Ocular irritation test on reconstructed corneal epithelium
| 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. |
Eye tolerability test
| 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. |
Posted in Detergents, Claim for cosmetics, Ophthalmologically tested
In vitro short term exposure test
| Regulatory reference: | OECD n° 491 |
| Claim: | Non-irritant for the eyes (CLP Labeling) |
| 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. |
Patch test for the evaluation of the irritation potential on 3D reconstructed epidermis
| Regulatory reference: | OECD n° 439 |
| Claim: | Non-irritant for the skin |
| Application field: | Chemical substances or mixtures. |
| Description of the test: | Patch test for the 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. |
Quantification of the titer of substances
| 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. |
Evaluation of bacterial adhesion on mammal cells
| 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. |
Challenge Test
| 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). |
Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Make up, Moisturizers, Preservative systems, Claim for cosmetics, Claim for medical devices, Efficacy of preservatives
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