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Table 2 US and EU data requirements for microbial products

From: Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health

 

OPPTS / OECD Guideline / Other

Data Requirements

US

EU

Acute Oral Toxicity

870.1100 / 425

420, 423

Acute Dermal Toxicity

870.1200 / 402

402

Acute Inhalation Toxicity

870.1300 / 403

403, 436

Acute Dermal Irritation

870.2500 / 404

404

in vitro tests acc. to OECD TG 430, 431, 435, 439

IATA for Skin Corrosion and Irritation, No. 203

Acute Eye Irritation

870.2400 / 405

405

in vitro tests acc. to OECD TG 437, 438, 460, 491, 492

IATA for Serious Eye Damage and Eye Irritation, No. 263

Dermal Sensitization

870.2600a / 429a

406, 429, 497

in vitro tests acc. to 442A, 442B, 442C, 442D, 442E

Additional toxicity information

submitted case by case

based on expert judgement case-by-case acc. to Reg 284/2013

  1. aDue to default label statement, dermal sensitization studies are not run for all TGAI and formulated products. Their applicability for microbial products is currently under discussion