| 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 |
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| 3.1.2 |
Formulating Plant's Name and Address |
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| 3.1.3 |
Trade Name |
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| 3.1.4 |
Other Names |
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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 |
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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 |
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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 |
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If applicable |
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| 3.5 |
Chemical and Physical Properties |
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| 3.5.1 |
Colour |
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Required for manufacturing concentrates only |
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| 3.5.2 |
Physical State |
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| 3.5.3 |
Odour |
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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 |
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| 3.5.6 |
Density or Specific Gravity |
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| 3.5.7 |
pH |
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| 3.5.8 |
Oxidizing or Reducing Action (Chemical Incompatibility) |
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| 3.5.9 |
Viscosity |
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| 3.5.10 |
Storage Stability Data |
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| 3.5.11 |
Flammability |
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| 3.5.12 |
Explodability |
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| 3.5.13 |
Miscibility |
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| 3.5.14 |
Corrosion Characteristics |
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| 3.5.15 |
Dielectric Breakdown Voltage |
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| 3.6 |
Sample(s) |
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If requested by PMRA |
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| 3.7 |
Other Studies/Data/Reports |
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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 |
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| 4.6.4 |
Primary Eye Irritation |
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| 4.6.5 |
Primary Dermal Irritation |
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| 4.6.6 |
Dermal Sensitization |
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| 4.6.7 |
Potentiation/Interaction |
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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 |
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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 |
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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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| 5.4 |
Mixer/Loader/Applicator- Passive Dosimetry Data |
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Required if significant exposure is likely |
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| 5.7 |
Post Application - Biological Monitoring Data |
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Required in the absence of dermal absorption data |
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| 5.8 |
Dermal Absorption |
CR |
Required in the absence of biological monitoring data |
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| 5.11 |
Glove/Clothing Penetration Data |
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May be required for risk mitigation purposes |
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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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| 10 |
Value (applicable to each pest/site or host combination) |
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| 10.1 |
Value Summaries |
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| 10.2 |
Efficacy Studies |
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| 10.2.1 |
Mode of Action |
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| 10.2.2 |
Description of Pest Problem |
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| 10.2.3 |
Efficacy Trials |
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| 10.2.3.1 |
Summaries |
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| 10.2.3.2 |
Efficacy: Laboratory, Growth Chamber Trials |
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| 10.2.3.3 |
Efficacy: Small-scale Trials (Field, Greenhouse) |
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One or both of 10.2.3.3 or 10.2.3.4 |
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| 10.2.3.4 |
Efficacy: Operational Trials |
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See 10.2.3.3 |
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| 10.3 |
Adverse Effects on Use Site |
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| 10.3.1 |
Summaries |
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| 10.3.2 |
Non-Safety Adverse Effects [e.g.: to crop, site of application (discoloration, corrosion), etc.] |
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| 10.3.3 |
Damage to Rotational Crops |
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| 10.4 |
Economics |
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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 |
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| 10.5.3 |
Resistance Management |
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| 10.5.4 |
Contribution to Risk Reduction |
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| 10.6 |
Other Studies/Data/Reports |
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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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| 12.5.10 |
Foreign Reviews of Value |
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| 12.7 |
Comprehensive Data Summaries |
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