Docusate Sodium

Plastics -> Pigments agents

Plastics -> N.a.

Cosmetic ingredients (Diethylhexyl Sodium Sulfosuccinate) -> CIR (Cosmetic Ingredient Review)

Emulsifying; Surfactant

SOL IN WATER (G/L): 15 (25 °C), 23 (40 °C), 30 (50 °C), 55 (70 °C); SOL IN CARBON TETRACHLORIDE, PETROLEUM ETHER, NAPHTHA, XYLENE, DIBUTYL PHTHALATE, LIQUID PETROLATUM, ACETONE, ALCOHOL, VEGETABLE OILS; VERY SOL IN WATER-MISCIBLE ORGANIC SOLVENTS

FREELY SOL IN GLYCERIN

Water Solubility = 71000 mg/L @ 25 °C

Liquid; CBI; Other Solid

Commercially available in rolls of very thin wax-like solid; as solution (50-75%) in various solvents; [Merck Index] White waxy solid; [MSDSonline]

This chemical does not meet GHS hazard criteria for 0.3% (20 of 5827) of reports.

Danger

H302 (24.6%): Harmful if swallowed [Warning Acute toxicity, oral]

P264, P264+P265, P270, P280, P301+P317, P302+P352, P305+P351+P338, P305+P354+P338, P317, P321, P330, P332+P317, P337+P317, P362+P364, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 5827 reports by companies from 31 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Warning

Chemical: Butanedioic acid, sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt

Butanedioic acid, 2-sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt (1:1) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Butanedioic acid, 2-sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt (1:1) 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: 04-04-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/16066

Sodium dioctylsulfosuccinate: Does not have an individual approval but may be used under an appropriate group standard

In studies of rabbits, causes minor and reversible eye injury at concentrations of 0.5% and 2% and severe eye injury at concentrations of 10%; [HSDB] A strong eye irritant; May cause skin irritation by removal of natural oils; [CAMEO] An irritant; [MSDSonline] See Docusate.

Acute Tox. 4 (24.6%)

Skin irritation - category 2

Skin corrosion/irritation - Category 2

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.

IN RABBITS 0.01% CONCN HAS BEEN SHOWN TO ACCELERATE DRAMATICALLY PERITONEAL DIALYSIS OF UREA.

DRAMATIC INCR IN DISSOLUTION RATE WAS OBSERVED AT ALL SURFACTANT CONCN.

Stool softeners (ie, docusate salts) ... may enhance the absorption of many orally administered drugs. Docusate sodium increases the extent of mineral oil absorption and the rate of phenolphthalein absorption.

TERRESTRIAL FATE: When dissolved in aqueous solutions, bis(2-ethylhexyl)sodium sulfosuccinate will have soil mobility ranging from low to very high(3) based on estimated Koc values ranging from 9.37 to 1041(1,2). Several studies have shown that bis(2-ethylhexyl)sodium sulfosuccinate biodegrades rapidly(4-8).

AQUATIC FATE: Bis(2-ethylhexyl)sodium sulfosuccinate is essentially nonvolatile from water based upon an estimated Henry's Law constant of 5X10-12 atm cu m/mol(1,2,SRC). Bis(2-ethylhexyl)sodium sulfosuccinate has estimated aqueous base-catalyzed hydrolysis half-lives of 243 days at pH of 8 and 6.7 years at pH of 7(3,SRC). Aquatic bioconcentration is not expected to be an important fate process although adsorption to sediment may be possible based on Koc values of 9.37 to 1041(4,2,SRC). Several studies have shown that bis(2-ethylhexyl)sodium sulfosuccinate biodegrades rapidly(5-9). For example, a river die-away screen test of river water demonstrated that bis(2-ethylhexyl)sodium sulfosuccinate biodegraded 95% (12 days), 91% (12 days), 91% (17 days), 97.3% (6 days), and 97.7% (3 days), at concentrations of 12.9, 4.5, 3.3, 11.3, and 12.9 ppm, respectively, with a lag period of 6 days(5).

ATMOSPHERIC FATE: Based on an estimated vapor pressure of approximately 2.17X10-11 mm Hg at 25 °C(1), bis(2- ethylhexyl)sodium sulfosuccinate will exist primarily in the particulate phase in the ambient atmosphere(2). In the vapor phase, it will degrade in the atmosphere by reaction with photochemically produced hydroxyl radicals with an estimated half-life of 18 hrs(3). Physical removal of particulate bis(2- ethylhexyl)sodium sulfosuccinate from air is likely to occur through wet and dry deposition(SRC).

The CIR Expert Panel concluded that the following 8 dialkyl sulfosuccinate salts are safe in the present practices of use and concentration in cosmetics in this safety assessment when formulated to be non-irritating...Diethylhexyl Sodium Sulfosuccinate...

Safe for use in cosmetics, with qualifications

Using a structure estimation method based on molecular connectivity indexes, the Koc for bis(2-ethylhexyl) sodium sulfosuccinate can be estimated to be about 1041(1). The Koc for bis(2-ethylhexyl) sodium sulfosuccinate can be estimated to be about 9.37 based on an estimated water solubility of 71000 mg/L(3) and a regression derived equation(2). According to a suggested classification scheme(4), these estimated Koc values suggest that bis(2-ethylhexyl) sodium sulfosuccinate soil mobility is low to very high.

IN OPHTHALMOLOGICAL FORMULATIONS, CONCN...GREATER THAN 0.1% MAY CAUSE CONJUNCTIVAL IRRITATION, & REPEATED USE OF DRUG MAY DELAY HEALING OF CORNEAL LESIONS.

ACUTE= MODERATE VIA ORAL...ROUTES. MODERATE= MAY CAUSE REVERSIBLE OR IRREVERSIBLE CHANGES TO EXPOSED TISSUE, NOT PERMANENT INJURY OR DEATH; CAN CAUSE CONSIDERABLE DISCOMFORT.

In a river die-away screen test of river water, bis(2-ethylhexyl)sodium sulfosuccinate biodegraded 95% (12 days), 91% (12 days), 91% (17 days), 97.3% (6 days), and 97.7% (3 days), at concentrations of 12.9, 4.5, 3.3, 11.3, and 12.9 ppm, respectively, with a lag period of 6 days(1). This study also conducted a sterile control in which there was 9% loss of bis(2-ethylhexyl)sodium sulfosuccinate(1). A BOD test of aerobic activated sludge biodegraded bis(2-ethylhexyl)sodium sulfosuccinate 80-95% after 8 hours from initial concentrations of 2-13 ppm with a 5-7 week lag(2). This same study tested sewage in the same manner and obtained 60-80% biodegradation of bis(2-ethylhexyl)sodium sulfosuccinate after a 3-9 week lag(2). A study using DOC found that bis(2-ethylhexyl)sodium sulfosuccinate (40 ppm) biodegraded 83% after 20 days in aerobic sewage(3). In an aerobic closed bottle screening study using activated sludge and soil inoculum, 100 mg/l bis(2-ethylhexyl)sodium sulfosuccinate had a 4 week theoretical BOD of 0-9%(4). With 1 mg added to 10 ml sediment, bis(2-ethylhexyl)sodium sulfosuccinate biodegraded 55-94% in river sediments, 8% in sand, and 13% in clay after 3 days(5).

Based upon an experimental water solubility of 71,000 mg/l(1), the BCF of bis(2-ethylhexyl)sodium sulfosuccinate can be estimated to be approximately 1.13 from a regression-derived equation(2). The BCF for bis(2-ethylhexyl) sodium sulfosuccinate has also been experimentally determined to be <0.9 at 0.5 mg/l and < 9.3 at 0.05 mg/l for a 6 week duration(1). Based on these BCF values, bioconcentration is not expected to be an important fate process(SRC).

The Henry's Law constant for bis(2-ethylhexyl) sodium sulfosuccinate can be estimated to be 5X10-12 atm-cu m/mole using a structure estimation method(1). This value of Henry's Law constant indicates that bis(2-ethylhexyl) sodium sulfosuccinate is essentially nonvolatile from water(2).

Docusate has been mildly and reversibly damaging to rabbit eyes at 0.5 and 2% concentration, but severely damaging at 10%.

IN ANIMALS, LARGE DOSES OF DRUG PRODUCE ANOREXIA, VOMITING, & DIARRHEA.

EVEN IN CHRONIC FEEDING TESTS, FATALLY POISONED ANIMALS SHOW ONLY DIARRHEA & INTESTINAL BLOATING, WITH NO GROSS LESIONS OUTSIDE OF GASTROINTESTINAL TRACT.

Docusate salts occasionally can cause diarrhea. Morphologic damage to the intestine has been observed in rats. They also may be hepatotoxic. /Docusate salts/

The rate constant for the vapor-phase reaction of bis(2-ethylhexyl) sodium sulfosuccinate with photochemically produced hydroxyl radicals has been estimated to be approximately 21.8X10-12 cu cm/molecule-sec at 25 °C which corresponds to an atmospheric half-life of about 18 hours at an atmospheric concn of 5X10+5 hydroxyl radicals per cu cm(1,SRC). Aqueous base-catalyzed hydrolysis (at 25 °C) is estimated as 0.03 l/mol-sec which corresponds to half-lives of 243 days at pH of 8 and 6.7 years at pH of 7(2,SRC).

Detergents and food additives, such as bis(2-ethylhexyl)sodium sulfosuccinate, can be absorbed into the body by three routes: dermal contact, inhalation, and ingestion(1). NIOSH (NOES Survey 1981-1983) has statistically estimated that 139,699 workers are potentially exposed to bis(2-ethylhexyl)sodium sulfosuccinate in the USA(2).

A06AA02

A - Alimentary tract and metabolism

QA - Alimentary tract and metabolism

A06AA02

In vitro studies suggest that these salts of dioctylsulfosuccinic acid lower the surface tension of the stool to permit water and lipids to enter more readily and thus soften the feces. ... More recent evidence indicates that they may stimulate the secretion of water and electrolytes on contact with the mucosa.

Reduce surface film tension of interfacing liquid contents of the bowel, promoting permeation of additional liquid into the stool to form a softer mass. /Laxatives/

Agents that modify interfacial tension of water; usually substances that have one lipophilic and one hydrophilic group in the molecule; includes soaps, detergents, emulsifiers, dispersing and wetting agents, and several groups of antiseptics.

...DRUG IS ABSORBED FROM GI TRACT & IS EXCRETED IN SIGNIFICANT CONCN IN BILE.

SINCE THE DRUG IS ABSORBED FROM GI TRACT & IS EXCRETED IN SIGNIFICANT CONCN IN BILE...

CIR ingredient: Diethylhexyl Sodium Sulfosuccinate

Used as a wetting agent (industrial, pharmaceutical, cosmetic, and food applications), processing aid in the sugar industry, stabilizer for hydrophilic colloids, dispersant and emulsifier, and stool softener; Also used in powderless etching systems; [HSDB]

Use in food products restricted; [HSDB]

WETTING AGENT IN INDUSTRIAL, PHARMACEUTICAL, COSMETIC & FOOD APPLICATIONS; DISPERSING AND SOLUBILIZING AGENT IN FOODS; ADJUVANT IN TABLET FORMATION.

FOOD ADDITIVE (PROCESSING AID IN SUGAR INDUSTRY, STABLILIZER FOR HYDROPHILIC COLLOIDS); DISPERSANT; EMULSIFIER

EMPLOYED AS DISPERSING & EMULSIFYING AGENT IN VARIOUS DERMATOLOGICAL PREPN...

DRUG IS SUPPLIED AS 50-, 60-, & 100-MG CAPSULES & TABLETS, AS 250- & 300 MG CAPSULES, IN SOLN FOR ORAL ADMIN (10 & 50 MG/ML), & AS SYRUP (4 MG/ML).

GRADE: NF; FCC

AVAILABLE AS WAX-LIKE SOLID, USUALLY IN ROLLS OF TISSUE-THIN MATERIAL; ALSO AS 50-75% SOLN IN VARIOUS SOLVENTS.

Fragrance Ingredients

Food Additives -> EMULSIFIER; HUMECTANT -> JECFA Functional Classes

Food Additives -> EMULSIFIER; HUMECTANT -> JECFA Functional Classes

Plastics -> Pigments agents

Plastics -> Polymer Type -> N.a.

Cosmetics -> Emulsifying; Surfactant

Non-metallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other non-metallic mineral product manufacturing)

Butanedioic acid, 2-sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt (1:1): ACTIVE

TO MAKE AQ GEL-LIKE SUSPENSION, SOAK SOLID IN SOME WATER OVERNIGHT BEFORE MAKING FINAL DILUTION.

USE IN FOOD PRODUCTS RESTRICTED.