Genotoxicity of flavoring agents

Kasamaki, Akiko; Takahashi, Hiroki; Tsumura, Noritoshi; Niwa, Jun; Fujita, Tatsuya; Urasawa, Shozo

doi:10.1016/0165-7992(82)90181-6

Cited by 97 publications

(73 citation statements)

References 4 publications

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“…In order to determine whether the conclusion for the 44 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: The EFSA Journal (2008) 637, 17-69 The EFSA Journal (2008) 637, 18-69 (Ishidate et al, 1984) Reverse mutation S. typhimurium TA98, TA100 > 500 mg/plate Negative b (Kasamaki et al, 1982) Chromosomal aberration…”

Section: Resultsmentioning

confidence: 99%

“…Mixed results were reported with paramethoxybenzaldehyde and vanillin in assays for sister chromatid exchange in several Chinese hamster cell lines and in human lymphocytes (Jansson et al, 1986;Jansson & Zech, 1987;Jansson et al, 1988 (Kawachi et al, 1980a;Kawachi et al, 1980b;Sasaki et al, 1987;Jansson et al, 1988 (Kawachi et al, 1980a;Kawachi et al, 1980b;Kasamaki et al, 1982;Ishidate et al, 1984;Kasamaki & Urasawa, 1985;Jansson & Zech, 1987 .019] in the assay for forward mutation in L5178Y mouse lymphoma cells, both with and without metabolic activation (Garberg et al, 1988;Wangenheim & Bolcsfoldi, 1988;Heck et al, 1989). Vanillin .018] and piperonal .016] were inactive in this assay (Heck et al, 1989).…”

Section: In Vitromentioning

confidence: 96%

“…The hydroxy-and alkoxy-substituted benzyl derivatives were not mutagenic in standard assays for reverse mutation with plate incorporation and/or preincubation in Salmonella typhimurium strains TA92, TA94, TA97, TA98, TA100, TA102, TA104, TA1535, TA1537, TA1538, and TA2637, at concentrations ranging up to those that are cytotoxic or at maximum test concentrations recommended by ICH/OECD, in the absence and presence of metabolic activation (S9) (White et al, 1977;Sasaki & Endo, 1978;Douglas et al, 1980;Florin et al, 1980;Kawachi et al, 1980a;Kawachi et al, 1980b;Nestmann et al, 1980;Rapson et al, 1980); and (Kasamaki et al, 1982;Pool & Lin, 1982;Sekizawa & Shibamoto, 1982;Haworth et al, 1983;Wild et al, 1983;Ball et al, 1984;Ishidate et al, 1984;Haresaku et al, 1985;Nagabhushan & Bhide, 1985); and (Mortelmans et al, 1986;Fujita & Sasaki, 1987;Heck et al, 1989;Watanabe & Morimoto, 1989c;Dillon et al, 1992;Müller et al, 1993;King & Harnasch, 1997;Dillon et al, 1998)). An assay for mutation in S. (Szybalski, 1958;Sekizawa & Shibamoto, 1982;Ohshima et al, 1989;Watanabe & Morimoto, 1989c;Takahashi et al, 1990) (Oda et al, 1979;Kawachi et al, 1980a;Kawachi et al, 1980b;Sekizawa & Shibamoto, 1982).…”

Section: In Vitromentioning

confidence: 99%

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Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy‐ and alkoxy‐substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000) ‐ Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC)

2008

EFS2

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The present consideration concerns 44 hydroxy-and alkoxy-substituted benzyl derivatives evaluated by JECFA (57 th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 35 benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated in the Flavouring Group Evaluation 20 (FGE.20). The Panel concluded that the 44 substances in the JECFA flavouring group of hydroxy-and alkoxysubstituted benzyl derivatives are structurally related to the group of benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in the FGE.20.Further two substances were evaluated by the JECFA in this group but are not in the Register (2-methoxybenzoic acid and ethyl vanillin propylene glycol acetal) and therefore not dealt with in this consideration.The Panel agrees with the application of the Procedure as performed by the JECFA for 43 of the 44 substances considered in this FGE. For butyl 4-hydroxybenzoate ] additional data would be required before it can be evaluated as a flavouring substance, using the Procedure.For eight substances 08.071, 08.076, 08.092, 09.145, 09.754, 09.807 and 16.075] the JECFA evaluation is only based on Maximised Survey-derived Daily Intake MSDI values derived from production figures from the USA. EU production figures are needed in order to finalise the evaluation of these substances.For all 44 substances use levels are needed to calculate the modified Theorical Added Maximum Daily Intake (mTAMDI) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.In order to determine whether the conclusion for the 44 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:Adequate specifications are available for 40 of the 44 JECFA evaluated substances. For four substances 09.087, 09.751 and 09.763] further information on specifications are requested.Thus, for 12 substances 06.132, 08.071, 08.076, 08.092, 09.087, 09.145, 09.751, 09.754, 09.763, 09.807 and 16.075] the Panel has reservations (only USA production volumes available and/or missing data on specifications and/or isomerism/composition). For one of these 12 substances, butyl 4-hydroxybenzoate .754], the Panel concluded that additional data would be required before it can be evaluated as a flavouring substance using the Procedure. For the remaining 32 JECFA evaluated hydroxy-and alkoxy-substituted benzyl derivatives 02.165, 02.213, 04.094, 05.015, 05.016, 05.017, 05.018, 05.019, 05.047, 05.055, 05.056, 05.091, 08.040, 08.043, 08.112, 09.019, 09.035, 09.058, 09.220, 09.430, 09.706, 09.713, 09.714, 09.748, 09.749, 09.750, 09.752, 09.753, 09.796, 09.811 and 09.933] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substance" based on the MSDI approach. KEYWORDSHydroxy-and alkoxy-substituted benzyl derivatives, JECFA 57 th meeting, FGE.20, butyl ...

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Section: Resultsmentioning

confidence: 99%

Section: In Vitromentioning

confidence: 96%

Section: In Vitromentioning

confidence: 99%

See 1 more Smart Citation

Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy‐ and alkoxy‐substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000) ‐ Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC)

2008

EFS2

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“…typhimurium TA97; TA102 1000 µg/plate Negative 1 (Fujita et al, 1992) Ames test S. typhimurium TA98; TA100 0.05 to 500 µg/plate Negative 1 (Kasamaki et al, 1982) Published non-GLP study with insufficient report of some details of method and results. Thus, the validity of the study cannot be evaluated.…”

Section: Sister Chromatid Exchange Assaymentioning

confidence: 99%

“…Although some details of results are not reported the study is considered valid. EFSA Journal 2010; 8(7):1405 (Kasamaki et al, 1982) Published non-GLP study with insufficient report of some details of method and results. Thus, the validity of the study cannot be evaluated.…”

Section: Chromosomal Aberration Testmentioning

confidence: 99%