Cosmetic & Agrochemical Testing

Conform to REACH

In vitro tests for toxicity and permeability originally developed for the drug-discovery industry are highly applicable for other consumer products, most especially:

• Cosmetics
• Food and nutritional products
• Consumer chemicals
• Pesticides

Contact us to discuss how Apredica's in vitro testing services can assure the safety of your consumer product.

Technological advances since the late 1990s have created a toolset of in vitro assays that nearly completely substitutes for in vivo testing, allowing companies to identify problems with their chemicals more rapidly, accurately, and cost effectively than with previous animal models. Now, with the European consumer safety program REACH (Registration, Evaluation, and Authorization of Chemicals), these in vitro tests are no longer just a good business decision, they are a government mandate.

Relevant In Vitro Assays

The following assays have common applicability for non-pharmaceutical consumer chemicals:

• Permeability and absorption
• Genotoxicity
• Sub-lethal hepatotoxicity
• Liver metabolism: CYP inhibition/induction
• Skin irritation, other endothelial irritation
• Phototoxicity
• Hemolysis

Special Challenges of Consumer Chemicals

• Solubility challenges
• Chronic, frequently life-long, exposure
• Low concentrations of active agents

Apredica's Expertise with Consumer Chemicals

11% of Apredica's clients are using our assays to research the safety of non-pharmaceutical products. Examples:

• Agrochemicals - evaluation of toxins in animal feed
• Cosmetics - active components and final products liver safety evaluation
• Industrial chemicals - evaluation of potential for liver toxicity after chronic exposure to new pesticides

REACH (Registration, Evaluation, and Authorization of Chemicals)

REACH (Registration, Evaluation, and Authorization of Chemicals) is a European consumer safety program that affects manufacturers worldwide. REACH requires manufacturers to demonstrate the safety of their chemicals, providing hazard, use, and risk data before they are allowed to sell their products in the EU. REACH characterization requirements include evaluation of potential for:

• Carcinogenesis
• Mutagenesis
• Reproductive toxicity
• Persistence
• Bio-accumulation

Many of these issues can be addressed with in vitro methods well-established in the biopharma industry, such as those for genotoxicity.

Since 2009, the EU has enforced a marketing ban on cosmetic products tested on animals, with the exception of a few vital tests for which there are no suitable in vitro alternatives. These include repeat-dose toxicity, reproductive toxicity, and toxicokinetics. And these the EU has signaled are to be replaced when alternatives are developed and validated. For all other kinds of safety evaluation, the EU endorses the use of currently available in vitro alternatives that are provided by Apredica.

Contact us to discuss how Apredica's in vitro testing services can assure the safety of your consumer product.