US Environmental Protection Agency
Office of Pesticide Programs
Suggested Format for Acute Toxicity
Studies
June 2008

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June 2008
Suggested Format for
Acute Toxicity Studies
The purpose of this document is to suggest the format for final reports (right column) and to
provide instructions for the creation of PDF Version 1.3 electronic submission documents (left
column.) Regarding PDF, both "bookmarks" and "links" are referenced. Bookmarks and links
are similar in function in that both provide the reader with a way to move efficiently through a
document. Bookmarks are a type of link that appear in the navigation pane on the left side of the
PDF Reader user screen. Links appear within the body of a document as blue text. They permit
the reader to jump to other locations with related information in the same document.
The same format is appropriate for oral, dermal, primary eve irritation, and skin irritation studies.
Slightly different formats are appropriate for acute toxicity - inhalation and skin sensitization study
reports.

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Suggested Format for Acute Toxicity Studies
June 2008
Acute Oral and Dermal; Primary Eye Irritation and Skin Irritation Studies
Instructions lo ('rente PDI-'
Document l-'orniiit
Create Bookmarks for each item
in the Document Format column.
•	Study Title Page,
•	Statement of Data Confidentiality,
•	GLP Statement,
•	QA Statement.
Create bookmarks for each item
in table of contents.
• Table of Contents.
Create links in summary to
related text and tables in body of
study report or appendices.
•	Executive Summary,
-	Summary of Materials and Methods,
-	Summary of Results.
•	Test Material Identification,
•	Test Animal Identification,
•	Test Material Administration.
Create links to related text,
tables, or appendices.
•	Results,
-	Mortality,
-	Clinical Observations,
-	Gross Necropsy,
•	Body Weights,
•	Deviations,
•	Tables.

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Suggested Format for Acute Toxicity Studies
June 2008
Acute Inhalation Toxicity Studies
Instructions to (resile I'DI-
Document l-'ormnl
Create Bookmarks for each item
in the Document Format column.
•	Study Title Page,
•	Statement of Data Confidentiality,
•	GLP Statement,
•	QA Statement.
Create bookmarks for each item
in table of contents.
• Table of Contents.
Create links in summary to
related text and tables in body of
study report or appendices.
•	Executive Summary,
-	Summary of Materials and Methods,
-	Summary of Results.
•	Test Material Identification,
•	Test Animal Identification,
•	Method,
-	Ambient Conditions,
-	Exposure Description (Chamber/Period),
-	Atmospheric Generation Model,
-	Chamber Concentration Measurements,
-	Particle Size Evaluation.
Create links to related text,
tables, or appendices.
•	Results
-	Mortality,
-	Exposure Concentration,
-	MMAD/GSD,
-	Clinical Observations,
-	Gross Necropsy.
•	Body Weights,
•	Deviations,
•	Tables.

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Suggested Format for Acute Toxicity Studies
June 2008
Skin Sensitization Studies
Instructions to (resile I'DI-
Document l-Ornint
Create Bookmarks for each item
in the Document Format column.
•	Study Title Page,
•	Statement of Data Confidentiality
•	GLP Statement,
•	QA Statement.
Create bookmarks for each item
in table of contents.
• Table of Contents.
Create links in summary to
related text and tables in body of
study report or appendices.
•	Executive Summary,
-	Summary of Materials and Methods,
-	Summary of Results.
•	Test Material Identification,
•	Test Animal Identification (Test, Naive, Control),
•	Primary Irritation Screening,
•	Test Material Administration (Induction),
•	Test material Administration (Challenge/Rechallenge).
Create links to related text,
tables, or appendices.
•	Results (Test material and Naive control)
-	Inducation,
-	Challenge.
•	Positive Control Description/Results
-	Induction,
-	Challenge.
•	Body Weights,
•	Deviations,
•	Tables.

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