Study of artificial flavouring substances for mutagenicity in the salmonella/microsome, Basc and micronucleus tests

Wild, D.; King, M.-T.; Gocke, Elmar; Eckhardt, K.

doi:10.1016/0278-6915(83)90202-8

Cited by 228 publications

(279 citation statements)

References 22 publications

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“…Chew 1979; Florin et al 1980;Yamaguchi 1982;Wild et al 1983;Andersen & Jensen 1984;Shimizu et al 1985;Al-Ani & Al-Lami 1988;Clary et al 1998;Zeiger & Margolin 2000). Based on the results of sub-acute toxicity/carcinogenicity and genotoxicity studies, we concluded that the metabolites of the four flavouring substances as well as substances structurally related to these flavouring substances do not pose a safety concern when used at low levels of intake or as flavouring substances.…”

Section: Genotoxicitymentioning

confidence: 95%

Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

Saito¹,

Hasegawa-Baba

Sekiya³

et al. 2017

Food Additives & Contaminants: Part A

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We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of 'aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups' and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer's classification. The estimated daily intake of each of the four substances was determined to be 0.007-2.9 μg/person/day by using the maximised surveyderived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250-600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake. ARTICLE HISTORY

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Section: Genotoxicitymentioning

confidence: 95%

Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

Saito¹,

Hasegawa-Baba

Sekiya³

et al. 2017

Food Additives & Contaminants: Part A

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“…Two members of this group (borneol,.016] and isobornyl propionate, .131]) consistently gave negative results in the Ames assay when incubated at a concentration of up to 5000 µg/plate with a variety of Salmonella typhimurium strains including TA97, TA98, TA100, TA1535, TA1537 and TA1538 with or without metabolic activation (Simmon et al, 1977;Wild et al, 1983;Azizan and Blevins, 1995).…”

Section: In Vitromentioning

confidence: 99%

“…No increased frequency of mutation was observed in flies fed with isobornyl propionate .131] in a 10 mmol/l solution for 3 days (Wild et al, 1983). …”

Section: In Vivomentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 87 Revision 1 (FGE.87Rev1): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and relat

Flavourings¹

2012

EFSA Journal

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Flavouring Group Evaluation 87, Revision 1 EFSA Journal 2012;10(2):2564 2 through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 17 substances considered in this FGE and agrees with the JECFA conclusion, "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for two substances, [FL-no: This consideration deals with 17 bicyclic secondary alcohols, ketones and related esters, which are in the Register and which were evaluated by the JECFA at its 63 rd meeting.The revision is made due to consideration of two additional substances [FL-no: 02.100 and 02.101] compared to the previous version. These two substances are alpha,beta-unsaturated substances which have been considered with respect to genotoxicity in FGE.211 and FGE.212Rev1, and the Panel concluded that the data available ruled out the concern for genotoxicity and thus concluded that the two substances can be evaluated through the Procedure in this FGE.87Rev1. EU production volume on two substances [FL-no: 09.153 and 09.319] and new information on stereoisomerism for 13 substances 02.038, 02.059, 07.159, 09.017, 09.082, 09.131, 09.153, 09.176, 09.218, 09.319, 09.456 and 09.457] are also included.The Panel concluded that all 17 substances are structurally related to the group of four bicyclic secondary alcohols, ketones and related evaluated by EFSA in the Flavouring Group Evaluation 47 (FGE.47).The Panel agrees with the application of the Procedure as performed by the JECFA for the 17 bicyclic secondary alcohols, ketones and related esters. It was concluded at step A3 of the Procedure that the 17 substances do not pose a safety concern when used as flavouring substances at estimated levels of intake, based on the MSDI approach.For all 17 substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation.In order to determine whether the conclusion for the JECFA-evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Specifications are available for all the materials of commerce. For two of the candidate substances [FL-no: 02.100 and 02.101] the stereoisomeric composition has not been specified. Thus, for these two JECFA-evaluated substances [FL-no: 02.100 and 02.101] the Panel has reservations (information on the stereoisomeric composition is lacking).For the remaining 15 JECFA-evaluated substances

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“…Supporting substances are listed in brackets. (Keith et al, 1996a) The method (based on 32 Ppostlabelling) is aimed at detecting hydrophobic DNA EFSA Journal 2011; 9(7):2164 (Wild et al, 1983) Limited quality since only a single sampling time (30 hours after treatment) was used and PCE/NCE ratio was not reported. Therefore it is not EFSA Journal 2011; 9(7):2164 (Singh et al, 1975) Reliable study, conclusion comprehensible.…”

Section: Embryo Transformation Assaymentioning

confidence: 99%

“…Therefore it is not EFSA Journal 2011; 9(7):2164 (Singh et al, 1975) Reliable study, conclusion comprehensible. 100 EFSA Journal 2011; 9(7):2164 (Wild et al, 1983) A single dose was tested in one experiment. Method not described in detail.…”

Section: Embryo Transformation Assaymentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 10, Revision 2 (FGE.10Rev2): Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30

Flavourings¹

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 evaluate 61 flavouring substances in the Flavouring Group Evaluation 10, Revision 2, 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 the 61 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. For four substances, information on composition of mixture and/or stereoisomerism has not been specified sufficiently.

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Study of artificial flavouring substances for mutagenicity in the salmonella/microsome, Basc and micronucleus tests

Cited by 228 publications

References 22 publications

Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

Scientific Opinion on Flavouring Group Evaluation 87 Revision 1 (FGE.87Rev1): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and relat

Scientific Opinion on Flavouring Group Evaluation 10, Revision 2 (FGE.10Rev2): Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30

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