Summarized data of genotoxicity tests for designated food additives in Japan

Masami Yamada,Masamitsu Honma

doi:10.1186/s41021-018-0115-2

Masami Yamada, Masamitsu Honma

Open Access

https://doi.org/10.1186/s41021-018-0115-2

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Abstract

The Ministry of Health, Labour and Welfare has carried out genotoxicity tests for food additives used in Japan in cooperation with the Japan Food Additives Association since 1979. Hayashi et al. summarized these data and published a list of 337 designated additives (Shitei-tenkabutsu in Japanese) with genotoxicity test data in 2000. Thereafter, 29 items were eliminated, and 146 items were newly added. Currently, 454 designated additives are allowed to be used as food additives in Japan. This report, based on the Hayashi report, covers the addition of newly derived genotoxicity test data. Routinely, the bacterial reverse mutation test (Ames test), mammalian cell chromosomal aberration test, and in vivo rodent bone marrow micronucleus test have been used for the evaluation of genotoxicity of food additives. In addition to the data from these tests being updated in this report, it newly includes results of transgenic rodent somatic and germ cell gene mutation assays (TGR assays), incorporated in the Organisation for Economic Co-operation and Development (OECD) test guidelines after 2000. We re-evaluated the genotoxicity of 13 designated food additives considering their TGR data.

Highlights

Since 1979, as part of the safety reassessment of food additives, the Ministry of Health, Labour and Welfare (MHLW; prior to January 2001, the Ministry of Health and Welfare) has carried out mutagenicity tests annually in cooperation with the Japan Food Additives Association
Chromosomal abnormalities in chromosomal aberration tests are observed as morphological abnormalities in chromosomes during the interphase of cell division because damaged DNA is not normally replicated and the abnormalities persist
Such structural abnormalities are lethal for cells in many cases, and the majority of chromosomal abnormalities are not inherited by the generation

Summary

Background

Since 1979, as part of the safety reassessment of food additives, the Ministry of Health, Labour and Welfare (MHLW; prior to January 2001, the Ministry of Health and Welfare) has carried out mutagenicity tests annually in cooperation with the Japan Food Additives Association. In FY2009, TGR testing using gpt delta mice was performed in the liver and glandular stomach for confirmation of in vivo mutagenicity; the results were negative in both organs following oral gavage for 28 days at a maximum dose of 1000 mg/kg body weight [H22(FY2010)]. 4) Five items for which the Ames test was negative 1-Methylnaphthalene In FY2005 this substance was reported to have induced structural abnormalities in a chromosome aberration test using CHL cells [H17(FY2005)] while in vivo bone marrow micronucleus testing conducted in FY2006 reported negative results in a two-dose study of 1000 mg/kg body weight at the maximum [H18(FY2006)]. TGR tests using gpt delta mice were carried out and the results were negative for mutagenicity in the large intestine following oral gavage for 28 days at doses of 250, 500 and 1000 mg/kg body weight [H23(FY2011)] From the above, it seems that there is no concern of genotoxicity of Food Red No 40 for living bodies. There are no concerns that Food Red No 105 induces genotoxicity (mutagenicity) in vivo

Discussion

Availability of data and materials Not applicable