Material - Technical Grade Active Ingredients: Data Requirements for Use Site Category (USC # 18):
Material - Technical Grade Active Ingredients
| 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 | See 8.2.1 | |
| 2.14.8 | Solvent Solubility (mg/L) | R | ||
| 2.14.9 | Vapour Pressure | R | See 8.2.1 | |
| 2.14.10 | Dissociation Constant | R | See 8.2.1 | |
| 2.14.11 | Octanol/Water Partition Coefficient | R | See 8.2.1 | |
| 2.14.12 | UV/Visible Absorption Spectra | R | See 8.2.1 | |
| 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) | CR | 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 | |
| 8 | Environmental Chemistry and Fate | |||
| 8.1 | Summaries | R | ||
| 8.2 | Laboratory Studies | |||
| 8.2.1 | Summary of Physicochemical Pro perties to Include, Solubility in Water, Vapour Pressure, Dissociation Constant, Octanol:Water Partition Coefficient, UV-Visible Absorption (See part 2) (TGAI) | R | See 2.14.7, 2.14.9, 2.14.10, 2.14.11, and 2.14.13 | |
| 8.2.2 | Analytical Methodology (parent compound and transformation products) | |||
| 8.2.2.1 | Soil | CR | If there is a potential for soil exposure | |
| 8.2.2.2 | Sediment | CR | If there is a potential for aquatic exposure | |
| 8.2.2.3 | Water | CR | See 8.2.2.2 | |
| 8.2.2.4 | Biota | CR | If there is a potential for exposure | |
| 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 | CR | If there is a potential for aquatic exposure | |
| 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 | CR | If there is a potential for soil exposure | |
| 8.2.3.5 | Biotransformation in Aquatic Systems | |||
| 8.2.3.5.2 | Aerobic Water 20°-30°C | CR | If there is a potential for aquatic exposure; preferred over part 8.2.3.5.4 | |
| 8.2.3.5.4 | Aerobic Water/Sediment 20°-30°C | CR | If there is a potential for aquatic exposure and partitioning into sediment is expected | |
| 8.2.3.5.6 | Anaerobic Sediment/Water 20°-30°C | CR | If there is a potential for aquatic exposure | |
| 8.2.4 | Laboratory Studies of Mobility | |||
| 8.2.4.1 | Summary | CR | ||
| 8.2.4.2 | Adsorption/Desorption | CR | With aquatic sediment, if there is a potential for aquatic exposure. One of 8.2.4.2; 8.2.4.3.1; 8.2.4.3.2; or 8.2.4.4 with soil, if there is a potential for soil exposure | |
| 8.2.4.3 | Soil Column Leaching | |||
| 8.2.4.3.1 | Unaged Soil | CR | One of 8.2.4.2 (with soil); 8.2.4.3.1; 8.2.4.3.2; or 8.2.4.4 if there is a potential for soil exposure | |
| 8.2.4.3.2 | Aged Soil | CR | See 8.2.4.3.1 | |
| 8.2.4.4 | Soil TLC Leaching | CR | See 8.2.4.3.1 | |
| 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 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 results of other studies | |
| 8.6 | Other Studies/Data/Reports | CR | If available | |
| 9 | Environmental Toxicology | |||
| 9.1 | Summary | CR | ||
| 9.3 | Non-Target Freshwater Invertebrates | |||
| 9.3.1 | Summary | CR | If there is a potential for freshwater exposure | |
| 9.3.2 | Daphnia sp. Acute | CR | See 9.3.1 | |
| 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 | CR | If there is a potential for exposure | |
| 9.5.2 | Acute Studies | |||
| 9.5.2.1 | Cold Water Fish (rainbow trout) | CR | If there is a potential for freshwater exposure | |
| 9.5.2.2 | Warm Water Fish (bluegill sunfish) | CR | See 9.5.2.1 | |
| 9.5.2.3 | Other Freshwater Fish Species | CR | If there is a potential for exposure | |
| 9.5.2.4 | Marine/Estuarine Fish | CR | Coho, Chinnok or Atlantic salmon, if there is a potential for exposure; to be followed by 9.5.2.4.1 | |
| 9.5.2.4.1 | Salinity Challenge | CR | For estuarine fish, if there is a potential for exposure; to follow 9.5.2.4 | |
| 9.5.3 | Sublethal and Chronic Studies | |||
| 9.5.3.1 | Fish [salmonid], Early Life Cycle Tox. Test | CR | Most sensitive (i.e., one of) daphnid (9.3.3); marine crustacean or estuarine/marine mollusk (9.4.5); or fish [salmonid] (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 Tox. Test | CR | Where there is concern based on acute effects, persistence, potential for exposure or frequency of application | |
| 9.5.6 | Bioaccumulation | CR | If there is a p otential for aquatic exposure and log Kow is greater than or equal to 3 | |
| 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 | CR | ||
| 9.8.2 | Fresh Water Algae | CR | If there is potential for freshwater exposure | |
| 9.8.3 | Marine Algae | CR | If there is a potential for estuarine/marine exposure | |
| 9.8.4 | Terrestrial Vascular Plants | CR | If there is a potential for exposure | |
| 9.8.5 | Aquatic Vascular Plants | CR | If there is a potential for aquatic exposure | |
| 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 | ||
| 12.5.8 | 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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