BENZALKONIUM CHLORIDE

Antimicrobial Agent; Antistatic Agent; Cosmetic Biocide; Deodorant Agent; Surfactant -Suspending Agent; PRESERVATIVE  

Also listed as

ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE; BENZALKONIUM CHLORIDE SOLUTION; QUATERNARY AMMONIUM COMPOUNDS, BENZYLCOCO ALKYLDIMETHYL, CHLORIDES; ALKYL DIMETHYLBENZYL AMMONIUM CHLORIDE; ALKYLDIMETHYL (PHENYLMETHYL) QUATERNARY AMMONIUM CHLORIDES; AMMONYX; ARQUAD DMMCB-75; BARQUAT MB-50; BAYCLEAN; BENIROL; BENZALKONIUM A


Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

This ingredient:
yes, weakCancer
noDevelopmental/reproductive toxicity
yes, moderateViolations, restrictions & warnings
yes, strongAllergies/immunotoxicity
noContamination concerns
noOther moderate concerns for this ingredient:
Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
 
See products containing BENZALKONIUM CHLORIDE

About BENZALKONIUM CHLORIDE: Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides that conformsgenerally to the formula: where R represents a mixture of alkyls, including all or some of the group beginning with capryl and extending through higher homologs with lauryl, myristyl and cetyl predominating. In the United States, Benzalkonium Chloride may be used as an active ing redient in OTC drug products. When used as an active drug ingredient, the established name is Benzalkonium Chloride. See "Regulatory and Ingredient Use Information," regarding the labeling names for U.S. OTC Drug Ingredients in Volume 1, Introduction, PartA.

BENZALKONIUM CHLORIDE has reported used in the following product types: eye drops/artificial tears (71); facial moisturizer/treatment (24); facial cleanser (20); pain relief (14); moisturizer (14); acne treatment (13); wound treatment (12); baby lotion (11); anti-itch/rash cream (11); sunscreen: moisturizer (10)


Allergies/immunotoxicity

type of concern product conditions reference
Known human immune system toxicant    National Library of Medicine HazMap
Human skin toxicant - strong evidence    Cosmetic Ingredient Review Assessments
Human immune and respiratory toxicant - strong evidence     Association of Occupational and Environmental Clinics
Human immune and respiratory toxicant - strong evidence   AND products that may be aerosolized (airborne)  Association of Occupational and Environmental Clinics
Human immune system toxicant - moderate evidence    National Library of Medicine HazMap
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Violations, restrictions & warnings

type of concern product conditions reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in some types of cosmetics (concentration limit)   Japan's Standards for Cosmetics
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics   Canada - Prohibited and Restricted Cosmetics Ingredients
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications   Cosmetic Ingredient Review Assessments

Organ system toxicity (non-reproductive)

type of concern product conditions reference
One or more animal studies show sense organ effects at very low doses products for use around the eyes, mouth, or lips  RTECS®- American Journal of Ophthalmology 1944
One or more animal studies show sense organ effects at very low doses products for use around the eyes, mouth, or lips  RTECS®- Toxicology and Applied Pharmacology 1964
Possible human immune system toxicant    National Library of Medicine HazMap
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Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Shigaku 1987
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Irritation (skin, eyes, or lungs)

type of concern product conditions reference
One or more animal studies show skin irritation at low doses    RTECS®- Acta Dermato-Venereologica 1990
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Data gaps

type of concern product conditions reference
832 studies on toxicity in PubMed see search results ->   PubMed

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be bioaccumulative     Environmental Canada Domestic Substance List
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Ecotoxicology

type of concern product conditions reference
Not suspected to be an environmental toxin     Environmental Canada Domestic Substance List



Government, industry, academic studies and classifications

government/industry list/academic study appears on list as classification(s)
Association of Occupational and Environmental ClinicsQUATERNARY AMMONIUM COMPOUNDS, NOS• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Association of Occupational and Environmental ClinicsBENZALKONIUM CHLORIDE• Asthmagen sensitizer
Canada - Prohibited and Restricted Cosmetics IngredientsBENZALKONIUM CHLORIDE•Use is restricted in Canadian cosmetics
Canada - Prohibited and Restricted Cosmetics IngredientsBENZALKONIUM CHLORIDE•Use is restricted in Canadian cosmetics
Canada - Prohibited and Restricted Cosmetics IngredientsBENZALKONIUM CHLORIDE•Use is restricted in Canadian cosmetics
Canada - Prohibited and Restricted Cosmetics IngredientsBENZALKONIUM CHLORIDE•Use is restricted in Canadian cosmetics
Canada - Prohibited and Restricted Cosmetics IngredientsBENZALKONIUM CHLORIDE•Use is restricted in Canadian cosmetics
Cosmetic Ingredient Review AssessmentsBENZALKONIUM CHLORIDE•Safe for use in cosmetics with some qualifications
•Determined safe for use in cosmetics up to a specified concentration limit
•Sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin
Environmental Canada Domestic Substance ListQUATERNARY AMMONIUM COMPOUNDS, BENZYLCOCO ALKYLDIMETHYL, CHLORIDES•This chemical was NOT flagged by CEPA for further attention. The chemical was flagged for as a low human health priority.
National Library of Medicine HazMapBENZALKONIUM CHLORIDE•Asthma - Reversible bronchoconstriction (narrowing of bronchioles) initiated by the inhalation of irritating or allergenic agents: Yes;
•Skin Sensitizer - An agent that can induce an allergic reaction in the skin or lungs: Yes;
Japan's Standards for CosmeticsBENZALKONIUM CHLORIDE•Japan - restricted for use in some types of cosmetics (concentration limit)
Japan's Standards for CosmeticsBENZALKONIUM CHLORIDE•Japan - restricted for use in some types of cosmetics (concentration limit)
RTECS®- "Animal Models in Dermatology: Relevance to Human Dermatopharmacology and Dermatotoxicology," Maibach, H 1975BENZALKONIUM CHLORIDE• skin - Primary skin irritant (rabbit )
RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977BENZALKONIUM CHLORIDE• skin - Primary skin irritant ( human )
RTECS®- Acta Dermato-Venereologica 1988BENZALKONIUM CHLORIDE• skin - Primary skin irritant ( human )
RTECS®- Acta Dermato-Venereologica 1990BENZALKONIUM CHLORIDE• skin - Primary skin irritant ( human )
RTECS®- American Journal of Ophthalmology 1944BENZALKONIUM CHLORIDE• sense organ - Primary eye irritant ( human )
RTECS®- Archives of Ophthalmology (Chicago) 1945BENZALKONIUM CHLORIDE• sense organ - Primary eye irritant (rabbit )
RTECS®- British Journal of Dermatology 2003BENZALKONIUM CHLORIDE• skin - Primary skin irritant ( human )
RTECS®- Mutation Research 1988BENZALKONIUM CHLORIDE• mutagenic - Positive mutation assay: DNA repair (Bacillus subtilis )
RTECS®- Shigaku 1987BENZALKONIUM CHLORIDE• mutagenic - Positive mutation assay: Sister Chromatid Exchange (hamster emb)
RTECS®- Toxicology and Applied Pharmacology 1980BENZALKONIUM CHLORIDE• sense organ - Primary eye irritant (rabbit )
RTECS®- Toxicology and Applied Pharmacology 1964BENZALKONIUM CHLORIDE• sense organ - Primary eye irritant (monkey )

references

government/industry list/academic study reference
Association of Occupational and Environmental ClinicsAOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
Canada - Prohibited and Restricted Cosmetics IngredientsHealth Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
Cosmetic Ingredient Review AssessmentsCIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
Environmental Canada Domestic Substance ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
National Library of Medicine HazMapNLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
Japan's Standards for CosmeticsJapan Ministry of Health, Labour and Welfare. 2006. Standards for Cosmetics. Evaluation and Licensing Division. Pharmaceutical and Food Safety Bureau.
RTECS®- "Animal Models in Dermatology: Relevance to Human Dermatopharmacology and Dermatotoxicology," Maibach, H 1975RTECS®- "Animal Models in Dermatology: Relevance to Human Dermatopharmacology and Dermatotoxicology," Maibach, H., ed., New York, Churchill Livingston, 1975 -,2,1975
RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 -,127,1977
RTECS®- Acta Dermato-Venereologica 1988RTECS®- Acta Dermato-Venereologica. (Almqvist & Wiksell, POB 45150, S-10430 Stockholm, Sweden) V.1- 1920- 68,192,1988
RTECS®- Acta Dermato-Venereologica 1990RTECS®- Acta Dermato-Venereologica. (Almqvist & Wiksell, POB 45150, S-10430 Stockholm, Sweden) V.1- 1920- 95,711,1990
RTECS®- American Journal of Ophthalmology 1944RTECS®- American Journal of Ophthalmology. (Ophthalmic Pub. Co., 435 N. Michigan Ave., Suite 1415, Chicago, IL 60611) Series 3: V.1- 27,1118,1944
RTECS®- Archives of Ophthalmology (Chicago) 1945RTECS®- Archives of Ophthalmology (Chicago). (AMA, 535 N. Dearborn St., Chicago, IL 60610) New series: V.1-44(3), 1929-50; V.64- 34,99,1945
RTECS®- British Journal of Dermatology 2003RTECS®- British Journal of Dermatology. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.63- 1951- 148,171,2003
RTECS®- Mutation Research 1988RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 193,21,1988
RTECS®- Shigaku 1987RTECS®- Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20 Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 74,1365,1987
RTECS®- Toxicology and Applied Pharmacology 1980RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 55,501,1980
RTECS®- Toxicology and Applied Pharmacology 1964RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 6,701,1964

"RTECS®" is a United States trademark owned and licensed under authority of the U.S. Government, by and through MDL Information Systems, Inc.

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