Pesticide Registration

Study Profile Templates

The study profile templates below describe the layout and scope of information that should be contained within a study profile and can serve as a guide for the preparation of study documents. Applicants may include additional information beyond that prescribed in a particular study profile; however, it should be done without affecting or changing the format and content of the template.

Registrants are encouraged to submit completed study profile(s) and supporting data in electronic format in Microsoft Word. See electronic data submissions for additional information.

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Product Chemistry: Series 830

Study Profile Template Guideline
Number
Version
Product Chemistry for Technical Grade of the Active Ingredient or Manufacturing Use Products (Group A and B data) (DOC)(7 pp, 152 K) N/A May 2004
Product Chemistry for End Use Products (DOC)(6 pp, 113 K) N/A May 2004

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Environmental Fate: Series 835

Study Profile Template Guideline
Number
Version
Adsorption and desorption of test compound in soils or sediments (DOCX)(11 pp, 87 K) 835.1230 May 2012
Laboratory Volatility of [test compound] (DOCX)(11 pp, 94 K) 835.1410 December 2012
Hydrolysis of [test compound] at pH [4,7, and 9, or other values studied] (DOCX)(7 pp, 96 K) 835.2120 May 2012
Aqueous Photolysis of [test compound] (DOCX)(12 pp, 107 K) 835.2240 May 2012
Soil Photolysis of [test compound] (DOCX)(15 pp, 115 K) 835.2410 May 2012
Aerobic (or Anaerobic) Degradation in Soil of [test compound] (DOCX)(14 pp, 135 K) 835.4100
835.4200
May 2012
Aerobic (or Anaerobic) Degradation in Aquatic Systems (DOCX)(14 pp, 137 K) 835.4300
835.4400
May 2012
Field Dissipation of [test compound] (DOCX)(22 pp, 995 K) 835.6100
835.6200
May 2012
Prospective Ground Water Monitoring of [test compound] (DOCX)(7 pp, 124 K) 835.7100 December 2012
Field volatility of [test compound] (DOCX)(15 pp, 7 MB) 835.8100 December 2012
Sample storage stability of [test compound(s)] in [frozen soil, water, etc.] (DOCX)(6 pp, 89 K) N/A December 2012

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Environmental Effects: Series 850

Study Profile Template Guideline
Number
Version
Acute Toxicity Effects of {TAI or EUP} on Earthworms (DOC)(9 pp, 159 K) N/A May 2004
Acute Toxicity of {TAI or EUP} to Freshwater Invertebrates - [Daphnia sp.] (DOC)(9 pp, 179 K) 850.1010 May 2004
Acute Toxicity of {TAI or EUP} to Fish - [name of species] (DOC)(10 pp, 197 K) 850.1075 May 2004
Chronic Toxicity of {TAI or EUP} to Fresh Water Invertebrates - [Daphnia sp.] (DOC)(11 pp, 142 K) 850.1300 May 2004
Toxicity of {TAI or EUP} to Fish Early Life-Stage (DOC)(10 pp, 175 K) 850.1400 May 2004
[Fish or Oyster] Bioconcentration Factor (BCF) of [Test Compound] (DOCX)(13 pp, 215 K) 850.1710
850.1730
December 2012
Acute Oral Toxicity of {TAI or EUP} to Avian Species - [name of species] (DOC)(8 pp, 144 K) 850.2100 May 2004
Acute Dietary Toxicity of {TAI or EUP} to Avian Species - [name of species] (DOC)(10 pp, 154 K) 850.2200 May 2004
Reproductive Effects of {TAI or EUP} on Avian Species - [name of species] (DOC)(10 pp, 199 K) 850.2300 May 2004
Acute Toxicity of {TAI or EUP} to Terrestrial Vascular Plant - [name of species - seed germination-root elongation/seedling emergence/vegetative vigour] (DOC)(21 pp, 393 K) 850.4100
850.4150
May 2004
Acute Toxicity of {TAI or EUP} to Aquatic Vascular Plants - [name of species] (DOC)(11 pp, 163 K) 850.4400 May 2004
Acute Toxicity of {TAI or EUP} to Algae - [name of species] (DOC)(12 pp, 328 K) 850.5400 May 2004
Analytical method for [analyte(s)] in [soil, water, air, or other environmental medium] (DOCX)(6 pp, 63 K) 850.6100 December 2012

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Chemistry: Series 860 - Residue Chemistry Test Guidelines

Study Profile Template Guideline
Number
Version
Study Profile Guidance (DOC)(5 pp, 46 K) N/A July 2010
Nature of the Residue in Plants (DOC)(7 pp, 130 K) 860.1300 July 2010
Nature of the Residue in Livestock (DOC)(8 pp, 143 K) 860.1300 July 2010
Residue Analytical Method (DOC)(6 pp, 112 K) 860.1340 July 2010
Storage Stability (DOC)(5 pp, 61 K) 860.1380 July 2010
Water Fish and Irrigated Crops (DOC)(12 pp, 220 K) 860.1400 July 2010
Food Handling (DOC)(8 pp, 75 K) 860.1460 July 2010
Livestock Feeding Study (DOC)(5 pp, 101 K) 860.1480 July 2010
Crop Field Trials (DOC)(7 pp, 124 K) 860.1500 July 2010
Processed Food and Feed (DOC)(5 pp, 73 K) 860.1520 July 2010
Confined Rotational Crops (DOC)(9 pp, 140 K) 860.1850 July 2010
Multiresidue Method (DOC)(3 pp, 51 K) 860.1860 July 2010
Field Rotational Crops (DOC)(6 pp, 85 K) 860.1900 July 2010

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Toxicology: Series 870 - Health Effects Test Guidelines

Study Profile Template Guideline
Number
Version
Acute Oral Toxicity - [species] (DOC)(2 pp, 172 K) 870.1100 May 2004
Acute Dermal Toxicity - [species] (DOC)(2 pp, 40 K) 870.1200 May 2004
Acute Inhalation Toxicity - [species] (DOC)(2 pp, 47 K) 870.1300 May 2004
Primary Eye Irritation - [species] (DOC)(3 pp, 48 K) 870.2400 May 2004
Primary Dermal Irritation - [species] (DOC)(1 pg, 30 K) 870.2500 May 2004
Dermal Sensitization - [species] (DOC)(4 pp, 87 K) 870.2600 May 2004
90-Day Oral Toxicity [dietary, gavage or drinking water] - [rodent species] (DOC)(9 pp, 179 K) 870.3100 July 2010
90-Day Oral Toxicity [dietary, gavage or drinking water] - [non-rodent species] (DOC)(8 pp, 177 K) 870.3150 July 2010
28-Day Dermal Toxicity - [species] (DOC)(9 pp, 178 K) 870.3200 July 2010
90-Day Dermal Toxicity - [species] (DOC)(9 pp, 178 K) 870.3250 July 2010
Subchronic Inhalation Toxicity - [species] (DOC)(8 pp, 179 K) 870.3465 July 2010
Prenatal Developmental Toxicity Study - [rodent species] (DOC)(8 pp, 146 K) 870.3700 July 2010
Prenatal Developmental Toxicity Study - [non-rodent species] (DOC)(8 pp, 146 K) 870.3700 July 2010
Reproduction and Fertility Effects Study - [species] (DOC)(12 pp, 243 K) 870.3800 July 2010
Chronic Toxicity [dietary, gavage, drinking water, dermal or inhalation] - [rodent species] (DOC)(9 pp, 184 K) 870.4100 July 2010
Chronic Toxicity [feeding, water, dermal or inhalation] - [non-rodent species] (DOC)(8 pp, 179 K) 870.4100 July 2010
Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 (XLSX)(1 pg, 39 K) N/A Feb 2012
Guidance and Examples for Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 (XLSX)(1 pg, 44 K) N/A Feb 2012
Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Mouse (DOC)(9 pp, 185 K) 870.4200 July 2010
Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Rat (DOC)(9 pp, 186 K) 870.4200 July 2010
Combined Chronic Toxicity/Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - [species] (DOC)(9 pp, 188 K) 870.4300 July 2010
In Vitro Microbial Gene Mutation (DOC)(4 pp, 75 K) 870.5xxx July 2010
In Vitro Mammalian Cells in Culture Gene Mutation Assay in [name cell type used] cells (DOC)(4 pp, 84 K) 870.5300 July 2010
In Vitro Mammalian Cytogenetics (specify assay) or In Vitro Sister Chromatid Exchange Assay in (name species/cell type) (DOC)(5 pp, 84 K) 870.5375
870.5900
July 2010
In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus Assay in [name species] (DOC)(4 pp, 88 K) 870.5395 July 2010
Other Genotoxicity: Unscheduled DNA Synthesis in Primary Rat Hepatocytes / Mammalian Cell Culture (DOC)(4 pp, 52 K) 870.5550 July 2010
Neurotoxicity Screening Battery - Rat (Acute) (DOC)(16 pp, 313 K) 870.6200 July 2010
Neurotoxicity Screening Battery - Rat (Subchronic) (DOC)(16 pp, 288 K) 870.6200 July 2010
Developmental Neurotoxicity Study - Rat (DOC)(29 pp, 630 K) 870.6300 July 2010
Metabolism Study - Rat (DOC)(7 pp, 134 K) 870.7485 July 2010
Dermal Penetration (DOC)(2 pp, 122 K) 870.7600 July 2010
Immunotoxicity (DOC)(10 pp, 167 K) 870.7800 July 2010

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Occupational / Residential: Series 875 - Occupational and Residential Exposure Test Guidelines

Study Profile Template Guideline
Number
Version
Use Pattern/Exposure Scenarios (DOC)(5 pp, 52 K) N/A July 2010
Residential Post Application Passive Dosimetry (DOC)(13 pp, 320 K) 875.xxxx July 2010
Mixer/Loader/Applicator Passive Dosimetry (DOC)(4 pp, 380 K) 875.1000 July 2010
Agricultural Post Application Passive Dosimetry (DOC)(14 pp, 334 K) 875.2000 July 2010
Dislodgeable Turf Residues (DOC)(9 pp, 101 K) 875.2100 July 2010
Dislodgeable Foliar Residue (DOC)(9 pp, 100 K) 875.2100 July 2010
Determination of Transferable Residue on Indoor Treated Surfaces (DOC)(13 pp, 145 K) 875.2300 July 2010
Hand Press Residues (DOC)(9 pp, 108 K) 875.2300 July 2010

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Endocrine: Series 890 - Endocrine Disruptor Screening Program Test Guidelines

Study Profile Template Guideline
Number
Version
Amphibian Metamorphosis (DOC)(25 pp, 450 K)
Amphibian Metamorphosis (PDF)
890.1100 September 2011
Androgen Receptor Binding (Rat Prostate) (DOC)(25 pp, 383 K)
Androgen Receptor Binding (Rat Prostate) (PDF)
890.1150 October 2011
Aromatase (Human Recombinant) (DOC)(12 pp, 296 K)
Aromatase (Human Recombinant) (PDF)
890.1200 July 2011
Estrogen Receptor Binding (DOC)(15 pp, 345 K)
Estrogen Receptor Binding (PDF)
890.1250 October 2011
Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903) (DOCX)(10 pp, 63 K)
Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903) (PDF)
890.1300 August 2011
Fish Short-Term Reproduction (DOCX)(31 pp, 159 K)
Fish Short-Term Reproduction (PDF)
890.1350 October 2011
Hershberger (Rat) (DOC)(13 pp, 244 K)
Hershberger (Rat) (PDF)
890.1400 October 2011
Female Pubertal (Rat) (DOC)(12 pp, 257 K)
Female Pubertal (Rat) (PDF)
890.1450 August 2011
Male Pubertal (Rat) (DOC)(12 pp, 274 K)
Male Pubertal (Rat) (PDF)
890.1500 August 2011
Steroidogenesis (Human Cell Line – H295R) (DOC)(9 pp, 211 K)
Steroidogenesis (Human Cell Line – H295R) (PDF)
890.1550 July 2011
Uterotrophic (Rat) (DOCX)(13 pp, 74 K)
Uterotrophic (Rat) (PDF)
890.1600 September 2011

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More Information and Additional Resources

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