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In-Vitro Toxicology
Division

CPT℠ offers an array of non-animal (in-vitro) methodologies.

Whether you require safety data before proceeding with clinical testing or you are looking for stand-alone results, with our decades of in-vitro experience, we can provide rapid and reliable results.

In-vitro toxicology studies the effects of toxic chemical substances on cultured cells or micro-tissues. It is used primarily to identify potentially hazardous chemicals in the early stages of the development of new pharmaceuticals or cosmetics.

Our current In-Vitro Toxicology offerings are detailed below:

Eye Irritation Equivalency Assays

The table below attempts to correlate product types with irritation potential and the corresponding test methodologies. One or more of these methods is sure to be appropriate for your test article.

The EpiOcular EIT is an in-vitro assessment assay that has the ability to differentiate articles that are ocular irritants from articles that are not ocular irritants. The EIT is accepted as OECD TG 492.

The EpiOcular MTT ET-50 (Neat) method is a risk assessment assay based on the effective time at which a material (applied neat) causes a 50% reduction in tissue viability (ET-50). Based on the ET-50, the test article is categorized into one of 4 classifications ranging from non-irritating to severe/extreme which correspond to groupings of Rabbit Draize Eye Scores (MMAS).

The EpiOcular MTT ET-50 (Dilution) method is similar to the MTT ET-50 Neat method. This assay is based on the effective time at which a material (diluted to 20% in water) causes a 50% reduction in tissue viability (ET-50). Based on the ET-50, the test article is categorized into one of 4 classifications ranging from non-irritating to severe/extreme which correspond to groupings of Rabbit Draize Eye Scores (MMAS). This method is recommended for surfactant based solutions and is applicable to water-soluble materials with a specific gravity of > 0.95.

The EpiOcular Sub Draize Ultra-Mildness Test. This assay is routinely utilized for mild materials for which the Draize test is insensitive. This highly reproducible assay allows for quantifiable discrimination among mild, milder and mildest product formulations.

The HET-CAM (Hen’s Egg Test Chorio-Allantoic-Membran) assay was developed for irritation studies as an alternative method to replace the Draize ocular irritation test. It can be used to determine quickly, reliably and inexpensively, the ocular irritation potential of virtually all product types.

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Please Note: CPT℠ only performs testing for companies. We do not perform product testing for the general public.

Skin Irritation and Corrosion Equivalency Assays

The Skin Irritation Test (SIT) (accepted as OECD TG 439). This assay uses MatTek’s EpiDerm tissue to determine the skin irritation potential of liquids, solids, gels, lotions, ointments or creams.

The Skin Corrosion assay (accepted as OECD TG 431). This assay uses MatTek’s EpiDerm tissue to determine the skin corrosion potential of test articles.

In-Vitro International’s Corrositex is an assay that determines the corrosivity of articles and allows the assignment of Packing Group classification for Class 8 corrosives.

Oral and Vaginal Tissue Irritation Equivalency Assays

Mucosal and Gingival Irritation Assays
These assays use MatTek’s EpiOral™ or EpiGingival™ tissue are determine oral or gingival epithelial tissue viability and both correlate well to documented in vivo studies.

EpiVaginal Assay
This assay uses MatTek’s EpiVaginal™ tissue for the safety testing of articles, especially feminine hygiene products. The EpiVaginal tissue structure and cellular physiology closely parallel in vivo vaginal epithelial tissue, making it ideal for irritation testing.

Skin Lightening Assay

MatTek’s MelanoDerm™ assay is ideal for the assessment of skin lightening agents and formulations providing an inexpensive and effective means of assessing skin pigmentation. Simple protocols and the evaluation of early cellular endpoints allow the acquisition of data in days, not weeks or months.

In-Vitro and In-Chemico Skin Sensitization Assays

Skin sensitization testing was previously achieved through testing performed on animals or human subjects. Today several in-vitro and in chemico assays are used including Direct Peptide Reactivity Assay (DPRA) (OECD TG 442C), ARE-Nrf2 Luciferase Test Method (OECD TG 442D), and Human Cell Line Activation Test (h-CLAT) (OECD TG 442E), eliminating the need to test on animal or human subjects.