Conventional Test Method:

Acute Eye Irritation/Corrosion (Draize rabbit eye irritation test) (OECD TG 405)

Alternative Test Method:

Name & Description:

Bovine Corneal Opacity and Permeability (BCOP) Test Method

Exposes isolated bovine cornea (obtained from slaughterhouses) to the test substance; evaluates permeability to fluorescein dye  and the change in transmission of light through the cornea (corneal opacity) to determine the irritation or corrosion potential of a substance.

Validation Status:

OECD: Validated

EU: Endorsed as valid by ESAC (2007)

US: Endorsed as valid by ICCVAM (2007)

Regulatory Status:

OECD: TG 437 (2013)

EU: Accepted for use to positively identify and label substances as severe eye irritants (R41) (2002)

US: Accepted as a screening test to detect ocular corrosives and severe irritants in a tiered testing strategy (2008)

Effect or Potential Effect on Animal Use:

Reduction
(Substances identified as irritants by test will not progress to animal testing)

References:

• ECVAM (2007) ESAC statement on the conclusions of the ICCVAM retrospective study on organotypic in vitro assays as screening tests to identify potential ocular corrosives and severe irritants as determined by US EPA, EU(R41) and UN GHS classifications in a tiered testing strategy, as part of a weight of evidence approach.
• NICEATM-ICCVAM (2008) In vitro test methods for detecting ocular corrosives and severe irritants.
• NICEATM (2006) Current status of in vitro test methods for identifying ocular corrosives and severe irritants: Bovine Corneal Opacity and Permeability test method (background review document).
• NICEATM (2006) ICCVAM test method evaluation report: in vitro ocular toxicity test methods for identifying severe irritants and corrosives.
• OECD (2011) Guidance Document on the Bovine Corneal Opacity and permeability (BCOP) and Isolated Chicken Eye (ICE) Test Methods: Collection of tissues for histological evaluation and collection of data on non-severe irritants, Series on Testing and Assessment No. 160.
• ECVAM DB-ALM (2009) Bovine Corneal Opacity and Permeability (BCOP) Assay INVITTOX no 127.
• OECD (2013) Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.

Information Last Reviewed:

June 2014