Insecticides, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheadings 3808.52 to 3808.69) (HS code(s): 380891); Insecticides (ICS code(s): 65.100.10)
DEAS 1120-1: 2022, Mosquito repellent — Performance test guidelines — Part 1: Skin applied, First Edition (26 page(s), in English)
This Draft East African standard provides guidelines for the design and execution of studies to evaluate the performance of mosquito repellents formulated and prepared for application directly to human skin. These guidelines apply to products in any formulation intended to be applied directly to human skin.
The purpose of these guidelines is to provide specific and standardized procedures and criteria for efficacy testing and evaluation of mosquito repellents for human skin. Their aim is to harmonize the testing procedures carried out in different laboratories and institutions in order to generate comparable data for registering and labelling such products by the national regulatory authorities. However, the requirements for registration of pesticides, including repellents, are determined by the national regulatory authorities.
The guidelines provide guidance and procedures on laboratory studies, field trials and evaluation of technical material used in mosquito repellent products and on the methods used to determine their application rate(s) and effectiveness. Guidance is also provided on the single-dose evaluation of formulated repellent products. With some modification, the guidelines can be used to determine the repellency of candidate compounds for other flying insects that blood-feed on humans.
Detailed treatment and analysis of repellent safety and toxicity data are beyond the scope of these guidelines, and it is assumed that preliminary human safety assessments have been undertaken before the material(s) are applied to human skin. Any side-effects and/or undesirable characteristics experienced in association with the application and use of repellents in laboratory studies and field trials should be recorded and reported. The protocol must include provision for medical care and the reporting of adverse events.
Products submitted for laboratory studies and/or field trials should be accompanied by the Material Safety Data Sheet, the labelling recommendation and the manufacturer's certification that the product is within the company's manufacturing specifications for that product. Independent physical and chemical assessment may be required before initiating the efficacy studies. Biological tests are subject to the variation that accompanies living organisms. Studies should therefore be conducted under the close supervision of personnel familiar with biological testing of repellents and with sound scientific and experimental procedures; the principles of good laboratory practice or other suitable quality schemes such as the International Organization for Standardization should be applied.