DATA REQUIREMENTS FOR REGISTRATION OF CYMBOPOGOM PLANT EXTRACT
| A. | CHEMISTRY | 9(3B) | 9(3) |
| 1. | Name of the Part of the Plant(s) to be used for extraction of the active ingredients. | R | R |
| 2. | Outline of Process of Formulation. | R | R |
| 3. | (a) Extract Contents "Geraniol" as one of the major active constituents. The concentration of a.i. i.e. Geraniol (Cymbopogom sp.) in the formulated extract should contain not less than ppm of Geraniol (Cymbopogom sp.) a.i. | R | R |
| 4. | Chemical composition of the formulations | R | R |
| 5. | Physico-chemical properties of a.i. & adjuvants | R | R |
| 6. | Product Specifications as BIS format | R | R |
| 7. | Method of analysis for Geraniol (Cymbopogom sp.) a.i. | R | R |
| 8. | An undertaking that the product does not contain any other chemical except plant extract | R | R |
| 9. | Analytical test report | R | R |
| 10. | Shelf-life claim | R | R |
| 11. | Shelf-life data | NR | R |
| B. | BIO-EFFICACY | ||
| 1. | Bio-effectiveness | R | R |
| 2. | Phytotoxicity | R | R |
| 3. | Compatibility with other chemicals | R | R |
| 4. | Purpose of manufacture | R | R |
| 5. | Direction of concerning dosage | R | R |
| 6. | Time of application | R | R |
| 7. | Waiting period | R | R |
| 8. | Application equipment | R | R |
| 9. | Information regarding registration status in other countries, if any | R | R |
| C. | TOXICITY | ||
| 1. | Acute Oral rat and mice | R | R |
| 2. | Acute dermal | R | R |
| 3. | Primary skin irritation | R | R |
| 4. | Primary eye irritation | R | R |
| 5. | Allergy/Sensitization | R | R |
| D. | PACKAGING AND LABELLING | ||
| 1. | Label and Leaflets as per IR 1971 existing norm | R | R |
| 2. | Type of package | R | R |
| 3. | Manner of Package (Container - content compatibility) | R | R |
| 4. | Specification for primary package | R | R |
| 5. | Specification for secondary package | R | R |
| 6. | Specification for transport package | R | R |
| 7. | manner of labelling | R | R |
| 8. | Instruction for storage and use | R | R |
| 9. | Inbformation regarding disposal of used package | R | R |
| 10. | Process of manufacturing / indicating material balance generation of wasted. | R | R |
R- Required
NR- Not required.