Data Requirements for Import MRLs on Use Site Category (USC # 1): Aquaculture
Data Code | Title | Data required | Conditions | Present/ Absent |
---|---|---|---|---|
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 | ||
2.10 | Canadian Patent Status | 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 | CR | A justification must be provided if standard limits are not met. | |
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 | Vapor Pressure | R | ||
2.14.10 | Dissociation Constant | R | ||
2.14.11 | Octanol/Water Partition Coefficient | R | ||
2.14.12 | pH | R | ||
2.14.13 | UV/Visible Absorption Spectra | R | ||
2.14.14 | Stability (Sunlight, Temperature, Metals) | R | ||
2.14.15 | Storage Stability Data | R | Ambient 1 year may be submitted later but short term data is required | |
2.15 | Other Studies/Data/Reports/Foreign Reviews | |||
3 | Chemistry Requirements for the Registration of Manufacturing Concentrates and End-Use Products Formulated from Registered technical grade of active ingredients or integrated system products. | |||
3.1 | Product Identification | |||
3.1.1 | Applicant's Name and Office Address | |||
3.1.2 | Formulating Plant's Name and Address | |||
3.1.3 | Trade Name | |||
3.1.4 | Other Names | |||
3.2 | Formulation Process | |||
3.2.1 | Description of Starting Materials | R | ||
3.2.2 | Description of the Formulation Process | R | ||
3.2.3 | Discussion of the Formation of Impurities of Toxicological Concern | CR | If applicable. | |
3.3 | Specifications | |||
3.3.1 | Establishing Certified Limits | CR | A justification must be provided if standard limits are not met. | |
3.3.2 | Additional Product Specific Requirements | |||
3.3.2.1 | Granules and Baits | CR | If applicable. | |
3.3.2.2 | Seed Coatings | CR | If applicable. | |
3.3.3 | Control Product Specification Form | R | ||
3.4 | Product Analysis | |||
3.4.1 | Enforcement Analytical Method | R | ||
3.4.2 | Impurities of Toxicological Concern | CR | If applicable. | |
3.5 | Chemical and Physical Properties | |||
3.5.1 | Colour | R | ||
3.5.2 | Physical State | R | ||
3.5.3 | Odour | R | ||
3.5.4 | Formulation Type | R | ||
3.5.5 | Container Material and Description | R | ||
3.5.6 | Density or Specific Gravity | R | ||
3.5.7 | pH | R | ||
3.5.8 | Oxidizing or Reducing Action (Chemical Incompatibility) | R | ||
3.5.9 | Viscosity | R | ||
3.5.10 | Storage Stability Data | R | Ambient 1 year may be submitted later but short term data is required | |
3.5.11 | Flammability | R | ||
3.5.12 | Explodability | R | ||
3.5.13 | Miscibility | R | ||
3.5.14 | Corrosion Characteristics | R | ||
3.5.15 | Dielectric Breakdown Voltage | R | ||
3.6 | Other Studies/Data/Reports/Foreign Reviews | |||
4 | Toxicology | |||
4.1 | Summaries | R | ||
4.2 | Acute Studies - TGAI | |||
4.2.1 | Acute Oral | R | ||
4.2.2 | Acute Dermal | NR | ||
4.2.3 | Acute Inhalation | NR | ||
4.2.4 | Primary Eye Irritation | NR | ||
4.2.5 | Primary Dermal Irritation | NR | ||
4.2.6 | Dermal Sensitization | NR | ||
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) | NR | ||
4.3.5 | Short-term Dermal (21/28-day) | NR | ||
4.3.6 | Short-term Inhalation (90-day) | NR | ||
4.3.7 | Short-term Inhalation (21/28-day) | NR | ||
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 |
|
4.6 | Acute Studies - EP | |||
4.6.1 | Acute Oral | CR | If available | |
4.6.2 | Acute Dermal | NR | ||
4.6.3 | Acute Inhalation | NR | ||
4.6.4 | Primary Eye Irritation | NR | ||
4.6.5 | Primary Dermal Irritation | NR | ||
4.6.6 | Dermal Sensitization | NR | ||
4.6.7 | Potentiation/Interaction | CR | If available | |
4.6.8 | Other Acute Studies | CR | If available | |
4.7 | Short-term Studies - EP | CR | Depending on use pattern, required if any component of the EP may increase absorption of the active ingredient(s) or increase toxic or pharmacologic effects | |
4.7.1 | Short-term Oral (90-day rodent) | CR | See 4.7 | |
4.7.2 | Short-term Oral (90-day and/or 12-month dog) | CR | See 4.7 | |
4.7.3 | Short-term Dermal (90-day) | NR | ||
4.7.4 | Short-term Dermal (21/28-day) | NR | ||
4.7.5 | Short-term Inhalation (21/28-day) | NR | ||
4.7.6 | Short-term Inhalation (90-day) | NR | ||
4.7.7 | Other Special Studies | CR | See 4.7 | |
4.8 | Other Studies/Data/Reports | CR | If available | |
6 | Metabolism/Toxicokinetics Studies (TGAI or EP) | |||
6.1 | Summaries | R | Input to assessment of toxicity to wildlife | |
6.2 | Livestock | CR | ||
6.3 | Plants | CR | Depends on request | |
6.4 | Other Studies/ Data/ Reports/ Foreign Reviews | CR | See 6.3 | |
7 | Food, Feed and Tobacco Residue Studies | |||
7.1 | Summaries | R | Input to assessment of toxicity to wildlife exposure | |
7.2 | Analytical Methodology (Food Crops & Tobacco) | |||
7.2.1 | Supervised Residue Trial Analytical Methodology | R | ||
7.3 | Freezer Storage Stability Tests | CR | ||
7.4 | Crop Residue Data | |||
7.4.1 | Supervised Residue Trial Study | R | ||
7.4.2 | Temporal Residue Trial Study | CR | Depends on size of crops | |
7.4.3 | Confined Crop Rotation Trial Study | CR | ||
7.4.4 | Field Crop Rotation Trial Study | CR | ||
7.4.5 | Processed Food/Feed | CR | ||
7.4.6 | Residue Data for Crops used as Livestock Feed | CR | ||
7.5 | Livestock, Poultry, Egg and Milk Residue Data (from feeding of treated crops) | CR | ||
7.6 | Livestock, Poultry, Egg and Milk Residue Data (external application) | CR | ||
7.8 | Other Studies/ Data/ Reports/ Foreign Reviews | CR |
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