U.S. EPA OCSPP Guideline: 885.4050 PMRA Data Code: M9.2.1 - Avian Oral OECD Data Code: IIM 8.1, IIIM 10.1

Q: What is the required guideline and data code for this avian oral toxicity DER template?

The template specifies U.S. EPA OCSPP Guideline 885.4050, with PMRA Data Code M9.2.1 and OECD Avian Oral Data Codes IIM 8.1 and IIIM 10.1.

Q: What information must be included in the test material and citation sections?

It requires test material identity (including purity/potency, lot/batch number, and relevant biological activity or concentration), synonyms, and a complete citation with study and laboratory details plus MRID and PMRA identifiers when applicable.

Q: What core study outcomes are expected in the executive summary?

The executive summary must describe the acute oral dosing/exposure design and report toxicity/pathogenicity results, including mortality and clinical signs, microbial clearance if assessed, and derived LD50 and NOEL values.

Sep 2, 2026

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DER template for avian acute oral toxicity and pathogenicity data submission under U.S. EPA OCSPP Guideline 885.4050 and corresponding PMRA and OECD data codes (M9.2.1; IIM 8.1, IIIM 10.1). Covers registrant/applicant instructions, required identification elements (test material, synonyms, citation, sponsor), compliance and GLP/QA/data confidentiality statements, executive-summary reporting of study design, dose/exposure details, mortality and clinical signs, LD50 and NOEL endpoints, and acceptability classification. Includes guideline-followed and deviations reporting, plus materials and methods sections for purity, storage, and test organism details.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages20

Reading Time7 min

AccessFree to download

Executive Summary

Toxicity and endpoint reporting

Classification and compliance

Acceptable/unacceptable/supplemental status

Materials and Methods

Guideline followed and deviations

Test material and storage

Test organism

[NOTE TO REGISTRANT/APPLICANT: PLEASE DISREGARD the header, footer, and reviewer information; reviewers’ comments in the conclusion section; and study classification statement. These sections are for EPA, PMRA, and OECD data entry only and will be populated upon Agency review.] REQUIREMENT: Avian Oral, Tier I U.S. EPA OCSPP Guideline: 885.4050 PMRA Data Code: M9.2.1–Avian Oral OECD Data Code: IIM 8.1, IIIM 10.1 TEST MATERIAL (PURITY): [use name of material tested as referred to in the study and include its potency, lot no., biological activity or concentration per unit weight or volume (% active ingredient name in parenthesis)] or [insert TGAI and EP names if a waiver request is made] SYNONYMS: [other names, code names and acronyms] CITATION: Author(s). [Year]. Study Title. Laboratory name and address. Laboratory report number, full study date. Unpublished [OR if published, list Journal name, vol.: pages]. MRID No. [no hyphen], PMRA [number if applicable]. SPONSOR: [Name and address of Study Sponsor - indicate if different from Applicant] COMPLIANCE: Signed and dated GLP, Quality Assurance, and Data Confidentiality statements were [not] provided. The study was [not] conducted in compliance with GLP [40 CFR § 160]. [Discuss deviations from regulatory requirements] This DER does [not] contain FIFRA CBI. EXECUTIVE SUMMARY: [Describe the study and its findings.] In a [#]-day acute oral toxicity and pathogenicity study of [test material] to [#]-day-old [common name of species (scientific name), enter the number of birds per treatment] were exposed to a [single OR #] [indicate exposure method] dose of [indicate doses used, e.g., mg a.i./kg bw and/or CFU/kg bw] of [formulation, note its potency, biological activity or concentration per unit weight or volume] (containing % a.i. name). [Include other pertinent details such as the controls used.] [Describe toxicity and/or pathogenicity briefly including mortality, behavioral abnormalities, and other clinical signs. If there was no toxicity, state that there was no test material-related toxic or pathogenic effect. Describe microbial clearance, if assessed] The [#]-day acute oral LD50 was [=, > or <] [insert LD50 in mg a.i/kg bw and/or CFU/kg bw]. The [#]-day NOEL of [test material] to the [species], based on [endpoint] was [=, > or <] [insert NOEL in mg a.i./kg bw and/or CFU/kg bw]. This toxicity [or] infectivity/pathogenicity study is classified as [acceptable / unacceptable / supplemental.] This study was [not] conducted in accordance with the guideline recommendations for an acute oral toxicity and pathogenicity study for birds (OCSPP 885.4050; PMRA: M9.2.1 and OECD: IIM 8.1, IIIM 10.1) in the [species]. [If it does not satisfy the requirement, concisely list only major deficiencies or refer to deficiency section.] CLASSIFICATION: [ACCEPTABLE / UNACCEPTABLE / SUPPLEMENTAL, but UPGRADEABLE] (Use the following template if a study report (i.e. toxicity test) was submitted. If a request for the use of alternative data is submitted in lieu of a new study, delete study template section and proceed to last section of DER template for alternative data requests) (NOTE: Guidance on populating the DER are reflected as [red italics]- please replace this text with requested data. Excerpts of study recommendations/criteria are reflected as blue italicized text from the respective OSCPP Guideline and should be deleted upon completion of the DER template. For best preparation of data submission- refer to respective OSCPP Guideline and use both the DER template and guideline criteria. However, the overall structure of the templates should not be altered and data evaluation elements reflected in black text should not be deleted (i.e. headings, test parameters, tables, results section). Also- note for data elements of the template that are not applicable- insert “not applicable.” For unavailable information- insert “not available” with a brief explanation for the omission of data.) MATERIALS AND METH

FAQs

What is the required guideline and data code for this avian oral toxicity DER template?

The template specifies U.S. EPA OCSPP Guideline 885.4050, with PMRA Data Code M9.2.1 and OECD Avian Oral Data Codes IIM 8.1 and IIIM 10.1.

What information must be included in the test material and citation sections?

It requires test material identity (including purity/potency, lot/batch number, and relevant biological activity or concentration), synonyms, and a complete citation with study and laboratory details plus MRID and PMRA identifiers when applicable.

What core study outcomes are expected in the executive summary?

The executive summary must describe the acute oral dosing/exposure design and report toxicity/pathogenicity results, including mortality and clinical signs, microbial clearance if assessed, and derived LD50 and NOEL values.

Sep 2, 2026

Upload by Melati