Lack of carcinogenicity of tartrazine (FD &amp; C Yellow No. 5) in the F344 rat

Maekawa, Akihiko; Matsuoka, Chiaki; Oda, Hiroshi; Tanigawa, Hiroyuki; Furuta, Kyoko; Kanno, Jun; Jang, Ja June; Hayashi, Yuzo; Ogiu, Toshiaki

doi:10.1016/0278-6915(87)90281-x

Cited by 40 publications

(26 citation statements)

References 11 publications

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“…Also, salivary glands absolute and relative weight increased in 0.1% treated group (p<0.05). Maekawa et al (1987) indicated that subchronic tartrazine ingestion in rats decreased the absolute and relative liver in 2% dose group. On the other hand, Osman et al (1995) showed that oral ingestion of synthetic dyes such Fast Green at 12.5 mg/kg/day and Sunset Yellow at 5 mg/kg/day for 30 days in mice increased the liver and kidney weight.…”

Section: Resultsmentioning

confidence: 95%

“…Mice were divided into five groups of 12 animals each. The first group was given drinking water as a control; the second received drinking water that contained 0.1% tartrazine (low dose level), in the third, the drinking water contained 0.45% tartrazine (presents the no observed adverse effect levels (NOAEL)) (Tanaka, 2006;Tanaka et al, 2008), for the fourth, the drinking water contained 1% (high dose level) and for the fifth, the drinking water contained 2.5% (high dose level) tartrazine each for 13 weeks (Maekawa et al, 1987;Borzelleca and Hallagan, 1988a;Borzelleca and Hallagan, 1988b). Standard food pellets diet and water were given ad libitum for the duration of the experiment.…”

Section: Animals and Treatmentsmentioning

confidence: 99%

“…No carcinogenic effect in chronic toxicity study (two years) of rats and mice have been reported at levels of 1.0 to 5.0% of tartrazine in drinking water or diet (Maekawa et al, 1987;Borzelleca and Hallagan, 1988a;Borzelleca and Hallagan, 1988b). Genotoxicology studies showed that tartrazine has possible clastrogenic activity (Ishidate et al, 1981;Ishidate et al, 1984;Giri et al, 1990;Durnev et al, 1995), may induce chromosomal aberrations in mammalian cells (Patterson and Butler, 1982) and DNA damage in the colon of mice by comet assay (Sasaki et al, 2002).…”

Section: Introductionmentioning

confidence: 99%

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A thirteen week ad libitum administration toxicity study of Tartrazine in Swiss mice

Mehedi¹,

Mokrane²,

Alami³

et al. 2013

Afr. J. Biotechnol.

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Tartrazine is a colorant widely used in food products, drugs and cosmetics. The current study evaluates the effect of sub-chronic ingestion of tartrazine in drinking water at doses of 0, 0.1, 0.45, 1 and 2.5% for 13 weeks in mice. Our results show that female body weight gain and food consumption decreased in all treated groups, while fluid consumption increased. The red blood cell count, hemoglobin and hematocrit were increased in male 2.5% treated groups and the white blood cell count decreased in all treated groups. In both sexes of the 2.5% doses groups, total proteins, albumin, creatinine, urea, uric acid, total bilirubin, alkaline phosphatase and transaminases were higher. Histological examinations showed brain, liver and kidney damages in animals treated with 1 and 2.5% doses. We concluded that at doses of 1 and 2.5% in drinking water, tartrazine induces weight depression and adverse effects on brain, liver and kidney.

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Section: Resultsmentioning

confidence: 95%

Section: Animals and Treatmentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A thirteen week ad libitum administration toxicity study of Tartrazine in Swiss mice

Mehedi¹,

Mokrane²,

Alami³

et al. 2013

Afr. J. Biotechnol.

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“…The results showed significant dose-related increase in blood chemistry parameters like glucose, creatinine, blood urea nitrogen, total cholesterol, total serum protein, triglycerides and aspartate aminotransferase when compared with the control group (Himri et al, 2011). A lack of carcinogenicity in F334 rats have been reported when tartrazine was administered in doses of 0, 1 and 2% in the drinking water of groups of 50 male and female rats for 2 years (Maekawa et al, 1987). No toxic lesions were reported in the treated groups at any of the dye doses.…”

Section: Long Term Carcinogenicity Testsmentioning

confidence: 98%

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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“…In a study by Maekawa et al (1987) groups of 50 male and 50 female F344 rats were given ad libitum drinking water with 0, 1 or 2 % of Tartrazine (equivalent to approximately 0, 500 and 1000 mg/kg bw/day) for up to two years.. No toxic lesions caused by Tartrazine were detected in any treated group of either sex. Except for mesotheliomas in males and endometrial stromal polyps in females, there were no significant increases in the incidences of any tumours compared to those in the corresponding control group.…”

Section: Chronic Toxicity and Carcinogenicitymentioning

confidence: 99%

Scientific Opinion on the re-evaluation Tartrazine (E 102)

Aguilar¹,

Charrondière²,

Dusemund³

et al. 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 Tartrazine (E 102). Tartrazine has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1966 and the EU Scientific Committee for Food (SCF) in 1975 and. Both committees established an Acceptable Daily Intake (ADI) of 0-7.5 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 a study by Sasaki et al. from 2002 reporting effects on nuclear DNA migration in the mouse in vivo Comet assay, a study by McCann et al. from 2007 that concluded that exposure to a mixture including Tartrazine resulted in increased hyperactivity in 3-year old and 8-to 9-year old children and studies on neurodevelopment by Tanaka. The Panel notes that Tartrazine was negative in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in the mouse in vivo Comet assay are not expected to result in carcinogenicity. The Panel also concurrs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI, and additionally considered that the Tanaka study can also not be used as a basis for altering the ADI. The Panel concludes that the present database does not give reason to revise the ADI of 7.5 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use, refined intake estimates are below the ADI. The Panel concludes that Tartrazine appears to be able to elicit intolerance reactions in a small fraction of the exposed population.The Panel also notes that sensitive individuals may react to Tartrazine at dose levels within the ADI. Tartrazine, FD&C Yellow No. 5, E 102, CAS 1934-21-0, 3-carboxy-5-hydroxy-1-(4'-sulphophenyl Tartrazine consists essentially of 3-carboxy-5-hydroxy-1-(4'-sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salts are also permitted (Directive 2008/128/EC). KEY WORDSThe purity is specified as not less than 85 % total colouring matters, calculated as the sodium salt. The remaining 15 % may be accounted for by sodium chloride or sodium sulphate (but this is never mentioned explicitly), water insoluble matter not more than 0.2 %, subsidiary colouring matters not more than 1.0 % and organic compounds other than colouring matters with a total not more than 0.5 % (4-hydrazinobenzene sulphonic acid, 4-aminobenzene-1-sulphonic acid, 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid, 4,4′-diazoaminodi(benzene sulphonic acid), tetrahydroxysuccinic acid).The absorption, distribution, metabolism and excretion of Tar...

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Lack of carcinogenicity of tartrazine (FD & C Yellow No. 5) in the F344 rat

Cited by 40 publications

References 11 publications

A thirteen week ad libitum administration toxicity study of Tartrazine in Swiss mice

A thirteen week ad libitum administration toxicity study of Tartrazine in Swiss mice

Toxicity of food colours and additives: A review

Scientific Opinion on the re-evaluation Tartrazine (E 102)

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