International regulatory agencies require that skin care products (topical drugs, cosmetics, personal care products or nutraceuticals…) available on the market do not cause damage to human health when applied under normal and reasonably foreseeable conditions of use. Adequate information must be readily available to demonstrate product safety and this information should be keep on file with all other studies supporting performance product claims. Such safety information could be based on the individual toxicity of ingredients but testing the final product is important and pertinent particularly in the following cases:
However, testing the final product may be pertinent and essential if:
- A new ingredient known to cause slight eye or skin irritation is present
- Significant modifications of the formulation have been made;
- The vehicle used in the formulation results in significantly greater skin penetration
- Interaction between ingredients is likely to result in the formation of a new, potentially toxic or irritant substance
- There is a specific safety claim
It is up to the manufacturers or distributors of new topically applied products on the market (active ingredient, formulation, cream, lotion, gel or device…) to ensure that adequate information may be provided for safety assessment. Let our professionals guide you in the selection of clinical studies and specific testing techniques.
Many options are available to support your product safety claims: No signs of skin irritation or sensitivity, Hypoallergenic (HRIPT), Dermatologist Tested, No signs of Eye Irritation, Ophthalmologist Tested, non phototoxic…
Antimicrobial Studies for Hand Sanitizers and Hand Rubs (In Vivo Study)
The aim of antimicrobial studies
for hand sanitizers and hand rubs is to determine the biocide activity of a product by measuring bacteria and fungus logarithmic reduction during a determined period of time.
RIPT/ HRIPT Hypoallergenic
(Repeat Insult Patch Test) or HRIPT (Human Repeat Insult Patch Test) method is used to assess the irritation, sensitization and contact allergy potential of a product.
The 48-hour patch test
allows the assessment of the primary irritation potential of a topical product. The test is conducted on a panel of at least 25 subjects. The patches used can be occlusive or semi-occlusive depending on the nature of the product.
Safety Assessment | Product Safety Report
According to the regulations ( EC) 1223/2009, the safety assessment
of a finished product requires elements…
A non-comedogenic test
evaluates the skin condition before and after one month of product usage. The evaluator counts the number of comedons and blackheads on the forehead, cheeks and chin.
A non-acnegenic test
evaluates skin condition before and after one month of product usage. The evaluator counts the number of acne lesions (papules and pustules) on the forehead, cheeks and chin.
For Sensitive Skin
A stinging test
allows to establish if a topical product is suitable for sensitive skin individuals.
The periocular tolerance test
allows to assess the irritation potential of a topical product applied on the eye contour area.
A comparative assessment of the test product to a reference “tear-free” product
is performed via self-evaluation questionnaire completed by study subjects.
The “Hen’s Egg Test ChorioAllantoic Membrane
” (HET-CAM) is an evaluation used prior to an ophthalmologist controlled study. This method evaluates the possible occurrence of vascular injury or coagulation after product application on a chorioallantoic membrane.
“Gentle” Product for Babies
The skin of study subjects is pre-treated with a chemical application to simulate babies’ skin properties
in terms of irritation, sensitivity and permeability. The skin condition is compared before and after product usage via different devices and/or by clinical evaluation.