Antimicrobial Cleaning Product Testing Strategy

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2008-16 (US)

Short Name of TM:

Antimicrobial Cleaning Product Testing Strategy

Year received:

2008

Responsible Organisation:

ICCVAM/NICEATM - United States

General Comments:

Method Description

Testing strategy uses the bovine corneal opacity and permeability (BCOP), Cytosensor microphysiometer (CM), and EpiOcular (EO) test methods to determine EPA hazard category and labeling requirements.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Jan 2008	Assessment finalised	EPA collaborated with seven consumer product safety companies to develop a proposal for a testing strategy. The Institute for In Vitro Sciences, Inc. (IIVS) coordinated the collaboration and prepared a background review document describing the final approach. EPA and the consumer product companies requested that ICCVAM/NICEATM conduct a technical review of the AMCP testing strategy.

Validation

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Date	Stage	Comment	Documents/Links
Mar 2009	Finalised	ICCVAM and NICEATM evaluated the validation status of the AMCP testing strategy, including the performance of the three in vitro test methods: BCOP, CM, and EO.	ICCVAM Test Method Evaluation Report: Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products

Peer-review

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Date	Stage	Comment	Documents/Links
Jul 2009	Finalised	Before finalizing recommendations for federal agencies, ICCVAM considered the comments of an independent international scientific review panel and comments from the Scientific Advisory Committee on Alternative Toxicological Methods and the public. Although not recommended at the time, due to insufficient data to classify all four EPA ocular hazard categories, ICCVAM recommended future studies considered in the final EPA strategy released in 2013 and updated in 2015.	Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches (July 2009)

Recommendation

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Date	Stage	Comment	Documents/Links
Jun 2013	Published	EPA published an alternative testing approach using in vitro and ex vivo assays to determine the eye irritation potential in the U.S. EPA's Office of Pesticide Programs (OPP) (U.S. EPA/OPP) under the U.S. EPA classification and labeling system (U.S. EPA, 2013) that expanded use of the BCOP to identify EPA Category III irritants, in addition to Category I and II. A testing strategy using the BCOP, EO and CM test methods was proposed. This document was updated in 2015.

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Mar 2015	Published	EPA published guidance on the use of an alternative testing framework for classification of eye irritation potential of EPA pesticide products in 2013 and published an update in 2015 that expanded the applicability of the BCOP for all EPA hazard categories for AMCP eye irritants.	Use of An Alternative Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products