Human Skin, Clothing and Proximal Sites - End Use Products: Data Requirements for Use Site Category (USC # 26)

Human Skin, Clothing and Proximal Sites - End Use Products

Data Requirements for Use Site Category ( USC # 26): Human Skin, Clothing and Proximal Sites - EP
Data Code Title Data required Conditions Volume No and Pages
0 Index R    
1 Label R    
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 R    
3.1.2 Formulating Plant's Name and Address R    
3.1.3 Trade Name R    
3.1.4 Other Names R    
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 R    
3.3.2 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 CR Required for manufacturing concentrates only  
3.5.2 Physical State R    
3.5.3 Odour CR Required for manufacturing concentrates only  
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    
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 Sample(s) CR If requested by PMRA  
3.7 Other Studies/Data/Reports CR If available  
4 Toxicology      
4.1 Summaries R    
4.6 Acute Studies - EP      
4.6.1 Acute Oral R    
4.6.2 Acute Dermal R    
4.6.3 Acute Inhalation R    
4.6.4 Primary Eye Irritation R    
4.6.5 Primary Dermal Irritation R    
4.6.6 Dermal Sensitization R    
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) CR See 4.7  
4.7.4 Short-term Dermal (21/28-day) CR See 4.7  
4.7.5 Short-term Inhalation (21/28-day) CR See 4.7  
4.7.6 Short-term Inhalation (90-day) CR See 4.7  
4.7.7 Other Special Studies CR See 4.7  
4.8 Other Studies/Data/Reports CR If available  
5 Exposure (Occupational and/or Bystander)      
5.1 Summaries R    
5.2 Use Description/Scenario (Application and Post Application) R    
5.4 Mixer/Loader/Applicator- Passive Dosimetry Data CR One of 5.4 or 5.5 is required when clothing or other materials are impregnated with products in an industrial setting  
5.5 Mixer/Loader/Applicator-Biological Monitoring Data R See 5.4  
5.7 Post Application - Biological Monitoring Data CR One of 5.7 or 5.8 may be required for products that are directly applied to human skin  
5.8 Dermal Absorption CR See 5.7  
5.10 Ambient Air Samples (Indoor - Outdoor) CR If there is a potential for post-application inhalation exposure  
5.14 Other Studies/Data/Reports CR Leaching and/or migration studies may be required for products impregnated into clothing or other materials  
10 Value (applicable to each pest/site or host combination)      
10.1 Value Summaries R    
10.2 Efficacy Studies      
10.2.1 Mode of Action R    
10.2.2 Description of Pest Problem R    
10.2.3 Efficacy Trials      
10.2.3.1 Summaries R    
10.2.3.2 Efficacy: Laboratory, Growth Chamber Trials CR    
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  
10.2.3.4 Efficacy: Operational Trials CR See 10.2.3.3  
10.3 Adverse Effects on Use Site      
10.3.1 Summaries R    
10.3.2 Non-Safety Adverse Effects [e.g.: to crop, site of application (discoloration, corrosion), etc.] R    
10.3.3 Damage to Rotational Crops CR    
10.4 Economics R    
10.5 Sustainability      
10.5.1 Survey of Alternatives (chemical and non-chemical) CR    
10.5.2 Compatibility with Current Management Practices Including IPM CR    
10.5.3 Resistance Management CR    
10.5.4 Contribution to Risk Reduction CR    
10.6 Other Studies/Data/Reports CR If available  
12.5 Foreign Reviews      
12.5.3 Foreign Reviews of Chemistry Requirements for MAs and EPs formulated from registered TGAIs or ISPs CR    
12.5.4 Foreign Reviews of Toxicology CR    
12.5.5 Foreign Reviews of Exposure (Occupational and/or Bystander) CR    
12.5.10 Foreign Reviews of Value CR    
12.7 Comprehensive Data Summaries R    
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