In vivo testing

• intracutaneous reactivity on rabbits
• ocular irritation on rabbits
• skin irritation on rabbits
• skin sensitization in the guinea-pig
• skin irritation in a group of volunteers

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

Dermatological Testing on Human Volunteers

Clinical methods

• single application open epicutaneous test
• repeated application open epicutaneous test
• single application closed patch epicutaneous test under occlusion
• repeated application closed patch epicutaneous test under occlusion

Cosmetic Product Test Guidelines for Assessment of Human Skin Compatibility, Colipa, Bruxelles 1995 COLIPA = The European Cosmetic Toiletry and Perfumery Association)

· human repeated insult patch test (hypoallergenic claim)

· supporting study for the claim „intended for sensitive skin“

· supporting study for the claim "opthalmologically tested"

· anti-wrinkle testing (digital image analysis)

· supporting study for the claim "non-comedonic"

Guidelines for the Evaluation of the Efficacy of Cosmetic Products, Colipa, Bruxelles 1997

· determinatuion of SPF in vivo

Sun protection test methods – In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)

· determination of UVA-PF in vivo

Draft International Standard ISO/DIS 24442 (2010) Sun protection test methods - In vivo determination of sunscreen UVA protection

· determination of UVA-PF in vitro - spectrophotometry

International Sun Protection Factor (SPF) Test method - Colipa Guidelines, May 2006,
Determination of sunscreen UVA photoprotection in vitro, ISO/CD 24443, Draft 2009

• evaluation of phototoxicity - human photopatch test

Neumann, N.J. et al. (2000) Photopatch testing: The 12-year experience of the German, Austrian, and Swiss Photopatch Test Group. Journal of American Academy of Dermatology, 183-192.

Instrumental studies

· hydratation (moisturizing) studies – short term / long term

· sebumetry studies – short term / long term

· skin pH studies – short term / long term

· skin elasticity - long term

Guidelines for the Evaluation of the Efficacy of Cosmetic Products, Colipa, Bruxelles 1997. Instruments are the products of Courage-Khazaka, Germany or Nikon, Japan.

Chemical analyses

· determination of free and hydrolyzed formaldehyde - water extraction method (ČSN EN ISO 14184 -1:part 1)

· determination of pH of aqueous extracts

(ČSN 68 1504, ČSN 68 1507, ČSN 68 1512,ČSN 68 1513, ČSN ISO 11 609,
ČSN ISO 4045, ČSN EN ISO 3071)

· determination of aromatic amines derived from azo colorants

(ČSN EN ISO 14184-1, ČSN 62 1156)

· identification of aromatic amines derived from azo colorants (ČSN 621156)

· dimethylglyoxime spot test detecting nickel release

(Annex 10 of the German Federal Code, §11, Part 1, Bundesgesetzblatt,
Jahrgang 1992, Teil I, Anlage 10 zu §11)

· tests for colour fastness

- to perspiration – alcalic

– acidic

(ČSN EN ISO 105-E04)

- to dry / wet rubbing

(ČSN EN ISO 105-X12)

· test of resistance against saliva nad sweat

(Annex 1 of the Decree of the Ministry of Health CR No. 84/2001 Coll.)

· determination of extractable hexavalent chromium (Chromium ⁶⁺)

(modified method from EN 420, article 6.1.2)

· determination of Cr, Co, Ni, Cu, As, Cd, Pb and Hg in extract alcalic, acidic

(ČSN EN ISO 17294-1, ČSN EN ISO 17294-2, TNV 75 7440)

determination of heavy metals content in extract in 0.07M HCl

(ČSN EN 71/3)

· determination of the fluoride content in toothpastes

(by ion selective electrodes or isotachophoresis)