Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
GB/T 31270 consists of 21 parts under the general title Test guidelines on environmental safety assessment for chemical pesticides:
——Part 1: Transformation in soils;
——Part 2: Hydrolysis;
——Part 3: Phototransformation;
——Part 4: Adsorption/desorption in soils;
——Part 5: Leaching in soil;
——Part 6: Volatility;
——Part 7: Bioconcentration test;
——Part 8: Degradation in water-sediment systems;
——Part 9: Avian acute toxicity test;
——Part 10: Honeybee acute toxicity test;
——Part 11: Silkworm acute toxicity test;
——Part 12: Fish acute toxicity test;
——Part 13: Daphnia sp. acute immobilisation test;
——Part 14: Alga growth inhibition test;
——Part 15: Earthworm acute toxicity test;
——Part 16: Soil microorganism toxicity test;
——Part 17: Trichogramma acute toxicity test;
——Part 18: Amphibian acute toxicity test;
——Part 19: Effects on non-target plants;
——Part 20: Livestock short-term dietary toxicity test;
——Part 21: Macro-crustacean toxicity test.
This is Part 9 of GB/T 31270.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by and is under the jurisdiction of the Ministry of Agriculture of the People's Republic of China.
Test guidelines on environmental safety assessment for chemical pesticides -
Part 9: Avian acute toxicity test
1 Scope
This part of GB/T 31270 specifies the basic requirements on materials, conditions, operation, quality control, data processing and test report of avian acute oral toxicity test and acute feeding toxicity test.
This part applies to avian acute oral toxicity test and acute feeding toxicity test performed for registration of chemical pesticides. It may serve as a reference for other types of pesticides.
This part does not apply to volatile and insoluble chemical pesticides.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
median lethal dose
dose of the test substance, at which 50% of the test organisms are killed in the acute oral toxicity test, expressed by LD50
Note: the unit is in mg a.i./kg body weight.
2.2
median lethal concentration
concentration of the test substance in the fodder, at which 50% of the test organisms are killed in the acute feeding toxicity test, expressed by LC50
Note: the unit is in mg a.i./kg fodder.
2.3
test substance
substance to be tested
2.4
chemical pesticide
pesticide made from chemical substances through artificial synthesis, some of which are synthetic bionic pesticides made through imitation, structural transformation and innovation by taking the active substances in natural products as the matrix
Synonym: synthetic organic pesticide.
[Definition 2.3.1, NY/T 1667.1-2008]
2.5
technical material
final product consisting of active ingredients and impurities obtained during the manufacturing process, which shall not contain visible foreign substances or any additives, and if necessary, a small amount of stabilizer may be added
[Definition 2.5.1, NY/T 1667.2-2008]
2.6
formulation
product stable in use and made from technical materials (or technical concentrate) of pesticides and auxiliaries
[Definition 2.4, NY/T 1667.2-2008]
2.7
active ingredient; a.i.
biologically active ingredient (with a specific chemical structure) in pesticide products
[Definition 3.1, NY/T 1667.2-2008]
3 Test overview
3.1 Method selection
The avian acute toxicity test can be conducted via oral or feeding, and relevant methods shall be selected according to regulations on pesticide registration management and other regulations.
3.2 Acute oral toxicity
Acute oral toxicity test is a kind of test method, under which different doses of test substances are given via a single administration by oral infusion method, with a dose ratio of 1.0 mL/100 g body weight. Then observe the poisoning and death of the test birds continuously for 7 days, and calculate the value of LD50 and the 95% confidence limit of 7 days. For less toxic technical materials and water-insoluble granular formulations, capsule feeding method can be used for contamination.
3.3 Acute feeding toxicity
Acute feeding toxicity test is a kind of test method, under which liquid pestcides of different concentrations are sprayed on the food with a sprayer, during this process, the food shall be mixed at the time of medicine spraying till it is mixed uniformly. Feed the test birds for 5 d with fodders containing different concentrations of test substances, from the 6th day, feed the test birds for 3 d with fodders containing no test substances. Record the poisoning and death of the birds every day, then calculate the value of LC50 and the 95% confidence limits of 8 days.
4 Test methods
4.1 Materials and conditions
4.1.1 Test organism
One or more species are available for selection, depending on the test purpose. The test species may breed on their own or via standardized breeding test materials purchased. The birds for test shall be in good health and free from obvious malformation. Test species, with a mortality in the first 7 d after being introduced into the laboratory <5%, and a growth state conforming to the growth law of this species, shall be considered to be in good health. See Annex A for the recommended species. The birds for test shall pass the animal quarantine inspection. Ensure that they are free from any diseases. The birds for test shall come from the same female parent population and be hatched on the same day.
4.1.2 Test substance
Pure pesticides, technical materials or formulation products shall be used as test substances. Insoluble test substances can be dissolved with a small amount of organic solvent which is less toxic to birds, and generally, the amount of the organic solvent shall not exceed 0.1 mL (g)/L.
4.1.3 Main apparatus and instruments
Main apparatus and instruments are as follows:
-bird cage for test;
-electronic balance;
-pipette;
-injection syringe, etc.
4.1.4 Test conditions
See Annex A for the recommended species and their corresponding test conditions.
4.2 Test operations
4.2.1 Acute oral toxicity
4.2.1.1 Pre-test
Under the conditions of a formal test, prepare 4~5 concentration groups set with large concentration difference, conduct the test and then calculate the minimum concentration of the test substance causing total death of the test birds as well as the maximum concentration of the test substance causing no death of the test birds. Set the concentration for formal test within this range.
4.2.1.2 Formal test
Prepare at least 5 concentration groups (set with a certain concentration difference) based on the concentration range determined via the pre-test, with 10 birds for each group, half male and half female. And each of the groups shall be set with a blank control group, and for groups with solvent as cosolvent, solvent control groups shall also be set. The control groups and the concentration groups shall not be set repetitively, and the concentration difference between various concentration groups shall not exceed 2 times. Observe and record the toxic symptom and death of the birds for test every 24 h. After the test, subject the data to mathematical statistics, and then calculate the value of the median lethal concentration LD50 and the 95% confidence limit.
Foreword i
1 Scope
2 Terms and definitions
3 Test overview
4 Test methods
5 Test report
Annex A (Informative) Recommended bird species and test conditions
Annex B (Informative) Classification of toxicity levels of pesticides to birds
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
GB/T 31270 consists of 21 parts under the general title Test guidelines on environmental safety assessment for chemical pesticides:
——Part 1: Transformation in soils;
——Part 2: Hydrolysis;
——Part 3: Phototransformation;
——Part 4: Adsorption/desorption in soils;
——Part 5: Leaching in soil;
——Part 6: Volatility;
——Part 7: Bioconcentration test;
——Part 8: Degradation in water-sediment systems;
——Part 9: Avian acute toxicity test;
——Part 10: Honeybee acute toxicity test;
——Part 11: Silkworm acute toxicity test;
——Part 12: Fish acute toxicity test;
——Part 13: Daphnia sp. acute immobilisation test;
——Part 14: Alga growth inhibition test;
——Part 15: Earthworm acute toxicity test;
——Part 16: Soil microorganism toxicity test;
——Part 17: Trichogramma acute toxicity test;
——Part 18: Amphibian acute toxicity test;
——Part 19: Effects on non-target plants;
——Part 20: Livestock short-term dietary toxicity test;
——Part 21: Macro-crustacean toxicity test.
This is Part 9 of GB/T 31270.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by and is under the jurisdiction of the Ministry of Agriculture of the People's Republic of China.
Test guidelines on environmental safety assessment for chemical pesticides -
Part 9: Avian acute toxicity test
1 Scope
This part of GB/T 31270 specifies the basic requirements on materials, conditions, operation, quality control, data processing and test report of avian acute oral toxicity test and acute feeding toxicity test.
This part applies to avian acute oral toxicity test and acute feeding toxicity test performed for registration of chemical pesticides. It may serve as a reference for other types of pesticides.
This part does not apply to volatile and insoluble chemical pesticides.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
median lethal dose
dose of the test substance, at which 50% of the test organisms are killed in the acute oral toxicity test, expressed by LD50
Note: the unit is in mg a.i./kg body weight.
2.2
median lethal concentration
concentration of the test substance in the fodder, at which 50% of the test organisms are killed in the acute feeding toxicity test, expressed by LC50
Note: the unit is in mg a.i./kg fodder.
2.3
test substance
substance to be tested
2.4
chemical pesticide
pesticide made from chemical substances through artificial synthesis, some of which are synthetic bionic pesticides made through imitation, structural transformation and innovation by taking the active substances in natural products as the matrix
Synonym: synthetic organic pesticide.
[Definition 2.3.1, NY/T 1667.1-2008]
2.5
technical material
final product consisting of active ingredients and impurities obtained during the manufacturing process, which shall not contain visible foreign substances or any additives, and if necessary, a small amount of stabilizer may be added
[Definition 2.5.1, NY/T 1667.2-2008]
2.6
formulation
product stable in use and made from technical materials (or technical concentrate) of pesticides and auxiliaries
[Definition 2.4, NY/T 1667.2-2008]
2.7
active ingredient; a.i.
biologically active ingredient (with a specific chemical structure) in pesticide products
[Definition 3.1, NY/T 1667.2-2008]
3 Test overview
3.1 Method selection
The avian acute toxicity test can be conducted via oral or feeding, and relevant methods shall be selected according to regulations on pesticide registration management and other regulations.
3.2 Acute oral toxicity
Acute oral toxicity test is a kind of test method, under which different doses of test substances are given via a single administration by oral infusion method, with a dose ratio of 1.0 mL/100 g body weight. Then observe the poisoning and death of the test birds continuously for 7 days, and calculate the value of LD50 and the 95% confidence limit of 7 days. For less toxic technical materials and water-insoluble granular formulations, capsule feeding method can be used for contamination.
3.3 Acute feeding toxicity
Acute feeding toxicity test is a kind of test method, under which liquid pestcides of different concentrations are sprayed on the food with a sprayer, during this process, the food shall be mixed at the time of medicine spraying till it is mixed uniformly. Feed the test birds for 5 d with fodders containing different concentrations of test substances, from the 6th day, feed the test birds for 3 d with fodders containing no test substances. Record the poisoning and death of the birds every day, then calculate the value of LC50 and the 95% confidence limits of 8 days.
4 Test methods
4.1 Materials and conditions
4.1.1 Test organism
One or more species are available for selection, depending on the test purpose. The test species may breed on their own or via standardized breeding test materials purchased. The birds for test shall be in good health and free from obvious malformation. Test species, with a mortality in the first 7 d after being introduced into the laboratory <5%, and a growth state conforming to the growth law of this species, shall be considered to be in good health. See Annex A for the recommended species. The birds for test shall pass the animal quarantine inspection. Ensure that they are free from any diseases. The birds for test shall come from the same female parent population and be hatched on the same day.
4.1.2 Test substance
Pure pesticides, technical materials or formulation products shall be used as test substances. Insoluble test substances can be dissolved with a small amount of organic solvent which is less toxic to birds, and generally, the amount of the organic solvent shall not exceed 0.1 mL (g)/L.
4.1.3 Main apparatus and instruments
Main apparatus and instruments are as follows:
-bird cage for test;
-electronic balance;
-pipette;
-injection syringe, etc.
4.1.4 Test conditions
See Annex A for the recommended species and their corresponding test conditions.
4.2 Test operations
4.2.1 Acute oral toxicity
4.2.1.1 Pre-test
Under the conditions of a formal test, prepare 4~5 concentration groups set with large concentration difference, conduct the test and then calculate the minimum concentration of the test substance causing total death of the test birds as well as the maximum concentration of the test substance causing no death of the test birds. Set the concentration for formal test within this range.
4.2.1.2 Formal test
Prepare at least 5 concentration groups (set with a certain concentration difference) based on the concentration range determined via the pre-test, with 10 birds for each group, half male and half female. And each of the groups shall be set with a blank control group, and for groups with solvent as cosolvent, solvent control groups shall also be set. The control groups and the concentration groups shall not be set repetitively, and the concentration difference between various concentration groups shall not exceed 2 times. Observe and record the toxic symptom and death of the birds for test every 24 h. After the test, subject the data to mathematical statistics, and then calculate the value of the median lethal concentration LD50 and the 95% confidence limit.
Contents of GB/T 31270.9-2014
Foreword i
1 Scope
2 Terms and definitions
3 Test overview
4 Test methods
5 Test report
Annex A (Informative) Recommended bird species and test conditions
Annex B (Informative) Classification of toxicity levels of pesticides to birds
Bibliography
