SERVICES

Assessment of the Safety IN VIVO

According to the Regulation (EC) no 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.
To this purpose specific studies are performed to protect both the manufacturer and the endconsumer.
After performing the toxicological evaluation and some in vitro preliminary tests, Bio Basic Europe can assess the tolerability of a cosmetic product with tests on human subjects. For this reason, our experts follow the ethical principles of the BIOMEDICAL RESEARCH described in the WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI (last update Seoul, October 2008).

SKIN IRRITATION TEST - Patch Test

Evaluation of the potential irritant effect of a cosmetic product according to the amended Draize method.

The aim of this test is to evaluate the tolerability of a cosmetic product by determining and classifying its potential irritant effect.

SKIN IRRITATION TEST - photopatch test

Evaluation of the potential irritant effect of a cosmetic product exposed to UVA and UVB radiations according to the amended Draize method.

The aim of this test is to evaluate the potential irritant effect of a cosmetic product exposed to UVA and UVB radiations according to the amended Draize method.

SKIN IRRITATION TEST - Open Patch Test

Evaluation of the potential irritant effect of a cosmetic product according to the amended Draize method.

The aim of this test is to evaluate the tolerability of a cosmetic product by determining and classifying its potential irritant effect.

HUMAN REPEAT INSULT PATCH TEST (96 HOURS)

Evaluation of the potential irritant effect of a cosmetic product and its potential sensitizing action.

The aim of this test is to evaluate the tolerability of a cosmetic product, through the identification and the classification of its potential irritant power and, at a preliminary level, also the potential pro-sensitizing power.

HYPOALLERGENICITY TEST

Evaluation of the potential of a cosmetic product to induce irritation or sensitization. This test is performed with repeated epicutaneous tests according to the amended Shelanski and Shelanski test (and its acceptability).

The aim of this test is to evaluate the tolerability of a cosmetic product by identifying its potential to induce irritation or sensitization (and to evaluate the acceptability of the investigated product).


The scope of this test is to evaluate the tolerability of a cosmetic product by identifying its potential to induce irritation or sensitization and to evaluate the acceptability of the investigated product.
This test may support the ‘hypoallergenic-low sensitization’ claim.




The scope of this test is to evaluate the tolerability of a cosmetic product by identifying its potential to induce irritation or sensitization and to evaluate the acceptability of the investigated product.
This test may support the ‘hypoallergenic-low sensitization’ claim.

PHOTO-HYPOALLERGENICITY TEST

Evaluation of the potential irritating or sensitizing power of a cosmetic product exposed to UVA and UVB radiations with repeated epicutaneous tests according to the amended Shelanski and Shelanski test.

The aim of this test is to evaluate the tolerability of a cosmetic product submitted to UVA and UVB radiations by identifying its potential irritant and/or sensitizing power (and to evaluate the acceptability of the investigated product).

HRIPT – HUMAN REPEAT INSULTED PATCH TEST

Dermatological Evaluation of Topical Compatibility
Primary and Accumulated Dermal Irritation and
Dermal Sensitivity

The aim of this test is to demonstrate the absence of irritation (Primary Dermal Irritation and Accumulated Dermal Irritation) and allergic potential (Accumulated Sensitivity) of a cosmetic product.

Determination of the sun protection factor SPF (ISO 24444:2011)

The test enables to determine the in vivo sun protection factor (SPF).

DETERMINATION OF WATER RESISTANCE OF A SUNSCREEN PRODUCT (Colipa Guidelines for Evaluating Sun Product Water Resistance, December 2005)

The aim of this assay is to determine the water resistance of a sunscreen product whose sun protection factor (SPF) is well-known and has been determined in accordance with UNI EN ISO 24444: 2011.

Determination of the sun protection factor (SPF) (FDA method- Final Rule 18th June 2012)

The assay includes 3 protocols that allow to determine the sun protection factor (in vivo tests), the determination of the broad spectrum protection (in vitro) and the in vivo determination of water resistance (40 minutes, 80 minutes) of sunscreen products (OTC).

CLINICAL TEST: EVALUATION OF THE NON COMEDOGENICITY

The scope of this test is to evaluate if the use of the investigated cosmetic product does not induce the occurrence of new closed and open comedones and/or does not worsen the status of comedones.

OPHTHALMIC TEST: EVALUATION OF THE OCULAR TOLERABILITY

The aim of this test is to evaluate if the investigated cosmetic product is well tolerated in the eye contour.

Dermo-cosmetic and medical R&D center