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Cosmetic ingredients (Benzethonium Chloride) -> CIR (Cosmetic Ingredient Review)

Preservative

10 to 50 mg/mL at 64 °F (NTP, 1992)

VERY SOL IN WATER GIVING FOAMY, SOAPY SOLN; SOL IN ALC, ACETONE, CHLOROFORM

SLIGHTLY SOL IN ETHER

Solubility in water: very good

327 to 331 °F (NTP, 1992)

164-166 °C (HOT STAGE)

EUTECTIC TEMP: PHENANTHRENE 86 °C; BENZANTHRENE 98 °C

160-165 °C

FCS -> FDA Cumulative Estimated Daily Intake (CEDI)

FCS -> FDA Inventory of Food Contact Substances Listed in 21 CFR

FCS -> FDA Inventory of Effective Food Contact Substance (FCS) Notifications

This chemical does not meet GHS hazard criteria for 1.3% (5 of 394) of reports.

Danger

H301 (81%): Toxic if swallowed [Danger Acute toxicity, oral]

P260, P264, P264+P265, P270, P273, P280, P301+P316, P301+P317, P301+P330+P331, P302+P361+P354, P304+P340, P305+P354+P338, P316, P317, P321, P330, P363, P391, P405, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 394 reports by companies from 25 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Warning

Chemical: Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]ethyl]-, chloride

Hazard Traits - Hazard Trait Undefined

Status: Active Update: 28-04-2022 https://echa.europa.eu/registration-dossier/-/registered-dossier/20277

Benzethonium chloride: Does not have an individual approval but may be used under an appropriate group standard

Flash point data for this chemical are not available. It is probably combustible. (NTP, 1992)

Combustible. Gives off irritating or toxic fumes (or gases) in a fire.

SYMPTOMS: Symptoms of exposure to this compound may include vomiting, collapse, convulsions and coma. Other symptoms may include corrosion or injury to the mucous membranes. It may cause nausea, esophageal damage and necrosis, hypotension and death. It may also cause dyspnea, cyanosis, paralysis of respiratory muscles possibly leading to asphyxia, and central nervous system depression (possibly with convulsions or preceded by excitement). It has depolarizing muscle relaxant properties. It can cause irritation to the skin, eyes, mucous membranes and upper respiratory tract. Intravenous or intrauterine administration may cause hemolysis.

When used as a spermaticide, can cause vaginal irritation; Fatal dose by ingestion is 1-3 grams; In fatal cases after accidental ingestion, patients had vomiting, convulsions, and coma; Concentrations of 0.1% to 1% are eye irritants; Skin absorption is probably insignificant; [HSDB] Corrosive to eyes; A skin irritant; [ICSC] Allergic contact dermatitis is infrequently documented; [Marks, p. 266] Quaternary ammonium compounds have curare-like properties when concentrated solutions are ingested; Affected patients may have methemoglobinemia and hemolysis and die within 1-3 hours; Elevated liver function tests were reported; Concentrated solutions can cause burns; No data on carcinogenicity or teratogenicity; [IPCS-PIMs] No interference with embryo development in rats; No human data; [REPROTOX] An irritant; May cause serious eye injury; Effects in high-dose animal studies include convulsions; [MSDSonline] See Benzalkonium chloride.

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

HECHT A; STANDARDS FOR NONPRESCRIPTION GERM KILLERS. FDA CONSUM 12(JUL-AUG) 15 (1978). THE FOOD AND DRUG ADMINISTRATION'S TENTATIVE STANDARDS FOR A VARIETY OF OVER-THE-COUNTER DRUGS THAT ARE USED TO KILL GERMS ON THE SKIN ARE DISCUSSED INCL THE INGREDIENT BENZETHONIUM CHLORIDE WHICH HAS BEEN FOUND SAFE & EFFECTIVE.

BENZETHONIUM CHLORIDE is incompatible with strong oxidizing agents. Incompatible with soap and anionic detergents. Can react with nitrates. Sensitive to light. Acids cause it to precipitate from aqueous solutions of >2% concentration. Stable for two weeks at temperatures up to 140 F, (NTP, 1992).

Acute Tox. 3 (81%)

Acute toxicity - category 4

Acute toxicity (Oral) - Category 4

Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)

Use water spray, powder.

Fresh air, rest.

Remove contaminated clothes. Rinse and then wash skin with water and soap.

First rinse with plenty of water for several minutes (remove contact lenses if easily possible), then refer for medical attention.

Rinse mouth. Give one or two glasses of water to drink. Refer for medical attention .

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.

... SOLUTIONS SHOULD BE STORED IN DISTINCTIVE BOTTLES (NEVER IN SOFT DRINK BOTTLES) IN A SAFE PLACE. /CATIONIC DETERGENTS/

IN GENERAL, MATERIALS WHICH ARE TOXIC AS STORED OR WHICH CAN DECOMP INTO TOXIC COMPONENTS ... SHOULD BE STORED IN A COOL, WELL-VENTILATED PLACE, OUT OF DIRECT RAYS OF THE SUN, AWAY FROM AREAS OF HIGH FIRE HAZARD, & SHOULD BE PERIODICALLY INSPECTED ... . INCOMPATIBLE MATERIALS SHOULD BE ISOLATED FROM EACH OTHER.

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.

Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Do NOT let this chemical enter the environment. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.

LC50 Pimephales promelas 1600 ug/l/96 hr /Conditions of bioassay not specified/

LC50 Lepomis macrochirus 1400 ug/l/96 hr /Conditions of bioassay not specified/

LC50 Oncorhynchus kisutch 53000 ug/l/96 hr /Conditions of bioassay not specified/

On the basis of the available animal and clinical data, the Expert Panel concludes that Benzethonium Chloride and Methylbenzethonium Chloride are safe at concentrations of 0.5 percent in cosmetics applied to the skin. A maximum concentration of 0.02 percent is safe for cosmetics used in the eye area. Note: FDA has prohibited the use of Methylene Chloride in cosmetic products, action which supercedes this CIR conclusion (21CFR700.19).

Safe for use in cosmetics, with qualifications

Redness. Pain.

Redness. Blurred vision. Pain. Severe burns.

Nausea. Vomiting. Diarrhoea. Convulsions. Shock or collapse.

The following link will take the user to the National Toxicology Program (NTP) Test Agent Search Results page, which tabulates all of the "Standard Toxicology & Carcinogenesis Studies", "Developmental Studies", and "Genetic Toxicity Studies" performed with this chemical. Clicking on the "Testing Status" link will take the user to the status (i.e., in review, in progress, in preparation, on test, completed, etc.) and results of all the studies that the NTP has done on this chemical. [http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=121-54-0]

... USED AS SPERMATOCIDES ... CAN CAUSE VAGINAL IRRITATION, WITH BURNING SENSATIONS & ITCHING.

FATAL DOSE BY INGESTION IS EST TO BE 1-3 G. AT LEAST 3 FATALITIES HAVE OCCURRED FROM ACCIDENTAL INGESTION. /CATIONIC DETERGENTS/

Ingestion may cause vomiting, collapse, convulsions, coma.

Highly toxic by ingestion; 1 gram may be fatal.

CATIONIC SURFACTANTS HAD NOBACTERIOSTATIC OR BACTERIOLYTIC ACTION ON HETEROTROPHIC BACTERIAL POPULATION ISOLATED FROM SEWAGE & RIVER WATERS, CYCLICAL ALKYLAMMONIUM CMPD ARE NOT DEGRADED.

Biodegradation: at 18 mg/l no degradation after 28 days by nonadapted sewage.

Benzethonium Chloride

TR-438: Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CASRN 121-54-0) in F344/N Rats and B6C3F1 Mice (Dermal Studies) (1995 )

06/21/94

No Evidence

No Evidence

No Evidence

... CONCN OF 0.1% TO 1.0% IN WATER HAVE BEEN SIGNIFICANTLY IRRITATING OR INJURIOUS TO RABBIT EYE ... .

BENZETHONIUM CHLORIDE CAUSED INJECTION-SITE FIBROSARCOMAS IN RATS WITH LOW MALIGNANCY.

APPLICATION OF HYAMINE 1622 TO HEALTHY SMOLTS OF COHO SALMON FOLLOWED BY DIRECT TRANSFER TO SEAWATER FOR 10 DAYS RESULTED IN HIGH MORTALITY; WHEN TREATED & HELD IN FRESH WATER FOR 4 DAYS & GRADUALLY CHANGED OVER A 4 HR PERIOD TO SEAWATER, MORTALITY WAS MUCH LOWER.

IN RATS BENZETHONIUM CHLORIDE SIGNIFICANTLY INCR THE INCIDENCE OF FIBROSARCOMAS AFTER REPEATED INJECTION OF 3 MG/KG SC, BIWEEKLY FOR 50 WK.

For more Non-Human Toxicity Excerpts (Complete) data for BENZETHONIUM CHLORIDE (7 total), please visit the HSDB record page.

... Male and female F344/N rats and B6C3FI mice were topically administered benzethonium chloride (greater than 98% pure) for ... 2 yr. ... 2 YEAR STUDY IN RATS: Groups of 60 male and 60 female F344/N rats were topically administered 0, 0.15, 0.5, or 1.5 mg benzethonium chloride/kg body weight 5 days/wk for 103 wk. ... 2 YEAR STUDY IN MICE: Groups of 60 male and 60 female B6C3F1 mice were topically administered 0, 0.15, 0.5, or 1.5 mg benzethonium chloride/kg body weight 5 days/wk for 103 wk. Doses were administered in ethanol, and dose volumes were adjusted weekly according to the average body weights of the groups. ... CONCLUSIONS: Under the conditions of these 2 yr dermal studies, there was no evidence of carcinogenic activity of benzethonium chloride in male or female F344/N rats receiving 0.15, 0.5, or 1.5 mg/kg. There was no evidence of carcinogenic activit,v in male or female B6C3F1 mice receiving 0.15, 0.5, or 1.5 mg/kg.

Benzethonium chloride was prepared in 95% ethanol, which also served as the vehicle. A 0.5% solution of 1-fluoro-2,4-dinitrobenzene ... was used as the positive control. In the primary irritancy studies, a 10% concentration of benzethonium chloride was not significantly irritating, therefore, 20% was chosen as the challenge concentration. For the hypersensitivity test, /female/ B6C3F1 mice were divided into 7 treatment groups of 8 mice/group and administered the test compound at the concentrations shown in Table 1. The irritancy response was determined by monitoring the extravasation of 125I-bovine serum albumin into the testing area. The contact hypersensitivity response was determined by monitoring the infiltration of 125I- iododeoxyuridine labeled cells into the challenge site. ... There were no treatment-related effects on survival or body weights. The Hypersensitivity Index (HI) values obtained with benzethonium chloride sensitization at 1%, 3%, and 10% were not significantly different from the baseline control value. The positive control group (6) produced a statistically significant hypersensitivity response at a sensitizing and challenge concentration of 0.5% 1-fluoro-2,4-dinitrobenzene. ... Under these experimental conditions, no statistically significant group or dose-dependent contact hypersensitivity responses to benzethonium chloride were observed in mice by dermal exposure.

Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

D - Dermatologicals

QD - Dermatologicals

Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects.

Substances that are destructive to protozoans.

CIR ingredient: Benzethonium Chloride

Used as a cationic detergent, germicide for cleansing food and dairy utensils, swimming pool algaecide, dandruff-control agent, deodorant, topical antiseptic, spermicide, and astringent; [HSDB] Used as a preservative in cosmetics and pharmaceuticals and as a reagent for determining protein in cerebrospinal fluid; [Merck Index]

Using Disinfectants or Biocides [Category: Clean]

MEDICATION: TOPICAL ANTI-INFECTIVE; (VET) TOPICAL ANTISEPTIC

SPERMICIDE, ASTRINGENT

ANTISEPTIC FOR WOUNDS, INFECTED SKIN SURFACES, MILD INFECTIONS OF THE EYE, & FORNASAL & ORAL MUCOSA; GERMICIDE FOR CLEANSING FOOD & DAIRY UTENSILS; FOR CONTROLLING SWIMMING POOL ALGAE; ADDITIVE IN HAIRDRESSING PREPNS TO CONTROL DANDRUFF; DEODORANT; PRESERVATIVE

...P-DIISOBUTYLPHENOL IS CONDENSED IN PRESENCE OF BASIC CATALYST WITH BETA,BETA'-DICHLORODIETHYL ETHER TO YIELD 2[2-(4-(1,1,3,3-TETRAMETHYLBUTYL)PHENOXY)ETHOXY]ETHYL CHLORIDE. ALKALINE DIMETHYLAMINATION...GIVE CORRESPONDING TERTIARY AMINE...PURIFICATION BY DISTILLATION...TREATED WITH BENZYL CHLORIDE...

Aqueous solution, crystals, ethanol/water solution.

V-TERGENT 8X, DETERGENT- DEODORANT; COMPOSITION: BENZETHONIUM CHLORIDE 1.6%; ISOPROPYL ALC 13.5%. APPLICATIONS: WIDELY USEFUL DETERGENT & DEODORANT. LIQUEFIES PUS & FATTY EXUDATES.

BENZETHONIUM CHLORIDE, USP (PHEMEROL CHLORIDE), AVAIL AS 0.133 & 3% SOLN, 0.2% TINCTURE, & 0.2% VAGINAL FOAM.

GRADE: NATIONAL FORMULARY.

Cosmetics product ingredient: Benzethonium chloride

Information on 34 consumer products that contain Benzethonium Chloride in the following categories is provided:

Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]ethyl]-, chloride (1:1): ACTIVE

THE CATIONIC DETERGENTS...SUCH AS BENZETHONIUM CHLORIDE...ARE SYNTHETIC DERIVATIVES OF AMMONIUM CHLORIDE.

A COMBINATION OF CATIONIC GERMICIDE & ANIONIC POLYMER FOR SORPTION ONTO THE TOOTH SURFACE INHIBITING CALCULUS OR PLAQUE FORMATION. BENZETHONIUM CHLORIDE IS AN INGREDIENT IN THE MOUTHWASH FORMULATION.

IT IS OF ONLY LIMITED VALUE IN TREATMENT OF FUNGUS INFECTIONS.

WHEN APPLIED TO SKIN, THEY TEND TO FORM A FILM UNDER WHICH BACTERIA MAY REMAIN VIABLE; INNER SURFACE OF FILM HAS LOW BACTERICIDAL POWER WHEREAS OUTER SURFACE IS STRONGLY BACTERICIDAL. THEY DO NOT KILL SPORES. ... ACTION IS RATHER SLOW WHEN COMPARED TO THAT OF IODINE. /QUATERNARY AMMONIUM COMPD/

For more General Manufacturing Information (Complete) data for BENZETHONIUM CHLORIDE (13 total), please visit the HSDB record page.