CPTC for In-Vitro Pre-Clinical Safety

7-Dec-2016

CPTC specialises in In-Vitro Pre-Clinical Safety for our ongoing Personal Care and Cosmetic clients. This in-vitro program for dermal and ocular irritation screening of products has been a critical part of the division’s focus for the last ten years.

• Skin Irritation Compliant with OECD TG 439

The EpiDerm Skin Irritation Test (SIT) is a formally validated in vitro method for the accurate and reliable prediction of articles that are either irritating to the skin or non-irritating to the skin.  This test method can be used as an in vitro alternative to animal skin irritation testing.

The EpiDerm test system is used to determine the skin irritation potential of articles including liquids, solids, gels, lotions, ointments or creams. Results for skin irritation potential are available within 72 hours of test initiation.

The skin irritation potential of the articles are determined based the viability of the EpiDerm tissue. An irritant is predicted if the mean relative tissue viability of the tissues exposed to a test article is reduced below 50% of the average viability of the negative controls. This according to the EU and GHS classification (R38 / Category 2 or no label).

• Skin Corrosion Compliant with OECD TG 431

The EpiDerm Skin Corrosion Test (SCT) is a formally validated in vitro method for the accurate and reliable prediction of chemicals that are either corrosive to the skin or non-corrosive to the skin.  This test method can be used for the classification of skin corrosion hazard according to the GHS System.

The EpiDerm test system is used to determine the skin corrosion potential of articles including liquids, solids, gels, lotions, ointments or creams. Results for skin corrosion potential are acquired within 24 hours of test initiation.

• Ocular Irritation Compliant with OECD TG 492

The EpiOcular Eye Irritation Test (EIT) is a formally validated in vitro which can predict the acute eye irritation potential of an article by the measurement of the article’s effect on the EpiOcular tissue.

Regulatory purposes:  as a test within a test battery and/or integrated testing strategy (replacement of the Draize Eye Irritation Test according to Method B.5 of Annex V to Directive 67/548/EEC or OECD TG 405). Approved as new OECD TG 492.

This assay has the ability to differentiate articles that are either ocular irritants or not ocular irritants. The EIT is applicable to a broad range of organic and inorganic chemicals.

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