Laboratory tests of the anti-moustic solution for the Neokiz linen
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After single application under occlusive dressing for 48 hours on 10 volunteers: method of patch tests.
Application area: back.
Product quantity : 0.02 ml.
Frequency and duration: single application for 48 hours.
Conditions of application: pure deposited product under occlusive patch.
Method of evaluation:
Clinical observation of the caused effects is performed by a dermatologist after the removal of the patch.
Clinical rating is given on a determined numerical scale, depending on the intensity of observed irritation phenomena (erythema, edema, drought, vesicle). The average irritating score of the product to the test is calculated by making the average of the scores obtained for all volunteers, thus allowing to classify the product of "no irritating to very irritating".
The evaluation is always done by comparison to the "negative" witness.
• Population: 12 adult volunteers, healthy.
• Outcome: The average irritating score of the product is 0.00.
In the experimental conditions of the study, the REPULSIVE NEOKIZ HUILE product may be considered non-irritating from the point of view of its primary skin tolerance.
Authenticity of results
The 031PT20V12 study was conducted in accordance with the experimental protocol and in compliance with good clinical practices.
Experimental sample: 100% cotton g/m2 bed sheet impregnated in a washing machine by micro-encapsulated formulation, recharges a dose of 120 ml.
Purpose of the study:
The purpose of the study is to measure the repulsive effectiveness of a textile impregnated with a formula for 3 species of mosquitoes. The tests are of type caged arm (WHO) and are carried out on target mosquito volunteers Aedes aegypti, Culex pipiens and Anopheles gambia.
Difficulties encountered :None
Secondary effects observed:
During the trial, no secondary level was observed on the forearms of volunteers (red, edema, etc.).
The test on the productless series showed the will of mosquitoes to pick, the test is validated. The average effectiveness time, as defined in the WHO method, is described in Table 1.
Under the conditions of this test, with the sample provided, insect strains and method used, the textile treated. “100% cotton g/m2 bed sheet impregnated in a washing machine by the micro-encapsulated formulation: charging a dose of 120 ml showed full protection over 24 hours against mosquito bites, in laboratory conditions.
Regulatory and Toxicological Expertise Centre.
Conclusion of the evaluation
In accordance with section 10 of Regulation 1223/2009, and taking into account the elements of Part A and the experience gained on similar formulae and products, I believe that under the foreseeable normal and reasonable conditions of use, and subject to particular individual sensitivity, the repulsive Oil product NEOKIZ meets the requirements of Article 3 of Regulation 1223/2009 of 30 November 2009.
It does not have a proven toxic effect that could affect human health for normal or reasonably foreseeable use, including:
• its presentation, including the case of products that do not have the appearance of what they are (1)
• its labelling
• its instructions on use and disposal
• information from the responsible person
(1) Council Directive 87/357/EEC of 25 June 1987.
Warnings and instructions to be included on the label
In view of the composition of the cosmetic product, stability test results, warnings and instructions for use are as follows:
• Follow the directions.