ALLURA RED
ALLURA RED
EC No. 247-368-0
CAS No. 25956-17-6
Chemical formula C18H14N2Na2O8S2
Chemical name, Disodium 6-hydroxy-5-(2-methoxy-5-methyl-4-sulfonato-phenylazo)-2- naphthalenesulfonate
SYNONYMS CI Food Red 17, FD&C Red No.40, CI (1975) No.16035, INS No. 129
PHYSICAL DESCRIPTION
FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. Allura Red is an orange red dye that has a red to brownish shade in applications.
COMMON USES
Allura Red is a highly versatile food color used in dairy fats and oil, snacks, convenient food, confectionery, dry mixes and seasonings, flavors, gelatins, puddings, custards, alcoholic and non-alcoholic beverages, fruit preparations, canned and frozen fruit juices, dairy products, bakery products, sausage casings, jams, jellies, condiments, candy, frostings, meat, poultry and seafood. FD&C Red No. 40 is also used in pharmaceuticals and cosmetics.
DEFINITION
Consists essentially of disodium 6-hydroxy-5-(2-methoxy-5-methyl-4- sulfonato-phenylazo)-2-naphthalene-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. May be converted to the corresponding aluminium lake in which case only the General Specifications for Aluminium Lakes of Colouring Matters shall apply.
MELTING POINT
>300 deg C[US EPA; High Production Volume (HPV) Challenge Program. The HPV voluntary challenge chemical list. Robust summaries and test plans. 2-Naphthalenesulfonic acid, 6-hydroxy-5-
SOLUBILITY
In water, 2.25X10+5 mg/L at 25 deg C
In 50% alcohol, 1.3%
Solubility at 25 deg C: in ethanol, 0.001 g/100 mL; in glycerol, 3.0 g/100 mL; in propylene glycol, 1.5 g/100 mL
DECOMPOSITION
When heated to decomposition it emits very toxic fumes of /nitrogen and sulfur oxides/.
SPECTRAL PROPERTIES
Lambda max: 504 nm
ABSORPTION,DISTRUBITION AND EXCRETION
Rats were fed a diet containing 5.19% of Allura Red. It was observed that 0.1% and 29% of the intact dye was excreted in the urine and feces respectively. In later studies, rats and dogs were pretreated daily with nonradioactive Allura Red. Subsequently, the animals were dosed with the 35S labelled compound and studied for up to 72 hours for excretion and distribution patterns of the color. Both species showed limited absorption of the compound with the major route of excretion being via the feces. In the dog 92-95% of the recovered radioactivity appeared in the feces within 72 hours while in the rat 76-92% of the recovered radioactivity appeared in the feces within this time period. Urinary recoveries of the color in rats and dogs, respectively varied between 5.7 and 19.8% and 2.7 and 3.6%. After sacrifice, significant retention of radioactivity was located in the intestinal contents of both species and in the washed intestines of the rats. This was thought to be due to adhesion of the compound to the intestinal wall, since the total carcass and viscera of these animals contained <0.4% of the administered dose.
METABOLISM/METABOLITES
Several metabolites, possibly resulting from azo-reduction in the gastrointestinal tract (two identified as aromatic amines, p-cresidine sulfonic acid being the major one), were also found in the feces and urine. Finally, significant retention in the washed intestines of rat was observed, probably due to adhesion to the intestinal wall.
Cresidinesulfonic acid was found to be the major metabolite of Allura Red in the urine of these two species, whereas the parent compound was not measurable. In addition, two other unidentifiable metabolites were found in the urine of the rats. In the rat fecal extracts, cresidinesulfonic acid was a major metabolite along with two unknowns and the parent compound. The dog fecal sample revealed an identical metabolite pattern as seen in the rat, and in addition, a third unknown was discovered. One of the urinary unknowns demonstrated an Rf value which was identical to that of the one of the fecal unknowns suggesting that they were one and the same. The other unknowns exhibited distinctive Rf values which indicated that these metabolites were different. It has been postulated that azo reduction by gut flora of the dye will yield the two components of the parent compound: 2-methoxy-5-methyl-aniline-4-sulfonic acid (cresidine-4-sulfonic acid) and 1-amino-2-naphthol-6-sulfonic acid. It appears that negligible quantities of intact Red are absorbed and excreted in the urine, and that the major portion of the color is excreted as metabolites in the feces.
SAFETY AND HAZARDS
Hazards Identification
EPA Safer Chemical
FD&C Red 40 – Green circle – The chemical has been verified to be of low concern based on experimental and modeled data.
ACCIDENTAL RELEASE MEASURES
DISPOSAL METHODS
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.
TOXICOLOGICAL INFORMATION
Interactions
In this study, the color and its alumina lake were applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hr periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The color did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period. … Allura Red and its lake were evaluated on sites under occlusion for five 48-hr, alternate-day periods. These sites had been previously irradiated for 5 min with Xenon light which had been filtered through a window-glass equivalent to limit the exposure to non-erythema-producing, long-wave radiation. A 10-day rest period followed this induction exposure, and then the color was applied to fresh skin sites, irradiated for 5 min with Xenon and subsequently removed and the sites were evaluated. Allura Red was shown not to produce photosensitization on the 25 subjects studied.
ANTIDOTE AND EMERGENCY TREATMENT
/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/
ENVIRONMENTAL FATE/EXPOSURE SUMMARY
Allura Red AC dye’s production and use as a color additive in foods, drugs and cosmetics may result in its release to the environment through various waste streams. If released to air, Allura Red AC dye will exist solely in the particulate phase in the atmosphere since it is a salt and will be nonvolatile. Particulate-phase Allura Red AC dye will be removed from the atmosphere by wet or dry deposition. Allura Red AC dye contains chromophores that absorb at wavelengths >290 nm, and therefore may be susceptible to direct photolysis by sunlight; its concentration decreased by 7% after 50 minutes in an experiment using 15-watt lamps as a UV source. If released to soil, Allura Red AC dye is expected to be mobile; 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. Volatilization from moist soil surfaces is not expected to be an important fate process because the compound exists as an anion and anions do not volatilize. If released into water, Allura Red AC dye is not expected to adsorb to suspended solids and sediment based upon this compound’s ionic nature in the environment. The concentrations of azo dyes with a phenolic OH and two sulfonic acid groups remain constant throughout activated sludge treatment and are therefore not expected to be biodegradable in water and soils. Volatilization from water surfaces is not expected to be an important fate process based upon the ionic character of the compound. The potential for bioconcentration in aquatic organisms is expected to be low based on the ionic character of the compound. Hydrolysis is not expected to be an important environmental fate process since this compound lacks functional groups that hydrolyze under environmental conditions. Occupational exposure to Allura Red AC dye may occur through dermal contact with this compound at workplaces where Allura Red AC dye is produced or used. Use data indicate that the general population may be exposed to Allura Red AC dye via ingestion of food, beverages, and drug products that contain this color additive, and dermal contact with cosmetics that use this compound. (SRC)
ABIOTIC DEGREDATION
Allura Red AC dye is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions(1). After 50 minutes exposure using two 15-watt low pressure lamps as a UV source, Allura Red AC dye concentration decreased by 7% in the direct experiment; in an indirect experiment in which acetone was used as a sensitizer, the concentration of Allura Red AC dye decreased by 99% after 20 minutes(2).[(1) Lyman WJ et al; Handbook of Chemical Property Estimation Methods. Washington, DC: Amer Chem Soc pp. 7-4, 7-5, 8-12 (1990) (2) US EPA; High Production Volume (HPV) Challenge Program. The HPV voluntary challenge chemical list. Robust summaries and test plans. 2-Naphthalenesulfonic acid, 6-hydroxy-5-
BIOCONCENTRATION
The ionic character of Allura Red AC dye indicates that the potential for bioconcentration in aquatic organisms is expected to be low. (SRC)
SOIL ADSORPTION/MOBILITY
Allura Red AC dye 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).
VOLATILIZATION FROM WATER/SOIL
Allura Red AC dye is expected to exist as an anion in the environment, and therefore volatilization from moist soil is not expected because anions do not volatilize. Allura Red AC dye is not expected to volatilize from dry soil surfaces because it is a salt, and salts do not volatilize. (SRC)
PROBABLE ROUTES OF HUMAN EXPOSURE
NIOSH (NOES Survey 1981-1983) has statistically estimated that 88,602 workers (50,574 of these were female) were potentially exposed to Allura Red AC dye in the US(1). Occupational exposure to Allura Red AC dye may occur through dermal contact with this compound at workplaces where Allura Red AC dye is produced or used. Use data indicate that the general population may be exposed to Allura Red AC dye via ingestion of food, beverages, and drug products that contain this color additive, and dermal contact with cosmetics(2) that use this compound.
ALLURA RED
EC No. 247-368-0
CAS No. 25956-17-6
SYNONYMS CI Food Red 17, FD&C Red No.40, CI (1975) No.16035, INS No. 129
Chemical formula C18H14N2Na2O8S2
Kimyasal isim, Disodyum 6-hidroksi-5- (2-metoksi-5-metil-4-sülfonato-fenilazo) -2-naftalensülfonat; disodium;(5Z)-5-[(2-methoxy-5-methyl-4-sulfonatophenyl)hydrazinylidene]-6-oxonaphthalene-2-sulfonate
FZKSEL TANIM
FD & C Krmz No. 40, esas olarak 6-hidroksi-5 – [(2-metoksi-5-metil-4-sülfenil) azo] -2-naftalensülfonik asidin disodyum tuzudur. Allura Red, uygulamalarda krmzdan kahverengiye bir renge sahip turuncu bir krmz boyadr.
YAYGIN KULLANIMLAR
Allura Red, süt yalar ve yalar, attrmalklar, elverili yiyecekler, ekerlemeler, kuru karmlar ve baharatlar, tatlandrclar, jelatinler, pudingler, kremalar, alkollü ve alkolsüz içecekler, meyve müstahzarlar, konserve ve dondurulmu meyve sularnda kullanlan çok yönlü bir gda boyasdr. , süt ürünleri, unlu mamuller, sosis klflar, reçeller, jöleler, çeniler, eker, kremalar, et, kümes hayvanlar ve deniz ürünleri. FD & C Krmz No. 40 da farmasötik ve kozmetikte kullanlmaktadr.
TANIM
Esas olarak renksiz bileenler olarak sodyum klorür ve / veya sodyum sülfat ile birlikte disodyum 6-hidroksi-5- (2-metoksi-5-metil-4-sülfonato-fenilazo) -2-naftalen-sülfonat ve yardmc renklendirme maddelerinden oluur. lgili alüminyum göle dönütürülebilir, bu durumda sadece Alüminyum Boyama Meseleleri Genel artlar geçerli olacaktr.
ERME NOKTASI
> 300 derece C [ABD EPA; Yüksek Üretim Hacmi (HPV) Zorluk Program. HPV gönüllü mücadelesi kimyasal listesi. Salam özetler ve test planlar. 2-Naftalinsülfonik asit, 6-hidroksi-5-
ÇÖZÜNÜRLÜK
Suda, 25 ° C’de 2.25X10 + 5 mg / L
% 50 alkolde,% 1.3
25 ° C’de çözünürlük: etanol içinde, 0.001 g / 100 mL; gliserol içinde, 3.0 g / 100 mL; Propilen glikol, 1.5 g / 100 mL
AYRIMA
Ayrmaya stldnda, çok az zehirli / azot ve sülfür oksitleri yayar.
SPEKTRAL ÖZELLKLER
Lambda max: 504 nm
EMLM, DAITIM, BOALTIM
Sçanlar,% 5.19 orannda Allura Red içeren bir diyetle beslendi. Salam boyalarn% 0,1 ve% 29’unun srasyla idrar ve dkda atld gözlendi. Daha sonraki çalmalarda, sçanlar ve köpekler günlük olarak nonradioactive Allura Red ile tedavi edildi. Daha sonra, hayvanlara 35S etiketli bileik verildi ve rengin boaltm ve datm modelleri için 72 saate kadar çalld. Her iki tür de, dk yoluyla olmak üzere ana atlm yolu ile bileiin snrl bir emilimini göstermitir. Köpekte, geri kazanlan radyoaktivitenin% 92-95’i dkda 72 saat içinde ortaya çkarken, sçanda geri kazanlan radyoaktivitenin% 76-92’si bu zaman zarfnda dklarda ortaya çkmtr. Sçanlarda ve köpeklerde rüpteki idrar geri kazanm, srasyla% 5.7 ve% 19.8 ile% 2.7 ve 3.6 arasnda deimitir. Kurban edildikten sonra, her iki türün barsak içeriinde ve sçanlarn ykanm barsaklarnda radyoaktivitenin önemli ölçüde tutulduu yer ald. Bu bileiin barsak duvarna yapmas nedeniyle olduu düünüldü, çünkü bu hayvanlarn toplam karkas ve iç organ uygulanan dozun <% 0.4’ünü içerdi.
METABOLZMA VE METABOLTLER
Dk ve idrarda mide barsak sisteminde azo-indirgemeden (iki tanesi aromatik aminler olarak tanmlanan iki, p-kesidin sülfonik asit, majör olmak üzere) meydana gelen çeitli metabolitler de bulunmutur. Son olarak, muhtemelen barsak duvarna yapmaya bal olarak, sçann ykanm barsaklarnda önemli bir tutulma gözlemlenmitir.
Bu iki türün idrarndaki Allura Red’in en önemli metaboliti olan kültivinesülfonik asit, ana bileik ölçülebilir deildi. Ayrca, sçanlarn idrarnda iki baka tanmlanamayan metabolit bulunmutur. Sçan fekal ekstraktlarnda, iki bilinmezle ve ana bileikle birlikte, krateridin sülfonik asit önemli bir metabolit idi. Köpek fekal numunesi, sçanda görüldüü gibi özde bir metabolit paterni ortaya çkard ve buna ek olarak üçüncü bir bilinmeyen kefedildi. Üriner bilinmeyenlerden biri, fekal bilinmeyenlerden birinin, bir ve ayn olduklarn düündüren ile ayn olan bir Rf deerini gösterdi. Dier bilinmeyenler, bu metabolitlerin farkl olduunu gösteren farkl Rf deerleri sergiledi. Boyann gözenekli florasndan azo azalmasnn, ana bileiin iki bileenini verecei öne sürülmütür: 2-metoksi-5-metil-anilin-4-sülfonik asit (kesidin-4-sülfonik asit) ve 1-amino- 2-naftol-6-sülfonik asit. hmal edilebilir miktarlarda bozulmam Krmz’nn idrarda emildii ve atld ve rengin büyük ksmnn dkda metabolit olarak atld anlalmaktadr.
GÜVENLK VE TEHLKE
TEHLKE TANITIMI
EPA Güvenli Kimyasal
FD & C Krmz 40 – Yeil daire – Kimyasal deneysel ve modellenmi verilere dayanan düük bir endie olduu dorulanmtr.
KAZALARA KARI ALINACAK ÖNLEMLER
Bertaraf Yöntemleri
SRP: En elverili etki, mesleki zarar / yaralanma / toksisite veya çevresel kirlenme için daha az yerleik eilime sahip alternatif bir kimyasal ürün kullanmaktr. Onaylanm kullanm için malzemenin kullanlmayan ksmlarn geri dönütürün veya üreticiye veya tedarikçiye iade edin. Kimyasaln nihai bertaraf unlar dikkate almaldr: malzemenin hava kalitesi üzerindeki etkisi; toprak veya suda potansiyel göç; hayvan ve bitki yaamna etkileri; ve çevre ve halk sal düzenlemelerine uygunluk.
TOKSKOLOJK BLGLER
Etkileimler
Bu çalmada, renk ve alümina gölü, volkan önkollar (200 kii), 10 alternatif gün boyunca, 24 saatlik periyotlar için sulu bir çözelti halinde uygulanm, ardndan 14 günlük dinlenme dönemi uygulanmtr. Meydan okuma gruplar daha sonra 24 saat süreyle skapular srtlar üzerinde taze cilt bölgelerine tkanma altnda uyguland. Renk, indüksiyon faznda tahri edici veya alerjik yantlar vermedi, ya da zorlama döneminde kontakt dermatit oluturmad. … Allura Red ve gölü, be 48 saatlik, alternatif gün periyotlar için oklüzyon altndaki sahalarda deerlendirildi. Bu siteler daha önce eritem üretmeyen uzun dalga radyasyonuna maruz kalmay snrlamak için bir pencere cam edeeri ile filtreden geçirilen Xenon ile 5 dakika boyunca nlanmtr. 10 günlük bir dinlenme periyodu, bu indüksiyon maruziyetini izledi ve daha sonra renk, taze cilt bölgelerine uyguland, Xenon ile 5 dakika süreyle nland ve daha sonra uzaklatrld ve siteler deerlendirildi. Allura Red’in çallan 25 kii üzerinde a duyarllk yaratmad gösterilmitir.
PANZEHR VE ACL TEDAV
/ SRP: / Hemen ilk yardm: Yeterli dekontaminasyonun yapldndan emin olun. Hasta nefes almyorsa, eitimli olarak tercihen bir talep valfi resusitatörü, torba-maske-maske cihaz veya cep maskesi ile suni teneffüse balayn. Gerekirse CPR gerçekletirin. Hemen akan gözleri yavaça akan suyla ykayn. Kusmay tevik etmeyin. Kusma oluursa, açk hava yolunu korumak ve aspirasyonu önlemek için hastay öne yatrn veya sol tarafa yerletirin (mümkünse ba aa pozisyon). Hastay sessiz tutun ve normal vücut ssn koruyun. Tbbi yardm aln. / Zehirler A ve B /
MARUZYET ÖZET
Allura Red AC boyalarnn üretimi, gdalarda, ilaçlarda ve kozmetiklerde renk katks olarak kullanlmas, çeitli atk aklaryla çevreye salnmasna neden olabilir. Havaya braklrsa, Allura Red AC boyas, yalnzca bir tuz olduu ve uçucu olamayaca için atmosferdeki partikül faznda bulunur. Partikül fazl Allura Red AC boyas atmosferden slak veya kuru çökeltme ile uzaklatrlacaktr. Allura Red AC boya,> 290 nm dalga boylarnda absorbe olan kromoforlar içerir ve bu nedenle güne ndan dolay dorudan fotoliziye duyarl olabilir; Bir UV kayna olarak 15-watt lamba kullanan bir deneyde konsantrasyonu 50 dakika sonra% 7 azalmtr. Topraa braklrsa, Allura Red AC boyasnn mobil olmas beklenir; Bu bileiin, ortamdaki anyon formunda neredeyse tamamen mevcut olmas beklenir ve anyonlar genellikle, organik karbon ve kil içeren nötrallere göre daha güçlü adsorbe etmezler. Nemli toprak yüzeylerinden buharlamann önemli bir kader süreci olmas beklenmemektedir çünkü bileik bir anyon olarak varolmaktadr ve anyonlar uçucu hale gelmemektedir. Suya braklrsa, Allura Red AC boyasnn bu bileiin ortamdaki iyonik yapsna bal olarak askda kat madde ve çökeltiye adsorbe olmas beklenmez. Bir fenolik OH ve iki sülfonik asit grubu ile azo boyalarnn konsantrasyonlar, aktif çamur muamelesi boyunca sabit kalr ve bu nedenle de su ve topraklarda biyolojik olarak bozunmas beklenmez. Su yüzeylerinden buharlamann, bileiin iyonik karakterine dayanan önemli bir kader süreci olmas beklenmemektedir. Sudaki organizmalarda biyokonsantrasyon potansiyelinin, bileiin iyonik karakterine bal olarak düük olmas beklenir. Hidrolizin, çevresel koullar altnda hidrolize olan fonksiyonel gruplardan yoksun olmas nedeniyle, önemli bir çevresel kader süreci olmas beklenmemektedir. Allura Red AC boyasna maruz kalma, Allura Red AC boyasnn üretildii veya kullanld iyerlerinde bu bileikle dermal temas yoluyla oluabilir. Kullanm verileri, genel popülasyonun bu renk katksn içeren yiyecek, içecek ve ilaç ürünlerinin yutulmas ve bu bileii kullanan kozmetiklerle dermal temas yoluyla Allura Red AC boyasna maruz kalabileceini göstermektedir. (SRC)
ABYOTK DEGREDASYON
Çevre koullarnda hidrolize olan fonksiyonel gruplarn bulunmamas nedeniyle Allura Red AC boyasnn ortamda hidrolize girmesi beklenmemektedir (1). Bir UV kayna olarak iki adet 15-watt’lk düük basnçl lambalar kullanlarak 50 dakikaya maruz kaldktan sonra, Allura Red AC boya konsantrasyonu dorudan deneyde% 7 azalmtr; asetonun bir hassaslatrc olarak kullanld dolayl bir deneyde, Allura Red AC boyas konsantrasyonu 20 dakika sonra% 99 azalmtr (2). [(1) Lyman WJ et al; Kimyasal Özellik Tahmin Yöntemlerinin El Kitab. Washington, DC: Amer Chem Soc s. 7-4, 7-5, 8-12 (1990) (2) ABD EPA; Yüksek Üretim Hacmi (HPV) Zorluk Program. HPV gönüllü mücadelesi kimyasal listesi. Salam özetler ve test planlar. 2-Naftalinsülfonik asit, 6-hidroksi-5-
BYO YOUNLAMA
Allura Red AC boyasnn iyonik karakteri, suda yaayan organizmalarda biyokonsantrasyon potansiyelinin düük olmas gerektiini göstermektedir. (SRC)
TOPRAK ADSORPSYON/HAREKETLLK
Allura Red AC boyasnn toprakta mobil olmas bekleniyor; Bu bileik, ortamdaki anyon formunda neredeyse tamamen mevcut olacaktr ve anyonlar, organik karbon ve kil içeren nötrallere göre daha güçlü bir ekilde adsorbe edilmezler (1).
SUDAN/TOPRAKTAN VOLATLZASYON
Allura Red AC boyasnn ortamda bir anyon olarak var olmas beklenir ve bu nedenle nemli topran uçucu hale gelmesi beklenmez çünkü anyonlar uçmaz. Allura Red AC boyasnn kuru toprak yüzeylerinden buharlamas beklenmemektedir çünkü bu bir tuzdur ve tuzlar uçmaz. (SRC)
NSAN MARUZYETNN OLASI YOLLARI
NIOSH (NOES Aratrmas 1981-1983), 88.602 çalann (bunlarn 50.574’ü dii) potansiyel olarak ABD’deki Allura Red AC boyasna maruz kaldn tahmin etmitir (1). Allura Red AC boyasna maruz kalma, Allura Red AC boyasnn üretildii veya kullanld iyerlerinde bu bileikle dermal temas yoluyla oluabilir. Kullanm verileri, genel populasyonun, bu renk katksn içeren yiyecek, içecek ve ilaç ürünlerinin yutulmasyla ve bu bileii kullanan kozmetiklerle (2) dermal temas yoluyla Allura Red AC boyasna maruz kalabileceini göstermektedir.