Table 1 US and EU data requirements for microorganisms as active substance

US Data Requirements

OPPTS / OECD Guideline / Other

Tier 1

 Acute Oral Toxicity/Pathogenicity^a

885.3050

 Acute Dermal Toxicity/Pathogenicity^a

885.3100

 Acute Pulmonary Toxicity/Pathogenicity^a

885.3150

 Acute Injection Toxicity/Pathogenicity^a

885.3200

 Hypersensitivity Incidents (reported)

885.3400

 Cell Culture^b

885.3500

 Acute Oral Toxicity^c

870.1100 / 425

 Acute Dermal Toxicity^c

870.1200 / 402

 Acute Inhalation Toxicity^c

870.1300 / 403

 Acute Eye Irritation

870.2400 / 405

 Acute Dermal Irritation

870.2500 / 404

 Dermal Sensitization

no study required due to absence of valid study due to default label statement

Tier 2

 Acute Toxicology

885.3550^d

 Subchronic Toxicity/Pathogenicity

885.3600

Tier 3

 Reproductive/Fertility Effects

885.3650

 Carcinogenicity^e

870.4200

 Immunotoxicity^e

870.7800

 Infectivity/Pathogenicity Analysis

885.3000^f

EU Data Requirements

OPPTS / OECD Guideline / Other

Basic infectivity and pathogenicity studies

 Oral Infectivity/Pathogenicity^g

885.3050

 Intratracheal/intranasal Infectivity/Pathogenicity^g

885.3150

 Intravenous, intraperitoneal or subcutaneous single exposure^g

885.3200

 Hypersensitivity Incidents (reported)

885.3400

 Cell Culture

885.3500

Specific infectivity and pathogenicity

study depending on finding which requires further investigation

 Subchronic Toxicity/Pathogenicity

885.3600

 Reproductive/Fertility Effects

885.3650

Information and toxicity studies on metabolites

SANCO/2020/12258

 Dermal Sensitization

no study required due to absence of valid study; Regulation (EU) 283/2013 provides for obligation to consider MO as potential sensitizers until a validated test is available and the possible absence of sensitization potential is demonstrated on a case-by-case basis