Consumer Products Toxicological Safety Assessments

BioScreen offers safety assessment by a board certified toxicologist for any product type. Safety assessments are suitable for use in the following areas:

  • EU registration
  • Documenting product safety in lieu of clinical testing
  • Adjuct to clinical testing

Ames Test

The Ames test is a biological assay to assess the mutagenic potential of chemical compounds A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen as cancer is often linked to mutation. However, a number of false-positives and false-negatives are known. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound since standard carcinogen assays on rodents are time-consuming (taking two to three years to complete) and expensive. The procedure is described in a series of papers from the early 1970s by Bruce Ames and his group at the University of California, Berkeley and work by Kristien Mortelmans at Stanford University.

Cytotocicty Testing

Cytotoxicity assays are widely used by the pharmaceutical and medical industry to screen for cytotoxicity in compound libraries or devices that come into contact with blood or cells. Researchers can either look for cytotoxic compounds, if they are interested in developing a therapeutic that targets rapidly dividing cancer cells, for instance; or they can screen "hits" from initial high-throughput drug screens for unwanted cytotoxic effects before investing in their development as a pharmaceutical.

In-Vitro Testing

The Irritection Assay System is a standardized, quantitative in-vitro test method that can be employed to detect, rank, and predict the ocular and/or dermal irritation potential of cosmetics, consumer products, pharmaceuticals, and chemical raw materials.

Why Use the Irritection Assay System?

  1. The Irritection Assay System provides a reliable alternative to the traditional animal tests of ocular and/or dermal irritancy tests.
  2. The Irritection assays are quantitative and highly reproducible, thus allowing comparative ranking of samples and formulations with great accuracy.
  3. Prior studies have demonstrated that the Irritection assay results are highly correlated with those obtained in standard Draize tests.

Ocular Irritection Assays
The corneal irritancy of test materials is known to be related to their propensity to promote denaturation and disruption of corneal proteins. The Ocular Irritection Assay System is an in vitro test method that mimics these biochemical phenomena. This test consists of two essential components:

  1. A membrane disc that permits controlled delivery of the test material to a reagent solution and;
  2. A proprietary reagent solution that is composed of proteins, glycoproteins, lipids and low molecular weight components that self-associate to form a complex macromolecular matrix. Controlled mixing of the test material and the reagent solution during the assay incubation period promotes protein denaturation and disaggregation of the macromolecular matrix.

The changes in protein structure that are induced by the test material may be readily quantitated by measuring the resulting changes in turbidity (OD405) of the reagent solution.

Comparison of these optical density measurements to those produced by standard chemical irritants permits calculation of an "irritancy score" that has been shown to be directly related to the potential corneal irritancy of the test material.

Dermal Irritection Assays
Chemicals that cause dermal irritation are known to induce alterations in the structure of keratin, collagen and other dermal proteins. The Dermal Irritection Assay System is an in vitro test that mimics these biochemical phenomena.

This test also consists of two components:

  1. A membrane substrate that has been modified by covalently crosslinking a mixture of keratin, collagen and an indicator dye to it and;
  2. A reagent solution consisting of a highly organized globulin/protein macromolecular matrix.

Application of an irritant chemical to the membrane disc disrupts the ordered structure of keratin and collagen and results in release of the bound indicator dye. Additionally, dermal irritants induce changes in conformation in the globular proteins found in the reagent solution.

The extent of dye release and protein denaturation may be quantitated by measuring the changes in optical density of the reagent solution at 450 nm (OD450).

Comparison of these optical density measurements to those produced by standard chemical irritants permits calculation of an "irritancy score" that has been shown to be directly related to the potential dermal irritancy of the test material.

Optisafe in vitro Ocular Irritation AssayTM

The OptiSafeTM in vitro ocular irritation test is a standardized and quantitative acute ocular irritation test method that can be used to determine the irritation potential of cosmetics, creams, shampoos, toiletries, cleaning agents and a wide variety of consumer products.

Why Use the the OptiSafe in vitro Ocular Irritation Test?

Animal testing of cosmetics and personal care products is discouraged in the U.S. and banned in Europe. The E.U. requires non animal safety testing and the FDA requires safety testing or a warning within the Principal Display Panel (PDP) that the product has not been tested. Since ocular non-irritants are also dermal non- irritants, OptiSafeTM is the best choice for single test screening. OptiSafeTM can be used  for:

  1. Satisfaction of FDA labeling requirements
  2. Due diligence to test whether the product is safe
  3. Product longevity: products that irritate do not last long in the marketplace

Test Description

OptiSafeTM Test:

  1. The product to be tested is applied to a semi-permeable membrane (”ocular membrane") which is a material developed to be similar to the layer of tissue on the outside of the cornea.
  2. When the sample moves through the ocular membrane, it contacts a macromolecular matrix. This matrix has one component that issimilar in structure and organization to macromolecules within the cornea and a second component that predicts damage to molecules related to the immune response and cell viability.
  3. Irritants induce a change in the optical density (measured with a spectrophotometer).
  4. The level of opacity and damage to specific molecules has been found to predict the sample’s irritation potential.

The  Advantages of OptiSafeTM include:

  • High Accuracy Ocular Irritancy Test
  • High Sensitivity for Mild and Moderate Irritants
  • Low Cost
  • Fast Results (standard 5 day turnaround time)
  • Neither uses nor harms animals
  • Satisfies minimal labeling requirements for Cosmetics, Personal Care and other Consumer Products.

The OptiSafeTM in vitro Assay Method has demonstrated value as a screening tool for a broad variety of consumer products.

HET-CAM Severe Ocular Irritation and Corrosion Assay

Early stage fertile hens eggs are used to determine if a substance is a severe ocular irritant or corrosive. Effects are measured by the onset of (1) hemorrhage; (2) coagulation; and (3) vessel lysis. The method followed is as described: NIH publication No. 10-7553- Published 2010: HET-CAM IS(A). Because early stage eggs are used this test is considered a non-animal test. This test can be used as a compliment to OptiSafeTM or as a standalone test to determine if a product is a severe ocular Irritant/corrosive.

Coming Soon (please inquire)

3T3 Neutral Red Uptake (3T3 NRU) Cytotoxicity Assay for the Identification of Substances not Requiring Classification for Acute Oral Toxicity

in vitro Dermal Irritation

  • Uses differentiated Human Skin Tissue grown in culture
  • Product to be tested is applied to differentiated Human tissue and cell viability is measured compared to the EpiskinTM , EpidermTM and SkinEthicTM test methods.
  • Anti-aging claims substantiation can be measured at the same time (see below).
  • Available February 2014


  1. Toxicol In Vitro. 1990;4(4-5):332-5.  An in vitro method for estimating ocular irritation.
  2. Soto RJ, Gordon VC.  Source: S. C. Johnson & Son, Inc., Racine WI and National Testing Corp., Palm Springs, CA, USA.
  3. Toxicol In Vitro. 1990;4(4-5):314-7.  Applications of the EYTEX method.  Gordon VC, Kelly CP, Bergman HC.  Ropak Laboratories, 16632 Milliken Avenue, Irvine, CA 92714, USA.
  4. Evaluation of the Eytex System for Use as a Predictor of Ocular Irritancy. I. Shampoos 1993, Vol. 12, No. 1 , Pages 35-47 (doi:10.3109/15569529309057657).  Denise Decker and Robert Harper  Helene Curtis, Inc., Chicago, Illinois
  5. Evaluation of the Eytex System for use as a Predictor of Ocular Irritancy: II. Conditioners and Styling Aids 1993, Vol. 12, No. 4 , Pages 371-380 (doi:10.3109/15569529309050153)  Denise Decker, Michelle Stemp and Robert Harper  Helene Curtis, Inc., 4401 W. North Avenue, Chicago, Illinois, 60639
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  7. Food Chem Toxicol. 1998 Jan;36(1):47-59.  A comparison of low volume, draize and in vitro eye irritation test data. II. Oil/water emulsions.  Gettings SD, Lordo RA, Feder PI, Hintze KL.  Cosmetic, Toiletry and Fragrance Association, Washington, DC 20036, USA.
  8. Food Chem Toxicol. 1996 Aug;34(8):737-49.  Comparison of low-volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations.  Gettings SD, Lordo RA, Demetrulias J, Feder PI, Hintze KL.  Cosmetic, Toiletry and Fragrance Association, Washington, DC 20036, USA.
  9. Toxicol In Vitro. 1999 Feb;13(1):45-72.  Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score.  Lordo RA, Feder PI, Gettings SD.  Battelle, Columbus, OH, 43201, USA.
  10. Toxicol In Vitro. 1999 Feb;13(1):209-17.  Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (11) EYTEX™.  Matsukawa K, Masuda K, Kakishima H, Suzuki K, Nakagawa Y, Matsushige C, Imanishi Y, Nakamura T, Mizutani A, Watanabe R, Shingai T, Kaneko T, Hirose A, Ohno Y.  Japan Cosmetic Industry Association, Hatsumei Bldg, 9-14 Toranomon 2-chome, Minato-ku, Tokyo, 105Japan; OPPEN Cosmetics Co., Ltd, 2-28-2 Shinzaike, Settu-shi, Osaka, 566Japan.
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  12. Cosmetics and Toiletries. 2012 July; Vol 127, No. 7 498-502. A Synthetic Tissue-Based in vitro Ocular Irritation Assay. Lebrun SJ