Sodium Sulfite

The Basics On Sodium Sulfite

What is Sodium Sulfite?

An ionic salt and reducing agent that alters the structure of hair.

What are other names for Sodium Sulfite?

PEG-60 ALMOND GLYCERIDE, PEG-60 ALMOND GLYCERIDES, POLYETHYLENE GLYCOL 3000 ALMOND GLYCERIDES, and POLYOXYETHYLENE (60) ALMOND GLYCERIDES

What is Sodium Sulfite used for?

In cosmetics and personal care products, sodium sulfite functions as an antioxidant preservative and a hair-waving/straightening agent. As an antioxidant preservative, sodium sulfite works by protecting the other ingredients in a formulation from oxidation, which is the loss of electrons.

How Sodium Sulfite is classified

Preservatives, Sensitizing

Recommendations for using Sodium Sulfite during pregnancy and breastfeeding

Limited data suggests no known risk

 

Sodium Sulfite During Pregnancy

What we know about using Sodium Sulfite while pregnant or breastfeeding

Limited information available.

Several oral-dose teratogenicity studies have been reported in which Sodium Sulfite, Bisulfite, and Metabisulfite or Potassium Metabisulfite were given to pregnant animals on certain gestation days (GDs). These studies are summarized in Table 7. Sodium Sulfite Groups of 12 pregnant Wistar rats were fed diets containing 0.32%, 0.63%, 1.25%, 2.5%, or 5% Sodium Sulfite heptahydrate (Na2SO3 · 7H2O) on GDs 8 to 20. Average daily intake of Sodium Sulfite heptahydrate was 0.3, 1.1, 2.1, and 3.3 g/kg. Maternal toxicity evidenced by decreased feed consumption and body weight gain was observed in rats of the 5% group. A significant (p < 0.05) reduction in fetal body weight was observed in all pups except females of the 2.5% group. The numbers of live fetuses, intrauterine deaths, or sex ratios of fetuses were comparable between treated and controls. External, skeletal, or internal malformations of the fetus were not observed at any dose. Fetal skeletal variations such as lumbar rib, hypoplastic rib, and delayed ossifications were noted in all treated groups, except the 1.25% group; these skeletal variations were not significant compared to controls. A slight increase in delayed ossification was observed with increasing doses. Fetuses with dilation of the renal pelvis and lateral ventricle were observed but the findings were not dose dependent. Postnatal body weights of offspring 3 weeks after birth indicated no evidence of growth retardation or other signs of toxicity. The investigators considered the administration of Sodium Sulfite heptahydrate to produced signs of fetal toxicity but not teratogenicity (Itami et al. 1989). Sodium Bisulfite Sodium Bisulfite was not teratogenic for mice, rats, hamsters, or rabbits at doses of 150, 110, 120, and 100 mg/kg, respectively (Food and Drug Research Labs 1972a, 1974a). Sodium Metabisulfite Sodium Metabisulfite was not teratogenic for mice, rats, hamsters, or rabbits at doses of 160, 110, 120, and 123 mg/kg, respectively (Food and Drug Research Labs 1972b, 1974b). It was also negative in sulfite oxidase–deficient rats when tested at doses up to 3.5 mmol/kg (Dulak, Chiang, and Gunnison 1984). Potassium Metabisulfite Potassium Metabisulfite was not teratogenic for mice at 125 mg/kg or rats at 155 mg/kg (Food and Drug Research Labs 1975). Groups of at least 21 pregnant Wistar rats received 0.1%, 1%, or 10% potassium metabisulfite on GDs 7 to 14. Some rats from each group were killed on day 20; the remaining were allowed to deliver and the offspring were reared until week 15. Maternal 76 COSMETIC INGREDIENT REVIEW TABLE 7 Sulfites, Bisulfites, and Metabisulfites oral-dose teratogenicity studies Animal Dosing protocol Findings Reference Sodium Sulfite (heptahydrate) Groups of 12 pregnant Wistar rats 0.3, 1.1, 2.1, and 3.3 g/kg in feed on GDs 8–20 Signs of fetal toxicity but not teratogenicity (see text) Itami et al. 1989 Sodium bisulfite Groups of at least 21 pregnant CD-1 mice 2, 7, 32, or 150 mg/kg in a water solution via oral intubation on GDs 6–15; caesareans on day 17 No adverse findings∗ Food and Drug Research Labs 1972a Groups of at least 22 pregnant Wistar rats 1, 5, 24, or 110 mg/kg on GDs 6–15; caesareans on day 20 No adverse findings∗ Food and Drug Research Labs 1972a Groups of at least 21 pregnant golden hamsters 1, 6, 26, or 120 mg/kg on GDs 6–10; caesareans on day 14 No adverse findings∗ Food and Drug Research Labs 1972a Groups of at least 11 Dutch-belted rabbits were artificially inseminated 1, 4.64, 21.6, or 100 mg/kg on GDs 6–18; caesareans on day 29 No adverse findings∗ Food and Drug Research Labs 1974a Sodium Metabisulfite Groups of at least 21 pregnant CD-1 mice 2, 7, 34, or 160 mg/kg in a water solution via oral intubation on GDs 6–15; caesareans on day 17 No adverse findings∗ Food and Drug Research Labs 1972b Groups of at least 23 pregnant Wistar rats 1, 5, 24, or 110 mg/kg on GDs 6–15; caesareans on day 20 No adverse findings∗ Food and Drug Research Labs 1972b Sulfite oxidase–deficient rats (females treated with a high-tungsten–lowmolybdenum diet to induce steady-state hepatic enzyme activity that was 1%–2% of levels in untreated rats) Drinking water supplemented to achieve 25 or 50 mM sulfite concentrations; treated continuously from week 3 prior to mating and continued to GD 20. Highest daily intake was 3.5 mmol/kg No treatment-related teratogenic changes compared to nonexposed rats with normal enzyme activity. A pilot study noted treatment-related anophthalmia in enzyme-deficient rats, but no intergroup differences were found in the teratogenicity study Dulak et al. 1984 Groups of at least 20 pregnant golden hamsters 1, 6, 26, or 120 mg/kg on GDs 6–10; caesareans on day 14 No adverse findings∗ Food and Drug Research Labs 1972b Groups of at least 12 Dutch-belted rabbits were artificially inseminated 1.23, 5.71, 26.5, or 123 mg/kg on GDs 6–18; caesareans on day 29 No adverse findings∗ Food and Drug Research Labs 1974b Potassium Metabisulfite Groups of at least 21 pregnant CD-1 mice 1.25, 5.47, 26.9, or 125 mg/kg via oral intubation on GDs 6–15; caesareans performed on GD 17 No adverse findings∗ Food and Drug Research Labs 1975 Groups of at least 20 pregnant Wistar rats 1.55, 7.19, 33.4 or 155 mg/kg on GDs 6–15; caesareans performed on GD 20 No adverse findings∗ Food and Drug Research Labs 1975 Groups of at least 12 pregnant Wistar rats 0.1%, 1%, or 10% on GDs 7–14; some rats from each group killed on day 20, remaining allowed to deliver, offspring reared until week 15 Fetal body weight significantly lower in 10% group, placental weight significantly lower in 1% group. No significant adverse teratogenic effects Ema et al. 1985 ∗No adverse findings defined as “Neither adverse effects in maternal or fetal survival nor a significant increase in fetal abnormalities in either soft or skeletal tissues was noted in any of the animals.” In these studies, positive controls in mice, rat, and hamster studies received aspirin and positive controls in rabbit studies received 6-aminonicotinamide; negative controls were sham-treated (Food and Drug Research Labs 1972a, 1972b, 1974a, 1974b, 1975). SULFITES AND METABISULFITES 77 feed intake and body weight gain were reduced in the 10% group but no other signs of toxicity were observed. Fetal body weight was significantly reduced in the 10% group, and placental weight was significantly lower in the 1% group. No significant teratogenic effects were observed (Ema, Itami, and Kanoh 1985). Intraperitoneal (IP) Sodium Bisulfite A cytotoxicity study was conducted in which Sodium Bisulfite was given to adult male Swiss mice in either a single IP injection (500, 600, 700, 800, 900, or 1000 mg/kg), or repeated IP doses (20, 30, and 40 doses of 200 or 400 mg/kg in 28, 42, and 56 days, respectively). The total dose in the long-term study ranged from 4 to 16 g/kg. Mice were killed 1 to 3 days after the last dosing. The testes were dissected and the tunica was fixed and stained in periodic acid Schiff and counter stained with Ehrlich's acid hematoxylin. Different types of spermatogonia and preleptotene spermatocytes were scored on the basis of nuclear cytology and frequency of each stage of the tubules. Sodium Bisulfite did not alter the population of various types of spermatogonia. At 1000 mg/kg, 80% of the mice died within 24 h post treatment (Bhattacharjee, Shetty, and Sundaram 1980). Sodium Metabisulfite A sperm-shape abnormality assay was conducted using male inbred albino Swiss mice (Pal and Bhunya 1992). Groups of four mice received five IP doses of Sodium Metabisulfite each given 24 h apart. Total doses were 200, 300, or 400 mg/kg. Mice were killed 35 days after the first injection and the caudae epididymides and vas deferens were dissected and prepared into a suspension. Slides were prepared and stained and sperm abnormalities were categorized. A dose-dependent response was observed.

General safety info about Sodium Sulfite from CIR

Sodium Sulfite, Ammonium Sulfite, Sodium Bisulfite, Potassium Bisulfite, Ammonium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite are inorganic salts that function as reducing agents in cosmetic formulations. All except Sodium Metabisulfite also function as hair-waving/straightening agents. In addition, Sodium Sulfite, Potassium Sulfite, Sodium Bisulfite, and Sodium Metabisulfite function as antioxidants. Although Ammonium Sulfite is not in current use, the others are widely used in hair care products. Sulfites that enter mammals via ingestion, inhalation, or injection are metabolized by sulfite oxidase to sulfate. In oral-dose animal toxicity studies, hyperplastic changes in the gastric mucosa were the most common findings at high doses. Ammonium Sulfite aerosol had an acute LC50 of >400 mg/m3 in guinea pigs. A single exposure to low concentrations of a Sodium Sulfite fine aerosol produced dose-related changes in the lung capacity parameters of guinea pigs. A 3-day exposure of rats to a Sodium Sulfite fine aerosol produced mild pulmonary edema and irritation of the tracheal epithelium. Severe epithelial changes were observed in dogs exposed for 290 days to 1 mg/m3 of a Sodium Metabisulfite fine aerosol. These fine aerosols contained fine respirable particle sizes that are not found in cosmetic aerosols or pump sprays. None of the cosmetic product types, however, in which these ingredients are used are aerosolized. Sodium Bisulfite (tested at 38%) and Sodium Metabisulfite (undiluted) were not irritants to rabbits following occlusive exposures. Sodium Metabisulfite (tested at 50%) was irritating to guinea pigs following repeated exposure. In rats, Sodium Sulfite heptahydrate at large doses (up to 3.3 g/kg) produced fetal toxicity but not teratogenicity. Sodium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite were not teratogenic for mice, rats, hamsters, or rabbits at doses up to 160 mg/kg. Generally, Sodium Sulfite, Sodium Metabisulfite, and Potassium Metabisulfite were negative in mutagenicity studies. Sodium Bisulfite produced both positive and negative results. Clinical oral and ocularexposure studies reported no adverse effects. Sodium Sulfite was not irritating or sensitizing in clinical tests. These ingredients, however, may produce positive reactions in dermatologic patients under patch test. In evaluating the positive genotoxicity data found with Sodium Bisulfite, the equilibrium chemistry of sulfurous acid, sulfur dioxide, bisulfite, sulfite, and metabisulfite was considered. This information, however, suggests that some bisulfite may have been present in genotoxicity tests involving the other ingredients and vice versa. On that basis, the genotoxicity data did not give a clear, consistent picture. In cosmetics, however, the bisulfite form is used at very low concentrations (0.03% to 0.7%) in most products except wave sets. In wave sets, the pH ranges from 8 to 9 where the sulfite form would predominate. Skin penetration would be low due to the highly charged nature of these particles and any sulfite that did penetrate would be converted to sulfate by the enzyme sulfate oxidase. As used in cosmetics, therefore, these ingredients would not present a genotoxicity risk. The Cosmetic Ingredient Review Expert Panel concluded that Sodium Sulfite, Potassium Sulfite, Ammonium Sulfite, Sodium Bisulfite, Ammonium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite are safe as used in cosmetic formulations.

Use this, not that!

Products where you might find Sodium Sulfite

Caudalie Premier Cru Anti-Aging Rich Cream;Smashbox Cover Shot Eye Shadow Palette;Caudalie Premier Cru Anti-Aging Cream;Shani Darden Skin Care Cleansing Serum;Caudalie Premier Cru Anti-Aging Eye Cream