Clinical trials of mouthwash PRANOYA

MICROBIOLOGICAL TEST

The study is accredited by RENAR and ILAC-MRA

CONFIRMED STANDARDS AND METHODS

SR EN ISO 16212: 2017 PSL 27
SR EN ISO 21149: 2017 PSL 01
SR EN ISO 22718: 2016 PSL 23
SR EN ISO 18416: 2016 PSL 26
SR EN ISO 21150: 2016 PSL 24
SR EN ISO 22717: 2016 PSL 25

CHALLENGE TEST

Accredited laboratory

Physical chemistry, PRANOYA ingredients

CONFIRMED STANDARDS AND METHODS

ISO 11930 standard

PHYSICAL CHEMICAL TESTS

Accredited laboratory

Physical chemistry, PRANOYA ingredients

CONFIRMED STANDARDS AND METHODS

Anton Paar - CONFORMABLEPB-234 ed. I of 03.10.2013r. - CONFORMABLE

ISO 6658 standard

DERMATOLOGICAL COMPATIBILITY TEST

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008. The dermatological study was performed on a sample of 25 people with a negative allergen history.Two assessments were made at 48 and 72 hours, respectively.The result of the study proved 0 (zero) allergenic reactions in all subjects tested.

STABILITY AND COMPATIBILITY IN VIEW OF DETERMINATION OF MINIMUM DURABILITY

THE STUDY IS CARRIED OUT, PROOF AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.“Guidelines on stability testing of cosmetic products, March 2004” (CTFA)Strictly tested with fluctuations 70 days. For the product, 2 stability studies were performed on both PET and HDPE.

Human Clinical Trials - UNDER DENTIST SUPERVISIONFor Cosmetic Dentistry and Natural Teeth

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008 The clinical study was performed over a period of 21 days with a sample of 10 people aged 18+.

Conclusions and results:

It was tested under supervision dentist ;The results of the tests concluded that the product is very good tolerated by all tested subjects, as a result there are no contraindications;Confirmed properties of the product following the clinical trial:

- The product offers a feeling of cleanliness- The product gives a feeling of freshness in the mouth- The product offers a hydrating sensation- The product helps to protect the condition of the oral cavity- The feeling of cleanliness and freshness lasts a long time after use- The product has a long-lasting invigorating effect- The product refreshes the breath- The product provides daily protection of the teeth- The product has adequate taste and consistency- The product is suitable for everyday use

SAFETY EVALUATION OF PRODUCT

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products ANNEX I