DATA REQUIREMENTS FOR IMPORT OF CONCENTRATED PYRETHRUM EXTRACT (AS APPROVED BY THE REGISTRATION COMMITTEE IN ITS 148th MEETING HELD ON 11.11.1994).
| A. | If the higher concentration of Pyrethrum extract is imported from the already approved source (which is approved for import of Pyrethrum extract (2%) i.e., Pyrethrum market board, Nakura, Kenya in that case the ollowing simplified data in all disciplies is required to be submitted. | |
| CHEMISTRY | ||
| 1. | Detailed chemical composition. | R |
| 2. | Physico-chemical properties | R |
| 3. | Specification and method of analysis alongwith undertaking for product quality. | R |
| 4. | Analytical test report from principal | R |
| 5. | Identification and quantification of identifiable impurities in addition to the presence of active constituents i.e. Pyrethrum 1 & 2, Cinerin 1 & 2 and Jasemolin 1 & 2. | R |
| 6. | Shelf-life data as per the relevant guidelines is required to be submitted. | R |
| BIO-EFFICACY | ||
| The higher concentrate is proposed to be imported to make the approved formulation. As such data on approved formulations is required w.r.t. bioefficacy | R | |
| TOXICITY | ||
| 1. | Acute oral toxicity in rat and mice | R |
| 2. | Acute dermal toxicity | R |
| 3. | Acute inhalation toxicity | R |
| 4. | Primary skin irritation | R |
| 5. | Irritation to mucous membrane. | R |
| PACKAGING | ||
| If kerosene is used as a solvent then container content compatibility data is not required. If the solvent is other than kerosene then container content compatibility data is required. | ||
| B. | In case higher concentration of Pyrethrum is to be imported from any other source then the approved one i.e. Pyrethrum Marketing Board, Nakura, Kenya then the applicant has to generate complete data as per the relevant guidelines u/s 9(3) of the Act. | |
| 1. | The individual component(s) is / are higher than registered formulations strength one acute toxicity data on higher strength has to be generated. | |
| 2. | Data / information on toxicity of registered strength / formulation have to be provided for comparision. | |
| 3. | The components of combination should preferably be limited to two only. | |
| PACKAGING AND LABELLING | ||
| 1. | Label and Leaflets as per Insecticides Rules, 1971 existing norms. | R |
| 2. | Type of packing | R |
| 3. | Manner of Packing (Packaging material plus compatibility with content) | R |
| 4. | Specifications for primary packaging | R |
| 5. | Specifications for secondary package | R |
| 6. | Specifications for transport package | R |
| 7. | Manner of Labelling | R |
| 8. | Instructions for storage and use, etc. | R |
| 9. | Information regarding disposal of used package. | R |
R- Required