DATA REQUIREMENTS FOR REGISTRATION OF HERBAL / BOTANICAL PLANT GROWTH REGULATORS UNDER SECTION 9(3) OF THE INSECTICIDES ACT, 1968 APPROVED BY THE REGISTRATION COMMITTEE IN ITS 161st MEETING HELD ON 06.03.96.
| A. | CHEMISTRY | |
| 1. | Source | R |
| 2. | Composition | R |
| 3. | Identity of the a. i. and Physico-chemical properties | R |
| 4. | Manufacturing experiments in details (Manufacturing process) | R |
| 5. | Specifications | R |
| 6. | Chemical method of analysis only. | R |
| 7. | Shelf-life | R |
| 8. | Test Report | R |
| B. | BIO-EFFICACY | |
| 1. | Two seasons multi-locational data on bio-effectiveness and phytotoxicity. | R |
| 2. | Compatibility - If the product is proposed to be mixed with other chemicals, data on compatibility are required to be submitted. | R |
| 3. | Registration status in other countries | R |
| 4. | One season data on persistence in soil and plants. | R |
| 5. | Bioefficacy claims on the labels & leaflets as per guidelines approved by Registration Committee. | R |
| C. | TOXICITY | |
| 1. | Acute oral toxicology study in rats and mice. | R |
| 2. | Acute dermal toxicology study in rats and rabbits. | R |
| 3. | Primary skin irritation | R |
| 4. | Irritation to mucous memberane | R |
| 5. | Actual oral toxicity to birds (Chicken & Pigeons) | R |
| 6. | Toxicity to Honeybees | R |
| 7. | Toxicity to fish | R |
| Data / information on following parameters are also required to be submitted. | ||
| Long Term Toxicity | R | |
| i. | Neuro-behaviour toxicity | R |
| ii. | Mutagenicity | R |
| iii. | Careinogenecity | R |
| iv. | Effect on reproduction | R |
| v. | Health records of workers / spray operators as per the protocol. | R |
| D. | PACKAGING AND LABELLING | |
| 1. | Label and Leaflets | R |
| 2. | Type of packing | R |
| 3. | Manner of Packing | R |
| 4. | Content container compatibility | R |
| 5. | Manner of Labelling | R |
| 6. | Specifications of packing | R |
| i. Primary packing | R | |
| ii. Secondary packing | R | |
| iii. Transport packing | R | |
| 7. | Instructions for storage and use | R |
| 8. | Disposal of empty containers | R |
R- Required
NR- Not required.