AltTox Digest
June 2011

Cell-based Assay for Botox^© Potency Developed and Approved

In recent years, one of the most high-profile and controversial areas of animal testing has been the potency testing of products that contain botulinum neurotoxin, such Botox^©. The regulatory standard in this field has been the mouse LD₅₀ test, with death by paralysis and suffocation as the endpoint. Over 100,000 animals per year are estimated to be used in this test worldwide. Although botulinum toxin-based products have a growing list of therapeutic uses, their cosmetic application (temporarily smoothing certain facial wrinkles) represents by far the greatest clinical use. It is primarily the large use of animals in LD₅₀ testing for a cosmetic application that has fueled criticism of this testing.

The LD₅₀ potency testing for botulinum-based products has been the subject of an exposé, undercover investigation, a lawsuit, and shareholder resolutions, as well as scientific workshops and expert groups. [Full disclosure: The Humane Society of the United States, which co-manages AltTox, has been an advocate for progress in this arena.] Various efforts at refinement, reduction, and replacement of animal use in this test have been made, with noteworthy successes, but a full replacement method with regulatory approval has proven elusive. Moreover, the companies that market botulinum-based products are not necessarily using the same sub-type of neurotoxin nor using the same reference standard for LD₅₀ testing, so that any one replacement method may not be directly transferable among companies. This has resulted in a fragmentation of 3Rs efforts by the companies involved.

However, a major breakthrough has been achieved. As reported recently in the AltTox Forum during the same weekend that the development was announced publicly, Botox-manufacturer Allergan revealed that the company has developed a cell-based alternative to the mouse LD₅₀ test and has received U.S. Food and Drug Administration approval for the new method. The California-based company will begin using the procedure immediately in the product release phase of the manufacturing process and seeking regulatory approval in its overseas markets. As a result, Allergan expects to reduce its animal use by 95% within 3 years. The company also plans to discuss its new procedure (which is being written up for publication) with other manufacturers of botulinum-based products to see if the method can be tailored to those products. Kudos to Allergan for developing the new procedure, and to the FDA for approving it.

Thank You to our Sponsors!

Forum Postings

Some of the recent messages in the AltTox Forum include the following:

• Botulinum Neurotoxin (BoNT) Expert Working Group website at BfR established
• BOTOX: FDA approves Allergan's first in vitro, cell-based potency assay CBPA
• Embryonic stem cell test (EST) protocol available at Nature Protocols
• NRC Workshop: Mixtures and Cumulative Risk Assessment
• Funding for Skin Sensitization Test Provided
• AXLR8-2 Workshop Summary & Recommendations
• ECEAE publishes critique of EC report on status of alternatives for cosmetics
• Expressions of interest for REACH testing proposals sought
• FDA Releases Draft Guidance on Use of Nanotechnology
• White House Office of Science and Technology Policy Student Volunteer Program
• PDF of "Tox Testing in 21st Century" now available for free

Be sure to visit the AltTox Forum and respond to previous postings, or post a new message.

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New and Updated Information

The AltTox.org Management Team and Editorial Board strive to give the AltTox community the most up-to-date summary information related to non-animal methods of toxicity testing. Check out our latest material:

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• Toxicity Endpoints & Tests: Genotoxicity
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Upcoming Events

Here are some of the many upcoming events and deadlines listed on AltTox that may be of interest to the AltTox community:

• Application deadline for NC3Rs PhD Studentships for UK graduate students, July 13, 2011
• Chinese Society for Cell Biology: National Cell Biology Conference, July 15-18, 2011, Beijing, China
• Computer Aided Drug Design Gordon Research Conference, July 17-22, 2011, West Dover, Vermont, US
• NTP Board of Scientific Counselors Meeting, July 21, 2011, Research Triangle Park, North Carolina, US
• Society for Developmental Biology 70th Annual Meeting, July 21-25, 2011, Chicago, Illinois, US
• Single Cell Analysis, July 22-24, 2011, Cold Spring Harbor, New York, US
• Reduced Animal Testing, July 28-29, 2011, Zurich, Switzerland
• Cellular and Molecular Mechanisms of Toxicity Gordon Research Conference, August 7-12, 2011, Andover, New Hampshire, US
• 8th World Congress on Alternatives & Animal Use in the Life Sciences, August 21-25, 2011, Montréal, Quebec, Canada

More Events >>

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We welcome your participation in the AltTox Forum, as well as your comments and suggestions, which can be submitted by using the online Website Feedback survey, or by e-mailing info@AltTox.org. Please submit your suggestions for the Informational Resources or Events section to info@AltTox.org.

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