Toxicity Test.
This test can provide the hazard characteristics of the test substance. For test substances that can cause acute life, the toxicity classification and classification of the test substances can be carried out according to the results of this test and in accordance with the United Nations Global Harmonized System of Classification and Labeling of Chemicals (GHS) []. TTTKAONYKACA
1 Range
Fixed concentration test method for acute inhalation toxicity of chemicals GB/T 27824—2011
This standard specifies the terminology, definitions and abbreviations, test principles, test methods, test data and reports for the fixed concentration test method for acute inhalation toxicity of chemicals.
This standard applies to fixed concentration tests for acute inhalation toxicity of chemicals. 2 Terms, definitions and abbreviations
2. 1 Definitions of terms
The following terms and definitions apply to this document. 2. 3, 1
Acute inhalation toxicity acute inhalation toxicity The harmful effects caused by continuous inhalation of the test substance in the air in a short period of time. 2. 1.2
Aerosol
Suspended body formed by solid particles or liquid droplets floating in gas, such as liquid or gaseous foam, powder or powder. 2. 1. 3
Dust
Solid particles that can float in the air formed by substances or mixtures. Most of them are irregular in shape, ranging from less than 1 μm to 100um.
Microscopic droplets of a substance or mixture suspended in the air ranging from 2 μm to 100 μm. It can be condensed by supersaturated vapor or by mechanical shear rate of the body, such as spraying, atomization, spraying or foaming. 2.1.5
Vapor or
The gas state formed by a liquid or solid substance or mixture at normal temperature and pressure. 2. t. 6
concentration
The test substance per unit volume of air. Vapor and dust are usually expressed in mg/L, and gas is expressed in mL/m, which is consistent with the expression method in the United Nations GHS system.
evident toxicity
Evident toxicity
Evident toxicity after animal exposure. If a higher fixed concentration is used for exposure, most animals are expected to show obvious pain, death or even death.
impending death
The state in which the animal is dying or may die before the end of the observation period. The symptoms of impending death of rodents include twitching, lying on the side, lying on the side and trembling.
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GB/T 27824—2011
limit dose
The upper limit of the dose, the upper limit of the dose of vapor, dust, etc. and gas test substances are 20mg/L, 5mg/L and 5 000 mL/m respectively.
moriband condition
A state in which the animal is about to die and cannot survive even if treatment is given. 2.2 Abbreviations
The following abbreviations apply to this document.
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
Note: Chemicals are classified according to uniform standards based on the degree of harm they cause to physical, health and the environment. Then, according to the classification level of chemicals, their harmful effects are marked and identified to protect human health and the environment. The harmful effects of chemicals can be communicated through pictograms, logos, hazard statements, warning statements and safety data sheets. GHS is a joint planning activity led by OFCD responsible for human health and environment, UN Committee of Experts on the Transport of Dangerous Goods responsible for physical and chemical properties and International Labor Organization (ILO) responsible for hazard information communication. It is coordinated by the Inter-Organization Programme for the Sound Management of Chemicals (IOMC). MMAD: Mass Median Aerodynamic Diameter (mass median aerodynamic diameter) Note: The calculated aerodynamic diameter is divided into two halves according to the mass of the particles. 50% of the particles have a mass greater than the median diameter, and 50% of the particles have a mass less than the median diameter. The median diameter and its geometric standard deviation (GSD) are the size of the mass of the particles.Statistical methods are used to describe the distribution of the particle size of the gas droplets (solid in the body): 3 Test principles
The basic principle of this method is to use a concentration that can produce a certain toxicity, rather than a concentration that can cause death. If the test substance causes obvious pain to animals due to corrosive or severe irritation at a certain concentration, this concentration should not be used for poisoning. Dead animals, animals showing obvious pain, and animals with persistent pain should be euthanized. When interpreting the results, these animals should be classified as dead animals. For standards and basis on when to kill dying or very painful animals and how to identify animals that are about to die, please refer to the QE guidance document - Ting.
The fixed concentrations that should be used in the test of vapor, dust/mist or gas test substances are shown in Appendix A. During the test, animals of the same sex are divided into several groups, and the test substances are acutely poisoned according to the poisoning concentrations required in Appendix A and the steps of the test procedure. A preliminary test should be carried out before the formal test. The toxic concentration used in the preliminary test should be able to cause obvious poisoning symptoms but not cause severe poisoning or animal death. The starting toxic concentration of the formal test should be selected based on the results of the preliminary test. The clinical manifestations of animal pain, suffering and death are described in detail in the OECD guidance document [2-]. Depending on whether the animals show toxic symptoms or death in the preliminary test, a higher or lower concentration should be selected for the test until the following situations occur: obvious toxic effects appear but the number of dead animals does not exceed 1, the highest toxic concentration does not show any toxic effects, and the lowest toxic concentration causes animal death.
4 Test method
4.1 Description of the method
4. 1.1 Selection of animal strains
Rats are preferred, but other species of rodents can also be used. The reason for using other rodents or non-rodents should be stated. 2
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GB/T 27824—2011
Female animals are usually used because although it is believed that the sensitivity of animals of different sexes to toxicity is not much different: if there is a difference, female animals are generally more sensitive. Male animals are used if the relevant toxicological knowledge or toxicokinetic properties of chemicals with similar structures to the test substance indicate that male animals are more sensitive. When male animals are selected for testing, appropriate reasons should be provided and their rationality should be explained.
Healthy adult animals of common strains should be used. Female animals should be nulliparous and not pregnant. The age of the animals at the beginning of the test is 56d to 84d, and their weight should not exceed ±20% of the average weight of animals of the strain used in the laboratory in the past. 4.1.2 Housing conditions
The temperature of the animal room is maintained at 22±3°C. The relative sensitivity is at least 30%, preferably not more than 70% (except during cleaning), and 50%-60% is most appropriate. Artificial lighting should be used, with 12h light-dark alternation. Feed the animals with routine laboratory feed and free access to water. Animals in the same concentration group should be housed in the same room, but the number of animals in a single cage should not affect the observation of each animal. 4.1.3 Animal preparation
Before starting the exposure, the animals should be housed and observed for at least 5 days to adapt to the laboratory environment. The animals should be randomly divided into groups and reduced in number. 4.1.4 Exposure method
4.1, 4.1 Overview
Either head/nose or whole body exposure can be used. The head/nose exposure method can minimize the absorption of the test substance by non-inhalation routes, and does not require the use of large amounts of the test substance when emitting high concentrations of the test substance (e.g., the concentration required for limit tests). Other advantages of this exposure method are: the test substance is easy to disperse evenly in the exposure airflow, the test substance is not easy to undergo unstable changes (for example, reacting with excreta such as urine and feces or changing stability due to the influence of a humid environment), and the required gas volume is small, so the test substance can be evenly distributed in the exposure cabinet more quickly. However, this exposure method requires restricting the activity of the animal during the entire exposure process (the whole body exposure method does not require restricting the activity of the animal). The selected exposure method should minimize the possible pain of the animal, which is consistent with the purpose of this test. 4.1.4.2 Head/tool exposure method
The animal is placed in a fixture for exposure. The fixture should not cause additional stress to the animal (e.g., heat stress caused by the heating of the fixture) and should ensure that the animal cannot avoid inhalation exposure. If the volume of air flowing into the poisoning cabinet is less than the volume of gas flowing out, it should be prevented that air enters the poisoning cabinet through other channels (e.g., through the fixture) to dilute the test substance aerosol. The poisoning cabinet should be placed in a well-ventilated chemical fume hood. The inside of the fume hood should be kept under pressure to prevent the test substance from leaking into the external environment. The inhalation rack should be equipped with dynamic airflow, and its ventilation volume should be at least twice the total ventilation volume of the animals in the poisoning device. The oxygen content should be at least 19% and each animal should be ensured to have similar poisoning conditions. When collecting aerosol samples, excessive influence on the dynamic airflow should be avoided. The sampling flow rate should be adjusted to ensure that the conditions in the poisoning cabinet remain unchanged.
4.1.4.3 Whole body poisoning method
The inhalation poisoning device is equipped with a dynamic ventilation device with about 12 to 15 air changes per hour. Other ventilation rates may be required for some test substances. However, the oxygen content should be at least 19 and the aerosol of the test substance should be evenly distributed throughout the poison cabinet. The general principle for ensuring even dispersion of the aerosol of the test substance is that the total volume occupied by the test animals should not exceed 5% of the volume of the poison cabinet. The poison cabinet should maintain a slight negative pressure to prevent the test substance from leaking into the external environment. 4.1.5 Poisoning conditions
4.1.5.1 The poisoning should last at least 4 hours (excluding the time for the concentration to reach a steady state). The duration of the rack can also be appropriately changed according to the specific test requirements.
GB/T 27824—2011
4.1,5.2 To ensure that the required poisoning release is achieved, a poisoning operation should be carried out without using animals to detect the poisoning concentration and pay attention to key operational issues. Since it is technically difficult to ensure that the concentration of the test substance in the poisoning cabinet is exactly the required poisoning concentration, in order to prevent unnecessary repeated tests, if the average concentration of the test substance in the poisoning cabinet is within ±25% of the required concentration, it is considered acceptable. If the test substance is potentially explosive, special attention should be paid to some conditions that may cause explosions. 4.1.6 Particle size of the test substance
Since it is difficult to predict which part of the respiratory tract will react most strongly to the test substance and at what particle size the test substance will cause the greatest harm, the particle size of the dust or aerosol should be able to ensure that it reaches every area of the respiratory tract. The recommended particle size range of the test substance aerosol is mass median aerodynamic diameter (MMAD) 1 μm-4 μm, and geometric standard deviation (GSD) 1.5-3. This ensures that the entire respiratory tract can be exposed to the test substance [1. If the aerosol used for poisoning does not meet the above particle size, its rationality should be explained: if the test substance particles are hygroscopic, smaller particles should be prepared to ensure that the particle size after hygroscopic swelling is still within the range of 1 μr-4 μm. 4.1,7 Generation of test substance aerosol
If necessary, appropriate solvents can be added to the test substance to help the test substance reach the required concentration or prepare it into inhalable particles. If a solvent is used in the process of aerosol generation, the acute inhalation toxicity of the solvent should be known in advance. When the selected solvent is fully understood, it is not necessary to set up a solvent control group at the same time. The granular test substance should be mechanically processed to obtain particles with the required particle size. However, care should be taken not to cause the test substance to decompose or change during the process. Chemical analysis can tell whether the test substance has decomposed or changed. At the same time, care should be taken not to contaminate the test substance. 4.2 Monitoring of poisoning conditions
4.2.1 Air flow in the poisoning cabinet
The air flow through the poisoning cabinet should be continuously monitored and recorded at least three times for each poisoning. 4.2.2 Temperature in the poisoning cabinet
The temperature of the animal's respiratory zone should be continuously monitored and recorded at least three times for each poisoning. The temperature should be kept within the range of 22°C. If it exceeds this range, the possible impact of this change on the poisoning results or toxic effects should be considered. 4.2.3 Relative humidity
Whether the oral and nasal poisoning method or the whole body poisoning method is used, the relative humidity (RH) of the animal's respiratory zone should be continuously monitored and recorded at least three times for each poisoning. RH should be maintained within the range of 30% to 70%, but sometimes this requirement cannot be met (for example, the test substance is a water-based preparation). Sometimes the relative humidity cannot be measured due to interference from the test substance. 4.2.4 Concentration of the test substance
4.2.4.1Whether oral or systemic exposure is used, the exact concentration of the test substance in the respiratory zone of the animal should be measured. During the exposure process, the exact concentration of the test substance should be kept constant as much as possible (see 4.1, 5.2) and monitored continuously or intermittently (depending on the analytical method). If it is intermittent monitoring, sampling should be done once every 1 hour or so, for a total of at least 5 times. For single-component solid powders or liquids with very low volatility, the gravimetric method can be used for concentration analysis. When the gravimetric method is used for concentration analysis of samples from higher concentration groups, the flowmeter used to measure the sampling volume should be calibrated. The volume of gas collected by the flowmeter is a function of the filter membrane pressure (the relationship is pressure × volume - constant). Each flowmeter should have a calibration volume curve. 4.2.4.2For some test substances, the remaining weight after volatilization is constant. In this case, the weighing method can be used to infer the concentration of the test substance before volatilization by weighing the remaining weight after volatilization. If the components of the test substance in the animal respiratory zone are different from the original components of the test preparation, it is not necessary to determine the inactive ingredients therein, and only the results in this regard need to be provided in the test report. If the test substance is easy to precipitate, contains different components, contains volatile components or other reasons that make it difficult to determine the concentration of the test substance in the poisoning cabinet, it is necessary to conduct an additional analysis of the inactive ingredients in the test substance. 4.2.4.3 When analyzing the poisoning concentration of the test substance, if the weight method is not suitable or the generated aerosol contains more than two components, the content of the main active ingredient of the test substance can be determined and the concentration of the test substance can be calculated accordingly, but its rationality must be explained. 4.2.4.4 If the test substance is a preparation, its poisoning concentration should be the concentration of the preparation and not just the concentration of its main active ingredient. 4.2.5 Particle size distribution (dispersion) During each 4-hour exposure process, at least 2 aerosol dispersion measurements should be performed. The selected sampling equipment should be able to calculate the MMAD (see 4.1.6). If the aerosol of the test substance contains multiple components, the concentration of the test substance should be determined in accordance with the above principles. The laboratory should be able to verify that the samples collected by the sampler can represent the aerosol actually inhaled by the animal. 4.2.6 Calculation of concentration
The concentration of the test substance in the exposure cabinet or exposure tube can be calculated by the following method: record the total amount of the test substance emitted into the exposure cabinet or exposure tube when the aerosol occurs, and divide it by the total air flow through the exposure cabinet or exposure tube during this period. 4.3 Test Procedure
Before conducting this test, the laboratory should consider all the information obtained on the test substance, such as the name of the chemical, chemical structure, physicochemical properties, any other in vivo or in vitro toxicity test results, quantitative structure-activity relationship (QSAR) data, toxicological data of chemical substances with similar structures, the intended use of the chemical and the possible degree of human exposure to the test substance. With the help of the above information, a suitable starting concentration is selected for the test. 4.3.1 Preliminary Test
The purpose of the preliminary test is to find the appropriate starting toxic concentration for the formal test. According to the flow chart in Appendix A, a sequential method is adopted, one animal is taken each time, and the inhalation toxicity is induced for at least 4 hours. If obvious toxic effects occur or one animal dies in the lowest toxic concentration group, the starting toxic concentration of the formal test can be determined based on this and the preliminary test is terminated accordingly. Select one of the several fixed concentrations specified in Appendix A as the starting toxic concentration of the preliminary test. This exposure concentration is expected to produce obvious toxic effects (the existing bioavailability data of chemicals with the same or similar structure as the test substance can provide this possible expected toxic effect). If there is no such data as a reference, the initial exposure concentrations of mist, dust/mist, and gas in the pre-test should be 10 Ⅱg/L, 1mg/L, and 2500mL/m respectively. After the end of exposure of one animal, at least 24 hours should be left before exposure of another animal. All animals should be observed for at least 7 consecutive days. If the lowest concentration in the pre-test causes animal death or obvious erythema, the test should be terminated and the test substance should be classified as GHS acute toxicity Category 1 substance (hereinafter referred to as "Category 1") (see Appendix A). If this classification is to be verified, the following test procedure can be used, that is, test another animal at the lowest concentration. If the second animal also dies, it can be determined as GHS Category 1 and the test is terminated immediately. If the second animal survives, a maximum of 3 more animals will be selected for testing at this concentration. Since there is a high possibility of animal death, for the sake of animal welfare, the three animals should be tested in a sequential manner. The time interval between the exposure of the previous and subsequent animals should be long enough to determine whether the first exposed animal is likely to survive. If the second of the three animals dies, the test should be terminated immediately and the third animal does not need to be exposed. Appendix A gives the classification criteria: if more than two of the three animals die (result A), it is "category 1", and if only one animal dies (result B), it is category 2\. 4.3.2 Formal test
4.3.2. 1 Number of animals and exposure concentration
It can be seen from the flow chart in Appendix A that the following three subsequent test procedures can be selected after the initial exposure: stop the test and conduct appropriate hazard grading and classification; conduct a higher concentration test or a lower concentration test. However, the concentration that caused animal death in the preliminary test will no longer be used in the formal test to avoid unnecessary suffering of the animals (see Appendix A). Experience shows that the test substance can generally be classified after the initial concentration is toxic without further testing. When the test is carried out in a decreasing concentration manner, if 2 to 3 animals die (within the scope of result A), the test should be terminated for animal welfare reasons and the test substance should be classified according to the next concentration (result C). Only 5 animals of the same sex can be used for each toxic concentration, and 1 animal can be used for the pre-test. The length of the time interval between the two toxic concentrations depends on the onset, duration and degree of toxicity after the previous concentration. The next concentration is toxic only when the animals exposed to the previous concentration are confirmed to be alive. The time interval between each concentration is generally recommended to be 3 to 4 days so that some delayed toxicity can be observed. The time interval between toxicity can be adjusted when necessary (for example, when the toxic reaction is unclear). 4, 3, 2, 2 Limit test
Limit tests are mainly carried out when the experimenter knows that the test substance may be non-toxic (that is, it will have toxic effects only at doses higher than the limit). Understand the existing physical data of compounds or mixtures with similar components to the test substance. Understand which components of these compounds or mixtures and their content produce toxic effects, and obtain relevant toxicity data of the test substance based on this information. If there is no or only a small amount of relevant toxicity data, or if the test substance is predicted to be toxic, formal tests should be carried out. According to the formal test procedure, the initial toxic concentrations of vapor, dust/mist, and gas test substances in formal tests should be 20 mg/L, 5 mg/L, and 5000 L/m as the initial concentration of animal toxicity, respectively. If the test results can complete the classification of the test substance, the rack toxicity test at this concentration is the limit test of this test.
If certain management agencies have requirements, the test procedure must be followed until the GHS Class 5 classification is reached before stopping the test. However, it is not encouraged to use animals to test until the GHS Class 5 classification is reached, unless the Class 5 classification result is likely to be related to the protection of human health. 4.3.2.3 Observation of Toxic Effects
Animals should be observed regularly during the exposure process. Animals should be observed for clinical signs for at least two days after exposure. Depending on the toxic reaction of the animal after exposure, the observation may be repeated more often. Thereafter, the animal should be observed at least once a day for a total of 14 days, unless the animal dies during the period. The observation period is not fixed and can be adjusted appropriately based on the characteristics of the symptoms, the onset time, and the length of the recovery period. The time when the symptoms of poisoning appear or disappear is very important, especially when the symptoms may appear later. All observations should be recorded systematically, and each animal should be recorded separately. Animals that are drooling, in obvious pain, or in severe pain should be euthanized promptly. The time of euthanasia and the time when the animal was found dead should be recorded as accurately as possible. If the animal continues to have symptoms, additional observations should be performed. Clinical observations include changes in the skin, coat, eyes, mucous membranes, respiratory system, circulatory system, autonomic and central nervous system, somatic motor function, and behavioral characteristics. When possible, the signs of poisoning should be used to distinguish whether the toxic effects are local or systemic. Signs of tremors, convulsions, loose stools, diarrhea, lethargy, lethargy, and coma should be observed. The OECD guidance document [], which contains principles and criteria for judging the signs of poisoning, should also be considered during clinical observation. Animals that are convulsed, in obvious pain, or in severe distress should be euthanized to protect animal welfare. When observing for signs of poisoning, care should be taken not to interpret the initial signs of poisoning and transient respiratory changes (such as these changes may occur in control animals exposed to air) as toxic effects of the test substance. 4.3.2, 4 Physical examination
The animals should be weighed on the day of exposure, before or immediately before exposure, and at least once a week thereafter. Surviving animals should be weighed and euthanized at the conclusion of the study.
4.3.2.5 Pathological examination
All animals (including those that died during the test and were euthanized) should be examined grossly and all lesions observed in each animal should be recorded. For animals that survived for more than 24 hours after exposure, histopathological examination should be performed when lesions were found during the gross dissection, as the results of this examination can provide useful information on toxic effects. 6
5 Data and reports
5.1 Data
GB/T 27824-2011
Data for each animal should be given and all test data should be summarized in a table. Information on the number of animals in each group, the number of animals with toxic symptoms, the number of animals that died during the test, the number of animals that were euthanized, the time of death of each animal, the characteristics of toxic effects, the onset, duration and recovery time of toxic effects, and gross anatomical findings should be given. 5.2 Test report
If possible, the test report should include the following information: a) Test substance:
1) Physical properties, purity and relevant physicochemical properties (including isomerization); 2) Identification information, including Chemical Abstracts Service CAS number (if known). 6) Solvent: Explain the reason for using a solvent, and the reason should also be stated when a non-aqueous solvent is selected. ) Test animals:
Species and strain;
Animal cleanliness level (if known);32
Time to adapt to the environment before the test:
Number, age and sex of animals (when appropriate, the reason for using male animals instead of male animals should be stated): Animal source, breeding conditions, historical data, feed, etc. 5)
d) Experimental conditions:
Detailed process for preparing the test substance, including detailed process for preparing test substance particles of smaller size and detailed steps for preparing test substance solution1
Description of the aerosol generating device used (preferably including diagrams) and the animal inhalation exposure process; Detailed description of the equipment used to monitor temperature, humidity and air flow in the exposure cabinet; 3
Description of all convenient instruments for determining the concentration of the test substance and the size of the aerosol particles in the exposure cabinet; Chemical analysis methods used to determine the concentration of the test substance and the confirmation of the methods used (including the extraction rate of the test substance in the sampling medium such as filter membrane or absorption liquid);
The time required for the test substance concentration in the exposure cabinet to reach a steady state before the animals began to inhale the poison, and the method of randomizing the animals into the exposure group and the control group; 7
Detailed information on the quality of feed and drinking water (including feed type/source, drinking water source): reasons for choosing the starting density.
e) Results,
Report the temperature, humidity and air flow rate in the poisoning cabinet in a tabular form1
Report the calculated concentration and measured concentration of the test substance in the poisoning cabinet in a tabular form;33
Report the relevant results of the particle size of the test substance in a tabular form, including the sampling results, dispersion and calculation of MMAD and GSD when performing concentration analysis:
Report the toxic reaction of each animal and its poisoning concentration in a tabular form (such as animal mortality, characteristics of poisoning symptoms, severity of toxic effects and duration of toxic effects); the weight of each animal before poisoning on the day of poisoning, the weight of each animal every week after poisoning, the weight at the time of death, and the weight at the time of euthanasia; the date and time of animal death, the time when toxic symptoms appeared, and whether the toxic symptoms were recoverable; the gross anatomy and histopathological findings of each animal (provide them in the report if any). 6)
f) Discussion and interpretation of results.
g) Conclusion.
Pre-test starting concentration 0.Bmg
1 animal
Domeiweiais
Formal test system 10.5
Appendix A
(Normative Appendix)
Test flow chart
1 moving hook
Pre-test super milk concentration 2m
1 animal
For GHS
Formal purchase 050.
Heiqinongkang
B Obvious toxicity
Non-toxicity
【animals
1 Animal
10mg/l
1 animal
10mg/L
1 animal
20mg/L
1 animal
20mu/L
102020
*1 animal is exposed to 0.5mg/L concentration. When the result is A, the test substance can be classified as Class B1. At this time, subsequent test procedures can be selected to further confirm its classification
Figure A.1 Steam pre-test flow chart
GB/T27824—20112 Test report
If possible, the test report should include the following information: a) Test substance:
1) Physical properties, purity and relevant physicochemical properties (including isomerization); 2) Identification information, including Chemical Abstracts Service CAS number (if known). 6) Solvent: Explain the reason for using a solvent, and the reason should also be stated when a non-aqueous solvent is selected. ) Test animals:
Species and strain;
Animal cleanliness level (if known);32
Time to adapt to the environment before the test:
Number, age and sex of animals (when appropriate, the reason for using male animals instead of male animals should be stated): Animal source, breeding conditions, historical data, feed, etc. 5)
d) Experimental conditions:
Detailed process for preparing the test substance, including detailed process for preparing test substance particles of smaller size and detailed steps for preparing test substance solution1
Description of the aerosol generating device used (preferably including diagrams) and the animal inhalation exposure process; Detailed description of the equipment used to monitor temperature, humidity and air flow in the exposure cabinet; 3
Description of all convenient instruments for determining the concentration of the test substance and the size of the aerosol particles in the exposure cabinet; Chemical analysis methods used to determine the concentration of the test substance and the confirmation of the methods used (including the extraction rate of the test substance in the sampling medium such as filter membrane or absorption liquid);
The time required for the test substance concentration in the exposure cabinet to reach a steady state before the animals began to inhale the poison, and the method of randomizing the animals into the exposure group and the control group; 7
Detailed information on the quality of feed and drinking water (including feed type/source, drinking water source): reasons for choosing the starting density.
e) Results,
Report the temperature, humidity and air flow rate in the poisoning cabinet in a tabular form1
Report the calculated concentration and measured concentration of the test substance in the poisoning cabinet in a tabular form;33
Report the relevant results of the particle size of the test substance in a tabular form, including the sampling results, dispersion and calculation of MMAD and GSD when performing concentration analysis:
Report the toxic reaction of each animal and its poisoning concentration in a tabular form (such as animal mortality, characteristics of poisoning symptoms, severity of toxic effects and duration of toxic effects); the weight of each animal before poisoning on the day of poisoning, the weight of each animal every week after poisoning, the weight at the time of death, and the weight at the time of euthanasia; the date and time of animal death, the time when toxic symptoms appeared, and whether the toxic symptoms were recoverable; the gross anatomy and histopathological findings of each animal (provide them in the report if any). 6)
f) Discussion and interpretation of results.
g) Conclusion.
Pre-test starting concentration 0.Bmg
1 animal
Domeiweiais
Formal test system 10.5
Appendix A
(Normative Appendix)
Test flow chart
1 moving hook
Pre-test super milk concentration 2m
1 animal
For GHS
Formal purchase 050.
Heiqinongkang
B Obvious toxicity
Non-toxicity
【animals
1 Animal
10mg/l
1 animal
10mg/L
1 animal
20mg/L
1 animal
20mu/L
102020
*1 animal is exposed to 0.5mg/L concentration. When the result is A, the test substance can be classified as Class B1. At this time, subsequent test procedures can be selected to further confirm its classification
Figure A.1 Steam pre-test flow chart
GB/T27824—20112 Test report
If possible, the test report should include the following information: a) Test substance:
1) Physical properties, purity and relevant physicochemical properties (including isomerization); 2) Identification information, including Chemical Abstracts Service CAS number (if known). 6) Solvent: Explain the reason for using a solvent, and the reason should also be stated when a non-aqueous solvent is selected. ) Test animals:
Species and strain;
Animal cleanliness level (if known);32
Time to adapt to the environment before the test:
Number, age and sex of animals (when appropriate, the reason for using male animals instead of male animals should be stated): Animal source, breeding conditions, historical data, feed, etc. 5)
d) Experimental conditions:
Detailed process for preparing the test substance, including detailed process for preparing test substance particles of smaller size and detailed steps for preparing test substance solution1
Description of the aerosol generating device used (preferably including diagrams) and the animal inhalation exposure process; Detailed description of the equipment used to monitor temperature, humidity and air flow in the exposure cabinet; 3
Description of all convenient instruments for determining the concentration of the test substance and the size of the aerosol particles in the exposure cabinet; Chemical analysis methods used to determine the concentration of the test substance and the confirmation of the methods used (including the extraction rate of the test substance in the sampling medium such as filter membrane or absorption liquid);bzxZ.net
The time required for the test substance concentration in the exposure cabinet to reach a steady state before the animals began to inhale the poison, and the method of randomizing the animals into the exposure group and the control group; 7
Detailed information on the quality of feed and drinking water (including feed type/source, drinking water source): reasons for choosing the starting density.
e) Results,
Report the temperature, humidity and air flow rate in the poisoning cabinet in a tabular form1
Report the calculated concentration and measured concentration of the test substance in the poisoning cabinet in a tabular form;33
Report the relevant results of the particle size of the test substance in a tabular form, including the sampling results, dispersion and calculation of MMAD and GSD when performing concentration analysis:
Report the toxic reaction of each animal and its poisoning concentration in a tabular form (such as animal mortality, characteristics of poisoning symptoms, severity of toxic effects and duration of toxic effects); the weight of each animal before poisoning on the day of poisoning, the weight of each animal every week after poisoning, the weight at the time of death, and the weight at the time of euthanasia; the date and time of animal death, the time when toxic symptoms appeared, and whether the toxic symptoms were recoverable; the gross anatomy and histopathological findings of each animal (provide them in the report if any). 6)
f) Discussion and interpretation of results.
g) Conclusion.
Pre-test starting concentration 0.Bmg
1 animal
Domeiweiais
Formal test system 10.5
Appendix A
(Normative Appendix)
Test flow chart
1 moving hook
Pre-test super milk concentration 2m
1 animal
For GHS
Formal purchase 050.
Heiqinongkang
B Obvious toxicity
Non-toxicity
【animals
1 Animal
10mg/l
1 animal
10mg/L
1 animal
20mg/L
1 animal
20mu/L
102020
*1 animal is exposed to 0.5mg/L concentration. When the result is A, the test substance can be classified as Class B1. At this time, subsequent test procedures can be selected to further confirm its classification
Figure A.1 Steam pre-test flow chart
GB/T27824—2011
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