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As recommended by the LLNA Peer Review Panel, a retrospective data audit was conducted by a National Toxicology Program (NTP) independent quality assurance contractor on the intra- and inter-laboratory LLNA validation studies submitted by the Sponsors. The purpose of the audit was to provide an independent assessment of published test data provided in the submission for accuracy, consistency, and completeness as compared to the original study records.

The published results on individual chemicals were compared against the original laboratory records from the following participating laboratories:

• Zeneca Central Toxicology Laboratory, Cheshire, UK;

• Unilever Safety and Environmental Assurance Center, Bedforshire, UK;

• Procter & Gamble Company, Cincinnati, OH;

• ITT Research Institute (IITRI), Chicago, IL; and

• E. I. du Pont de Nemours, Inc., Newark, DE.

The pertinent data from each laboratory for one chemical from each of the three published papers provided below were reviewed for completeness and accuracy. The chemical evaluated is provided in parentheses.

• Kimber, I., J. Hilton, R. J. Dearman, G. F. Gerberick, C. A. Ryan, D. A. Basketter, E. W. Scholes, G. S. Ladics, S. E. Loveless, R. V. House, and A. Guy. 1995. An international evaluation of the murine local lymph node assay and comparison of modified procedures. Toxicology 103:63-73. (2,4-dinitrochlorobenzene [DNCB])

• Kimber, I., J. Hilton, R. J. Dearman, G. F. Gerberick, C. A. Ryan, D. A. Basketter, L. Lea, R. V. House, G. S. Ladics, S. E. Loveless, and K. L. Hastings. 1998. Assessment of the skin sensitization potential of topical medicaments using the local lymph node assay: An interlaboratory evaluation. J. Toxicol. Environ. Health 53:563-579. (penicillin-G)

• Loveless, S. E., G. S. Ladics, G. F. Gerberick, C. A. Ryan, D. A. Basketter, E. W. Scholes, R. V. House, J. Hiltong, R. J. Dearman, and I. Kimber. 1996. Further evaluation of the local lymph node assay in the final phase of an international collaborative trial. Toxicology 108:141-152. (sodium lauryl sulfate [SLS])

Minimal findings were identified in the audit report. Audit procedures and findings are presented in the quality assurance report on file at the National Institute of Environmental Health Sciences (NIEHS). The audit supports the conclusion that the transcribed test data in the submission were accurate, consistent, and complete as compared to the original study records.

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