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Negative and positive control ranges in the bacterial reverse mutation test: JEMS/BMS collaborative study. 2018

Masayuki Kato, and Kei-Ichi Sugiyama, and Toshiro Fukushima, and Yasuyoshi Miura, and Takumi Awogi, and Shigetomo Hikosaka, and Kumiko Kawakami, and Madoka Nakajima, and Masato Nakamura, and Hajime Sui, and Kumiko Watanabe, and Atsushi Hakura
CMIC Bioresearch Center, CMIC Pharma Science Co., Ltd., Hokuto-shi, Yamanashi, 408-0044 Japan.

A large-scale study was conducted by multiple laboratories affiliated with the Japanese Environmental Mutagen Society and the Bacterial Mutagenicity Study Group to investigate possible proficiency indicators for the bacterial reverse mutation test with a preincubation procedure. Approximately 30 laboratories generated negative and positive control count data and dose-response curves of the positive control articles for the bacterial reverse mutation test, with assays conducted annually from 2013 to 2016. Overall, the majority of the negative and positive control counts for Salmonella Typhimurium strains TA100, TA1535, TA98, and TA1537, and Escherichia coli strain WP2uvrA, with and without S9 mix, were within the range of the means ±2× standard deviation. The negative counts were normally distributed (strains TA100, TA98, and WP2uvrA) or followed Poisson distribution (strains TA1535 and TA1537), and the positive control counts for all strains were approximately normally distributed. In addition, the distribution of the negative and positive control counts was relatively constant over the 4 years. The number of revertant colonies increased in a dose-dependent linear or exponential fashion up to the recommended doses for the respective positive control articles in Japan. These data are valuable for determining the acceptance criteria and an estimation of the laboratory proficiency for the bacterial reverse mutation test.

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