Cetylpyridinium Chloride

FCS -> FDA Cumulative Estimated Daily Intake (CEDI)

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

Dry Powder

White solid; [HSDB]

White powder; mp: 77-83 °C; freely sol in water, alcohol, chloroform; very slightly sol in benzene, ether; ph (1% aq soln): 6.0 to 7.0; surface tension (25 °C): 43 dyn/cm (0.1% aq soln), 41 dyn/cm (1.0% aq soln), 38 dyn/cm (10% aq soln) /Cetylpyridinium chloride monohydrate/

This chemical does not meet GHS hazard criteria for 19.3% (36 of 187) of reports.

Danger

H301 (33.7%): Toxic if swallowed [Danger Acute toxicity, oral]

P260, P261, P264, P264+P265, P270, P271, P273, P280, P284, P301+P316, P301+P317, P302+P352, P304+P340, P305+P354+P338, P316, P317, P319, P320, P321, P330, P332+P317, P362+P364, P391, P403+P233, P405, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 187 reports by companies from 27 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Danger

Chemical: Pyridinium, 1-hexadecyl-, chloride (1:1)

Hazard Traits - Hazard Trait Undefined

Pyridinium, 1-hexadecyl-, chloride (1:1) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Pyridinium, 1-hexadecyl-, chloride (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: 25-01-2019 https://echa.europa.eu/registration-dossier/-/registered-dossier/17221

Pyridinium, 1-hexadecyl-, chloride: Does not have an individual approval but may be used under an appropriate group standard

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

Irritating to the skin and eyes; [HSDB] Allergic contact dermatitis is infrequently documented for quaternary ammonium compounds; [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] See Benzalkonium chloride.

As the federal pesticide law FIFRA directs, EPA is conducting a comprehensive review of older pesticides to consider their health and environmental effects and make decisions about their future use. Under this pesticide reregistration program, EPA examines health and safety data for pesticide active ingredients initially registered before November 1, 1984, and determines whether they are eligible for reregistration. In addition, all pesticides must meet the new safety standard of the Food Quality Protection Act of 1996. Pesticides for which EPA had not issued Registration Standards prior to the effective date of FIFRA, as amended in 1988, were divided into three lists based upon their potential for human exposure and other factors, with List B containing pesticides of greater concern and List D pesticides of less concern. Cetylpyridinium chloride is found on List C. Case No: 3013; Pesticide type: insecticide, fungicide, rodenticide, antimicrobial; Case Status: No products containing the pesticide are actively registered ... The case /is characterized/ as "cancelled." Under FIFRA, pesticide producers may voluntarily cancel their registered products. EPA also may cancel pesticide registrations if registrants fail to pay required fees or make/meet certain reregistration commitments, or if EPA reaches findings of unreasonable adverse effects.; Active ingredient (AI): Cetylpyridinium chloride; AI Status: The active ingredient is no longer contained in any registered pesticide products ... "cancelled."

Acute Tox. 3 (33.7%)

Acute toxicity (Oral) - Category 3

Acute toxicity (Oral) - Category 3

Mild skin irritation

A skin & eye irritant.

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.

0.060 [mg/m3]

0.66 [mg/m3]

4.0 [mg/m3]

AVOID ALCOHOL, WHICH HAS BEEN SHOWN TO INCREASE THE ORAL TOXICITY OF ... CETYL PYRIDINIUM CHLORIDE ... .

CURARE ANTAGONISTS SUCH AS NEOSTIGMINE AND EDROPHONIUM (TENSILON) ... MAY ENHANCE THE PARALYSIS ... . /BENZALKONIUM CHLORIDE/

... ANTAGONIZED BY ANIONIC SURFACTANTS, INCL SOAPS ... .

ETHANOL ACTIVATED UDP-GLUCURONOSYLTRANSFERASE ACTIVITY (P-NITROPHENOL SUBSTRATE) IN RAT LIVER IN VITRO, BUT INHIBITED ACTIVITY @ HIGHER ETHANOL CONCN. ACTIVATION NOT SEEN IN MICROSOMES PRETREATED IN VITRO WITH CETYLPYRIDINIUM CHLORIDE.

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 200(SRC), determined from a log Kow of 1.71(2) and a regression-derived equation(3), indicates that cetylpyridinium chloride is expected to have moderate mobility in soil(SRC). However, quaternary ammonium compounds are known to sorb strongly and rapidly in well-mixed systems, to a wide variety of materials (such as sewage sludge, sediment, clay)(4) and the mobility of cetylpyridinium bromide in soil may be considerably less than estimated. Volatilization of cetylpyridinium chloride from moist soil surfaces is not expected as this compound is a salt(SRC). Cetylpyridinium chloride is also not expected to volatilize from dry soil surfaces(SRC) as ions do not volatilize. Cetylpyridinium chloride is expected to biodegrade rapidly in soil(SRC) based on sewage studies for structurally-similar compounds. Dodecyl and tetradecylpyridinium chloride, were biodegraded in the Spanish official test (93 and 94%, respectively) and in the OECD Confirmatory test (91 and 92%, respectively)(4).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 200(SRC), determined from a log Kow of 1.71(2) and a regression-derived equation(3), indicates that cetylpyridinium chloride is not expected to adsorb to suspended solids and sediment(SRC). However, quaternary ammonium compounds are known to sorb strongly, and rapidly in well-mixed systems, to a wide variety of materials (such as sewage sludge, sediment, clay)(7); therefore, cetylpyridinium bromide should be strongly adsorbed to suspended solids and sediment in water. This compound is expected to exist in the dissociated form in the environment and therefore volatilization from water surfaces will not be an important fate process(SRC). According to a classification scheme(5), an estimated BCF of 2(SRC), from its log Kow(2) and a regression-derived equation(6), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Cetylpyridinium chloride is expected to biodegrade rapidly in water(SRC) based on sewage studies for structurally-similar compounds. Dodecyl and tetradecylpyridinium chloride, were biodegraded in the Spanish official test (93 and 94%, respectively) and in the OECD Confirmatory test (91 and 92%, respectively)(7).

ATMOSPHERIC FATE: Cetylpyridinium chloride will exist as the ion in the environment and, thus, will be present solely in the particulate phase in the atmosphere. Particulate-phase cetylpyridinium chloride may be removed from the air by wet and dry deposition. (SRC)

The Koc of cetylpyridinium chloride is estimated as 200(SRC), using a measured log Kow of 1.71(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that cetylpyridinium chloride is expected to have moderate mobility in soil. However, quaternary ammonium compounds are known to sorb strongly, and rapidly in well-mixed systems, to a wide variety of materials (such as sewage sludge, sediment, clay)(4) and the mobility of cetylpyridinium chloride in soil may be considerably less than estimated(SRC).

CONCN SOLN CAN PRODUCE CORROSIVE SKIN LESIONS WITH DEEP NECROSIS & SCARRING. /BENZALKONIUM CHLORIDE/

... POISONING FROM ORAL INGESTION HAS OCCURRED. /CATIONIC SURFACTANTS/

/Investigators/ ... studied the offspring of 292 women using this medication in the first trimester and found 9 malformations. The rate was 31 congenital defects per 1000 while the mean rate was 16 per 1000. This increase was not statistically significant.

Large quantities may cause nausea, vomiting, collapse, convulsions and coma.

Cetylpyridinium chloride's production and use as an antiseptic, as a preservative in cosmetics and pharmaceuticals(1) and as an ingredient in external deodorants(2), and in mouthwash(3) may result in its release to the environment through various waste streams(SRC).

ALKYLPYRIDINIUM DERIVATIVES ARE LESS BIODEGRADABLE THAN MONOALKYLTRIMETHYL & ALKYLBENZYL DIMETHYL AMMONIUM CHLORIDES. /ALKYLPYRIDINIUM DERIVATIVES/

AEROBIC: Biodegradation data for cetylpyridinium chloride were not located although, based on data for structurally-similar compounds, this compound is expected to biodegrade rapidly in the environment(SRC). Structurally-similar compounds, dodecyl and tetradecylpyridinium chloride, were biodegraded in the Spanish official test (93 and 94%, respectively) and in the OECD Confirmatory test (91 and 92%, respectively)(1). Mean cetylpyridinium (counterion unspecified) removal of 96.0 and 77.2%, respectively, was observed at an activated sludge and a trickling filter wastewater treatment plant in England; in the Heidelsheim plant in Germany, 95% removal was reported(1). Cetylpyridinium bromide is readily biodegraded in sewage, particularly when the inoculum has been previously acclimated(2,3).

Whole body BCF values of 21, 22, and 13, were measured for clams, fathead minnows, and tadpoles, respectively, under flow-through conditions over a 7-day period, for a structurally-similar compound, cetylpyridinium bromide(1). An estimated BCF of 2 was calculated for cetylpyridinium chloride(SRC), using a log Kow of 1.71(2) and a regression-derived equation(3). According to a classification scheme(4), these BCF values suggest the potential for bioconcentration in aquatic organisms is low(SRC).

Cetylpyridinium chloride is expected to exist in the dissociated form in the environment and, therefore, volatilization from water surfaces or moist soil surfaces will not an important fate process. Cetylpyridinium chloride is not expected to volatilize from dry soil surfaces as it exists as an ion in the environment and ions do not volatilize. (SRC)

IN ISOLATED OBSERVATION ... NO INHIBITION OF PLASMA CHOLINESTERASE WAS FOUND IN RATS SACRIFICED IN EXTREMIS AFTER AN IP INJECTION OF ... CETYL PYRIDINIUM CHLORIDE. A 50% INHIBITION OF RED CELL CHOLINESTERASE ... /WAS/ NOTED, BUT SUCH A DEPRESSION IS NOT EXPECTED TO PRODUCE UNTOWARD REACTIONS.

A CURARE-LIKE PARALYSIS OF SKELETAL MUSCLES ... ASCRIBED ... SPECIFICALLY TO CETYL PYRIDINIUM CHLORIDE ... . PARENTERAL INJECTIONS IN RATS, RABBITS AND DOGS HAVE RESULTED IN PROMPT BUT TRANSIENT LIMB PARALYSIS AND SOMETIMES FATAL PARESIS OF THE RESPIRATORY MUSCLES.

... TESTED ... @ CONCN OF 0.1% TO 1.0% IN WATER ... SIGNIFICANTLY IRRITATING OR INJURIOUS TO RABBIT EYE.

CETYLPYRIDINIUM CHLORIDE FOUND ... TO BE LETHAL TO RABBITS IN ORAL DOSE 400 MG/KG (180 MG/LB). TOXIC EFFECTS INCL ACTION ON CARDIOVASCULAR SYSTEM ... .

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

Cetylpyridinium chloride is not expected to undergo hydrolysis in the environment due to the lack of hydrolyzable functional groups(1). Pyridine has a weak absorption band that extends into the environmental UV spectrum(3), which suggests that direct photolysis is not likely to be an important fate process for cetylpyridinium chloride (SRC).

NIOSH (NOES Survey 1981-1983) has statistically estimated that 98,375 workers (86,013 of these are female) are potentially exposed to cetylpyridinium chloride in the US(1). Occupational exposure to cetylpyridinium chloride may occur through inhalation and dermal contact with this compound at workplaces where cetylpyridinium chloride is produced or used(SRC). The general population may be exposed to cetylpyridinium chloride predominantly via ingestion or dermal contact due to its use in consumer products, such as mouthwash, external deodorants, and cough lozenges and syrups(SRC).

As the federal pesticide law FIFRA directs, EPA is conducting a comprehensive review of older pesticides to consider their health and environmental effects and make decisions about their future use. Under this pesticide reregistration program, EPA examines health and safety data for pesticide active ingredients initially registered before November 1, 1984, and determines whether they are eligible for reregistration. In addition, all pesticides must meet the new safety standard of the Food Quality Protection Act of 1996. Pesticides for which EPA had not issued Registration Standards prior to the effective date of FIFRA, as amended in 1988, were divided into three lists based upon their potential for human exposure and other factors, with List B containing pesticides of greater concern and List D pesticides of less concern. Cetylpyridinium chloride is found on List C. Case No: 3013; Pesticide type: insecticide, fungicide, rodenticide, antimicrobial; Case Status: No products containing the pesticide are actively registered ... The case /is characterized/ as "cancelled." Under FIFRA, pesticide producers may voluntarily cancel their registered products. EPA also may cancel pesticide registrations if registrants fail to pay required fees or make/meet certain reregistration commitments, or if EPA reaches findings of unreasonable adverse effects.; Active ingredient (AI): Cetylpyridinium chloride; AI Status: The active ingredient is no longer contained in any registered pesticide products ... "cancelled."

MODE OF ACTION ... NOT YET FULLY UNDERSTOOD BUT HAS BEEN ASCRIBED TO ... THE DENATURING OF LIPOPROTEIN COMPLEXES, & POSSIBLY OTHER ACTIONS. /QUATERNARY AMMONIUM COMPD/

EVIDENCE HAS BEEN PRESENTED THAT THE MAJOR SITE OF ACTION ... MAY BE THE CELL MEMBRANE, WHERE THE AGENTS MAY CAUSE CHANGES IN PERMEABILITY THAT PERMIT ESCAPE OF ENZYMES, COENZYMES, & METABOLIC INTERMEDIATES. /CATIONIC SURFACTANTS/

EMULSIFY SEBACEOUS MATERIAL, WHICH IS THEN REMOVED TOGETHER WITH DIRT & BACTERIA. THE MILD DESQUAMATING EFFECT OF THE QUATERNARY AMMONIUM COMPOUNDS AIDS IN CLEANING. /QUATERNARY AMMONIUM COMPD/

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.

Purifying or cleansing agents, usually salts of long-chain aliphatic bases or acids, that exert cleansing (oil-dissolving) and antimicrobial effects through a surface action that depends on possessing both hydrophilic and hydrophobic properties.

Used as a preservative/antibacterial agent in cosmetics, pharmaceuticals, cough lozenges, mouthwashes, deodorants, and antiseptics; [HSDB] Quarternary ammonium compounds are used as algaecides/slimicides (swimming pools, industrial water reservoirs, and farm ponds), antiseptics for cleaning wounds, antistatic agents for textiles, softeners for paper products, and pigment dispersers; [IPCS-PIMs]

Using Disinfectants or Biocides [Category: Clean]

For Cetylpyridinium chloride (USEPA/OPP Pesticide Code: 069160) there are 0 labels match. /SRP: Not registered for current use in the U.S., but approved pesticide uses may change periodically and so federal, state and local authorities must be consulted for currently approved uses./

The active ingredient is no longer contained in any registered pesticide products ... "cancelled."

Pharmaceutic aid (preservative), antiseptic; disinfectant/monohydrate/

Antiseptic; preservative(cosmetics, pharmaceuticals)

2023: 75,000 - <500,000 lb

(1972) PROBABLY GREATER THAN 4.54X10+5 G

(1975) PROBABLY GREATER THAN 4.54X10+5 G

ANHYD CMPD PREPD BY HEATING MIXT OF CETYL CHLORIDE & SLIGHT EXCESS OF PYRIDINE @ 140 °C FOR 6 HR. CRUDE PRODUCT IS DECOLORIZED WITH CHARCOAL & RECRYSTALLIZED FROM MIXED SOLVENT COMPOSED OF METHYL ETHYL KETONE & ALCOHOL ... THEN WASHED WITH ETHER & VACUUM DRIED @ 50-60 °C. /THEN RECRYSTALLIZED/ ... FROM WATER ... .

Pyridine + cetyl chloride (quaternization)

CEPACAINE SOLN (BENZOCAINE, COMBINATION, CETYLPYRIDINIUM CHLORIDE, DIBUCAINE).

CETYLPRIDINIUM CHLORIDE LOZENGES, 0.067% ... WITH BENZYL ALC (CEPACOL). LOZENGES, 0.067% ... WITH NEOMYCIN SULFATE 2.5 MG ... TYROTHRICIN 1 MG, METHYLPARABEN 4 MG, PROPYLPARABEN 1 MG, ETHYL AMINOBENZOATE 5 MG (CEPACOL ANTIBIOTIC TROCHES). SOLN, 0.025% ... WITH ALC 14% & PHOSPHATE BUFFERS; 150 & 420 ML BOTTLES (CEPACOL).

AVAILABLE AS AQUEOUS OR ALCOHOL SOLUTIONS (EG, TINCTURE) IN CONCN OF 10% OR LESS.

GRADES: TECHNICAL; NF

Lozenges, 0.07%. Mouthwash, 0.05%.

Cosmetics product ingredient: Cetylpyridinium chloride

Information on 33 consumer products that contain Cetylpyridinium chloride in the following categories is provided:

Food, beverage, and tobacco product manufacturing

Pyridinium, 1-hexadecyl-, chloride (1:1): ACTIVE

/CETYLPYRIDINIUM CHLORIDE IS/ MONOHYDRATE OF QUATERNARY SALT OF PYRIDINE & CETYL CHLORIDE.

BACTERIAL SPORES RESIST EVEN PROLONGED CONTACT. AQ SOLN OF THESE CMPD ARE NOT TUBERCULOCIDAL. /QUATERNARY AMMONIUM CMPD/

SURFACTANTS ... ARE BLENDED INTO SOME DRUG PRODUCTS TO IMPROVE DISINTEGRATION OF TABLETS OR SPREAD & CONTACT OF MEDICATIONS ... WITH BODY SURFACES. ... PRECAUTIONS ... BECAUSE SOME ... CAN INACTIVATE OTHER DRUG PRODUCT INGREDIENTS. ... TWEEN 80 BINDS ... CETYLPYRIDINIUM CHLORIDE.

PHARMACEUTICAL INSULIN PREPN FOR RECTAL ADMIN COMPRISE INSULIN, A BASE, & AS ABSORPTION ACCELERATOR, SOMETIMES A CATIONIC SURFACTANT.