Chronic toxicity of two food colors, Brilliant Blue FCF and Indigotine

doi:10.1016/0041-008X(66)90097-4

Toxicology and Applied Pharmacology

Volume 8, Issue 1, January 1966, Pages 29-36

https://doi.org/10.1016/0041-008X(66)90097-4 Get rights and content

Abstract

Brilliant Blue FCF (FD & C Blue No. 1) and Indigotine (FD & C Blue No. 2) were fed to groups of 24 Osborne-Mendel rats for two years at dietary levels of 0.5, 1.0, 2.0, and 5.0%. Growth inhibition occurred in the male animals fed Indigotine at the 2.0 and 5.0% levels. No effect was observed on survival, hematology, or organ weights. No significant pathologic changes were observed in animals fed either color.

Five beagle dogs received a dietary level of 2.0%, and three dogs a level of 1.0% of Brilliant Blue FCF for one year. One dog died after 17 days on the 2% dietary level and another died after 46 weeks on the 1% level. Indigotine was fed to beagle dogs for periods up to two years at dietary levels of 1.0 and 2.0%. Four of the six dogs at the 2.0% level died during the two years, and one of the four at the 1.0% level was sacrificed in a moribund condition. All the deaths were attributed to intercurrent virus infections. No clinical signs, gross lesions, or microscopic pathology were attributed to intercurrent virus infections. No clinical signs, gross lesions, or microscopic pathology were attributed to ingestion of Brilliant Blue FCF or Indigotine; however, because of deaths from intercurrent virus infections a no-effect level has not been established for Indigotine.

Subcutaneous injections of 30 mg of Brilliant Blue FCF or 20 mg of Indigotine into rats weekly for two years produced fibrosarcomas at the site of injection.

Other than acute convulsive deaths of some of the test mice immediately after injection, no deleterious effects attributable to the weekly subcutaneous injection of 2.5 mg of Indigotine were observed over a two-year period.

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Waste material, hen feather, a biosorbent, was successfully utilized in removing a water-soluble hazardous triphenylmethane dye, Brilliant Blue FCF from wastewater. The paper incorporates effect of pH, temperature, amount of adsorbent, contact time, concentration of adsorbate, etc. The adsorption data validates Langmuir and Freundlich adsorption isotherms and on the basis of these isotherms thermodynamic parameters like Gibb's free energy, change in enthalpy and entropy were calculated. Kinetics of the ongoing adsorption was also monitored and specific rate constants for the involved process were calculated at different temperatures. Kinetic measurements suggest a first order adsorption kinetics and adsorption was found to be applicable via film diffusion process in the entire concentration range.
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Citation Excerpt :
The ban was imposed due to its severe toxicity particularly toward children. In humans its toxicity [1–3] includes carcinogenicity, reproductive and neurological disorders. Even trace amount of the dye effects living being with severe allergies [4] and unfortunately, so far, there has been no first aid treatment available for such ill effects.
Two waste materials—bottom ash, a power plant waste, and de-oiled soya, an agricultural waste—are meticulously and successfully used as adsorbent for the removal and recovery of a hazardous triphenylmethane dye, Brilliant Blue FCF. Both the materials were characterized by chemical analysis, IR, DTA, SEM and XRD studies. Their physical characteristics like surface area, porosity, density and loss on ignition were also determined. The adsorption of the dye over both materials was achieved under different pH, adsorbate concentration, sieve size, adsorbent dosage, contact time and temperature, etc. conditions. For both the systems Langmuir and Freundlich adsorption isotherm models were applied and, based on these models, useful thermodynamic parameters were calculated. For both the adsorbents, the kinetic measurements indicate that the adsorption process follows first order kinetics and film diffusion and particle diffusion mechanisms are operative at lower and higher concentrations, respectively, in each case. By percolating the dye solution through fixed-bed columns the bulk removal of the Brilliant Blue FCF was carried out and necessary parameters were determined to find out the percentage saturation of both the columns. Recovery of Brilliant Blue FCF was made by eluting dilute NaOH of pH 11 through each column.
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FD & C Blue No. 1 was fed to Charles River CD rats and CD-1 mice as a dietary admixture in lifetime toxicity/carcinogenicity studies. The rat study was conducted with an in utero phase in which the compound was administered to the F₀ generation rats (60/sex/group) at dietary concentrations of 0.0%, 0.0%, 0.1%, 1.0% or 2.0%. After randomly selecting the F₁ animals, the lifetime phase was initiated at the same levels with 70 rats/sex/group, including two control groups. The maximum exposure times were 116 and 111 wk for males and females, respectively. The no-observed-adverse-effect levels are dietary concentrations of 2.0% for males (1072 mg/kg body weight/day), and 1.0% for females (631 mg/kg/day) based on a 15.0% decrease in terminal body weight and decreased survival in the high-dose females compared with the combined control groups. Charles River CD-1 mice (60/sex/group) were fed FD & C Blue No. 1 as a dietary admixture at levels of 0.0%, 0.0%, 0.5%, 1.5% or 5.0% in a lifetime toxicity/carcinogenicity study. The maximum exposure time was 104 wk for both males and females. No consistent, significant compound-related adverse effects were noted. The no-observed-adverse-effect level established in this study is a dietary concentration of 5.0% (7354 mg/kg/day and 8966 mg/kg/day for male and female mice, respectively).
Chronic toxicity/carcinogenicity study of FD & C blue no. 2 in mice
1985, Food and Chemical Toxicology
Charles River CD-1 mice were fed FD & C Blue No. 2 in the diet levels of 0.5, 1.5 and 5.0% in a long-term toxicity/carcinogenicity study. Each group consisted of 60 males and 60 females. Two concurrent control groups each of 60 males and 60 females received the basal diet. Maximum exposure was 23 months. No consistent compound-related or statistically significant biologically adverse effects were noted.
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1985, Food and Chemical Toxicology
FD & C Blue No. 2 was fed to rats in the diet in a long-term toxicity/carcinogenicity study, The study included an in utero phase in which the compound was administered to groups of 60 male and 60 female Charles River CD albino rats at levels of 0.5, 1.0 and 2.0%. Two concurrent control groups, each containing 60 rats of each sex, received the basal diet. After random selection of the F₁ animals, the long-term phase was initiated at the same dietary levels, with 70 rats of each sex in each dose group and in each of two control groups. Maximum exposure was 30 months. No consistent compound-related biologically adverse effects were noted. There were random statistically significant differences from the controls with respect to body weight, food consumption and clinical chemistry tests. Food consumption by the test groups showed a dose-related increase. This was probably due to the non-nutritive character of the colouring. A statistically significant increase in gliomas in the high-dose male rats was not found to be biologically significant, since none of the criteria for determining the neurocarcinogenic potential of chemical substances was met. The overall brain-tumour incidence in this study was within the range typical for 2-yr-old CD rats. Under the conditions of this study, FD & C Blue No. 2 did not produce evidence of any toxicity, including carcinogenicity.
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Chronic toxicity of two food colors, Brilliant Blue FCF and Indigotine

Abstract

The composition of commercial ethylbenzylaniline sulfonic acid

J. Assoc. Official Agr. Chemists

Absorption and excretion of certain triphenylmethane colors in rats and dogs

J. Pharmacol. Exptl. Therap.

The fate of FD&C Blue No. 2 in rats