Bioscience Labs

Services | Clinical Safety Testing



Clinical Safety Testing

The Skin Technology Center offers a broad spectrum of clinical and in vitro safety testing services. In clinical safety testing, BSLI evaluates in-use safety of products by means of standard, validated protocols. Our clinical experts can also design custom protocols to support specific testing needs and claims. The high elevation and year-round low humidity of Bozeman, Montana provides an excellent environment for specialized skin studies.

In in vitro safety testing, the elimination of testing using animals, with the labor costs, expenses and social issues, is just one of the many benefits that BioScience Laboratories can provide. BSLI uses an in vitro methodology to evaluate cosmetics, surfactant-based products, pharmaceuticals and chemicals as well as, products for personal care, hair care, and household cleaning. In vitro safety testing uses tissue models prepared by the company leading the development of alternatives to animal testing methods.

BSLI tests the irritancy potential of topical antimicrobial products by means of multiple applications (15 or more) of a product beyond those necessary to demonstrate the antimicrobial efficacy of a healthcare personnel hand cleanser per the FDA Tentative Final Monograph [FR 43:4, 06 Jan 78, p. 1244]. We also conduct sensitization testing to support 510K submissions using a modified Draize testing protocol, as well as cosmetic and personal care products.

  • In-Use Product Testing
  • Acute Irritation
  • Cumulative Irritation Test
  • Sensory Irritation
  • Dermal Irritation
  • Ocular Irritation
  • Ocular Corrosion
  • Vaginal Irritation
  • Esophageal Irritation

Clinical Safety Testing Services

Sensitization Testing

BioScience Laboratories performs sensitization testing by the Modified Draize test in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing, December 1999.
Learn More

Cumulative Irritation Evaluations

BioScience Laboratories Skin Technology Center performs clinical evaluations for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry,
Learn More