| 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 |
|
|
| 2.14.11 |
Octanol/Water Partition Coefficient |
R |
See 8.2.1 |
|
| 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) |
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 Properties to Include: Solubility in Water, Vapour Pressure, Octanol/Water Coefficient (See parts 2 and 3) |
R |
Data submitted under 2.14.7; 2.14.9; and 2.14.11 |
|
| 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 |
|
|
|
| 8.2.3.3.3 |
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 |
|
| 8.2.4 |
Laboratory Studies of Mobility |
|
|
|
| 8.2.4.1 |
Summary |
CR |
If there is a potential for soil exposure |
|
| 8.2.4.2 |
Adsorption/Desorption |
CR |
If there is a potential for soil exposure; one of 8.2.4.2; 8.2.4.3.1; 8.2.4.3.2; or 8.2.4.4 |
|
| 8.2.4.3 |
Soil Column Leaching |
|
|
|
| 8.2.4.3.1 |
Unaged Soil |
CR |
See 8.2.4.2 |
|
| 8.2.4.3.2 |
Aged Soil |
CR |
See 8.2.4.2 |
|
| 8.2.4.4 |
Soil TLC Leaching |
CR |
See 8.2.4.2 |
|
| 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 |
|
| 9.4 |
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 |
|
| 9.5 |
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 |
|
| 9.5.2.4 |
Marine/Estuarine Fish |
CR |
If there is a potential for estuarine/marine exposure |
|
| 9.6 |
Wild Birds |
|
|
|
| 9.6.1 |
Summary |
CR |
If there is a potential for exposure |
|
| 9.6.6 |
Special Studies Related to the Intended Use-Pattern (TGAI and EP) |
CR |
Acute inhalation (LD50) with bobwhite quail or mallard duck, if there is a potential for avian exposure |
|
| 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 |
|
| 9.9 |
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 |
|
|
| 12.5.10 |
Foreign Reviews of Value |
CR |
|
|
| 12.7 |
Comprehensive Data Summaries |
R |
|
|
