Assessment of the Safety IN VITRO/INSTRUMENTAL
According to the European Regulation (EC) n. 1223/2009, a cosmetic product put on the market within the community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. This Regulation forbids the animal testing both for the finished product and the raw materials used in the production of these cosmetic products. In order to comply with such Regulation, specific in vitro tests are performed to protect both the manufacturer and the consumer, and, differently from the animal testing, it allows to carry out experimentations without limits in number and in conditions of greater control and standardization, as well as to adopt quantitative and objective measurements.
After doing the toxicological evaluation, Bio Basic Europe can assess the safety of a cosmetic product with in vitro essays on skin cell lines. Such tests are performed by professionals of the field in specialized laboratories and university institutes.
DETERMINATION OF THE NICKEL CONCENTRATION
The aim of this test is to determine nickel concentrations in a cosmetic product in order to verify its presence within the limits establishe and to exclude the potential pro-sensitizing effect. A nickel conentration <1ppm grants that the investigated product doesn't have any pro-sensitizing effect. The test is carried out through EPA 3051A + EPA 6010C.
MTT – IN VITRO EVALUATION OF THE CYTOTOXICITY WITH AN ASSAY ON FIBROBLASTS/KERATINOCYTE CELL CULTURES (UNI/EN ISO 10993-5)
This test, carried out according to the UNI EN ISO 10993-5 standard, evaluates the potential release of cytotoxic substances of a medical device/cosmetic product.
NRU - EVALUATION OF THE POTENTIAL SKIN/OCULAR IRRITATION WITH AN IN VITRO CYTOTOXICITY TEST ON KERATINOCYTES/FIBROBLASTS (UNI EN ISO 10993-5)
The NRU Test - Neutral Red Uptake – is performed to evaluate the toxicity of a cosmetic product/medical device on keratinocyte cell cultures and to establish the tolerability (potential skin/ocular irritation) of a product when applied on skin or mucosa.
IN VITRO 3T3 NRU PHOTOTOXICITY TEST (OECD 432)
This assay (performed according the OECD 432) enables to assess the phototoxicity of a product, that’s to say if the product has a toxic action after a light exposure on BALB/C 3T3 murine fibroblasts cell cultures.
The purpose of the test is the simulation of exposure to solar radiation (UV, Visible and IR) of cosmetic products to verify the stability of the color and any other organoleptic properties. The reference standard for exposure is ISO 16474-2.
The test allows to evaluate, in vitro, the color stability of the tested product by subjecting it to accelerated aging and radiation (as close as possible to the total radiation level of the sun at the Zenith as defined by COLIPA or DIN67501.
STABILITY TEST (SHELF-LIFE)
The test allows to evaluate, in vitro, the stability of the chemical-physical and organoleptic-microbiological characteristics of a medical device / cosmetic product by subjecting it to accelerated aging conditions that simulate, in vitro, the natural aging of the product itself.
HEAVY METAL ANALYSIS (As, Ni, Cr, Pb, Hg, Cd, Co, Sb)
The toxicological profile of heavy metals is well known. As we know, human beings suffer from various effects caused by heavy metals as: sensitizing effect (Ni), effects on the nervous system (Pb, Hg), effects on liver (Pb), effects on kidneys (Pb, Hg), on hematopoietic system (Pb), on circulatory and lung systems (Sb). The aim of this test is to assess the quantity of heavy metals contained in the product in order to verify its presence within the limits permitted. The methods used are EPA3051A, EPA6010C, and for Chromo, ISO 17294-2.
DETERMINATION OF HEXAVALENT CHROMIUM (Cr VI)
The determination of hexavalent chromium (Cr VI) is important in order to check the carcinogenic properties in this oxidation state. The test is performed according to the methods: EPA3060A + APAT CNR IRSA 3150C.
HCHO FORMALDEHYDE ANALYSIS
The formaldehyde is treated as an impurity in cosmetic products and is conseidered carcinogenic ( IARC classification group 1 from 2004) and, thus, limited. The aim of this test is to determine the concentration of formaldheyde in the investigated product in order to verify its presence within the limits accepted (0.2% and 0.1% in oral care products, forbidden in aerosol, but not in foams, 5% in nail polish products).
DETERMINATION OF ALUMINUM SESQUICHLOROHYDRATE
The aluminum sesquichlorohydrate is used in cosmetic products as an antitranspirant. The aim of this test is to assess the quantities used in order to verify whether its presence is within the limits or not. Its determination is performed through EPA3051A +EPA6010C and APAT CNR IRSA 4090 methods.
DETERMINATION OF SILICONE OIL
The aim of the test is to verify the compliance with the standard concentration of silicone oil that ensures the flow of the syringe plunger and avoid pollution phenomena.
The determination of the silicone oil is made according to the official method of the European Pharmacopoeia.
EVALUATION OF ANTIDANDRUFF ACTIVITY
In order to assess the antidandruff action of the investigated product it is evaluated its antimicrobial efficacy towards Malassezia furfur (belonging to the normal microbial flora of sculp) whose excessive proliferation causes the appearance of dandruff.
EVALUATION OF THE ANTIBACTERIAL ACTIVITY
In order to evaluate the capacity of the investigated product of keeping under control the bacterial charge, it is evaluated the antimicrobial efficacy towards specific microorganisms (chosen on the basis of the product type, on its purpose and instructions for use of the product itself).
THE MICROBIOLOGICAL IN-USE TEST
In order to get realistic data on the efficacy and stability of the preservative properties (in terms of microbial contamination) of a cosmetic product in the post-production phase and during the usage, it is performed the In-Use test. The cosmetic product (in its final pack or something really similiar) is given to a panel of consumers so that they can use it for a determined period. The total microbial count is performed before and after its use in order to evaluate the entity of the microbial contamination during the usage.
CHALLENGE TEST- EVALUATION OF THE PRESERVATIVE SISTEM
The aim of this test is to evaluate the preservative system of the investigated cosmetic product. The determination of the efficacy of the preservative system is assessed through its microbiological stability at pre-set time intervals in response to the contamination with standardize microoganism strains.
The test can be carried out according to:
USP- Chapter 51
AEROBI MESOFILE BACTERIAL COUNT (UNI EN ISO 21149) / YEAST AND MOLDS COUNT (UNI EN ISO 16212)
The evaluation of the microbial contamination of a cosmetic product is a very important aspect for the consumer's health. The cosmetic product must be characterized by the limited presence of microorganisms. To this purpose, it is carried out a research in bacteria, yeast and fungi and, if contamination is detected, it is possible to identificate pathogenic microorganisms.
Medical devices such as needles and syringes must be sterilized before use.
The test is performed according to the guidelines of the Italian and European Pharmacopoeia.
DETERMINATION OF SUNSCREEN UVA PHOTOPROTECTION IN VITRO (ISO 24443)
This International Standard specifies an in vitro procedure to determinate the UVA protection of sunscreen
The test is based on the assessment of UV-transmittance through a thin film of sunscreen product spread on a rough substrate (PMMA plates), before and after exposure to a controlled dose of radiation from a defined UV exposure source.
A series of calculation allow to determine the static SPF value, the UVAPF value (UVA protection), the SPF/UVAPF value and the critical wavelength.
DETERMINATION OF THE SUN PROTECTION FACTOR AND OF THE WATERRESISTANCE ACCORDING TO THE AUSTRALIAN/NEW ZEALAND STANDARD (AS/NZS 2604)
This Standard sets out procedures for determining the performance of sunscreen products in terms of their mean protection factors. It includes test methods for both broad-spectrum and water-resistant sunscreen products.