Genotoxicity studies in vitro and in vivo on carminic acid (natural red 4)

Loprieno, G.; Boncristiani, Guido; Loprieno, N.

doi:10.1016/0278-6915(92)90077-x

Cited by 11 publications

(4 citation statements)

References 7 publications

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“…Negative results from Ames tests performed mostly with carminic acid and using as test model Salmonella Typhimurium strains and/or other microorganisms were reported in a series of publications (Kada et al, 1972;Brown and Brown, 1976;Barale et al, 1978;Haveland-Smith and Combes, 1980;Ishidate et al, 1984;Loprieno et al, 1992;Sarıkaya et al, 2012;Andres, 2014). Negative results for the induction of structural chromosome damage were observed in two in vitro studies performed in CHO or CHL cells (Ishidate et al, 1984;Loprieno et al, 1992). A significant increase of polyploidy was reported by Ishidate et al (1984); however, it was considered not biologically relevant because of the possible presence of impurity in the test item used (e.g.…”

Section: Genotoxicitymentioning

confidence: 97%

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Safety and efficacy of a feed additive consisting of carmine for cats and dogs (Mars Petcare GMbH)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the re-evaluation of the safety and efficacy of carmine (sensory additive, functional group: colourantssubstances that add or restore colour in feeds) for cats and dogs. The additive consists of aluminium lakes of carminic acid (carmines), which are complexes of aluminium and carminic acid. Carminic acid, produced from the female insect Dactylopius coccus Costa, is the colouring principle and is present in the final additive at 50%. The additive does not pose a risk concerning genotoxicity and is considered safe for dogs and cats at 264 and 220 mg Carmine/kg feed, respectively (which correspond to 132 and 110 mg carminic acid/kg feed, respectively). Due to the nature of the additive, the FEEDAP Panel concluded that allergic reactions may occur in the target species following the ingestion of feeds containing the additive. The FEEDAP Panel concluded that the exposure of users by inhalation is very likely, and that carmine is a respiratory and skin sensitiser; however, due to the lack of data, a conclusion cannot be reached on the potential skin and eye irritation of the additive. The additive is considered to be efficacious in feeds for dogs and cats under the proposed conditions of use.

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Section: Genotoxicitymentioning

confidence: 97%

“…indigo carmine). Loprieno et al (1992) conducted an in vivo micronucleus test in mice exposed to carminic acid, while Geissel (2014) . All these studies gave negative results.…”

Section: Genotoxicitymentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of carmine for cats and dogs (Mars Petcare GMbH)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

EFS2

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“…A series of in vitro and in vivo studies was performed with two commercial samples of carminic acid with different purity (Loprieno et al, 1992). In the Salmonella typhimurium reverse mutation test, carminic acid (53.1 % pure) was not mutagenic in strains TA 1535, TA 1537, TA 98 or TA 100 at doses from 125 to 2 000 µg/plate, in the presence and in the absence of S9 at two concentration levels (Loprieno et al, 1992). Negative results were also obtained with a sample of higher purity (87.5 % pure) tested only in strain TA 100 at concentrations up to 2 000 µg/plate.…”

Section: Carminic Acidmentioning

confidence: 99%

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

2015

EFS2

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Cochineal, carminic acid, carmines (E 120) have been previously evaluated by JECFA and by the SCF. Both committees established an ADI of 5 mg/kg bw/day. The Panel noted that the title of the EC specifications for E 120 does not adequately correspond to the specified food additive and therefore, proposes to modify it to "E 120 cochineal extract, carminic acid and carmines", which would more accurately reflect the material used. The Panel also noted that the specifications need to be updated with regard to the maximum limits for certain toxic elements present as impurities, to ensure that E 120 will not be a significant source of exposure to these toxic elements in food. No ADME studies on cochineal extract, carminic acid or carmines were available for evaluation, but indirect evidence suggests that carmines are absorbed and distributed in the body. Acute, shortterm, subchronic, carcinogenicity, reproduction and developmental toxicity studies conducted in rats or mice did not show toxicological potential. Consideration of the available information regarding genotoxicity indicated that carminic acid is not genotoxic. The Panel concluded that the present dataset does not give reason to revise the ADI of 5 mg carmine (containing approximately 50 % carminic acid)/kg bw, allocated by the SCF in 1983. The Panel concluded that this ADI should be expressed as carminic acid content, which would correspond to 2.5 mg carminic acid/kg bw/day. The Panel considered that, since no threshold dose can be established for allergic reactions, it is advisable that exposure to the eliciting allergens, such as proteinaceous compounds, in E 120 is avoided by introducing appropriate purification steps in the manufacturing process. Refined exposure estimates show that exposure to E 120 for the non-brand-loyal scenario, is below the ADI of 2.5 mg carminic acid/kg bw/day for all population groups. for the preparatory work on this scientific opinion and EFSA staff members Petra Gergelova, Ana Maria Rincon and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. Re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive EFSA Journal 2015;13(11):4288 2 SUMMARY Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of cochineal, carminic acid, carmines (E 120) as a food additive. 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 information available following public calls for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. To assist in identifying any emerging issue or any information relevant for the...

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“…Other applications have been found for (CA) such as an indicator in acidbase titrations and the spectrophotometric determination of certain transition metal ions [9,10], lanthanides metal ions [11], gallium(III) [12], and boron [13], and it has other analytical applications [14][15][16][17]. (CA) complexes also have applications in medicinal chemistry [18][19][20].…”

mentioning

confidence: 99%

Protonation Equilibria of Carminic Acid and Stability Constants of Its Complexes with Some Divalent Metal Ions in Aqueous Solution

Atabey

Sarı

Al-Obaidi³

2012

J Solution Chem

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The dissociation constants of carminic acid (7-D-glucopyronosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxo-anthracene-2-carboxylic acid) (CA), together with the stability constants of its Cu(II), Zn(II), Ni(II), Co(II) and Hg(II) complexes, were studied potentiometrically in aqueous medium at 25.0 (1)°C, and at the ionic background of 0.1 mol·dm −3 of NaCl, and determined with the SUPERQUAD computer program. It has been observed that carminic acid has five dissociation constants, and for H 5 L their values are 3.39 (7), 5.78 (7), 8.35 (7), 10.27 (7), and 11.51 (7). This ligand behaves as a bi-dentate ligand, and the carboxyl and the ortho hydroxy groups of the ligand coordinate to the metal ions. Various metal complexes were produced in solution under the experimental conditions, for each metal ion used, including hydrolyzed species. The species distribution curves of the complexes formed in the solution were calculated and reviewed. The stability of the complexes was found to follow the order: Cu(II) > Zn(II) > Ni(II) > Co(II) > Hg(II).

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Genotoxicity studies in vitro and in vivo on carminic acid (natural red 4)

Cited by 11 publications

References 7 publications

Safety and efficacy of a feed additive consisting of carmine for cats and dogs (Mars Petcare GMbH)

Safety and efficacy of a feed additive consisting of carmine for cats and dogs (Mars Petcare GMbH)

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

Protonation Equilibria of Carminic Acid and Stability Constants of Its Complexes with Some Divalent Metal Ions in Aqueous Solution

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