Testing of sunset yellow and orange II for genotoxicity in different laboratory animal species

Wever, J.; Münzner, Ruth; Renner, H.W.

doi:10.1002/em.2850130311

Cited by 16 publications

(14 citation statements)

References 18 publications

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“…The metabolites were monitored in the faeces using HPLC and reported to be non-genotoxic as well. The results of these studies agrees with that of Wever et al (1989) who did not find any mutagenicity or clastogenicity effects when the dye was administered to rodents by gavage.…”

Section: In Vivo Testingsupporting

confidence: 90%

“…They also justified the use of the intra-peritoneal route on the poor uptake of allura red from the intestine and suggested that this coupled with the possibility of microbial formation of substances with local cellular action might partly explain the toxicity seen in the report by Shimada et al (2010). Early reports demonstrated the non-mutagenicity of sunset yellow on E. coli, four tester strains of S. typhimurium TA 1538, 1535, 100 and 98 strains with or without metabolic activation (Chung et al, 1981;JECFA, 1982;Wever et al, 1989). Haveland-Smith and Combes (1980), also tested the ability of twenty five dyes to induce mutations in a tryptophan-requiring E. coli strain (sensitive to base substitutions) and a histidine auxotroph of S. typhimurium strain TA1538 (specific for frameshifts).…”

Section: In Vivo Assaysmentioning

confidence: 99%

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Toxicity of food colours and additives: A review

Thomas¹,

Adegoke²

2015

Afr. J. Pharm. Pharmacol.

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Majority of consumer goods are required to be presented with good aesthetics in order to improve acceptability in terms of colours and in some instances taste. When related to food, beverages and drug products, additives are usually added to mask un-inviting colours, obscure offensive odours and increase taste. Food additives therefore include colourants, sweeteners, preservatives and anti-caking agents. Admissible daily intake limits are often recommended for these additives. Being food products, the amount consumed over time may be subject to individual preferences and thus negating the desire to regulate and control the amount consumed cumulatively. There have been several concerns about the safety of food additives and several batteries of tests, and reports are available in literature. This review attempted to give an update on reports that have surfaced in literature over recent past on the use and safety of food colours and other additives. Some safety concerns have been related to three determinations; cytotoxicity, genotoxicity and induction or potential of inducing mutagenicity. In order to accomplish these targeted evaluations, several tests have been prescribed by International conference on harmonization (ICH), organization for economic co-operation and development (OECD) and European food safety authority (EFSA). It is observed that no single test can give a full proof of safety of these food colours and additives, hence minimal tests are recommended to be carried out in order to guarantee safety of these products. Survey of literature, revealed that once some approved additives or colours become a subject of safety concerns, comprehensive evaluations are carried out by researchers and these have often led to the de-classification of some hitherto reported agents as being non-genotoxic or non-carcinogenic. The declassifications of some food colors and additives as human carcinogens are regularly done following the comprehensive evaluation of results of mutagenicity and genotoxicity tests in vitro and some in vivo tests in mammalian tissues and whole animals. However, such declassifications are often done with caution and the implication is that regular and more comprehensive tests must be carried out. In addition, the requirements of testing for chronic exposures to this and other agents must be emphasized to prevent occurrence of subtle yet terrible side effects resulting from consuming sub-toxic doses of the additives over time.

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Section: In Vivo Testingsupporting

confidence: 90%

Section: In Vivo Assaysmentioning

confidence: 99%

Toxicity of food colours and additives: A review

Thomas¹,

Adegoke²

2015

Afr. J. Pharm. Pharmacol.

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“…It was concluded by the authors that no genotoxic harm is to be expected from the ingestion of Sunset Yellow FCF (Wever et al, 1989). It was concluded by the authors that no genotoxic harm is to be expected from the ingestion of Sunset Yellow FCF (Wever et al, 1989).…”

Section: Genotoxicitymentioning

confidence: 97%

“…Sunset Yellow FCF was administered to rodent species by gavage to check for possible mutagenic activity in the Ames test, or for clastogenicity in bone marrow cells using cytogenetic test systems. It was concluded by the authors that no genotoxic harm is to be expected from the ingestion of Sunset Yellow FCF (Wever et al, 1989). EFSA Journal 2009; 7(11):1330 Mice orally exposed to 0.17 or 1.7 mg/kg bw of Sunset Yellow FCF did not display any increase in the number of cells with chromosomal damages (Durnev et al, 1995).…”

Section: Genotoxicitymentioning

confidence: 99%

Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive

Publication¹

2009

EFSA Journal

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The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Sunset Yellow FCF (E 110). Sunset Yellow FCF has been previously evaluated by JECFA and the SCF. Both committees established an Acceptable Daily Intake (ADI) of 0-2.5 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. New studies included studies by Mathur et al. reporting significant effects on the testes in rats exposed for 90 days to 250 and 1500 mg Sunset Yellow FCF/kg bw/day. The Panel notes that the Sunset Yellow FCF administered in these studies was obtained at the local market and that its specifications or purity were not defined. The Panel also notes that the 90 day rat study used by JECFA to derive the ADI also reported effects on testes weight, occurring without accompanying histological changes, although sperm morphology and sperm mobility were not analysed. The Panel concludes that these findings do give reason for re-definition of the ADI. The Panel decided to reduce the ADI, by an extra uncertainty factor of 2.5, to 1 mg/kg bw/day and to make the ADI temporary for 2 years. Within this period, clarification of the effects of Sunset Yellow FCF on the testis, sperm morphology and sperm mobility should be provided, based on a 28-day study performed according to the recently updated OECD test guideline 407. The Panel concludes that at the maximum reported levels of use of Sunset Yellow FCF, refined intake estimates are generally below the temporary ADI of 1 mg/kg bw/day, although in 1-to10-year old children the mean and the high percentiles of exposure (95 th /97.5 th ) can be higher than this ADI, at the upper end of the range.

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“…Negative results were also obtained in tests with the chemically reduced component amines of three of the dyes (Allura Red AC, Amaranth and Tartrazine), both in presence and absence of exogenous metabolic activation. Some positive findings have been observed in some in vitro tests with extracts from or rat metabolites of Allura Red AC, Amaranth and Sunset Yellow FCF (Henschler et al, 1985;Münzner and Wever, 1987;Prival et al, 1988;Wever et al, 1989).…”

Section: Discussionmentioning

confidence: 97%

Statement on Allura Red AC and other sulphonated mono azo dyes authorised as food and feed additives

2013

EFSA Journal

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The ANS Panel has been asked by EFSA to assess the new scientific information that has become available since the adoption of the opinion on the re-evaluation of the food colouring agent Allura Red AC in 2009, in particular the positive findings from an in vivo comet assay in mice. The findings from this study have been interpreted in conjunction with all the available relevant data from genotoxicity testing, metabolism and carcinogenicity, and in consideration of possible species differences between mouse and rat. These new data have been considered in the context of the overall relevant data available not only for Allura Red AC but also for a number of other structurally related sulphonated mono azo dyes authorised as food additives, namely: Amaranth, Ponceau 4R, Sunset Yellow FCF, Tartrazine and Azorubine/Carmoisine. The Panel concluded that the new data by themselves were insufficient at this time to change the conclusions of the 2009 opinion on the safety of Allura Red AC and that there is currently no reason to revise the ADI. The read-across exercise has highlighted a shared pattern of effects for this class of substances that would warrant further investigation The Panel therefore recommended a repetition of the in vivo comet assay in mice, to be performed in compliance with the most recent and internationally validated experimental protocol, using whole cells and examining a wide range of tissues. These recommendations apply to all the sulphonated mono azo dyes included in this review. This request originates from an opinion adopted by the FEEDAP Panel in April 2012 on the reevaluation of the substance for use in feedingstuffs for cats and dogs. In its opinion, the FEEDAP Panel had concluded that the genotoxic potential of Allura Red AC could not be excluded and that the data available were insufficient to demonstrate the safety of the substance for its proposed use.In the context of the re-evaluation of Allura Red AC for use as a food additive, a first positive in vivo comet assay in mice by Tsuda et al. (2001) The ANS Panel critically reviewed the study by Shimada et al. (2010) and noted that these results were observed by a single group of researchers using an in-house developed protocol that uses isolated nuclei from homogenised tissues. Although this protocol was considered to meet the minimum criteria for acceptance of the in vivo comet assay (EFSA, 2012), the Panel noted that such protocol had not been included in the international validation exercise. Under the same experimental conditions, no effect could be observed in the rat. The Panel noted that the same findings observed for Allura Red AC were also reported by Shimada et al. (2010) for the two other authorised food dyes tested in this study, Amaranth and Ponceau 4R.The Panel acknowledged the role of the comet assay as an indicator test for the detection of DNA lesions and/or DNA repair activity and concluded that the findings reported cannot be considered conclusive evidence of mutagenicity, i.e. of induced permanent genetic cha...

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Testing of sunset yellow and orange II for genotoxicity in different laboratory animal species

Cited by 16 publications

References 18 publications

Toxicity of food colours and additives: A review

Toxicity of food colours and additives: A review

Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive

Statement on Allura Red AC and other sulphonated mono azo dyes authorised as food and feed additives

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