Companion Animals - Technical Grade Active Ingredients: Data Requirements for Use Site Category (USC # 24)
Companion Animals - Technical Grade Active Ingredients
| 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 | ||
| 2.14.8 | Solvent Solubility (mg/L) | R | ||
| 2.14.9 | Vapour Pressure | R | ||
| 2.14.10 | Dissociation Constant | R | ||
| 2.14.11 | Octanol/Water Partition Coefficient | R | ||
| 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 | |
| 12.5 | Foreign Reviews | |||
| 12.5.2 | Foreign Reviews of Chemistry Requirements for TGAIs or Integrated System Products | |||
| 12.5.4 | Foreign Reviews of Toxicology | |||
| 12.7 | Comprehensive Data Summaries |
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