| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 87.1% (263 of 302) of all reports.WarningH315 (10.6%): Causes skin irritation [Warning Skin corrosion/irritation]P264, P264+P265, P280, P302+P352, P305+P351+P338, P321, P332+P317, P337+P317, and P362+P364 (click each P-code to see the statement)Aggregated GHS information provided per 302 reports by companies from 10 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies. |
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| Regulatorische Informationen | Chemical: Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 3',6'-dihydroxy-, disodium saltSpiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 3',6'-dihydroxy-, sodium salt (1:2) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Spiro[isobenzofuran-1(3H),9'-[9H]xanthen]-3-one, 3',6'-dihydroxy-, 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)Status: Active Update: 18-05-2018 https://echa.europa.eu/registration-dossier/-/registered-dossier/17278C.I. Acid Yellow 73: Non hazardous |
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| Weitere Sicherheitsinformationen | IMAP assessments - Fluorescein and its sodium salt: Human health tier II assessment |
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| Brandgefahren | Flash point data for this chemical are not availablehowever, it is probably combustible. (NTP, 1992) |
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| Brandpotenzial | This material is assumed to be combustible. |
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| Gesundheitsgefahren | SYMPTOMS: Symptoms of exposure to this compound include irritation of the eyes. It may also cause irritation of the skin. Excess inhalation of the dust can cause the onset of asthma. Other symptoms include nausea, urticaria, sneezing, bitter taste and dizziness. There is a low incidence of serious side effects including respiratory embarrassment, pulmonary edema, pharyngeal edema, cardiac arrest, myocardial infarction, shock, hypotension and death. Symptoms that may occur after intravenous injection include vomiting, syncope and urticaria. The skin and urine may be transiently colored. |
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| Gefahrenübersicht | Causes changes in motor activity, ataxia, and dyspnea in oral lethal-dose studies of mice and rats[RTECS] A skin, eye, and respiratory tract irritant[HSDB] May cause irritationTargets the kidney[Sigma-Aldrich MSDS] See Fluorescein. |
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| FDA-Anforderungen | The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl fluorescein sodium, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.All batches of this color additive when used as a color additive for externally applied 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 as a color additive in externally applied 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.A batch of this straight color may be certified, in accordance with 21 CFR Part 82, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of 21 CFR 82.5 and to the specifications in 21 CFR Part 82. |
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| Reaktive Gruppe | Ethers |
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| Reactivity Profile | FLUORESCEIN, DISODIUM SALT is incompatible with strong oxidizers. Also incompatible with acids, acid salts and salts of heavy metals (NTP, 1992). |
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| Air and Water Reactions | Hygroscopic. Water soluble. |
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| Toxic Combustion Products | Emits toxic fumes under fire conditions. |
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| Hazard Classes and Categories | Skin Irrit. 2 (10.6%) |
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| Brandbekämpfung | Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. A water spray may also be used. (NTP, 1992) |
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| Erste Hilfe | 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. |
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| Brandbekämpfungsverfahren | Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials. This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. |
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| Lagerbedingungen | Store at 2 deg - 25 °C (36 deg - 77 °F). Do Not Freeze |
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| Reinigungsverfahren | Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately-labelled container for disposal. Wash spill site. |
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| Freisetung ohne Brand | 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. |
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| Entsorgungsverfahren | 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 qualitypotential migration in soil or watereffects on animal and plant lifeand conformance with environmental and public health regulations. |
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| Preventive Measures | SRP: The scientific literature for the use of contact lenses by industrial workers is inconsistent. The benefits or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place. |
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| Personal Protective Equipment (PPE) | 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)Wear approved respiratory protection, chemically compatible gloves and protective clothing. |
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| Ökotoxizitätswerte | LC50Species: Daphnia pulex (Water Flea) age <24 hr neonateConditions: freshwater, static, 25 °C, pH 7.4-7.8, hardness 80-100 mg/L CaCO3, alkalinity 60-70 mg/L CaCO3, conductivity 260-320 umhos/cm, dissolved oxygen >8.0 mg/LConcentration: 337000 ug/L for 48 hr (95% confidence interval: 278000-403000 ug/L) /formulation/Species: Oryzias latipes (Medaka)Conditions: freshwater, static, 25 °CConcentration: 3000000 ug/L for 48 hrSpecies: Psetta maxima (Left-Eyed Flounder) length 4 cm, weight 1.5 gConditions: saltwater, static, 14.0 °C, pH 8.1, salinity 36.0'%, dissolved oxygen 7.9 mg/LConcentration: 997100 ug/L for 24 hrConcentration: 997100 ug/L for 96 hr |
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| Umweltverhalten | TERRESTRIAL FATE: Based on a classification scheme(1), measured Koc values of 88.81 in a silty clay soil and 69.43 in a sediment(2), indicate that D&C Yellow No. 8 is expected to have high mobility in soil(SRC). Volatilization of D&C Yellow No. 8 from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 2.8X10-16 atm-cu m/mole(SRC), using a fragment constant estimation method(3). D&C Yellow No. 8 is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.6X10-17 mm Hg at 25 °C(SRC), determined from a fragment constant method(3). D&C Yellow No. 8, present at 100 mg/L, exhibited <25% elimination in 42 days using an activated sludge inoculum at 0.5 mg/L dry material in the modified static test suggesting the dye may be resistant to biodegradation(4).TERRESTRIAL FATE: A field study was conducted to identify critical parameters governing the mobility and fate of pesticides in soil/aquifer systems. The test field as located in Juelich, Krauthausen, Germany, characterized as a loamy 20-20% claythe underlying aquifer consists of fluvial sands and gravel. Only 0.18% of the injected uranine mass could be recovered after 365 days. A mean plume velocity of 0.089 m/day was calculated(1).AQUATIC FATE: Based on a classification scheme(1), measured Koc values of 88.81 in a silty clay soil and 69.43 in a sediment(2), indicate that D&C Yellow No. 8 is not expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 2.8X10-16 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), an estimated BCF of 75(SRC), from an estimated log Kow of -0.67(4) and a regression-derived equation(4), suggests the potential for bioconcentration in aquatic organisms is moderate(SRC). D&C Yellow No. 8, present at 100 mg/L, exhibited <25% elimination in 42 days using an activated sludge inoculum at 0.5 mg/L dry material in the modified static test suggesting the dye may be resistant to biodegradation(6).AQUATIC FATE: Sure-Dye formulation was accidentally spilled on the staging area of the Kaiku agricultural landing strip on Kauai Island, HI, October 18, 1996. The formulation was comprised of phloxine B and uraninespill amounts of 1.2 and 0.54 kg, respectively. The concentration of uranine in a puddle immediately following the spill was approximately 500 ppmlevels decreased to 3 ppb 26 days after the spill. None was detected in the Halenanahu Reservoir, 100 feet away. No uranine was detected in sediment samples from the puddle(1). /Uranine/ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), D&C Yellow No. 8, which has an estimated vapor pressure of 1.6X10-17 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase D&C Yellow No. 8 may be removed from the air by wet or dry deposition(SRC). D&C Yellow No. 8 absorbs light at wavelengths of 493 nm(3), and therefore may be susceptible to direct photolysis by sunlight(SRC). |
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| Milk Concentrations | Fluorescein sodium has been demonstrated to be excreted in human milk. |
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| Ökotoxizitätsauszüge | /AQUATIC SPECIES/ The toxicity of two xanthene dyes, fluorescein sodium salt and phloxine B, to Daphnia pulex was assessed using acute and chronic level toxicological endpoints. The 48-hr LC50 (95% FL) of fluorescein and phloxine B to D. pulex neonates was 337 (278-403) mg/L and 0.423 (0.376-0.477) mg/L, respectively. Statistical comparison of the lethal concentration regressions showed no significant difference between the slopes of the two curves. Acute exposure to combinations of these two dyes together resulted in a synergistic increase in mortality compared to exposure to each dye separately. Following 10-day chronic exposure under static conditions, fluorescein caused a concentration-dependent decline in the mean number of offspring produced by D. pulex. In contrast, chronic exposure to phloxine B did not appear to result in significant sublethal effects with respect to the reproductive potential of exposed organisms. |
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| Effluent Concentrations | Uranine was detected, not quantified in unspecified Japanese sewage plant effluent which received dye industry wastewater(1). /Uranine/ |
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| Soil Adsorption/Mobility | A Koc of 88.81 in Lihue silty clay (pH 7.018.6 % iron7640 ug/g Ca1632 ug/g Mg3.10% organic carbon) was been reported for uranine(1). According to a classification scheme(2), this Koc value suggests that uranine is expected to have high mobility in soil. The octanol-isotonic salt solution partition coefficient is 0.72 at 25 °C. Sorption experiments indicate that uranine tends to stay in the aqueous phase at low concentration. A Koc of 69.43 has been measured in sediment (pH 8.018.7 % iron2398 ug/g Ca109 ug/g Mg3.94% organic carbon)(1). Freundlich sorption coefficients in Rur gravel and Rhine gravel of 0.76 and 0.42, respectively, have been reported using a uranine concentration in the range of 2-500 ug/L(3). /Uranine/ |
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| Human Toxicity Excerpts | /SIGNS AND SYMPTOMS/Eye, skin, ... and/or respiratory tract irritation./SIGNS AND SYMPTOMS/ ... Side effects or adverse events reported in the literature were related to intravenous bolus injection. Transient nausea and vomiting may occur. Other adverse events such as vasovagal reaction, cardiac or respiratory effects and anaphylaxis are extremely rare but may be fatal. Intradermal injection may cause mild itch or painsystemic adverse event was reported. Epicutaneous labeling is associated with no reported problem. A typical local dose is several magnitudes of order smaller than a typical intravenous dose. .../CASE REPORTS/ The case of a 35-yr-old man with hypertension and diabetes mellitus who underwent fluorescein angiography (FAG) to evaluate diabetic retinopathy and developed a psoriasiform drug eruption several days after receiving fluorescein sodium during FAG is presented. Concomitant therapy included insulin and cilazapril. Initially, cilazapril was suspected as the cause of the psoriasiform eruption. However, a drug-induced lymphocyte stimulation test (DLST) and patch testing with cilazapril were both negative. Topical application of steroid ointments was effective, and the eruption resolved within 7 days. The eruption recurred after fluorescein sodium was readministered for a second FAG examination the following month. Patch testing with fluorescein sodium was negative, but a DLST was positive for this agent. Two months after the psoriasiform eruption resolved, a similar eruption recurred on the trunk in the absence of FAG and had the histological features of psoriasis. The patient was rechallenged with an intravenous injection of 2.5 mL of fluorescein sodium. Three days after the injection, a similar psoriatic eruption occurred./CASE REPORTS/ A serious cutaneous adverse effect associated with parenteral diagnostic injection of sodium fluorescein, 16.7 mg/kg, in a sick neonate at 2 days of age, with hyperbilirubinemia and necrotizing enterocolitis, was reported. After the appearance of skin lesions, phototherapy was discontinued and the lesions were treated with local application of silver sulfadiazine cream and sterile dressings. The skin lesions resolved completely over the ensuing 21 days.For more Human Toxicity Excerpts (Complete) data for D&C Yellow No. 8 (11 total), please visit the HSDB record page. |
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| Artificial Pollution Sources | D&C Yellow No. 8's production and use as a dye(1) may result in its release to the environment through various waste streams(SRC). D&C Yellow No. 8's use as a tracer for underground streams and effluent discharges(2) releases the compound directly to the environment(SRC). |
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| Environmental Biodegradation | AEROBIC: D&C Yellow No. 8, present at 100 mg/L, exhibited <25% elimination in 42 days using an activated sludge inoculum at 0.5 mg/L dry material in the modified static test. Therefore, the dye may be resistant to biodegradation(1). |
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| Drug Induced Liver Injury | Drug Induced Liver Injury Rank (DILIrank 2.0)Fluorescein sodiumvNo-DILI-concernNo matchDOI:10.1016/j.drudis.2016.02.015 |
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| Environmental Bioconcentration | An estimated BCF of 75 was calculated in fish for D&C Yellow No. 8(SRC), using an estimated log Kow of -0.67(1) and a regression-derived equation(1). According to a classification scheme(2), this BCF suggests the potential for bioconcentration in aquatic organisms is moderate(SRC). |
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| Volatilization from Water/Soil | The Henry's Law constant for D&C Yellow No. 8 is estimated as 2.8X10-16 atm-cu m/mole(SRC) using a fragment constant estimation method(1). This Henry's Law constant indicates that D&C Yellow No. 8 is expected to be essentially nonvolatile from water surfaces(2). D&C Yellow No. 8's Henry's Law constant indicates that volatilization from moist soil surfaces is not expected occur(SRC). D&C Yellow No. 8 is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.6X10-17 mm Hg(SRC), determined from a fragment constant method(1). |
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