Toxicology and ecotoxicologyA holistic approach to safety, from ingredients to end-products
The safety of ingredients for humans and the environment is of utmost priority. Safety is guaranteed with evaluations conducted from the early stages of a new ingredient’s development, right up to its placement on the market in accordance with current regulations. Monitoring takes place throughout the marketing process. Seppic takes a holistic approach to safety, from ingredients to end products.
Safety for humans and their environment is subject to a continuous process which starts in the early stages of an ingredient’s development by establishing its toxicological and ecotoxicological profile, including all the raw materials used in its manufacturing process. This early evaluation is an integral part of innovation, and helps to optimize the ingredient design – in particular by removing undesirable impurities.
An assessment of the potential hazard to health and the environment is then carried out before the ingredient is placed on the market, which also ensures compliance with chemical regulations. In Europe, this assessment is an integral part of the REACH regulatory dossiers.
Toxicological monitoring is in place to track ingredients placed on the market and anticipate scientific and regulatory developments.
An ecotoxicological monitoring is also carried out in order to follow and anticipate regulatory developments in the field of environmental risk assessment of our ingredients.
For the purpose of regulatory compliance and ethics, Seppic has developed its own in vitro strategy to evaluate the skin sensitizing potential of ingredients for topical, cosmetic and dermopharmaceutical applications. No one in vitro test today is able to effectively replace an in vivo test. Seppic has therefore implemented a sequential approach based on the combination of three models that take into account the key biological steps leading to the triggering of an allergic reaction (Adverse Outcome Pathway). This strategy, which minimizes the risk of "false negative" results, has been validated on ingredients known to be difficult to evaluate, such as surfactants or poorly soluble substances, and published in collaboration with experts in the in vitro models.
While responsibility for the safety of a formulation in which ingredients are added belongs to the person who places the finished product on the market, Seppic provides all toxicology data, as well as basic data on the tolerance of ingredients at the use dose. This is provided either in simple dilution in a suitable vehicle such as water or oil, or in minimalist formulations, to assist customers in the selection of ingredients and realization of their formulations.
During in vivo studies to evaluate the clinical efficacy of ingredients on volunteers, a formulation’s safety is first guaranteed by the existing data and the choice of concentrations used for each ingredient, according to the sectoral regulations on which the formulation depends.
In vitro models to guide customers in their formulations
Seppic is involved in developing innovative in vitro models to guide its customers in the pre-clinical phase on the most suitable ingredient, or the optimal dose, depending on the final application.
In vitro Approach to Assess Local Tolerance of Ingredients Dedicated to Specific Topical Care Applications
With cosmetic applications for example, Seppic, in partnership with IDEA Lab, developed a model of "immature" reconstructed human epidermis. This model, based on the use of epithelium with a reduced culture time, results in a thinner stratum corneum layer than for adult skins. Validated as being more sensitive to irritation phenomena, and combined with a specific risk analysis, this model provides information for the use of ingredients in formulas intended for young children or babies. Results were presented at a conference.
An in vitro model of impaired skin was developed in partnership with Vitroscreen to evaluate the tolerance of ingredients for dermopharmacy and medical devices. This reconstructed epidermis provides information on the behavior of an ingredient or formulation applied to skin with an impaired barrier function. This model was presented at a conference.
The impact of formulas on the environment
Seppic takes into account the environmental impact of its ingredients by generating data on their biodegradability and ecotoxicity, and by evaluating the percentage of readily biodegradable substances in prototype cosmetic formulas. This calculation, based on generated data, and data from literature, is available to customers.