TABLE B-3 Microbial Pesticides Toxicology Data Requirements

Guideline All Use Test Test
Number Data Requirement Patterns Substance Notesc
Tire I
885.3050 Acute oral toxicity/pathogenicity R TGAI 1
885.3150 Acute pulmonary toxicity pathogenicity R TGAI
885.3200 Acute injection toxicity/pathogenicity/Cintravenous) Acute injection toxicity/pathogenicity/(intraperitoneal) R TGAI 2
885.3400 Hypersensitivity incidents R All 3
885.3500 Cell culture R TGAI 4
870.1100 Acute oral toxicity R MP, EP 1,5
870.1200 Acute dermal toxicity R MP. EP 5
870.1300 Acute inhalation toxicity R MP.EP 5,6
870.2400 Acute eye irritation R MP. EP 5
870.2500 Primary dermal irritation R MP, EP 5
Tire II
885.3550 Acute toxicology CR TGAI 7
885.3600 Subchronic toxicity/pathogenicity CR TGAI 8
Tire III
885.3650 Reproductive fertility effects CR TGAI 9,13
870.4200 Carcinogenicity CR TGAI 10,13
870.7800 Immunotoxicity CR TGAI 11,13
885.3000 Infectivity pathogenicity analysis CR TGAI 12,13

Abbreviations: CR, conditionally required: EP. end-use product; MP. manufacturing-use product: R. required; TGAI. teclmical grade of the active ingredient

aTest notes. The following test notes are applicable to the data requirements for microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section:

1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.

2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.

3. Hypersensitivity incidents, including immediate type and delayed-type reactions of humans or domestic animals, occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.

4. Data must be submitted only for products whose active ingredient is a virus.

5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.



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