| Data Code |
Title |
Data required |
Conditions |
Volume No and Pages |
| 0 |
Index |
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| 1 |
Label |
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| 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 |
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| 3.1 |
Product Identification |
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| 3.1.1 |
Applicant's Name and Office Address |
R |
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| 3.1.2 |
Formulating Plant's Name and Address |
R |
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| 3.1.3 |
Trade Name |
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| 3.1.4 |
Other Names |
R |
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| 3.2 |
Formulation Process |
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| 3.2.1 |
Description of Starting Materials |
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| 3.2.2 |
Description of the Formulation Process |
R |
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| 3.2.3 |
Discussion of the Formation of Impurities of Toxicological Concern |
CR |
If applicable |
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| 3.3 |
Specifications |
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| 3.3.1 |
Establishing Certified Limits |
R |
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| 3.3.2 |
Control Product Specification Form |
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| 3.4 |
Product Analysis |
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| 3.4.1 |
Enforcement Analytical Method |
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| 3.4.2 |
Impurities of Toxicological Concern |
CR |
If applicable |
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| 3.5 |
Chemical and Physical Properties |
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| 3.5.1 |
Colour |
CR |
Required for manufacturing concentrates only |
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| 3.5.2 |
Physical State |
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| 3.5.3 |
Odour |
CR |
Required for manufacturing concentrates only |
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| 3.5.4 |
Formulation Type |
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| 3.5.5 |
Container Material and Description |
R |
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| 3.5.6 |
Density or Specific Gravity |
R |
See 8.2.1 |
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| 3.5.7 |
pH |
R |
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| 3.5.8 |
Oxidizing or Reducing Action (Chemical Incompatibility) |
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| 3.5.9 |
Viscosity |
R |
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| 3.5.10 |
Storage Stability Data |
R |
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| 3.5.11 |
Flammability |
R |
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| 3.5.12 |
Explodability |
R |
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| 3.5.13 |
Miscibility |
R |
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| 3.5.14 |
Corrosion Characteristics |
R |
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| 3.5.15 |
Dielectric Breakdown Voltage |
R |
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| 3.6 |
Sample(s) |
CR |
If requested by PMRA |
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| 3.7 |
Other Studies/Data/Reports |
CR |
If available |
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| 4 |
Toxicology |
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| 4.1 |
Summaries |
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| 4.6 |
Acute Studies - EP |
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| 4.6.1 |
Acute Oral |
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| 4.6.2 |
Acute Dermal |
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| 4.6.3 |
Acute Inhalation |
R |
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| 4.6.4 |
Primary Eye Irritation |
R |
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| 4.6.5 |
Primary Dermal Irritation |
R |
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| 4.6.6 |
Dermal Sensitization |
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| 4.6.7 |
Potentiation/Interaction |
CR |
If available |
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| 4.6.8 |
Other Acute Studies |
CR |
If available |
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| 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 |
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| 4.7.1 |
Short-term Oral (90-day rodent) |
CR |
See 4.7 |
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| 4.7.2 |
Short-term Oral (90-day and/or 12-month dog) |
CR |
See 4.7 |
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| 4.7.3 |
Short-term Dermal (90-day) |
CR |
See 4.7 |
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| 4.7.4 |
Short-term Dermal (21/28-day) |
CR |
See 4.7 |
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| 4.7.5 |
Short-term Inhalation (21/28-day) |
CR |
See 4.7 |
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| 4.7.6 |
Short-term Inhalation (90-day) |
CR |
See 4.7 |
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| 4.7.7 |
Other Special Studies |
CR |
See 4.7 |
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| 4.8 |
Other Studies/Data/Reports |
CR |
If available |
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| 5 |
Exposure (Occupational and/or Bystander) |
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| 5.1 |
Summaries |
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| 5.2 |
Use Description/Scenario (Application and Post Application) |
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| 5.3 |
Pesticides Handlers Exposure Database Assessment (or other database) |
R |
One of 5.3, 5.4 or 5.5 |
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| 5.4 |
Mixer/Loader/Applicator- Passive Dosimetry Data |
R |
See 5.3 |
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| 5.5 |
Mixer/Loader/Applicator-Biological Monitoring Data |
R |
See 5.3 |
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| 5.8 |
Dermal Absorption |
CR |
May be required if the margin of safety is inadequate |
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| 5.11 |
Glove/Clothing Penetration Data |
CR |
May be required for risk mitigation purposes and inadequate margin of safety |
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| 5.13 |
Package Integrity Study |
CR |
Required if packaged in water soluble bags |
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| 5.14 |
Other Studies/Data/Reports |
CR |
If available |
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| 6 |
Metabolism/Toxicokinetics Studies (TGAI or EP) |
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| 6.1 |
Summaries |
R |
Input to assessment of toxicity to wildlife |
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| 6.2 |
Livestock (Fish) |
R |
Peer review of toxicology review |
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| 6.3 |
Plants |
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| 6.4 |
Other Studies/Data/Reports |
CR |
If available |
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| 7 |
Food, Feed and Tobacco Residue Studies EP |
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| 7.1 |
Summaries |
R |
Input to assessment of wildlife exposure |
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| 7.2 |
Analytical Methodology (Food Crops & Tobacco) |
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| 7.2.1 |
Supervised Residue Trial Analytical Methodology |
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| 7.2.2 |
Enforcement Analytical Methodology |
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| 7.2.3 |
Inter-laboratory Analytical Methodology Validation |
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| 7.2.4 |
Multi-residue Analytical Methodology Evaluation |
R |
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| 7.2.5 |
Storage Stability of Working Solutions in Analytical Methodology |
R |
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| 7.3 |
Freezer Storage Stability Tests |
CR |
Depends on the length of storage |
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| 7.4 |
Crop Residue Data |
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| 7.4.1 |
Supervised Residue Trial Study |
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| 7.4.2 |
Residue Decline Study |
CR |
Depends on size of crop |
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| 7.4.3 |
Confined Crop Rotation Trial Study |
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| 7.4.4 |
Field Crop Rotation Trial Study |
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| 7.4.5 |
Processed Food/Feed |
CR |
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| 7.4.6 |
Residue Data for Crops used as Livestock Feed (if needed in forage crops) |
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| 7.5 |
Livestock, Poultry, Egg and Milk Residue Data (from feeding of treated crops) |
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| 7.6 |
Livestock, Poultry, Egg and Milk Residue Data (external application) |
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| 7.8 |
Other Studies/Data/Reports |
CR |
If available |
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| 8 |
Environmental Chemistry and Fate |
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| 8.1 |
Summaries |
R |
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| 8.2 |
Laboratory Studies |
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| 8.2.1 |
Summary of Physicochemical Properties to Include, Solubility in Water, Vapour Pressure, Octanol:Water Partition Coefficient, Dissociation Constant, UV-Visible Absorption, Density or Specific Gravity (See parts 2 and 3) |
R |
See 2.14.7, 2.14.9, 2.14.11, 2.14.10, 2.14.13, 2.14.6, and 3.5.6 |
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| 8.2.3 |
Laboratory Studies of Transformation |
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| 8.2.3.1 |
Summary |
R |
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| 8.2.3.6 |
Special Studies Related to Use-Pattern or Formulation |
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| 8.2.4 |
Laboratory Studies of Mobility |
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| 8.2.4.1 |
Summary |
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| 8.2.4.6 |
Special Studies Related to Use-Pattern or Formulation |
R |
Rate of release from treated surface |
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| 8.3 |
Field Studies of Dissipation/ Accumulation [May be Small- or Large-Scale] |
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| 8.3.1 |
Summary |
R |
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| 8.3.3 |
Aquatic |
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| 8.3.3.1 |
Canada |
CR |
Based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, non-target aquatic toxicity or bioaccumulation |
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| 8.3.3.2 |
Northern U.S. |
CR |
Can augment Canadian studies |
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| 8.3.3.3 |
Other |
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| 8.3.4 |
Special Studies Related to Intended Use Pattern |
R |
See 8.2.4.6 for rate of release from treated surface |
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| 8.4 |
Storage, Disposal and Decontamination (TGAI or EP) |
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| 8.4.1 |
Summary |
R |
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| 8.5 |
Other Environmental Fate Studies (TGAI or EP) |
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| 8.5.1 |
Summary |
CR |
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| 8.5.2 |
Incineration - thermal decomposition at high and low temperatures |
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| 8.6 |
Other Studies/Data/Reports |
CR |
If available |
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| 9 |
Environmental Toxicology |
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| 9.1 |
Summary |
R |
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| 9.3 |
Non-Target Freshwater Invertebrates |
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| 9.3.1 |
Summary |
R |
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| 9.3.5 |
Laboratory Studies with End-Use product |
CR |
If components of the EP are of concern |
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| 9.3.6 |
Field Studies |
CR |
Based on concerns arising from results of other studies |
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| 9.4 |
Non-Target Marine Invertebrates |
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| 9.4.1 |
Summary |
R |
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| 9.4.6 |
Laboratory Studies with End-Use product |
CR |
If components of the EP are of concern |
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| 9.4.7 |
Field Studies |
CR |
Based on concerns arising from results of other studies |
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| 9.5 |
Fish |
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| 9.5.1 |
Summaries |
R |
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| 9.5.4 |
Laboratory Studies with End-Use product |
CR |
If components of the EP are of concern |
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| 9.5.5 |
Field Studies |
CR |
Based on concerns arising from results of other studies |
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| 9.6 |
Wild Birds |
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| 9.6.1 |
Summary |
R |
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| 9.6.4 |
Laboratory Studies with End-Use product |
CR |
If components of the EP are of concern |
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| 9.6.5 |
Field Studies |
CR |
Based on concerns arising from results of other studies |
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| 9.6.6 |
Special Studies Related to the Intended Use-Pattern (TGAI or EP) |
CR |
See 9.6.5 |
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| 9.7 |
Wild Mammals |
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| 9.7.1 |
Summary |
CR |
Based on concerns arising from results of other studies |
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| 9.7.2 |
Field Studies |
CR |
See 9.7.1 |
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| 9.8 |
Non-Target Plants |
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| 9.8.1 |
Summary |
R |
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| 9.8.6 |
Laboratory Studies with End-Use product |
CR |
If components of the EP are of concern |
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| 9.8.7 |
Field Studies |
CR |
Based on concerns arising from results of other studies |
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| 9.9 |
Other Studies/Data/Reports |
CR |
If available |
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| 10 |
Value (applicable to each pest/site or host combination) |
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| 10.1 |
Value Summaries |
R |
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| 10.2 |
Efficacy Studies |
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| 10.2.1 |
Mode of Action |
R |
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| 10.2.2 |
Description of Pest Problem |
R |
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| 10.2.3 |
Efficacy Trials |
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| 10.2.3.1 |
Summaries |
R |
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| 10.2.3.2 |
Efficacy: Laboratory, Growth Chamber Trials |
CR |
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| 10.2.3.3 |
Efficacy: Small-scale Trials (Field, Greenhouse) |
R |
One or both of 10.2.3.3 or 10.2.3.4 may be required |
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| 10.2.3.4 |
Efficacy: Operational Trials |
R |
See 10.2.3.3 |
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| 10.3 |
Adverse Effects on Use Site |
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| 10.3.1 |
Summaries |
R |
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| 10.3.2 |
Non-Safety Adverse Effects [e.g.: to crop, site of application (discoloration, corrosion), etc.] |
R |
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| 10.3.3 |
Damage to Rotational Crops |
CR |
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| 10.4 |
Economics |
CR |
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| 10.5 |
Sustainability |
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| 10.5.1 |
Survey of Alternatives (chemical and non-chemical) |
CR |
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| 10.5.2 |
Compatibility with Current Management Practices Including IPM |
CR |
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| 10.5.3 |
Resistance Management |
CR |
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| 10.5.4 |
Contribution to Risk Reduction |
CR |
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| 10.6 |
Other Studies/Data/Reports |
CR |
If available |
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| 12.5 |
Foreign Reviews |
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| 12.5.3 |
Foreign Reviews of Chemistry Requirements for MAs and EPs formulated from registered TGAIs or ISPs |
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| 12.5.4 |
Foreign Reviews of Toxicology |
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| 12.5.5 |
Foreign Reviews of Exposure (Occupational and/or Bystander) |
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| 12.5.6 |
Foreign Reviews of Metabolism / Toxicokinetics Studies |
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| 12.5.7 |
Foreign Reviews of Food, Feed and Tobacco Residue Studies |
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| 12.5.8 |
Foreign Reviews of Environmental Chemistry and Fate |
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| 12.5.9 |
Foreign Reviews of Environmental Toxicology |
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| 12.5.10 |
Foreign Reviews of Value |
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| 12.7 |
Comprehensive Data Summaries |
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