Validation Study on Five Cytotoxicity Assays by JSAAE -- III. Quality of Collected Data Files

Takashi Omori1, Kaoru Saijo2, Mayako Kato2, Hiroshi Itagaki3, Makoto Hayashi4, Satoru Miyazaki5, Tadao Ohno2, Hideaki Sugawara5, Noriko Teramoto2, Noriho Tanaka6, Shinobu Wakuri6, and Isao Yoshimura1

1Department of Management Science, Faculty of Engineering, Science University of Tokyo, 1-3 Kagurazaka, Shinjuku-ku, Tokyo 162;
2RIKEN Cell Bank, The Institute of Physical and Chemical Research (RIKEN), 3-1-1 Koyodai Tsukuba Science City, Ibaraki 305;
3Shiseido Safety & Analytical Research Center, 1050 Nippa-cho, Kohoku-ku, Yokohama-shi 223;
4Division of Genetics and Mutagenesis, Mitamura Building, 26-1 Kaitaicho, Shinjuku-ku, Tokyo 112-0012 Japan 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158;
5Life Science Research Information Laboratory, The Institute of Physical and Chemical Research (RIKEN), 2-1 Hirosawa, Wako-shi, Saitama 351-01;
6Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano-shi, Kanagawa 257, Japan

Original paper :AATEX 5(1-2):59-73,1998
In the inter-laboratory validation study organized by JSAAE to evaluate the practicability of five cytotoxicity assays as feasible alternatives to the Draize eye irritation test, we have carried out thorough data cleaning before data analysis in order to be assured of the reliability and correctness of the results of the study, since so many errors on protocol understanding and data recording were found which were assumed to have primarily originated from the participating laboratories. We call these errors "human errors." In this article, various human errors were categorized and analyzed for their possible causes such as lack of description of serum that might have led to the use of mismatched serum types. Based on our experience on data cleaning, we also described proposals with key points that should be taken into consideration at the planning stage of further validation studies to assure the quality of data and to attain reliable results.

Key words: alternatives, cytotoxicity assay, colony formation assay, crystal-violet staining assay, Draize eye irritation test, inter-laboratory validation, LDH release assay, MTT assay, neutral red uptake assay, quality of data.