Data Requirements for Use Site Category (USC # 14): Terrestrial Food Crops - TGAI
| Data Code | Title | Data required | Conditions | Volume No and Pages |
|---|---|---|---|---|
| 0 | Index | R | ||
| 1 | Label | R | ||
| 2 | Chemistry requirements for the registration of a technical grade of active ingredient (TGAI) or an integrated system product. | |||
| 2.1 | Applicant's Name and Office Address | R | ||
| 2.2 | Manufacturer's Name and Office Address and Manufacturing Plant's Name and Address | R | ||
| 2.3 | Product Trade Name | R | ||
| 2.3.1 | Other Names | R | ||
| 2.4 | Common Name | R | ||
| 2.5 | Chemical Name | R | ||
| 2.6 | Chemical Abstracts Registry Number | R | ||
| 2.7 | Structural Formula | R | ||
| 2.8 | Molecular Formula | R | ||
| 2.9 | Molecular Weight | R | ||
| 2.11 | Manufacturing Methods for the TGAI | |||
| 2.11.1 | Manufacturing Summary | R | ||
| 2.11.2 | Description of Starting Materials | R | ||
| 2.11.3 | Detailed Production Process Description | R | ||
| 2.11.4 | Discussion of Formation of Impurities | R | ||
| 2.12 | Specifications | |||
| 2.12.1 | Establishing Certified Limits | R | ||
| 2.12.2 | Control Product Specification Form | R | ||
| 2.13 | Preliminary Analysis | |||
| 2.13.1 | Methodology/Validation | R | ||
| 2.13.2 | Confirmation of Identity | R | ||
| 2.13.3 | Batch Data | R | ||
| 2.13.4 | Impurities of Toxicological Concern | CR | If applicable | |
| 2.14 | Chemical and Physical Properties | |||
| 2.14.1 | Colour | R | ||
| 2.14.2 | Physical State | R | ||
| 2.14.3 | Odour | R | ||
| 2.14.4 | Melting Point / Melting Range | R | Solid at room temperature | |
| 2.14.5 | Boiling Point / Boiling Range | R | Liquid at room temperature | |
| 2.14.6 | Density or Specific Gravity | R | ||
| 2.14.7 | Water Solubility (mg/L) | R | ||
| 2.14.8 | Solvent Solubility (mg/L) | R | ||
| 2.14.9 | Vapour Pressure | R | ||
| 2.14.10 | Dissociation Constant | R | ||
| 2.14.11 | Octanol/Water Partition Coefficient | R | ||
| 2.14.12 | UV/Visible Absorption Spectra | R | ||
| 2.14.13 | Stability (Temperature, Metals) | R | ||
| 2.14.14 | Storage Stability Data | R | ||
| 2.15 | Sample(s) of Analytical Standards and ROC | R | ||
| 2.16 | Other Studies/Data/Reports | CR | If available | |
| 4 | Toxicology | |||
| 4.1 | Summaries | R | ||
| 4.2 | Acute Studies - TGAI | |||
| 4.2.1 | Acute Oral | R | ||
| 4.2.2 | Acute Dermal | R | ||
| 4.2.3 | Acute Inhalation | R | ||
| 4.2.4 | Primary Eye Irritation | R | ||
| 4.2.5 | Primary Dermal Irritation | R | ||
| 4.2.6 | Dermal Sensitization | R | ||
| 4.2.7 | Potentiation/Interaction | CR | If available | |
| 4.2.8 | Antidote | CR | If available | |
| 4.2.9 | Other Acute Studies | CR | If available | |
| 4.3 | Short-term Studies - TGAI | |||
| 4.3.1 | Short-term Oral (90-day rodent) | R | ||
| 4.3.2 | Short-term Oral (90-day and/or 12-month dog) | R | ||
| 4.3.3 | Short-term Oral (28-day) | CR | If available | |
| 4.3.4 | Short-term Dermal (90-day) | CR | If available | |
| 4.3.5 | Short-term Dermal (21/28-day) | R | ||
| 4.3.6 | Short-term Inhalation (90-day) | CR | Required if there is the likelihood of significant repeated inhalation exposure to the product as a gas, vapor or aerosol | |
| 4.3.7 | Short-term Inhalation (21/28-day) | CR | If available | |
| 4.3.8 | Other Short-term Studies | CR | If available | |
| 4.4 | Long-term Studies - TGAI | |||
| 4.4.1 | Chronic (rodent) | R | 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4 | |
| 4.4.2 | Oncogenicity (rodent species 1) | R | 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4 | |
| 4.4.3 | Oncogenicity (rodent species 2) | R | ||
| 4.4.4 | Combined Chronic/Oncogenicity (rodent) | CR | 4.4.1 and 4.4.2 could be submitted as a combined study under 4.4.4 | |
| 4.4.5 | Other Long-term Studies | CR | If available | |
| 4.5 | Special Studies - TGAI | |||
| 4.5.1 | Multigeneration Reproduction (rodent) | R | ||
| 4.5.2 | Prenatal Developmental Toxicity (rodent) | R | ||
| 4.5.3 | Prenatal Developmental Toxicity (non-rodent) | R | ||
| 4.5.4 | Genotoxicity: Bacterial Reverse Mutation Assay | R | ||
| 4.5.5 | Genotoxicity: In vitro Mammalian Cell Assay | R | ||
| 4.5.6 | Genotoxicity: In vitro Mammalian Clastogenicity | CR | Required if not addressed in study submitted for 4.5.5 | |
| 4.5.7 | Genotoxicity: In vivo Cytogenetics | R | ||
| 4.5.8 | Other Genotoxicity Studies | CR | If available | |
| 4.5.9 | Metabolism/Toxicokinetics in Mammals (laboratory animals) | R | ||
| 4.5.10 | Acute Delayed Neurotoxicity (hen) | CR | Required if the test substance is an organophosphorus substance or is structurally related to other substances that may cause delayed neurotoxicity | |
| 4.5.11 | 28-day Delayed Neurotoxicity (hen) | CR | Required if results of acute delayed neurotoxicity study indicates effects, or if other available data indicate the potential for this type of delayed neurotoxicity | |
| 4.5.12 | Acute Neurotoxicity (rat) | CR | Required if there is neurotoxic potential | |
| 4.5.13 | 90-day Neurotoxicity (rat) | CR | Required if there is neurotoxic potential | |
| 4.5.14 | Developmental Neurotoxicity | CR | Required if neurological effects are observed in other studies Should be considered if test substance: i) causes neuropathology or neurotoxicity in adults; ii) is hormonally active in vivo; or iii) causes other types of nervous system involvement at a developmental stage |
|
| 4.8 | Other Studies/Data/Reports | CR | If available | |
| 6 | Metabolism/Toxicokinetics Studies (TGAI or EP) | |||
| 6.1 | Summaries | R | ||
| 6.2 | Livestock | CR | Depends on end use of crop and byproducts | |
| 6.3 | Plants | R | ||
| 6.4 | Other Studies/Data/Reports | CR | If available | |
| 8 | Environmental Chemistry and Fate | |||
| 8.1 | Summaries | R | ||
| 8.2 | Laboratory Studies | |||
| 8.2.1 | Summary of Physicochemical Properties to include, Solubility in Water, Vapour Pressure, Octanol:Water Partition Coefficient, Dissociation Constant and UVVisible Absorption (See Part 2) (TGAI) | R | Data submitted under 2.14.7; 2.14.9; 2.14.10; 2.14.11; and 2.14.12 | |
| 8.2.2 | Analytical Methodology (parent compound and transformation products) | |||
| 8.2.2.1 | Soil | R | ||
| 8.2.2.2 | Sediment | R | Can be satisfied by analytical methodology for soil (8.2.2.1) | |
| 8.2.2.3 | Water | R | ||
| 8.2.2.4 | Biota | R | Required for both plant and animal (preferably fish) matrices | |
| 8.2.3 | Laboratory Studies of Transformation | |||
| 8.2.3.1 | Summary | R | ||
| 8.2.3.2 | Hydrolysis | R | ||
| 8.2.3.3 | Phototransformation | |||
| 8.2.3.3.1 | Soil | R | Not required if application is only by soil injection or soil incorporation | |
| 8.2.3.3.2 | Water | R | ||
| 8.2.3.3.3 | Air | CR | If volatilization is indicated by vapour pressure or Henry's Law Constant | |
| 8.2.3.4 | Biotransformation in Soil | |||
| 8.2.3.4.2 | Aerobic Soil 20°-30°C | R | ||
| 8.2.3.4.4 | Anaerobic Soil (Flooded) 20°-30°C | R | ||
| 8.2.3.5 | Biotransformation in Aquatic Systems | |||
| 8.2.3.5.4 | Aerobic Water/Sediment 20°-30°C | R | ||
| 8.2.3.5.6 | Anaerobic Sediment/Water 20°-30°C | R | ||
| 8.2.4 | Laboratory Studies of Mobility | |||
| 8.2.4.1 | Summary | R | ||
| 8.2.4.2 | Adsorption/Desorption | R | Adsorption and desorption (8.2.4.2) is preferred, however in some cases, soil column leaching (8.2.4.3) with unaged or aged columns may be necessary to fully characterize the potential mobility of the parent compound and major transformation products | |
| 8.2.4.3 | Soil Column Leaching | |||
| 8.2.4.5 | Volatilization | CR | If volatilization is indicated by vapour pressure or Henry's Law Constant; studies conducted with a typical EP are acceptable and should be submitted under 8.2.4.6 | |
| 8.4 | Storage, Disposal and Decontamination (TGAI and EP) | |||
| 8.4.1 | Summary | R | ||
| 8.5 | Other Environmental Fate Studies (TGAI and EP) | |||
| 8.5.1 | Summary | CR | Based on concerns arising from the results of other studies | |
| 8.6 | Other Studies/Data/Reports | CR | If available | |
| 9 | Environmental Toxicology | |||
| 9.1 | Summary | R | ||
| 9.2 | Non-Target Terrestrial Invertebrates | |||
| 9.2.1 | Summaries | R | ||
| 9.2.3 | Earthworms | |||
| 9.2.3.1 | Acute Toxicity | R | ||
| 9.2.4 | Bees/Pollinators | |||
| 9.2.4.1 | Acute Contact | CR | If there is a potential for exposure | |
| 9.2.4.2 | Acute Oral | CR | See 9.2.4.1 | |
| 9.2.4.3 | Hive Study (including Brood) | CR | If there is a potential for exposure, especially for Insect Growth Regulators (IGRs) | |
| 9.2.5 | Predators | CR | If there is a potential for exposure | |
| 9.2.6 | Parasites | CR | See 9.2.5 | |
| 9.2.7 | Other Terrestrial Invertebrates | CR | See 9.2.5 | |
| 9.3 | Non-Target Freshwater Invertebrates | |||
| 9.3.1 | Summary | R | ||
| 9.3.2 | Daphnia sp. Acute | R | ||
| 9.3.3 | Daphnia sp. Chronic (Life-Cycle) | CR | Most sensitive (i.e., one of) daphnid (9.3.3); marine crustacean or estuarine/marine mollusk (9.4.5); or fish (9.5.3.1), where there is concern based on acute effects, persistence, potential for exposure or frequency of application | |
| 9.3.4 | Laboratory Studies with Other Species | CR | If there is a potential for exposure | |
| 9.4 | Non-Target Marine Invertebrates | |||
| 9.4.1 | Summary | CR | If there is a potential for estuarine/marine exposure | |
| 9.4.2 | Acute (Crustacean) | CR | See 9.4.1 | |
| 9.4.3 | Mollusk Embryo Larvae | CR | One of 9.4.3 or 9.4 .4 is required, if there is a potential for estuarine/marine exposure | |
| 9.4.4 | Mollusk Shell Deposition | CR | See 9.4.3 | |
| 9.4.5 | Chronic (Mollusk or Crustacean) | CR | Most sensitive (i.e., one of) daphnid (9.3.3); marine crustacean or estuarine/marine mollusk (9.4.5); or fish (9.5.3.1), where there is concern based on acute effects, persistence, potential for exposure or frequency of application | |
| 9.4.8 | Bioconcentration/Depuration (Bivalve or Crustacean) | CR | If there is a potential for exposure and log Kow is greater than or equal to 3 | |
| 9.5 | Fish | |||
| 9.5.1 | Summaries | R | ||
| 9.5.2 | Acute Studies | |||
| 9.5.2.1 | Cold Water Fish (Rainbow Trout) | R | ||
| 9.5.2.2 | Warm Water Fish (Bluegill Sunfish) | R | ||
| 9.5.2.3 | Other Freshwater Fish Species | CR | If there is a potential for exposure | |
| 9.5.2.4 | Marine/Estuarine Fish | CR | If there is a potential for estuarine/marine exposure | |
| 9.5.2.4.1 | Salinity Challenge | CR | For estuarine fish; to follow 9.5.2.4 (if there is a potential for exposure) | |
| 9.5.3 | Sublethal and Chronic Studies | |||
| 9.5.3.1 | Fish, Early Life Cycle Toxicity Test | CR | Most sensitive (i.e., one of) daphnid (9.3.3); marine crustacean or estuarine/marine mollusk (9.4.5); or fish (9.5.3.1), where there is concern based on acute effects, persistence, potential for exposure or frequency of application | |
| 9.5.3.2 | Fish, Life Cycle Toxicity Test | CR | Where there is concern based on acute effects, persistence, potential for exposure or frequency of application | |
| 9.5.6 | Bioaccumulation | CR | If log Kow is greater than or equal to 3 | |
| 9.6 | Wild Birds | |||
| 9.6.1 | Summary | R | For granular formulations, the summary should include: (a) granule size (mm) distribution by weight; (b) number granules/kg product; (c) g ai/kg product; (d) kg product/ha; and (e) type of carrier (e.g., type of clay, corn cob, cellulose, etc.) | |
| 9.6.2 | Acute Studies | |||
| 9.6.2.1 | Oral (LD50) Bobwhite Quail | CR | One of 9.6.2.1 or 9.6.2.2 is required (R) | |
| 9.6.2.2 | Oral (LD50) Mallard Duck | CR | See 9.6.2.1 | |
| 9.6.2.3 | Oral (LD50) Other Species | CR | If avian acute oral toxicity is of concern and there is a potential for exposure | |
| 9.6.2.4 | Dietary (LC50) Bobwhite Quail | R | ||
| 9.6.2.5 | Dietary (LC50) Mallard Duck | R | ||
| 9.6.2.6 | Dietary (LC50) Other Species | CR | If avian acute dietary toxicity is of concern and there is a potential for exposure | |
| 9.6.3 | Chronic Studies | |||
| 9.6.3.1 | Avian Reproduction Bobwhite Quail | R | ||
| 9.6.3.2 | Avian Reproduction Mallard Duck | R | ||
| 9.6.3.3 | Avian Reproduction Other Species | CR | If avian reproductive toxicity is of concern and there is a potential for exposure | |
| 9.6.6 | Special Studies Related to the Intended Use-Pattern (TGAI and EP) | CR | Based on concerns arising from results of other studies | |
| 9.7 | Wild Mammals | |||
| 9.7.1 | Summary | CR | Based on concerns arising from results of other studies | |
| 9.8 | Non-Target Plants | |||
| 9.8.1 | Summary | R | ||
| 9.8.2 | Fresh Water Algae | R | ||
| 9.8.3 | Marine Algae | CR | If there is a potential for estuarine/marine exposure | |
| 9.8.4 | Terrestrial Vascular Plants | R | ||
| 9.8.5 | Aquatic Vascular Plants | R | ||
| 9.9 | Other Studies/Data/Reports | CR | If available | |
| 12.5 | Foreign Reviews | |||
| 12.5.2 | Foreign Reviews of Chemistry Requirements for TGAIs or Integrated System Products | CR | ||
| 12.5.4 | Foreign Reviews of Toxicology | CR | ||
| 12.5.6 | Foreign Reviews of Metabolism / Toxicokinetics Studies | CR | ||
| 12.5.8 | Foreign Reviews of Environmental Chemistry and Fate | CR | ||
| 12.5.9 | Foreign Reviews of Environmental Toxicology | CR | ||
| 12.7 | Comprehensive Data Summaries | R |
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