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 15670 consists of the following parts under the general title Toxicological test methods for pesticides registration:
——Part 1: General principles;
——Part 2: Acute oral toxicity test - Horn's method;
——Part 3: Acute oral toxicity test - Up-and-down-procedure;
——Part 4: Acute oral toxicity test - Miller and Taninters method;
——Part 5: Acute dermal toxicity test;
——Part 6: Acute inhalation toxicity test;
——Part 7: Dermal irritation/corrosion test;
——Part 8: Acute eye irritation/corrosion test;
——Part 9: Skin sensitisation test;
——Part 10: Short-term repeated dose 28-day oral toxicity study;
——Part 11: Short-term repeated dose 28-day dermal toxicity study;
——Part 12: Short-term repeated dose 28-day inhalation toxicity study;
——Part 13: Subchronic toxicity study;
——Part 14: Bacterial reverse mutation test;
——Part 15: In vivo mammalian bone marrow polychromatic erythrocyte micronucleus test;
——Part 16: In vivo mammalian bone marrow cell chromosome aberration test;
——Part 17: Mammalian spermatogonial/spermatocyte chromosome aberration test;
——Part 18: Rodent dominant lethal test;
——Part 19: In vitro mammalian cells chromosome aberration test;
——Part 20: In vitro mammalian cell gene mutation test;
——Part 21: Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo;
——Part 22: DNA damage and repair/unscheduled DNA synthesis test in mammalian cells in vivo;
——Part 23: Teratogenicity study;
——Part 24: Two-generation reproduction toxicity study;
——Part 25: Acute delayed neurotoxicity test;
——Part 26: Chronic toxicity study;
——Part 27: Carcinogenicity study;
——Part 28: Combined chronic toxicity/carcinogenicity study;
——Part 29: Metabolism and toxicokinetics study.
This part is Part 6 of GB/T 15670.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 15670-1995 Toxicological test methods of pesticides for registration partly.
The following main changes have been made with respect to the part of acute inhalation toxicity test in GB/T 15670-1995:
——The overall structure and format are modified and adjusted;
——Some clauses and subclauses are added (see clauses 1, 2, 3 and 5, 6.1.1, 6.1.2, 6.1.3, 6.1.4, 6.2.1 and clause 8);
——It is explicitly required to adopt the dynamic inhalation method, and the inhalation time is changed from 2 h to 4 h (see 6.1.3; 4.5 in Edition 1995);
——The requirements for laboratory animals are modified (see 6.1.5; 4.3 of Edition 1995);
This part was proposed by and is under the jurisdiction of the Ministry of Agriculture of the People's Republic of China.
The previous edition of this part is as follows:
——GB/T 15670-1995.
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 of acute inhalation toxicity test.
This part is applicable to acute inhalation toxicity test conducted for pesticides 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
Order of the Ministry of Agriculture of the People's Republic of China [2007] No.10 Data requirements on pesticide registration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acute inhalation toxicity
health damage effect on laboratory animal when continuously inhale at a time the test objects with high concentration (gas, steam, aerosol or particulate matter) in a short time (24 h or within 24 h, and usually 4 h)
3.2
inhaled dose
the amount of test object inhaled per unit body weight of animal, i.e.:
(1)
where,
Dih——the inhaled dose, mg/kg;
c——the concentration of the test object in the inhaled gas, mg/L;
t——the inhalation duration, min;
R——the respiratory rate, time/min;
Tv——the tidal volume of the tested animal, L/time;
α——the retention coefficient related to the reactivity and solubility of the test object;
W——the body weight, kg.
3.3
median lethal concentration
LC50
statistical concentration of the toxicant that caused half of the overall laboratory animals to die after a single continuous respiratory inhalation of the test object over a specified period of time, which is expressed as the mass of the test object per unit volume of air (mg/m3)
3.4
dose-response relationship
relationship between dose and incidence of specific effects
3.5
aerodynamic equivalent diameter; AD
comparing aerosol particles of different shapes and densities with spherical particles of different diameters with standard unit density (1.0g/cm3), when both kinds of particles have the same terminal settling velocity, the diameter of the aerosol particles is expressed by the diameter of the standard spherical particles, and is called the aerodynamic equivalent diameter of the aerosol particles, expressed in micrometers (μm)
3.6
mass median aerodynamic diameter; MMAD
when the particles smaller than or equal to a certain aerodynamic equivalent diameter (for example, 5μm) account for 50% of the total mass or total weight of an aerosol sample composed of particles of different aerodynamic equivalent diameters, the aerodynamic equivalent diameter of this kind of aerosol particles is the mass median aerodynamic diameter (5μm) of the aerosol sample
3.7
geometric standard deviation; GSD
dimensionless number used to describe the size range of aerosol particles; the smaller the geometric standard deviation is, the higher the content of particles of similar size will be, that is, the better the uniformity of aerosol particles is, the lower the dispersion will be. In general, aerosol sample with geometric standard deviation less than or equal to 2 is called monodisperse aerosol
3.8
inhalable diameter
aerodynamic equivalent diameter of particles that can be inhaled through the mouth and/or nose of a subject and deposited at any part of the respiratory tract, aerosol particles with aerodynamic equivalent diameter less than 10μm are usually called inhalable particulate matters
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test purpose
5 Test overview
6 Test methods
7 Test results and evaluation
8 Test report
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 15670 consists of the following parts under the general title Toxicological test methods for pesticides registration:
——Part 1: General principles;
——Part 2: Acute oral toxicity test - Horn's method;
——Part 3: Acute oral toxicity test - Up-and-down-procedure;
——Part 4: Acute oral toxicity test - Miller and Taninters method;
——Part 5: Acute dermal toxicity test;
——Part 6: Acute inhalation toxicity test;
——Part 7: Dermal irritation/corrosion test;
——Part 8: Acute eye irritation/corrosion test;
——Part 9: Skin sensitisation test;
——Part 10: Short-term repeated dose 28-day oral toxicity study;
——Part 11: Short-term repeated dose 28-day dermal toxicity study;
——Part 12: Short-term repeated dose 28-day inhalation toxicity study;
——Part 13: Subchronic toxicity study;
——Part 14: Bacterial reverse mutation test;
——Part 15: In vivo mammalian bone marrow polychromatic erythrocyte micronucleus test;
——Part 16: In vivo mammalian bone marrow cell chromosome aberration test;
——Part 17: Mammalian spermatogonial/spermatocyte chromosome aberration test;
——Part 18: Rodent dominant lethal test;
——Part 19: In vitro mammalian cells chromosome aberration test;
——Part 20: In vitro mammalian cell gene mutation test;
——Part 21: Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo;
——Part 22: DNA damage and repair/unscheduled DNA synthesis test in mammalian cells in vivo;
——Part 23: Teratogenicity study;
——Part 24: Two-generation reproduction toxicity study;
——Part 25: Acute delayed neurotoxicity test;
——Part 26: Chronic toxicity study;
——Part 27: Carcinogenicity study;
——Part 28: Combined chronic toxicity/carcinogenicity study;
——Part 29: Metabolism and toxicokinetics study.
This part is Part 6 of GB/T 15670.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 15670-1995 Toxicological test methods of pesticides for registration partly.
The following main changes have been made with respect to the part of acute inhalation toxicity test in GB/T 15670-1995:
——The overall structure and format are modified and adjusted;
——Some clauses and subclauses are added (see clauses 1, 2, 3 and 5, 6.1.1, 6.1.2, 6.1.3, 6.1.4, 6.2.1 and clause 8);
——It is explicitly required to adopt the dynamic inhalation method, and the inhalation time is changed from 2 h to 4 h (see 6.1.3; 4.5 in Edition 1995);
——The requirements for laboratory animals are modified (see 6.1.5; 4.3 of Edition 1995);
This part was proposed by and is under the jurisdiction of the Ministry of Agriculture of the People's Republic of China.
The previous edition of this part is as follows:
——GB/T 15670-1995.
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 of acute inhalation toxicity test.
This part is applicable to acute inhalation toxicity test conducted for pesticides 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
Order of the Ministry of Agriculture of the People's Republic of China [2007] No.10 Data requirements on pesticide registration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acute inhalation toxicity
health damage effect on laboratory animal when continuously inhale at a time the test objects with high concentration (gas, steam, aerosol or particulate matter) in a short time (24 h or within 24 h, and usually 4 h)
3.2
inhaled dose
the amount of test object inhaled per unit body weight of animal, i.e.:
(1)
where,
Dih——the inhaled dose, mg/kg;
c——the concentration of the test object in the inhaled gas, mg/L;
t——the inhalation duration, min;
R——the respiratory rate, time/min;
Tv——the tidal volume of the tested animal, L/time;
α——the retention coefficient related to the reactivity and solubility of the test object;
W——the body weight, kg.
3.3
median lethal concentration
LC50
statistical concentration of the toxicant that caused half of the overall laboratory animals to die after a single continuous respiratory inhalation of the test object over a specified period of time, which is expressed as the mass of the test object per unit volume of air (mg/m3)
3.4
dose-response relationship
relationship between dose and incidence of specific effects
3.5
aerodynamic equivalent diameter; AD
comparing aerosol particles of different shapes and densities with spherical particles of different diameters with standard unit density (1.0g/cm3), when both kinds of particles have the same terminal settling velocity, the diameter of the aerosol particles is expressed by the diameter of the standard spherical particles, and is called the aerodynamic equivalent diameter of the aerosol particles, expressed in micrometers (μm)
3.6
mass median aerodynamic diameter; MMAD
when the particles smaller than or equal to a certain aerodynamic equivalent diameter (for example, 5μm) account for 50% of the total mass or total weight of an aerosol sample composed of particles of different aerodynamic equivalent diameters, the aerodynamic equivalent diameter of this kind of aerosol particles is the mass median aerodynamic diameter (5μm) of the aerosol sample
3.7
geometric standard deviation; GSD
dimensionless number used to describe the size range of aerosol particles; the smaller the geometric standard deviation is, the higher the content of particles of similar size will be, that is, the better the uniformity of aerosol particles is, the lower the dispersion will be. In general, aerosol sample with geometric standard deviation less than or equal to 2 is called monodisperse aerosol
3.8
inhalable diameter
aerodynamic equivalent diameter of particles that can be inhaled through the mouth and/or nose of a subject and deposited at any part of the respiratory tract, aerosol particles with aerodynamic equivalent diameter less than 10μm are usually called inhalable particulate matters
Contents of GB/T 15670.6-2017
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test purpose
5 Test overview
6 Test methods
7 Test results and evaluation
8 Test report
