C.I. Direct Yellow 11

452.37

451.972473

215-393-6

H77VEI93A8

DTXSID8025206

Orange-red crystals|Orange powder

172.62000

3.14150

Fd & c yellow no. 6 appears as orange-red crystals or a red powder. (NTP, 1992)

Decomposes without melting at 734° F (NTP, 1992)

50 to 100 mg/mL at 75° F (NTP, 1992)

1.43X10-22 mm Hg at 25 °C (estimated)

Henry law constant = 3.29X10-23 cu m-atm/mol at 25 °C (estimated)

pKa1 = 0.82; pKa2 = 1.46, for the sulfonic acid groups (est)

Azo dyes can be explosive when suspended in air at specific concentrations. Soluble in water.

Azo, Diazo, Azido, Hydrazine, and Azide Compounds

Explosive

DIRECT YELLOW 11 is an azo compound. Azo, diazo, azido compounds can detonate. This applies in particular to organic azides that have been sensitized by the addition of metal salts or strong acids. Toxic gases are formed by mixing materials of this class with acids, aldehydes, amides, carbamates, cyanides, inorganic fluorides, halogenated organics, isocyanates, ketones, metals, nitrides, peroxides, phenols, epoxides, acyl halides, and strong oxidizing or reducing agents. Flammable gases are formed by mixing materials in this group with alkali metals. Explosive combination can occur with strong oxidizing agents, metal salts, peroxides, and sulfides.|FD & C YELLOW NO. 6 is an azo compound. Azo, diazo, azido compounds can detonate. This applies in particular to organic azides that have been sensitized by the addition of metal salts or strong acids. Toxic gases are formed by mixing materials of this class with acids, aldehydes, amides, carbamates, cyanides, inorganic fluorides, halogenated organics, isocyanates, ketones, metals, nitrides, peroxides, phenols, epoxides, acyl halides, and strong oxidizing or reducing agents. Flammable gases are formed by mixing materials in this group with alkali metals. Explosive combination can occur with strong oxidizing agents, metal salts, peroxides, and sulfides.

36/37/38

26-36

Xi

Stable. May be flammable.

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.

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.

DHHS/NTP; Toxicology & Carcinogenesis Studies of FD & C Yellow No. 6; Technical Report Series No. 208 (1991) NIH Publication No. 81-1764 U.S. Department of Health and Human Services, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709[Available from, as of April 4, 2003: http://ntp.niehs.nih.gov/ntp/htdocs/LT_rpts/tr208.pdf]|Combes RD, Haveland-Smith RB; Mutat Res 98 (2): 101-248 (1982). A review of the genotoxicity of food drug and cosmetic colors and other azo tri phenyl methane and xanthene dyes.|WHO Food Additive Series 549: Sunset Yellow FCF (1964).[Available from, as of October 26, 2004: http://www.inchem.org/documents/jecfa/jecmono/v17je29.htm]|EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans.[Available from, as of November 3, 2004: http://www.epa.gov/hpv/pubs/hpvrstp.htm]|The U.S. high production volume (HPV) chemicals are those which are manufactured in or imported into the United States in amounts equal to or greater than one million pounds per year. Robust Summaries include health effects, ecotoxicity data, and environmental fate information for selected chemicals. EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans.[Available from, as of November 3, 2004: http://www.epa.gov/hpv/pubs/hpvrstp.htm]

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

|Warning|H315 (99.62%): Causes skin irritation [Warning Skin corrosion/irritation]|P261, P264, P271, P280, P302+P352, P304+P340, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362, P403+P233, P405, and P501|Aggregated GHS information provided by 2887 companies from 9 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|H317 (23.08%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P261, P264, P272, P280, P302+P352, P305+P351+P338, P321, P333+P313, P337+P313, P363, and P501|Aggregated GHS information provided by 87 companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Fires involving this compound can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)|Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)

SMALL SPILLS AND LEAKAGE: If you spill this chemical, you should dampen the solid spill material with water, then transfer the dampened material to a suitable container. Use absorbent paper dampened with water to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Wash all contaminated surfaces with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should store this material in a refrigerator. (NTP, 1992)|SMALL SPILLS AND LEAKAGE: If you spill this chemical, you should dampen the solid spill material with water, then transfer the dampened material to a suitable container. Use absorbent paper dampened with water to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Wash all contaminated surfaces with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should store this material under ambient temperatures. (NTP, 1992)

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)

LD50 Mouse ip (Females) 4600 mg/kg bw|LD50 Mouse ip (Males) 5500 mg/kg bw|LD50 Rat ip 3800 mg/kg bw|LD50 Mice oral > 6000 mg/kg bw|For more Non-Human Toxicity Values (Complete) data for C.I. FOOD YELLOW 3 (8 total), please visit the HSDB record page.

A carcinogenesis bioassay was conducted using groups of 50 male and 50 female F344 rats and B6C3F1 mice which were fed diets containing 12,500 or 25,000 ppm FD & C Yellow No. 6 ... for 103 wk. Groups of 90 male and 90 female rats and 50 male and 50 female mice served as controls. ... Under the conditions of this bioassay, there was no clear evidence of the carcinogenicity of FD & C Yellow No. 6 in F344 rats or B6C3F1 mice of either sex.

C.I. Food Yellow 3 is not known to occur in nature(1).

C.I. Food Yellow 3's production and use as a pigment in printing inks(1) and as a dye for food, drugs and cosmetics(2) may result in its release to the environment through various waste streams(SRC).

TERRESTRIAL FATE: If released to soil, C.I. Food Yellow 3 may have high mobility; the pKa1 of C.I. Food Yellow 3 is estimated as 0.82(1), indicating that 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(2). Volatilization of C.I. Food Yellow 3 from moist soil surfaces is not expected to be an important fate process(SRC) because this compound will exist as an anion, and anions do not volatilize(SRC). C.I. Food Yellow 3 is not expected to volatilize from dry soil surfaces(SRC) since it is a salt and will be nonvolatile(SRC). Biodegradation in soil may be slow based on a standard 5 day BOD test using a sewage inoculum in which C.I. Food Yellow 3 did not biodegrade(3).|AQUATIC FATE: C.I. Food Yellow 3 is not expected to adsorb to suspended solids and sediments. The pKa1 of C.I. Food Yellow 3 is 0.82(1), indicating that 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(2). Volatilization from water surfaces is not expected(3) because this compound will exist as an anion, and anions do not volatilize(SRC). The potential for bioconcentration in aquatic organisms is expected to be low based on this compound's ionic character(SRC). A first order rate constant of 0.00398 per day was determined for an aqueous solution of C.I. Food Yellow 3 (0.0001% w/v) exposed to sunlight for approximately 80 days(4), corresponding to a half-life of 174 days(SRC). Biodegradation in water may be slow based on a standard 5 day BOD test using a sewage inoculum in which C.I. Food Yellow 3 did not biodegrade(5).|ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), C.I. Food Yellow 3 is expected to exist solely in the particulate phase in the ambient atmosphere, since it is a salt and will be nonvolatile(SRC). Particulate-phase C.I. Food Yellow 3 may be removed from the air by wet or dry deposition(SRC). C.I. Food Yellow 3 is susceptible to direct photolysis by sunlight; a first order rate constant of 0.00398 per day was determined for an aqueous solution of C.I. Food Yellow 3 (0.0001% w/v) exposed to sunlight for approximately 80 days(2), corresponding to a half-life of 174 days(SRC).

C.I. Food Yellow 3 is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions(1). C.I. Food Yellow 3 is susceptible to direct photolysis by sunlight(SRC). In a study of the stability of various dyes to sunlight, an aqueous solution of C.I. Food Yellow 3 (0.0001% w/v) was exposed to sunlight for approximately 80 days; a first order rate constant of 0.00398 per day was determined for the degradation of C.I. Food Yellow 3(2), which corresponds to a half-life of 174 days(SRC).

The ionic character of C.I. Food Yellow 3 suggests the potential for bioconcentration in aquatic organisms is expected to be low. (SRC)

The pKa1 of C.I. Food Yellow 3 is 0.82(1), indicating that 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(2).

Estimated pKa1 and pKa2 of 0.82 and 1.46, respectively, for the sulfonic acid groups(1) indicate that C.I. Food Yellow 3 will exist almost entirely in the anion form at pH values of 5 to 9 and therefore volatilization from water and moist soil surfaces is not expected to be an important fate process(2). The compound is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.4X10-22 mm Hg(SRC), determined from a fragment constant method(3).

NIOSH (NOES Survey 1981-1983) has statistically estimated that 195,835 workers (103,566 of these are female) are potentially exposed to C.I. Food Yellow 3 in the US(1). Occupational exposure to C.I. Food Yellow 3 may occur through dermal contact with this compound at workplaces where C.I. Food Yellow 3 is produced or used(SRC). Use data indicate that the general population may be exposed to C.I. Food Yellow 3 via ingestion of food, beverages, and drug products that contain this color additive, and dermal contact with cosmetics(2) that use this compound.

Natural or synthetic dyes used as coloring agents in processed foods. (See all compounds classified as Food Coloring Agents.)

When color is given orally to rats, 3% is absorbed and excreted unchanged in urine and in bile: thus little is reduced in liver. ...After its iv injection in rats, 20-30% was excreted in bile.|... A trace to 1.5 percent of unchanged monomeric dyes was excreted in urine and bile during the first 24 hr after dosing. No unchanged dye was absorbed after administration of the polymeric derivatives. In animals dosed with sunset yellow and its polymer derivative, absorption of the azo-bound cleavage product 1-amino-2-naphthol-6-sulphonic acid was 8.5 and 6.9 percent, respectively, while absorption of the cleavage product sulphanilic acid was 37.4 and 0 percent, respectively. ...|In 5 animals dosed with 14C-sunset yellow (2.7 mg, 4.62 uCi) after 96 hours urinary excretion of radioactivity was 8.5 +/- 3.4% of the dose. The 24 hours urine collection from the sunset yellow rats contained 40% of the molar equivalents of sulfanilic acid. Intact dye in the 24 hours urine represented 1-2% of the dose. Peak fecal excretion occurred during the first 24 hours. The recovery of radioactivity was 94.5 +/- 5.7%. Total recovery of radioactivity was 103 +/- 3.3%.|Fourteen rats were dosed with sunset yellow within the range of 2-25 mg and within 72 hours excreted 0.3 and 1.5% of the administered dye in urine and bile respectively and 37% of the sulfanilic acid equivalents in the urine.

When color is given orally to rats... unabsorbed was mainly reduced by intestinal bacteria and excreted as sulfanilic acid and 1-amino-2-hydroxy-6-naphthalenesulfonic acid in urine. ...n-Acetylsulfanilic acid as metabolite in rabbits after oral administration...|Sunset yellow FCF is easily reduced in vitro by bacteria present in intestine and cecum of rats. It binds with serum proteins.|The anaerobic reduction of 4... sulfonated azo dyes, amaranth, sunset yellow, new coccine and tartrazine, has been studied by incubating bacterial suspensions isolated from human feces and from the intestinal contents of rats with 50 um concentrations of the dyes in phosphate buffer pH 4 /with/ nitrogen as the gaseous phase. Human fecal flora from 5 male volunteers reduced the 4 dyes at mean rates of 38.4, 25.1, 18.2 and 6.5 nmol/mg/protein/hr, respectively. For each dye, there was little difference in the reduction rates effected by the bacterial suspensions from the different individuals in spite of considerable divergence in age, daily diets and living circumstances. ...The rates of amaranth and sunset yellow reduction by rat gut flora were 4-5 times higher than those by human fecal flora, but there was no significant difference between the two types of bacterial suspension in the reduction rates for new coccine and tartrazine. ...|When rabbits were fed 0.5 g/kg bw of the color, the following metabolites could be identified in 48 hours urine: sunset yellow (2%), sulfanilic acid (54%), p-acetamido benzene-sulfonic acid (23%), 1-amino-2-naphthol-6-sulfonic acid (55% in 24 hours). ... The metabolites in the urine were predominantly products resulting from the reductive fission of the azolinkage. The liver enzyme that reduces azolinkages plays little part in metabolism. Reduction of the color by the intestinal bacteria is therefore the most probable way to aromatic amines and aminosulfonic acids; these are then partly absorbed by the intestinal tract.|The sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid (SS-AN), which is a subsidiary color present in Food Yellow No. 5 [Sunset Yellow FCF, disodium salt of 6-hydroxy-5-(4-sulfophenylazo)-2-naphthalenesulfonic acid], was orally administered to Sprague-Dawley rats. Metabolite A, metabolite B, and unaltered SS-AN were detected as colored metabolites in the rat urine. Analysis of the chemical structures showed that metabolite A (major peak) was 6-hydroxy-5-(4-sulfooxyphenylazo)-2-naphthalenesulfonic acid, the sulfuric acid conjugate of SS-AN, and metabolite B (minor peak) was 6-hydroxy-5-(4-hydroxyphenylazo)-2-naphthalenesulfonic acid (SS-PAP), which is a derivative of metabolite A without the sulfuric acid. ...The orally administered SS-AN had been metabolized to the colorless metabolites (p-aminophenol 45.3%, o-aminophenol 9.4%, aniline 0.4%) in the 24-hr urine samples. Analysis of the colored metabolites... indicated the presence of metabolite A (0.29%), SS-PAP (0.01%), and SS-AN (0.02%) were detected in the 24-hr urine samples. Approximately 56% of SS-AN was excreted into the urine and the rest is probably excreted into feces.

SYMPTOMS: It can cause enlargement of the caecum and weight loss. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992)|EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. If symptoms (such as redness or irritation) develop, immediately transport the victim to a hospital. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992)

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/|/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

/HUMAN EXPOSURE STUDIES/ A total of 54 patients with an allergic disease randomly recruited in five university hospitals in Korea were enrolled in a double-blind, placebo-controlled (DBPC) oral challenge with crossover design. ... After seven days on a low-food additive diet, oral challenges were performed with a mixture of seven food additives or placebo. Enrolled patients completed a questionnaire designed to screen for the presence of a food-related hypersensitivity and underwent skin prick and patch testing using seven common food additives: Amaranth, Erythrosine, Tartrazine, Sunset Yellow FCF, sodium sulphite, sodium benzoate, and monosodium glutamate. The amount of each food additive in the mixture was 1/10 of the /acceptable dail intake/ ADI determined for the Korean population. Test substances were administered in three divided doses (i.e., 1/6, 2/6, and 3/6 of the total amount in order), with 30-minute intervals between doses. Five patients (9.3 %) had a positive reaction to food additives but no reactions to the placebo, two patients (3.7 %) reacted to both food additives and to the placebo, three patients (5.5 %) reacted to the placebo only, and the remaining 44 patients (81.5 %) reacted to neither. Urticaria, periorbital edema, and facial flushing accompanied by itching were the major symptoms. Statistically significant differences between those who reacted positively to food additives and those who reacted positively to the placebo were not observed.|/HUMAN EXPOSURE STUDIES/ A skin test with the color showed, in patients sensitive to p-phenylenediamine, eczematous hypersensitivity produced by cross-sensitization. This reaction is explained by the ease of its transformation into compounds of quinone structure and upon the ability of the quinone compound to couple with certain body constituents.|/CASE REPORTS/ A 53-yr-old woman with a loculated tuberculous abscess, who was given 2 tablets of Rifinah 300 (rifampicin 300 mg and isoniazid 150 mg in each tablet), developed GI symptoms. When the drugs were discontinued the symptoms subsided. ...Rifinah 300 tablets contain the coloring agent FD&C Yellow No. 6 (sunset yellow, 0.76 mg/tablet). The patient was challenged with one mg of sunset-yellow powder by mouth. Within 6 hr all GI symptoms returned and they continued for 12 hr.|/ALTERNATIVE and IN VITRO TESTS/ The synthetic food dyes studied were rose bengal (RB), phroxine (PL), amaranth, erythrosine B (ET), allura red, new coccine, acid red (AR), tartrazine, sunset yellow FCF, brilliant blue FCF, and indigo carmine. First, data confirmed that these dyes were not substrates for /human drug-metabolizing enzymes/ CYP2A6, UGT1A6, and UGT2B7. ET inhibited UGT1A6 (glucuronidation of p-nitrophenol) and UGT2B7 (glucuronidation of androsterone). ... /This study/ showed the inhibitory effect of xanthene dye on human UGT1A6 activity. Basic ET, PL, and RB in those food dyes strongly inhibited UGT1A6 activity, with IC50 values = 0.05, 0.04, and 0.015 mM, respectively. Meanwhile, AR of an acidic xanthene food dye showed no inhibition. Next, investigators/ studied the inhibition of CYP3A4 of a major phase I drug-metabolizing enzyme and P-glycoprotein of a major transporter by synthetic food dyes. Human CYP3A4 and P-glycoprotein were also inhibited by basic xanthene food dyes. Human CYP3A4 /a major phase I drug-metabolizing enzyme/ and P-glycoprotein were also inhibited by basic xanthene food dyes. The IC50 values of these dyes to inhibit CYP3A4 and P-glycoprotein were the same as the inhibition level of UGT1A6 by three halogenated xanthene food dyes (ET, PL, and RB) described above... . /The study/ confirmed the noninhibition of CYP3A4 and P-gp by other synthetic food dyes. Part of this inhibition depended upon the reaction of /singlet oxygen/ originating on xanthene dyes by light irradiation, because inhibition was prevented by /singlet oxygen/ quenchers. /Investigators/ studied the influence of superoxide dismutase and catalase on this inhibition by dyes and /observed/ prevention of inhibition by superoxide dismutase but not catalase. This result suggests that superoxide anions, originating on dyes by light irradiation, must attack drug-metabolizing enzymes. It is possible that red cosmetics containing phloxine, erythrosine, or rose bengal react with proteins on skin under lighting and may lead to rough skin.|/OTHER TOXICITY INFORMATION/ ...Synthetic azo dyes and their degraded products inhibit both human true and pseudo-Cholinesterase activities in vitro. ...

6-hydroxy-5-((p- sulfophenyl)azo)-2-naphthalenesulfonic acid disodium salt

ESSENTIALLY 100% AS A DYE (APPROXIMATELY 40% FOR FOODS IN 1976)|ESSENTIALLY 100% AS A DYE

Synthetic dye and pigment manufacturing|C.I. Direct Yellow 11: ACTIVE|Food, beverage, and tobacco product manufacturing|2-Naphthalenesulfonic acid, 6-hydroxy-5-[2-(4-sulfophenyl)diazenyl]-, sodium salt (1:2): ACTIVE|The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2- naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid (CAS Reg. No. 50880-65-4) may be added in small amounts.|Specifications for... foods, drugs or cosmetics require that product contain minimum of 85% pure compound. Specifications... are also given by British Standards Institution... must contain minimum of 85% pure color; FAO/WHO standard requires same minimum. When used as color reference standard... must contain 99.9% pure color.|Added to certified food colorant list in 1929

Method: AOAC 930.38; Procedure: column chromatographic method; Analyte: sunset yellow FCF; Matrix: food; Detection Limit: not provided.|AOAC Method 972.30: Intermediates in FD&C Yellow No. 6; Spectrophotometric Method.|AOAC Method 980.24: Sulfanilic Acid, Schaeffer's Salt, 4,4'-(Diazoamino)-dibenzene-sulfonic Acid, and 6,6'-Oxybis(2-Naphthalene Sulfonic Acid) in FD&C Yellow No. 6; Liquid Chromatographic Method.

EPA Safer Chemical Functional Use Classes -> Colorants|Safer Chemical Classes -> Yellow triangle - The chemical has met Safer Choice Criteria for its functional ingredient-class, but has some hazard profile issues|Food additives|Cosmetics -> Cosmetic colorant; Hair dyeing

Food Additives -> COLOUR;