Regulatory reference: | OECD n° 492 |
Claim: | Non-irritant for the eyes |
Application field: | Chemical substances or mixtures. |
Description of the test: | Identification of chemical substances or mixtures that do not require classification as (severe) irritants through evaluation of their cytotoxic effects on an in vitro reconstructed corneal epithelium model. NOTE: if the sample qualifies as irritant, further tests are required in order to determine the degree of irritant action. |
Regulatory reference: | Guidelines to Commission Regulation (EU) No 655/2013 |
Claim: | Ophthalmologically tested |
Application field: | Children shampoos and body washes. |
Description of the test: | Ophthalmology experts evaluate the conditions of the eye surface and periocular region before and after 5 and 60 minutes of application of the diluted product. Self-evaluation of itching, burning, and irritaiton feeling. |
Regulatory reference: | OECD n° 491 |
Claim: | Non-irritant for the eyes (CLP Labelling) |
Application field: | Raw ingredients or finished products. |
Description of the test: | Short term exposure analysis by application of each tested substance on SIRC (Statens Seruminstitut Rabbit Cornea) cells for the determination of the effect on cell viability through MTT test. |
Regulatory reference: | OECD n° 439 |
Claim: | Non-irritant for the skin |
Application field: | Chemical substances or mixtures. |
Description of the test: | Evaluation of the irritation potential of chemical substances or mixtures through evaluation of their cytotoxic effect on an in vitro reconstructed model of human skin. |
Regulatory reference: | Regulation 1223/209 |
Claim: | Titer of substances and Limit of preservatives |
Application field: | Preservatives, dyes, sunscreen filters. |
Description of the test: | Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps. |
Regulatory reference: | Proprietary method |
Claim: | Inhibition of bacterial adhesion |
Application field: | Medical devices design to inhibit bacterial adhesion. |
Description of the test: | Evaluation of bacterial adhesion on mammal cells, performed on the CACO-2 cell line. |
Regulatory reference: | ISO 11930 for cosmetics; European Pharmacopoeia for medical devices |
Claim: | Efficacy of preservatives |
Application field: | Cosmetics and medical devices. |
Description of the test: | Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices). |