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EU 1223/2009 Annex V — SCCS görüşü: Opinion concerning Restrictions on Materials listed in annex VI of Directive 76/768/EEC on Cosmetic Products

Definition and Structure All 7 sulfite ingredients are inorganic salts that conform to the general structure in Figure 1. Individual structures are presented in Table 1.2 Figure 1. Sulfite ingredients, wherein M is sodium, potassium, or ammonium; and R is OH, OM, or SO3M Physical and Chemicals Properties An ultraviolet (UV) spectral analysis of Sodium Metabisulfite indicates an absorbance peak at 209 nm.1 Sodium Sulfite has been identified as having a similar absorbance pattern. The sulfites reviewed in this safety assessment are all water-soluble compounds. Properties of sulfites are presented in Table 2.1,3,4 Method of Manufacture Sodium Sulfite and Sodium Metabisulfite may be manufactured by reacting sulfur dioxide with sodium carbonate (soda ash). This step is followed by purification and drying to form crystals or powder.5,6 Composition/Impurities Food grade specifications for sulfites are listed in Table 3.7 Specifications for Sodium Metabisulfite and Potassium Metabisulfite listed in the United States Pharmacopoeia are presented in Table 4.8,9 USE Cosmetic The safety of these cosmetic ingredients is evaluated based, in part, on data received from the United States (US) Food and Drug Administration (FDA) and the cosmetics industry on the expected use of this ingredient in cosmetics. Use frequencies of individual ingredients in cosmetics are collected from manufacturers and reported by cosmetic product category in FDA’s Voluntary Cosmetic Registration Program (VCRP) database.10 Use data are submitted by the cosmetics industry in response to surveys, conducted by the Personal Care Products Council (Council), of maximum reported use … [kırpıldı — bölüm toplam 7103 karakter]

Sulfur dioxide is one of the species to which the sulfites reviewed in this safety assessment may convert. In 2019, the United States Environmental Protection Agency (USEPA) completed their review of the primary health-based National Ambient Air Quality Standards (NAAQS) for SOx, a group of closely related gaseous compounds that includes sulfur dioxide (SO2) (40 CFR Part 50). The current primary standard is set a a level of 75 parts per billion (ppb), as the 99th percentile of daily maximum 1-h SO2 concentrations, averaged over 3 years. Based on the EPA’s review of key aspects of the currently available health effects evidence, quantitative risk and exposure information, advice from the Clean Air Scientific Advisory Committee (CASAC), and public comments, the EPA is retaining the current standard without revision. Provocative Studies Sulfite Sensitivity Many asthmatics with bisulfite sensitivity have negative allergy skin tests suggesting a nonatopic nature.1 It has also been reported that IgE, total eosinophil counts, and histamine concentrations were normal during acute reactions, suggesting the lack of an IgE mechanism. Approximately 2% to of asthmatics are estimated to be sulfite-sensitive; most sulfite-sensitive individuals are asthmatics. Sulfite-sensitive asthmatics react to ingestion or parenteral administration of sulfites. Asthmatics in general are more sensitive to inhaled sulfur dioxide (tested as Sodium Metabisulfite) than are  Distributed for Comment Only -- Do Not Cite or Quote nonasthmatic control normal subjects, but inhalation sensitivity alone is not considered indicative of sulfite sensitivity. In the majority of instances, manifestations include dermatological signs and symptoms such as urticaria, angioedema, hives and pruritus, flushing, tingling, and swelling. Respiratory signs and symptoms include dyspnea, wheezing, and … [kırpıldı — bölüm toplam 14659 karakter]

Absorption, Distribution, Metabolism, and Excretion (ADME) Sulfites are generated in the human body by processing of the sulfur-containing amino acids, cysteine and methioneine.1 Endogenous sulfate is maintained at a low, steady-state concentration by a mitochondrial enzyme, sulfate oxidase, that promotes the oxidation of sulfite to sulfate that is excreted in the urine. Sulfite that enters the body via ingestion, inhalation, or injection is metabolized by sulfite oxidase to sulfate. One difference in the metabolism kinetics of exogenous sulfite versus endogenous sulfite is that hepatic oxidation of exogenous sulfite (at least in rats) is diffusion limited. The liver metabolizes a constant fraction of sulfite that it receives, but a finite amount will pass through the organ and enter the systemic circulation. Sulfites can also be metabolized to thiosulfates (enzymatic reaction of sulfite with disulfide bonds).1 Thiosulfate and S-sulfonate were detected at very low concentrations in the urine of normal humans or rats, but were excreted in large amounts by those deficient in sulfite oxidase. Review articles note that hepatic sulfite oxidase activity was estimated to be 10 to 20 times greater in rats when compared to humans. Animal Oral Oral dosing studies using dogs and rats demonstrated rapid metabolic clearance.1 In all species, ≤ 10% of the administered dose was excreted unchanged in the urine.  Distributed for Comment Only -- Do Not Cite or Quote Human Total serum sulfite concentrations in 41 women and 35 men have been determined.1 Blood was taken and serum sulfite concentrations were analyzed by the separation of sulfite-bimane from thiol-bimanes by reverse-phase high-performance liquid chromatography (HPLC) and quantization of sulfite-bimane fluorescence detection. The intra- and inter-assay … [kırpıldı — bölüm toplam 2371 karakter]

EPA ToxValDB cilt/göz verisi — endpoint: skin sensitisation: in vivo (LLNA), sınıflandırma: Not likely to be sensitizing, tür: mouse, çalışma: skin sensitization, kılavuz: according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) , 2002-04-24, yıl: 2010. Sınır: bu bir derleme kayıttır; doz, tür ve maruziyet yolu birlikte değerlendirilmelidir.

EPA ToxValDB genotoksisite: positive — pozitif rapor: 16, negatif: 5, Ames: positive, mikronükleus: negative. Sınır: bu bir derleme kayıttır; doz, tür ve maruziyet yolu birlikte değerlendirilmelidir.

EPA ToxValDB cilt/göz verisi — endpoint: skin irritation: in vivo, sınıflandırma: Studies Indicate No Significant Irritation, tür: rabbit, çalışma: skin irritation, kılavuz: OECD Guideline 404 (Acute Dermal Irritation / Corrosion) , adopted 1981-05-12 equivalent or similar to, yıl: 1981. Sınır: bu bir derleme kayıttır; doz, tür ve maruziyet yolu birlikte değerlendirilmelidir.

EPA ToxValDB cilt/göz verisi — endpoint: eye irritation: in vivo, sınıflandırma: Studies Indicate No Significant Irritation, tür: rabbit, çalışma: eye irritation, kılavuz: OECD Guideline 405 (Acute Eye Irritation / Corrosion) equivalent or similar to, yıl: 1981. Sınır: bu bir derleme kayıttır; doz, tür ve maruziyet yolu birlikte değerlendirilmelidir.

EPA ToxValDB cilt/göz verisi — endpoint: Eye Irritation, sınıflandırma: Eye damage - category 1. Sınır: bu bir derleme kayıttır; doz, tür ve maruziyet yolu birlikte değerlendirilmelidir.