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Study Profile Templates
Current as of October 2011
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 in such a way that the format and content of the template is not affected or changed.
Registrants are encouraged to submit completed study profile(s) and supporting data in electronic format in Microsoft Word whether the submission is for one or more studies. See electronic data submissions for additional information.
On this page:
- 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
Product Chemistry: Series 830
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Product Chemistry for Technical Grade of the Active Ingredient or Manufacturing Use Products (Group A and B data) | N/A | (7 pp, 148k, Word) | May 2004 |
| Product Chemistry for End Use Products | N/A | (6 pp, 110k, Word) | May 2004 |
Environmental Fate: Series 835
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Adsorption-Desorption of {Test Material} in Soil | 835.1230 | (12 pp, 427k, Word) | May 2004 |
| Hydrolysis of {Test Material} | 835.2120 | (9 pp, 388k, Word) | May 2004 |
| Phototransformation of {Test Material} in Water | 835.2240 | (11 pp, 188k, Word) | May 2004 |
| Phototransformation of {Test Material} on Soil | 835.2410 | (15 pp, 237k, Word) | May 2004 |
| Aerobic Biotransformation of {Test Material} in Soil | 835.4100 | (14 pp, 229k, Word) | May 2004 |
| Aerobic Biotransformation of {TGAI or EUP} in Water-Sediment System | 835.4300 | (11 pp, 228k, Word) | May 2004 |
| Anaerobic Biotransformation of {Test Material} in Water/Sediment System | 835.4400 | (11 pp, 229k, Word) | May 2004 |
| Terrestrial Field Dissipation of {Test Material} | 835.6100 | (20 pp, 452k, Word) | May 2004 |
Environmental Effects: Series 850
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Acute Toxicity Effects of {TAI or EUP} on Earthworms | N/A | (9 pp, 155k, Word) | May 2004 |
| Acute Toxicity of {TAI or EUP} to Freshwater Invertebrates - [Daphnia sp.] | 850.1010 | (9 pp, 175k, Word) | May 2004 |
| Acute Toxicity of {TAI or EUP} to Fish - [name of species] | 850.1075 | (10 pp, 192k, Word) | May 2004 |
| Chronic Toxicity of {TAI or EUP} to Fresh Water Invertebrates - [Daphnia sp.] | 850.1300 | (11 pp, 138k, Word) | May 2004 |
| Toxicity of {TAI or EUP} to Fish Early Life-Stage | 850.1400 | (10 pp, 170k, Word) | May 2004 |
| Acute Oral Toxicity of {TAI or EUP} to Avian Species - [name of species] | 850.2100 | (8 pp, 141k, Word) | May 2004 |
| Acute Dietary Toxicity of {TAI or EUP} to Avian Species - [name of species] | 850.2200 | (10 pp, 150k, Word) | May 2004 |
| Reproductive Effects of {TAI or EUP} on Avian Species - [name of species] | 850.2300 | (10 pp, 194k, Word) | May 2004 |
| Acute Toxicity of {TAI or EUP} to Terrestrial Vascular Plant - [name of species - seed germination-root elongation/seedling emergence/vegetative vigour] | 850.4100 850.4150 |
(21 pp, 384k, Word) | May 2004 |
| Acute Toxicity of {TAI or EUP} to Aquatic Vascular Plants - [name of species] | 850.4400 | (11 pp, 159k, Word) | May 2004 |
| Acute Toxicity of {TAI or EUP} to Algae - [name of species] | 850.5400 | (12 pp, 320k, Word) | May 2004 |
Chemistry: Series 860 - Residue Chemistry Test Guidelines
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Study Profile Guidance | N/A | (5 pp, 45k, Word) | July 2010 |
| Nature of the Residue in Plants | 860.1300 | (7 pp, 127k, Word) | July 2010 |
| Nature of the Residue in Livestock | 860.1300 | (8 pp, 140k, Word) | July 2010 |
| Residue Analytical Method | 860.1340 | (6 pp, 110k, Word) | July 2010 |
| Storage Stability | 860.1380 | (5 pp, 60k, Word) | July 2010 |
| Water Fish and Irrigated Crops | 860.1400 | (12 pp, 215k, Word) | July 2010 |
| Food Handling | 860.1460 | (8 pp, 74k, Word) | July 2010 |
| Livestock Feeding Study | 860.1480 | (5 pp, 99k, Word) | July 2010 |
| Crop Field Trials | 860.1500 | (7 pp, 122k, Word) | July 2010 |
| Processed Food and Feed | 860.1520 | (5 pp, 72k, Word) | July 2010 |
| Confined Rotational Crops | 860.1850 | (9 pp, 137k, Word) | July 2010 |
| Multiresidue Method | 860.1860 | (3 pp, 50k, Word) | July 2010 |
| Field Rotational Crops | 860.1900 | (6 pp, 83k, Word) | July 2010 |
Toxicology: Series 870 - Health Effects Test Guidelines
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Acute Oral Toxicity - [species] | 870.1100 | (2 pp, 39k, Word) | May 2004 |
| Acute Dermal Toxicity - [species] | 870.1200 | (2 pp, 40k, Word) | May 2004 |
| Acute Inhalation Toxicity - [species] | 870.1300 | (2 pp, 46k, Word) | May 2004 |
| Primary Eye Irritation - [species] | 870.2400 | (3 pp, 47k, Word) | May 2004 |
| Primary Dermal Irritation - [species] | 870.2500 | (1 pp, 29k, Word) | May 2004 |
| Dermal Sensitization - [species] | 870.2600 | (4 pp, 85k, Word) | May 2004 |
| 90-Day Oral Toxicity [dietary, gavage or drinking water] - [rodent species] | 870.3100 | (9 pp, 175k, Word) | July 2010 |
| 90-Day Oral Toxicity [dietary, gavage or drinking water] - [non-rodent species] | 870.3150 | (8 pp, 173k, Word) | July 2010 |
| 28-Day Dermal Toxicity - [species] | 870.3200 | (9 pp, 174k, Word) | July 2010 |
| 90-Day Dermal Toxicity - [species] | 870.3250 | (9 pp, 174k, Word) | July 2010 |
| Subchronic Inhalation Toxicity - [species] | 870.3465 | (8 pp, 175k, Word) | July 2010 |
| Prenatal Developmental Toxicity Study - [rodent species] | 870.3700 | (8 pp, 143k, Word) | July 2010 |
| Prenatal Developmental Toxicity Study - [non-rodent species] | 870.3700 | (8 pp, 143k, Word) | July 2010 |
| Reproduction and Fertility Effects Study - [species] | 870.3800 | (12 pp, 238k, Word) | July 2010 |
| Chronic Toxicity [dietary, gavage, drinking water, dermal or inhalation] - [rodent species] | 870.4100 | (9 pp, 180k, Word) | July 2010 |
| Chronic Toxicity [feeding, water, dermal or inhalation] - [non-rodent species] | 870.4100 | (8 pp, 175k, Word) | July 2010 |
| Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 | N/A | (1 pp, 38k, Excel File) | Feb 2012 |
| Guidance and Examples for Supplementary Tumor Data Spreadsheet for Toxicology 870.4200 and 870.4300 | N/A | (1 pp, 43k, Excel File) | Feb 2012 |
| Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Mouse | 870.4200 | (9 pp, 181k, Word) | July 2010 |
| Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - Rat | 870.4200 | (9 pp, 182k, Word) | July 2010 |
| Combined Chronic Toxicity/Carcinogenicity [dietary, gavage, drinking water, dermal or inhalation] - [species] | 870.4300 | (9 pp, 184k, Word) | July 2010 |
| In Vitro Microbial Gene Mutation | 870.5xxx | (4 pp, 73k, Word) | July 2010 |
| In Vitro Mammalian Cells in Culture Gene Mutation Assay in [name cell type used] cells | 870.5300 | (4 pp, 83k, Word) | July 2010 |
| In Vitro Mammalian Cytogenetics (specify assay) or In Vitro Sister Chromatid Exchange Assay in (name species/cell type) |
870.5375 870.5900 |
(5 pp, 82k, Word) | July 2010 |
| In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus Assay in [name species] | 870.5395 | (4 pp, 86k, Word) | July 2010 |
| Other Genotoxicity: Unscheduled DNA Synthesis in Primary Rat Hepatocytes / Mammalian Cell Culture | 870.5550 | (4 pp, 51k, Word) | July 2010 |
| Neurotoxicity Screening Battery - Rat (Acute) | 870.6200 | (16 pp, 306k, Word) | July 2010 |
| Neurotoxicity Screening Battery - Rat (Subchronic) | 870.6200 | (16 pp, 281k, Word) | July 2010 |
| Developmental Neurotoxicity Study - Rat | 870.6300 | (29 pp, 615k, Word) | July 2010 |
| Metabolism Study - Rat | 870.7485 | (7 pp, 131k, Word) | July 2010 |
| Dermal Penetration | 870.7600 | (2 pp, 119k, Word) | July 2010 |
| Immunotoxicity | 870.7800 | (10 pp, 164k, Word) | July 2010 |
Occupational / Residential: Series 875 - Occupational and Residential Exposure Test Guidelines
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Use Pattern/Exposure Scenarios | N/A | (5 pp, 51k, Word) | July 2010 |
| Residential Post Application Passive Dosimetry | 875.xxxx | (13 pp, 313k, Word) | July 2010 |
| Mixer/Loader/Applicator Passive Dosimetry | 875.1000 | (4 pp, 372k, Word) | July 2010 |
| Agricultural Post Application Passive Dosimetry | 875.2000 | (14 pp, 327k, Word) | July 2010 |
| Dislodgeable Turf Residues | 875.2100 | (9 pp, 99k, Word) | July 2010 |
| Dislodgeable Foliar Residue | 875.2100 | (9 pp, 98k, Word) | July 2010 |
| Determination of Transferable Residue on Indoor Treated Surfaces | 875.2300 | (13 pp, 142k, Word) | July 2010 |
| Hand Press Residues | 875.2300 | (9 pp, 106k, Word) | July 2010 |
Endocrine: Series 890 - Endocrine Disruptor Screening Program Test Guidelines
| Study Profile Template | Guideline Number |
Available Formats |
Version |
|---|---|---|---|
| Amphibian Metamorphosis | 890.1100 | (25 pp, 247k, PDF) (25 pp, 439k, Word) |
September 2011 |
| Androgen Receptor Binding (Rat Prostate) | 890.1150 | (14 pp, 255k, PDF) (14 pp, 374k, Word) |
October 2011 |
| Aromatase (Human Recombinant) | 890.1200 | (12 pp, 178k, PDF) (12 pp, 296k, Word) |
July 2011 |
| Estrogen Receptor Binding | 890.1250 | (15 pp, 255k, PDF) (15 pp, 337k, Word) |
October 2011 |
| Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903) | 890.1300 | (10 pp, 156k, PDF) (10 pp, 62k, Word) |
August 2011 |
| Fish Short-Term Reproduction | 890.1350 | (31 pp, 483k, PDF) (31 pp, 155k, Word) |
October 2011 |
| Hershberger (Rat) | 890.1400 | (13 pp, 236k, PDF) (13 pp, 238k, Word) |
October 2011 |
| Female Pubertal (Rat) | 890.1450 | (12 pp, 170k, PDF) (12 pp, 251k, Word) |
August 2011 |
| Male Pubertal (Rat) | 890.1500 | (12 pp, 171k, PDF) (12 pp, 268k, Word) |
August 2011 |
| Steroidogenesis (Human Cell Line – H295R) | 890.1550 | (9 pp, 121k, PDF) (9 pp, 204k, Word) |
July 2011 |
| Uterotrophic (Rat) | 890.1600 | (13 pp, 190k, PDF) (13 pp, 73k, Word) |
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)