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

In-vitro Eye 

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. 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 
  • 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. 

EpiOcularTM OECD 492 

The OptiSafeTM in vitro Acute Ocular Irritation Test Method is a standardized, comprehensive and quantitative acute ocular irritation test system that predicts ocular irritation based on a substance's potential for macromolecule disruption.

Short Time Exposure OECD 491

The STE test method is a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells. After exposure to a test chemical, the cytotoxicity is quantitatively measured as the relative viability of SIRC cells using the MTT assay. Decreased cell viability is used to predict potential adverse effects leading to ocular damage.

CAMVA

The CAMVA employs the vascularized membrane of a fertile hen's egg to assess eye irritation potential. This irritation potential is a function of alterations in the vasculature following the administration of test material.

BCOP OECD 437

The BCOP test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test chemical is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an IVIS, which is used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of a test chemical.

ICE OECD 438 

The ICE uses otherwise discarded chicken eyes that are enucleated and mounted in an eye holder with the cornea positioned horizontally. The test chemical and negative/positive controls are applied to the cornea. Toxic effects to the cornea are measured by a qualitative assessment of opacity, a qualitative assessment of damage to epithelium based on fluorescein retention, a quantitative measurement of increased thickness (swelling), and a qualitative evaluation of macroscopic morphological damage to the surface. The endpoints are evaluated separately to generate an ICE class for each endpoint, which are then combined to generate an Irritancy Classification for each test chemical.

 

In-vitro Derm 

EpiDermTM SIT

The RhE test system uses human derived non-transformed keratinocytes as cell source to reconstruct an epidermal model with representative histology and cytoarchitecture.

 

DermaSafe RHETM Follows OECD Guidance 439

The DermaSafeTM RHE Test Method is consistent with the guidance document for Reconstituted Human Epithelium. The test is similar to the other Reconstituted Human Epithelium tests; the DermaSafeTM RHE Test Method incorporates non-transformed human keratinocytes (epithelial skin cells) differentiated into four layers of the human epidermis, basal, spinous and granular layers, with a functional stratum corneum. Mature RHE models are evaluated for specific characteristics including barrier function, morphology, sterility and response to quality controls according to OECD 439 (Skin Irritation) standards. RHE tissues that pass quality assurance are used to determine test substance irritation potential. The tissues can also be used for other test objectives, including genetically based claims substantiation.

EpiDermTM SCT ECVAM Protocol for EPIDERM (EPI-200)

The RhE test method is based on findings that chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the cells in the underlying layers. Cell viability is measured by enzymatic conversion of the vital dye MTT, into a blue formazan salt that is quantitatively measured after extraction from tissues. Corrosive chemicals are identified by their ability to decrease cell viability below defined threshold levels. The RhE-based skin corrosion test methods have shown to be predictive of in vivo skin corrosion effects assessed in rabbits according to the OECD guideline 404.

EpiDermTM (PGA) packing group assignment

The test is designed to predict and classify the skin corrosivity potential of a chemical by assessment of its effect on a reconstituted three-dimensional human epidermis which can be used to predict packing groups. 

DermaSafe RHETM Follows OECD 431

The DermaSafeTM RHE Test Method is consistent with the guidance document for Reconstituted Human Epithelium. The test is similar to the other Reconstituted Human Epithelium tests; the DermaSafeTM RHE Test Method incorporates non-transformed human keratinocytes (epithelial skin cells) differentiated into four layers of the human epidermis, basal, spinous and granular layers, with a functional stratum corneum. Mature RHE models are evaluated for specific characteristics including barrier function, morphology, sterility and response to quality controls according to OECD 431 (Skin Corrosion) standards. RHE tissues that pass quality assurance are used to determine test substance corrosion potential. 

KeratinoSensTM  OECD 422D

The ARE-Nrf2 luciferase test method makes use of HaCaT human keratinocytes stably transfected with a selectable plasmid. The cell line contains the luciferase gene under the transcriptional control of a constitutive promoter fused with an ARE element from a gene that is known to be up-regulated by contact sensitizers. The luciferase signal reflects the activation by sensitizers of endogenous Nrf2 dependent genes, and the dependence of the luciferase signal in the recombinant cell line on Nrf2 has been demonstrated. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test substances.

Oral Toxicity

Acute Oral Toxicity Range-finding. OECD 24

The NRU in vitro basal cytotoxicity assay procedure is based on the ability of viable cells to incorporate and bind neutral red (NR), a supravital dye. NR is a weak cationic dye that readily diffuses through the plasma membrane and concentrates in lysosomes where it electrostatically binds to the anionic lysosomal matrix. Toxicants can alter the cell surface or the lysosomal membrane to cause lysosomal fragility and other adverse changes that gradually become irreversible. Such adverse changes cause cell death and/or inhibition of cell growth, which then decrease the amount of NR retained by the culture. Since the concentration of NR dye desorbed from the cultured cells is directly proportional to the number of living cells, cytotoxicity is expressed as a concentration-dependent reduction of the uptake of NR after chemical exposure. The NRU assay uses a 96-well plate format for the production of replicate measurements at eight test substance concentrations.