Data Requirements for Use Site Category (USC # 10): Seed Treatments Food and Feed - Technical Grade Active Ingredients

Data Requirements for Use Site Category (USC # 10): Seed Treatments Food and Feed - 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 CR Required for integrated system products  
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 If available  
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 label directions and/or residues in progeny plant or seed  
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: Water Solubility, Vapour Pressure, Dissociation Constant, Octanol/Water Partition Coefficient and UV-Visible 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    
8.2.2.4 Biota R Required for animal (preferable birds) matrix only  
8.2.3 Laboratory Studies of Transformation      
8.2.3.1 Summary R    
8.2.3.2 Hydrolysis R    
8.2.3.3 Phototransformation      
8.2.3.3.2 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 (TGAI)      
8.2.3.5.2 Anaerobic Water 20°-30°C CR For aquatic uses only  
8.2.4 Laboratory Studies of Mobility      
8.2.4.1 Summary R    
8.2.4.2 Adsorption/Desorption R    
8.2.4.5 Volatilization CR If volatilization is indicated by vapour pressure or Henry's Law Constant  
8.4 Storage, Disposal and Decontamination (TGAI or 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 results of other studies  
8.6 Other Studies/Data/Reports CR If available  
9 Environmental Toxicology      
9.1 Summary R    
9.3 Non-Target Freshwater Invertebrates (TGAI)      
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  
9.4 Non-Target Marine Invertebrates (TGAI)      
9.4.1 Summary CR If there is a potential for estuarine/marine exposure  
9.4.2 Acute (Crustacean) CR See 9.4.1  
9.4.5 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  
9.5 Fish (TGAI)      
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    
9.5.2.4 Marine/Estuarine Fish CR If there is a potential for estuarine/marine exposure  
9.5.3 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  
9.6 Wild Birds      
9.6.1 Summary R Summary should include: (a) number of seeds/unit weight of seeds; (b) weight of ai/unit weight of seeds; and (c) number of seeds applied/unit area  
9.6.2 Acute Studies      
9.6.2.1 Oral (LD50) Bobwhite Quail R Preferred over 9.6.2.2  
9.6.2.2 Oral (LD50) Mallard Duck CR 9.6.2.1 is preferred  
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 (TGAI)      
9.7.1 Summary CR Based on concerns arising from results of other studies  
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      
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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