Method for Testing Mosquito Repellent Creams Applied from January 01, 2016

Illustrative Image (Source: Internet)

Circular 22/2015/TT-BYT prescribes the method for testing mosquito repellent cream as utilizing the biological testing method in mosquito cages with human volunteers to evaluate the efficacy, safety, and any unwanted effects of the mosquito repellent cream directly on the volunteers. Each test includes 03 trials, and all trials must adhere to the requirements, procedures, and evaluations stipulated in this Circular.

In addition, the Circular requires the following for the tests:

- Requirements for tools and equipment:

- Mosquito cages of size 40cmx40cmx40cm made of tulle with a mesh size of 32-36/cm2. Each test requires 04 cages (02 control cages numbered 01, 02 marked in green, two test cages numbered 03, 04 marked in red). The cage doors have sleeves to prevent mosquitoes from escaping;- A 01-meter measuring tape accurate to 01 mm to measure the surface area where the mosquito repellent cream is applied on the volunteer's arm;- Personal protective equipment: clothes, hats with protective nets, glasses, gloves, elbow guards, boots;- Test result recording table stipulated in Appendix 1 issued with this Circular;- Questionnaire for interviewing about the unwanted effects of the test sample stipulated in Appendix 2 issued with this Circular.

- Number of volunteers participating in the tests: 04 people (02 males, 02 females). Volunteers must be selected according to the criteria in Appendix 3 issued with this Circular and must not use perfume, repellent chemicals, or topical oils on their skin 12 hours before the test.

- Mosquitoes used for testing must be female mosquitoes that meet the standards in the guidance of the World Health Organization (WHO/CDS/CPC/MAL/98.2), raised in a biosafety level II room, sensitive to chemicals, not blood-fed, of the same age group 05 - 07 days old, fed with 10% glucose solution.

- Laboratory meeting ISO/IEC 17025:2005 standard with normal temperature and humidity conditions.

Details are available at Circular 22/2015/TT-BYT, effective from January 01, 2016.

Le Hai

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