Tests performed by Department of Biomedicine
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)