산 청색 9 (디암모늄 염)

Foods, Drugs, Cosmetics -> FDA Regulatory Status of Color Additives

COLOR OR COLORING ADJUNCT, FLAVOR ENHANCER, FLAVORING AGENT OR ADJUVANT -> FDA Substance added to food

Reddish-violet powder or granules with a metallic luster

Dark-purple to bronze powder with metallic luster

In water, 30 mg/mL (3.0X10+4 mg/L)

In ethanol, 3 mg/mL; in ethylene glycol monomethyl ether, 20 mg/mL

Practically insoluble in vegetable oils; pale amber solution in concentrated sulfuric acid, changing to yellow then greenish blue on dilution

Soluble in ether

Other Solid; Dry Powder; Dry Powder; Wet Solid; Liquid; Wet Solid; Other Solid; Liquid

Reddish-blue powder or granules

Chemical: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, disodium salt

Regulation (EC) No 1831/2003 (amended)

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, sodium salt (1:2) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, sodium salt (1:2) are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)

C.I. Acid blue 9, disodium salt: Does not have an individual approval but may be used under an appropriate group standard

All batches of this color additive when used in foods shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

All batches of this color additive when used in drugs shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

All batches of this color additive when used in cosmetics shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Use: dye. Limit: Not more than 0.2% of pesticide formulation.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals. Use: dye, coloring agent. Limit: none.

F.D.&C. Blue No. 1 is exempted from the requirement of a tolerance when used as an aquatic plant control agent.

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal and plant life; and conformance with environmental and public health regulations.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Use: dye. Limit: Not more than 0.2% of pesticide formulation.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals. Use: dye, coloring agent. Limit: none.

F.D.&C. Blue No. 1 is exempted from the requirement of a tolerance when used as an aquatic plant control agent.

30 [mg/m3]

330 [mg/m3]

2000 [mg/m3]

Although individual tar food colors are controlled based on acceptable daily intake (ADI), there is no apparent information available for how combinations of these additives affect food safety. In the current study, the potencies of single and combination use of /dyes/ were examined on neural progenitor cell (NPC) toxicity, a biomarker for developmental stage, and neurogenesis, indicative of adult central nervous system (CNS) functions. /Allura red AC/ and /amaranth/ reduced NPC proliferation and viability in mouse multipotent NPC, in the developing CNS model. Among several combinations tested in mouse model, combination of /tartrazine /and /brilliant blue FCF / at 1000-fold higher than average daily intake in Korea significantly decreased numbers of newly generated cells in adult mouse hippocampus, indicating potent adverse actions on hippocampal neurogenesis. However, other combinations including /allura red AC/ and /amaranth/ did not affect adult hippocampal neurogenesis in the dentate gyrus. Evidence indicates that single and combination use of most tar food colors may be safe with respect to risk using developmental NPC and adult hippocampal neurogenesis. However, the response to excessively high dose combination of /tartrazine/ and /brilliant blue FCF/ suggestive of synergistic effects to suppress proliferation of NPC in adult hippocampus. Data indicated that combinations of tar colors may adversely affect both developmental and adult hippocampal neurogenesis...

LC50; Species: Colinus virginianus (Northern Bobwhite Quail, age 10 days) diet >5620 ppm for 8 days

LD50; Species: Colinus virginianus (Northern Bobwhite Quail, age 35 weeks) oral via capsule >2250 mg/kg

LC50; Species: Anas platyrhynchos (Mallard Duck, age 10 days) diet >5620 ppm for 8 days

LD50; Species: Anas platyrhynchos (Mallard Duck, age 22 weeks) oral via capsule >2250 mg/kg

For more Ecotoxicity Values (Complete) data for Brilliant Blue (45 total), please visit the HSDB record page.

TERRESTRIAL FATE: Brilliant Blue is expected to be mobile in soil(SRC). This compound is expected to exist almost entirely in anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(1). Volatilization from moist soil is not expected because the compound exists as an anion and anions do not volatilize. Brilliant Blue is not expected to volatilize from dry soil surfaces because it is a salt and salts do not volatilize(SRC). Activated sludge and chemical precipitation treatment of wastewater containing anionic dyes resulted in dye removal efficiencies of less than 25% for Brilliant Blue(2), suggesting that biodegradation in soils is not expected to be an important environmental fate process(SRC).

AQUATIC FATE: Brilliant Blue is not expected to adsorb to suspended solids and sediment(SRC). This compound will almost entirely exist in anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(1). Volatilization from water surfaces is not expected(2) based on its expected ionic character in the environment. The potential for bioconcentration in aquatic organisms is expected to be low, based on the ionic character of the compound(SRC). Activated sludge and chemical precipitation treatment of wastewater containing anionic dyes resulted in dye removal efficiencies of less than 25% for Brilliant Blue(3), suggesting that biodegradation in water is not expected to be an important environmental fate process(SRC).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), Brilliant Blue, a salt, is expected to exist solely in the particulate phase in the ambient atmosphere because salts are nonvolatile(SRC). Particulate-phase Brilliant Blue may be removed from the air by wet or dry deposition(SRC). Brilliant Blue may be susceptible to direct photolysis by sunlight; its absorption maximum is 630 nm(2).

Brilliant Blue is expected to be mobile in soil; this compound will almost entirely exist in anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(1).

/CASE REPORTS/ ... Two cases of refractory shock and metabolic acidosis in critically ill patients are reported. The patients received Brilliant Blue FCF added to enteral nutrition formulations in order to facilitate the detection of aspiration. ... The dose did not exceed 0.7 mg/kg bw/day for the first patient and 2 mg/kg bw/day for the second one. ... Although in healthy subjects absorption of Brilliant Blue FCF appears to be limited, critically ill patients have increased gastrointestinal permeability to Brilliant Blue FCF secondary to enterocyte death and stress induced release of neuro-endocrine factors in the intestinal epithelium.

Brilliant Blue's production and use as a color additive in foods, drugs, cosmetics(1) and in lavaoratory freshners or flushing water(2) may result in its release to the environment through various waste streams(SRC). Its use in aquatic plant control(3) will result in its direct release to the environment(SRC).

AEROBIC: Activated sludge and chemical precipitation treatment of wastewater containing anionic dyes resulted in dye removal efficiencies of less than 25% for Brilliant Blue(1), suggesting that biodegradation is not expected to be an important environmental fate process(SRC).

Brilliant Blue FCF, disodium salt

Group 3: Not classifiable as to its carcinogenicity to humans

Volume 16: (1978) Some Aromatic Amines and Related Nitro Compounds – Hair Dyes, Colouring Agents and Miscellaneous Industrial Chemicals

1987

1987

3, not classifiable as to its carcinogenicity to humans. (L135)

Brilliant Blue is expected to be essentially nonvolatile from water surfaces; this compound is expected to exist as an anion in the environment, and therefore volatilization from moist soil is not expected because anions do not volatilize. Brilliant Blue is not expected to volatilize from dry soil surfaces because it is a salt and is nonvolatile. (SRC)

/LABORATORY ANIMALS: Acute Exposure/ Groups of 5 young rats were given injections of /Brilliant Blue/ subcutaneously twice daily for three days. The rats were killed on the fourth day. /Brilliant Blue/ was administered in aqueous solution at a level of 250 mg/kg body weight each injection. No estrogenic activity was detected. No other abnormalities were found.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Parenteral injection into cats of /Brilliant Blue/ a 5 % aqueous solution, 1.0 g on the first day and 0.1 g from the ninth to the eighteenth day, did not produce methemoglobinemia or Heinz bodies.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Mice fed 1200 mg of the dye /Brilliant Blue/ over 19 days showed no damage.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Daily injections of 2 mg of /Brilliant Blue/ over 30 days were well tolerated by mice. Some animals showed swelling of the liver and spleen after receiving a total of 4 mg.

For more Non-Human Toxicity Excerpts (Complete) data for Brilliant Blue (29 total), please visit the HSDB record page.

All batches of this color additive when used in foods shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

All batches of this color additive when used in drugs shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

All batches of this color additive when used in cosmetics shall meet the specifications, uses and restrictions, and labeling regulations contained in 21 CFR Part 74 and be certified in accordance with regulations in 21 CFR Part 80.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Use: dye. Limit: Not more than 0.2% of pesticide formulation.

Residues of FD&C blue No. 1 are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals. Use: dye, coloring agent. Limit: none.

F.D.&C. Blue No. 1 is exempted from the requirement of a tolerance when used as an aquatic plant control agent.

The absorption, metabolism and excretion of (14)C-labelled Green S and Brilliant Blue FCF have been studied in the rat, mouse and guinea-pig. Following administration of a single oral dose of Green S at either 100 ug/kg or 10 mg/kg of Brilliant Blue FCF at either 30 ug/kg or 3 mg/kg to male or female rats, substantially all of the dose was excreted unchanged in the feces within 72 hr. Pretreating male rats with unlabelled Green S or Brilliant Blue FCF in the diet (100 or 30 mg/kg day, respectively) for 21 days prior to dosing with (14)C-labelled coloring had no effect on the route of excretion or the time taken to eliminate all of the label. Similarly male mice and guinea-pigs excreted in the feces all of a single oral dose of Green S or Brilliant Blue FCF. The lack of absorption and metabolism of the labelled dye in the gastro-intestinal tract of all three species investigated was confirmed by studies using isolated loops of small intestine. It was shown that no radioactivity was taken up by the fetuses of pregnant rats given (14)C-labelled Green S or Brilliant Blue FCF.

Female Sprague-Dawley rats were given a single dose (0.27 mg; 1.74 uCi) of the (14)C-labelled coloring by gavage. In bile-duct ligated rats, intestinal absorption of FD & C Blue No.1 (estimated from urinary (14)C excretion, expired (14)CO2 and residual radioactivity in internal organs and tissues 96 hr after oral administration) averaged 2.05% of the dose. Mean fecal excretion was 97.28% and the total recovery of administered radioactivity was 99.38%. Intestinal absorption (14)C-FD & C Blue No. 1 in intact rats averaged only 0.27% (91% recovery), while biliary excretion in bile-duct cannulated animals averaged 1.32% of the dose. Thin-layer chromatography of urine and bile samples revealed that about 95% of excreted radioactivity was unaltered FD & C Blue No. 1 and that about 5% was an unidentified metabolite or degradation product of FD & C Blue No. 1. The results show that FD & C Blue No.1 is poorly absorbed from the gastro-intestinal tract, and undergoes subsequent rapid and complete biliary excretion /of the absorbed compound/.

... Less than 0.05% of a labeled dose of 3 mg/kg bw was excreted in the bile of rats over a 5-hour period. Very little radioactivity (0.004 - 0.006% of dose) was detected on day 11 in the fetuses of pregnant rats given (14)C-labelled Brilliant Blue FCF orally on day 8 of gestation. ... Brilliant Blue FCF was labeled with (14)C in the central methane ring and had a radioactive purity of greater than 95%. ...

Following administration of either 30 ug/kg bw or 3 mg/kg bw of (14)C-Brilliant Blue FCF by gavage to male or female rats, substantially all of the dose was excreted unchanged in the feces within 72 hours (99.9% at low dose, 95.4% at high dose). No radioactivity was detected in the expired air and less than 0.5% was detected in the urine. ...

For more Absorption, Distribution and Excretion (Complete) data for Brilliant Blue (6 total), please visit the HSDB record page.

For FD&C Blue No. 1 (USEPA/OPP Pesticide Code: 110301) ACTIVE products with label matches. /SRP: Registered for use in the U.S. but approved pesticide uses may change periodically and so federal, state and local authorities must be consulted for currently approved uses./

Colorant in food, drugs and cosmetics; biological stain; textile dye; wood stain; indicator

Dyes wool, silk and nylon greenish-blue from an acid bath. Nylon is dyed less intensely ... dyeing leather, surface-coating paper, and preparing heavy-metal lakes for use as pigments.

... /Used/ to dye lavatory fresheners or flushing water.

... used as an aquatic plant control agent.

2023: 2,500,000 - <4,000,000 lb

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt is listed as a High Production Volume (HPV) chemical (65FR81686). Chemicals listed as HPV were produced in or imported into the U.S. in >1 million pounds in 1990 and/or 1994. The HPV list is based on the 1990 Inventory Update Rule. (IUR) (40 CFR part 710 subpart B; 51FR21438).[EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program. Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt is listed as an Extended High Production Volume (EHPV). Chemicals listed as EHPV were produced in or imported into the U.S. in >1 million pounds according to the 2002 Toxic Substances Control Act (TSCA) Inventory Update. The EHPV program is a voluntary initiative that allows companies to demonstrate that adequate screening data exist for organic HPV chemicals.

Production volumes for non-confidential chemicals reported under the Inventory Update Rule. [Table#7899]

Production volume for non-confidential chemicals reported under the 2006 Inventory Update Rule. Chemical: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-hydroxy-. Aggregated National Production Volume: 1 to <10 million lbs.[US EPA; Non-Confidential 2006 Inventory Update Reporting. National Chemical Information. Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl

Its leuco compound is obtained from 2-formylbenzenesulfonic acid and N-ethyl-N-(3-sulfobenzyl)aniline and oxidized ... in the presence of (dihydrodibenzotetraaza[14]annulene)iron as the catalyst with peroxomonosulfuric acid or hydrogen peroxide.

Admiral Liquid: Erioglaucine 15.31%, Tartrazine 1.00%

Admiral WSP: Erioglaucine 49.72%, Tartrazine 3.27%

Aquashade: Erioglaucine 12.6%, Tartrazine 1.04%

EPA Safer Chemical Functional Use Classes -> Colorants

Safer Chemical Classes -> Green circle - The chemical has been verified to be of low concern

Food additives

Fragrance Ingredients

Food Additives -> COLOUR -> JECFA Functional Classes

Food Additives -> COLOUR -> JECFA Functional Classes

Synthetic Dye and Pigment Manufacturing

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, sodium salt (1:2): ACTIVE