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 - Horns 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 vitro; ——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 is Part 8 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 eye irritation test in GB/T 15670-1995:
——The overall structure and format of standard are modified and adjusted;
——Some clauses and subclauses are added (see clauses 1, 2, 3 and 5, 6.1, 6.2.2, and clauses 7 and 8); ——Requirements for the number of laboratory animals are modified (see 6.2.1; 6.3 of Edition 1995);
——Grading standard of eye damage is modified (see Table 1; Table 6 of Edition 1995);
——The classification of eye irritative reaction is modified (see Table 2; Table 7 of Edition 1995).
This part was proposed by the Ministry of Agriculture of the People's Republic of China.
This standard is under the jurisdiction of the Planting Industry Management Department, 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 8: Acute eye irritation/corrosion test
1 Scope
This part of GB/T 15670 specifies the basic principles, methods and requirements of acute eye irritation/corrosion test.
This part is applicable to acute eye irritation/corrosion 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
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
eye irritation
reversible inflammatory change occurred on the eye surface after contact with the test object, which can completely recover within 21 days
3.2
eye corrosion
irreversible tissue damage occurred on the eye surface after contact with the test object, which cannot completely recover within 21 days
4 Test objective
To determine and evaluate whether or not the test object has irritation or corrosion effect on mammalian eyes and its degree.
5 Test overview
Drip (put) the test object into the conjunctival sac of each laboratory animal's one eye in one dose, and use the untreated eye of the other side as self-control. Within the specified time interval, observe and grade the degree of irritation and corrosion of animal eyes, so as to evaluate the irritation of the test object to the eyes. The observation period shall be sufficient to evaluate the reversibility or irreversibility of the irritation effect.
6 Test methods
6.1 Test object
Generally, the liquid test object does not need to be diluted, and the original liquid shall be directly used, with the exposure dose of 0.1 mL. If the test object is solid or granular, it shall be ground into fine powder, and the exposure dose shall be 0.1 mL or 100 mg. For aerosol product, the rabbit eyes shall be opened up. At 10 cm directly in front of the eye, the aerosol sprayer shall be pressed into the rabbit's eyes for 1s, taking care not to damage the eyes due to pressure.
If the pH value of the test object is less than 2 or greater than 11.5, or it has been proved to be corrosive to the skin, or it is predicted by literature materials and other methods to be severely irritation/corrosive to the eyes, the eye irritation/corrosive test may not be carried out, but the test object shall be deemed to be corrosive to the eyes.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test objective
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 - Horns 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 vitro; ——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 is Part 8 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 eye irritation test in GB/T 15670-1995:
——The overall structure and format of standard are modified and adjusted;
——Some clauses and subclauses are added (see clauses 1, 2, 3 and 5, 6.1, 6.2.2, and clauses 7 and 8); ——Requirements for the number of laboratory animals are modified (see 6.2.1; 6.3 of Edition 1995);
——Grading standard of eye damage is modified (see Table 1; Table 6 of Edition 1995);
——The classification of eye irritative reaction is modified (see Table 2; Table 7 of Edition 1995).
This part was proposed by the Ministry of Agriculture of the People's Republic of China.
This standard is under the jurisdiction of the Planting Industry Management Department, 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 8: Acute eye irritation/corrosion test
1 Scope
This part of GB/T 15670 specifies the basic principles, methods and requirements of acute eye irritation/corrosion test.
This part is applicable to acute eye irritation/corrosion 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
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
eye irritation
reversible inflammatory change occurred on the eye surface after contact with the test object, which can completely recover within 21 days
3.2
eye corrosion
irreversible tissue damage occurred on the eye surface after contact with the test object, which cannot completely recover within 21 days
4 Test objective
To determine and evaluate whether or not the test object has irritation or corrosion effect on mammalian eyes and its degree.
5 Test overview
Drip (put) the test object into the conjunctival sac of each laboratory animal's one eye in one dose, and use the untreated eye of the other side as self-control. Within the specified time interval, observe and grade the degree of irritation and corrosion of animal eyes, so as to evaluate the irritation of the test object to the eyes. The observation period shall be sufficient to evaluate the reversibility or irreversibility of the irritation effect.
6 Test methods
6.1 Test object
Generally, the liquid test object does not need to be diluted, and the original liquid shall be directly used, with the exposure dose of 0.1 mL. If the test object is solid or granular, it shall be ground into fine powder, and the exposure dose shall be 0.1 mL or 100 mg. For aerosol product, the rabbit eyes shall be opened up. At 10 cm directly in front of the eye, the aerosol sprayer shall be pressed into the rabbit's eyes for 1s, taking care not to damage the eyes due to pressure.
If the pH value of the test object is less than 2 or greater than 11.5, or it has been proved to be corrosive to the skin, or it is predicted by literature materials and other methods to be severely irritation/corrosive to the eyes, the eye irritation/corrosive test may not be carried out, but the test object shall be deemed to be corrosive to the eyes.
Contents of GB/T 15670.8-2017
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test objective
5 Test overview
6 Test methods
7 Test results and evaluation
8 Test report