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.

• Product Chemistry: Series 830
• Environmental Fate: Series 835
• Environmental Effects: Series 850
• Chemistry: Series 860 - Residue Chemistry Test Guidelines
• Toxicology: Series 870 - Health Effects Test Guidelines
• Occupational / Residential: Series 875 - Occupational and Residential Exposure Test Guidelines
• Endocrine: Series 890 - Endocrine Disruptor Screening Program Test Guidelines
• More Information and Additional Resources

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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) (docx) (45.64 KB)	N/A	May 2016
Product Chemistry for End Use Products (docx) (41.73 KB)	N/A	May 2016

Environmental Fate: Series 835

Study Profile Template	Guideline Number	Version
Adsorption and desorption of test compound in soils or sediments (docx) (85.1 KB)	835.1230	May 2012
Laboratory Volatility of [test compound] (docx) (91.46 KB)	835.1410	December 2012
Hydrolysis of [test compound] at pH [4,7, and 9, or other values studied] (docx) (94.19 KB)	835.2120	May 2012
Aqueous Photolysis of [test compound] (docx) (104.36 KB)	835.2240	May 2012
Soil Photolysis of [test compound] (docx) (112.16 KB)	835.2410	May 2012
Aerobic (or Anaerobic) Degradation in Soil of [test compound] (docx) (131.4 KB)	835.4100 835.4200	May 2012
Aerobic (or Anaerobic) Degradation in Aquatic Systems (docx) (133.61 KB)	835.4300 835.4400	May 2012
Field Dissipation of [test compound] (docx) (971.71 KB)	835.6100 835.6200	May 2012
Prospective Ground Water Monitoring of [test compound] (docx) (121.36 KB)	835.7100	December 2012
Field volatility of [test compound] (docx) (7.01 MB)	835.8100	December 2012
Sample storage stability of [test compound(s)] in [frozen soil, water, etc.] (docx) (87.05 KB)	N/A	December 2012

Environmental Effects: Series 850

Study Profile Template	Guideline Number	Version
Acute Toxicity Effects of {TAI or EUP} on Earthworms (doc) (155.5 KB)	N/A	May 2004
Acute Toxicity of {TAI or EUP} to Freshwater Invertebrates - [Daphnia sp.] (doc) (175.13 KB)	850.1010	May 2004
Acute Toxicity of {TAI or EUP} to Fish - [name of species] (doc) (192 KB)	850.1075	May 2004
Chronic Toxicity of {TAI or EUP} to Fresh Water Invertebrates - [Daphnia sp.] (doc) (138.5 KB)	850.1300	May 2004
Toxicity of {TAI or EUP} to Fish Early Life-Stage (doc) (170.5 KB)	850.1400	May 2004
[Fish or Oyster] Bioconcentration Factor (BCF) of [Test Compound] (docx) (209.75 KB)	850.1710 850.1730	December 2012
Acute Oral Toxicity of {TAI or EUP} to Avian Species - [name of species] (doc) (141 KB)	850.2100	May 2004
Acute Dietary Toxicity of {TAI or EUP} to Avian Species - [name of species] (doc) (150 KB)	850.2200	May 2004
Reproductive Effects of {TAI or EUP} on Avian Species - [name of species] (doc) (194 KB)	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) (384 KB)	850.4100 850.4150	May 2004
Acute Toxicity of {TAI or EUP} to Aquatic Vascular Plants - [name of species] (doc) (159.5 KB)	850.4400	May 2004
Acute Toxicity of {TAI or EUP} to Algae - [name of species] (doc) (320 KB)	850.5400	May 2004
Analytical method for [analyte(s)] in [soil, water, air, or other environmental medium] (docx) (61.13 KB)	850.6100	December 2012

Chemistry: Series 860 - Residue Chemistry DER Templates

Study Profile Template	Guideline Number	Version
B.7 Residue Data (docx) (31.01 KB)	N/A	February 2016
B.7.1 Plant Metabolism (docx) (41.21 KB)	860.1300	February 2016
B.7.2 Livestock Metabolism (docx) (61 KB)	860.1300	February 2016
B.5.2 Residue Analytical Methods (docx) (75.8 KB)	860.1340	February 2016
B.7.6.2 Freezer Storage Stability in Plants (docx) (35.82 KB)	860.1380	February 2016
B.7.8.3 Freezer Storage Stability in Livestock (docx) (34.47 KB)	860.1380	February 2016
B.7.8 Livestock Feeding (docx) (43.73 KB)	860.1480	February 2016
B.7.6 Crop Residue Trials (docx) (55.93 KB)	860.1500	February 2016
B.7.7 Processing (docx) (33.75 KB)	860.1520	February 2016
B.7.9 Confined Crop Rotation (docx) (39.71 KB)	860.1850	February 2016
B.7.9.2 Field Accumulation (docx) (40.03 KB)	860.1900	February 2016

Toxicology: Series 870 - Health Effects Test Guidelines

Study Profile Template	Guideline Number	Version
Acute Oral Toxicity - [species] (doc) (167.5 KB)	870.1100	May 2004
Acute Dermal Toxicity - [species] (doc) (39.5 KB)	870.1200	May 2004
Acute Inhalation Toxicity - [species] (doc) (45.5 KB)	870.1300	May 2004
Primary Eye Irritation - [species] (doc) (47 KB)	870.2400	May 2004
Primary Dermal Irritation - [species] (doc) (29 KB)	870.2500	May 2004
Dermal Sensitization - [species] (doc) (84.5 KB)	870.2600	May 2004
90-Day Oral Toxicity [dietary, gavage or drinking water] - [rodent species] (doc) (175 KB)	870.3100	July 2010
90-Day Oral Toxicity [dietary, gavage or drinking water] - [non-rodent species] (doc) (173 KB)	870.3150	July 2010
28-Day Dermal Toxicity - [species] (doc) (174 KB)	870.3200	July 2010
90-Day Dermal Toxicity - [species] (doc) (173.5 KB)	870.3250	July 2010
Subchronic Inhalation Toxicity - [species] (doc) (174.5 KB)	870.3465	July 2010
Prenatal Developmental Toxicity Study - [rodent species] (doc) (143 KB)	870.3700	July 2010
Prenatal Developmental Toxicity Study - [non-rodent species] (doc) (142.5 KB)	870.3700	July 2010
Reproduction and Fertility Effects Study - [species] (doc) (237.5 KB)	870.3800	July 2010
Chronic Toxicity [dietary, gavage, drinking water, dermal or inhalation] - [rodent species] (doc) (180 KB)	870.4100	July 2010
Chronic Toxicity [feeding, water, dermal or inhalation] - [non-rodent species] (doc) (175 KB)	870.4100	July 2010
Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 (xlsx) (38.28 KB)	N/A	Feb 2012
Guidance and Examples for Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 (xlsx) (43.2 KB)	N/A	Feb 2012
Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Mouse (doc) (181 KB)	870.4200	July 2010
Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Rat (doc) (182 KB)	870.4200	July 2010
Combined Chronic Toxicity/Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - [species] (doc) (183.5 KB)	870.4300	July 2010
In Vitro Microbial Gene Mutation (doc) (73 KB)	870.5xxx	July 2010
In Vitro Mammalian Cells in Culture Gene Mutation Assay in [name cell type used] cells (doc) (82.5 KB)	870.5300	July 2010
In Vitro Mammalian Cytogenetics (specify assay) or In Vitro Sister Chromatid Exchange Assay in (name species/cell type) (doc) (82 KB)	870.5375 870.5900	July 2010
In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus Assay in [name species] (doc) (85.5 KB)	870.5395	July 2010
Other Genotoxicity: Unscheduled DNA Synthesis in Primary Rat Hepatocytes / Mammalian Cell Culture (doc) (51 KB)	870.5550	July 2010
Neurotoxicity Screening Battery - Rat (Acute) (doc) (305.5 KB)	870.6200	July 2010
Neurotoxicity Screening Battery - Rat (Subchronic) (doc) (281 KB)	870.6200	July 2010
Developmental Neurotoxicity Study - Rat (doc) (615 KB)	870.6300	July 2010
Metabolism Study - Rat (doc) (131 KB)	870.7485	July 2010
Dermal Penetration (doc) (119 KB)	870.7600	July 2010
Immunotoxicity (doc) (163.5 KB)	870.7800	July 2010

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

Study Profile Template	Guideline Number	Version
Use Pattern/Exposure Scenarios (doc) (50.5 KB)	N/A	July 2010
Residential Post Application Passive Dosimetry (doc) (312.5 KB)	875.xxxx	July 2010
Mixer/Loader/Applicator Passive Dosimetry (doc) (371.5 KB)	875.1000	July 2010
Agricultural Post Application Passive Dosimetry (doc) (326.5 KB)	875.2000	July 2010
Dislodgeable Turf Residues (doc) (98.5 KB)	875.2100	July 2010
Dislodgeable Foliar Residue (doc) (97.5 KB)	875.2100	July 2010
Determination of Transferable Residue on Indoor Treated Surfaces (doc) (141.5 KB)	875.2300	July 2010
Hand Press Residues (doc) (105.5 KB)	875.2300	July 2010

Endocrine: Series 890 - Endocrine Disruptor Screening Program Test Guidelines

Study Profile Template	Guideline Number	Version
Amphibian Metamorphosis (doc) (439 KB) Amphibian Metamorphosis (PDF)	890.1100	September 2011
Androgen Receptor Binding (Rat Prostate) (doc) (374.5 KB) Androgen Receptor Binding (Rat Prostate) (PDF)	890.1150	October 2011
Aromatase (Human Recombinant) (doc) (289.5 KB) Aromatase (Human Recombinant) (PDF)	890.1200	July 2011
Estrogen Receptor Binding (doc) (337 KB) Estrogen Receptor Binding (PDF)	890.1250	October 2011
Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903) (docx) (61.75 KB) Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903) (PDF)	890.1300	August 2011
Fish Short-Term Reproduction (docx) (155.61 KB) Fish Short-Term Reproduction (PDF)	890.1350	October 2011
Hershberger (Rat) (doc) (238 KB) Hershberger (Rat) (PDF)	890.1400	October 2011
Female Pubertal (Rat) (doc) (250.5 KB) Female Pubertal (Rat) (PDF)	890.1450	August 2011
Male Pubertal (Rat) (doc) (267.5 KB) Male Pubertal (Rat) (PDF)	890.1500	August 2011
Steroidogenesis (Human Cell Line – H295R) (doc) (206 KB) Steroidogenesis (Human Cell Line – H295R) (PDF)	890.1550	July 2011
Uterotrophic (Rat) (docx) (72.51 KB) Uterotrophic (Rat) (PDF)	890.1600	September 2011

More Information and Additional Resources

• OCSPP Harmonized Test Guidelines
• Pesticides Science and Policy Information - policy and guidance documents, test guidelines, models and databases, and analytical methods.
• Endocrine Disruptor Screening Program (EDSP)