Mutagenicity tests with gallic and tannic acid in the<i>salmonella</i>/mammalian microsome assay

Rashid, Kamal A.; Baldwin, Ian Thomas; Babish, John G.; Schultz, Jack C.; Mumma, Ralph O.

doi:10.1080/03601238509372473

Cited by 20 publications

(11 citation statements)

References 20 publications

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“…Tannic acid was not mutagenic in five bacterial reverse mutation tests (Mohtashamipur and Norpoth, 1984;Rashid et al, 1985;Nagabhushan et al, 1991;Watanabe et al, 1998;Chen and Chung, 2000) and one SOS chromotest in E. coli (Kevekordes et al, 1999). Positive results for mutagenicity were obtained in some in vitro tests in mammalian cells, including comet assays (Chu, 2002) and tests for chromosomal aberrations (Stich and Powrie, 1982;Stich and Dunn, 1986) and micronuclei (Stich and Dunn, 1986;Sanyal et al, 1997).…”

Section: Toxicologymentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of tannic acid when used as feed flavouring for all animal species

Högstrand¹

2014

EFSA Journal

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Tannic acid is a synonym for hydrolysable tannins, which are widely distributed in nature. The use of tannic acid as a feed additive up to 15 mg/kg feed is safe for all animal species. The use of tannic acid as a feed additive under the proposed conditions of use presents no safety risk to consumers. In the absence of data, it would be prudent to regard the additive as potentially hazardous to workers by exposure to the skin, eyes and mucous membranes or by inhalation exposure. Tannic acid is naturally present in many plant species. The use of tannic acid as a feed additive is considered safe for the environment. Tannic acid is recognised as a food flavouring agent and is included in the European Union list of food flavourings. As its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

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Section: Toxicologymentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of tannic acid when used as feed flavouring for all animal species

Högstrand¹

2014

EFSA Journal

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“…The effect was reproducible in a second, not reproducible in a third experiment. Ames test (preincubation method) S. typhimurium TA98; TA100; TA1535 5000 µg/plate Negative 1 (Rashid et al, 1985) Inhibition was noted at the 5000-µg/plate dose-level; however, this may have been due to toxicity. (Mortelmans et al, 1986) Ames test S. typhimurium TA98; TA100 0.05 to 1000 µg/plate Negative 1 (Kasamaki et al, 1982) Published non-GLP study with insufficient report of some details of method and results.…”

Section: Chromosomal Aberration Testmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Publication¹

2012

EFS2

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[FL no: 09.858]. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all the substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 45 candidate substances. Twenty-five flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.According to the default MSDI approach, the 41 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The four substances in structural class II 05.066, 05.221 and 06.104] have estimated intakes of 0.011, 1.2, 0.61 and 100 microgram/capita/day, respectively. These intakes are below the threshold values of 540 microgram/person/day for structural class II.

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“…The effect was reproducible in a second, not reproducible in a third experiment. Ames test (preincubation method) S. typhimurium TA98; TA100; TA1535 5000 µg/plate Negative 1 (Rashid et al, 1985) Inhibition was noted at the 5000-µg/plate dose-level; however, this may have been due to toxicity. (Takahashi et al, 1990) Mitotic recombination assay S. cerevisiae D7 10,000 µg/ml Negative 2 (Rosin, 1984) Published non-GLP study with insufficient report of experimental details and results.…”

Section: Not Reportedmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 20, Revision 3(FGE.20Rev3): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Publication¹

2011

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in this revision 3 of Flavouring Group Evaluation 20, the SCF Opinion on benzoic acid. Furthermore information on stereoisomeric composition for two substances and new information to support the re-allocation of the structural class for the candidate substance piperonyl alcohol ] has been submitted. The 41 flavouring substances in Flavouring Group Evaluation 20 were evaluated using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all the substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Twenty-two of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.According to the default MSDI approach, the 37 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The four substances in structural class II 05.066, 05.221 and 06.104] have estimated intakes of 0.011, 1.2, 0.61 and 100 microgram/capita/day, respectively. These intakes are below the threshold values of 540 ...

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Mutagenicity tests with gallic and tannic acid in thesalmonella/mammalian microsome assay

Cited by 20 publications

References 20 publications

Scientific Opinion on the safety and efficacy of tannic acid when used as feed flavouring for all animal species

Scientific Opinion on the safety and efficacy of tannic acid when used as feed flavouring for all animal species

Scientific Opinion on Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

Scientific Opinion on Flavouring Group Evaluation 20, Revision 3(FGE.20Rev3): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

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