POTASSIUM SORBATE || Skin Deep: Cosmetic Safety Reviews

POTASSIUM SORBATE

Fragrance Ingredient; Preservative

SCORE

	1	low hazard
	85%	data gap
(why scores have changed)

Also listed as

2,4-HEXADIENOIC ACID, POTASSIUM SALT; POTASSIUM SALT 2,4-HEXADIENOIC ACID; 2,4HEXADIENOIC ACID, POTASSIUM SALT; 2,4-HEXADIENOIC ACID POTASSIUM SALT; POTASSIUM 2,4-HEXADIENOATE; SORBISTAT-POTASSIUM

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:
	Cancer
	Developmental/reproductive toxicity
	Restrictions & warnings
	Allergies/immunotoxicity
	Contamination concerns
	Lesser or emerging concerns for this ingredient: Neurotoxicity, Organ system toxicity (non-reproductive), Data gaps
	See products containing POTASSIUM SORBATE

About POTASSIUM SORBATE: Potassium Sorbate is the organic salt that conforms generally to the formula:

POTASSIUM SORBATE has reported used in the following product types: facial moisturizer/treatment (272); moisturizer (236); anti-aging (144); body wash/cleanser (140); shampoo (131); conditioner (126); facial cleanser (121); hand cream (62); exfoliant/scrub (51); around-eye cream (50)

Cancer

type of concern

product conditions

reference

One or more in vitro tests on mammalian cells show positive mutation results

RTECS^®- Archives of Toxicology, Supplement 1980

Organ system toxicity (non-reproductive)

type of concern

product conditions

reference

One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)

RTECS^®- FAO Nutrition Meetings Report Series 1974

Neurotoxicity

type of concern	product conditions	reference
One or more animal studies show brain, nervous system, or behavioral effects at high doses		RTECS^®- FAO Nutrition Meetings Report Series 1967

Data gaps

type of concern	product conditions	reference
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		Cosmetic Ingredient Review Assessments
69 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

Ecotoxicology

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

Multiple, additive exposure sources

type of concern	product conditions	reference
Designated as safe for general or specific, limited use in food		FDA Food Additive Status
Designated as safe for general or specific, limited use in food		FDA Everything Added to Food

Persistence and bioaccumulation

type of concern

product conditions

reference

Not suspected to be persistent

Environment Canada Domestic Substance List

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
FDA Food Additive Status	POTASSIUM SORBATE	• Food additive: chemical preservative • Substances generally recognized as safe in foods but limited in standardized foods where the standard provides for its use - CFR182.3640 • less than 0.3% as sorbic acid - refers to part number under Title 21 Code of Federal Regulations 133 (133.123; 133.173; 133.179; 133.180; 133.188) Cheeses • Food additive: permitted as optional ingredient in a standardized food • less than 0.1% by weight - refers to part number under Title 21 Code of Federal Regulations 150 (150.141; 150.161) • Fruit Butter and Art Sw Jelly and Preserves • less than 0.1% or 0.2% total in combination w/other pres • Ma
Cosmetic Ingredient Review Assessments	POTASSIUM SORBATE	•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR) •Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product •
FDA Everything Added to Food	POTASSIUM SORBATE	• Fully up-to-date toxicology information has been sought.
Environment Canada Domestic Substance List	2,4-HEXADIENOIC ACID, POTASSIUM SALT	•This chemical was NOT flagged by CEPA for further attention.
RTECS^®- Archives of Toxicology, Supplement 1980	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS^®- Archives of Toxicology, Supplement 1980	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS^®- FAO Nutrition Meetings Report Series 1967	POTASSIUM SORBATE	• kidney or renal system - Changes in bladder weight (rat TDLo) • brain, nervous system, or behavioral effect - Food intake (animal) (rat TDLo)
RTECS^®- FAO Nutrition Meetings Report Series 1974	POTASSIUM SORBATE	• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS^®- Food and Chemical Toxicology 1984	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Sister Chromatid Exchange (hamster lng)
RTECS^®- Food and Chemical Toxicology 1984	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Sister Chromatid Exchange (hamster lng)
RTECS^®- Food and Chemical Toxicology 2002	POTASSIUM SORBATE	• kidney or renal system - Other changes in urine composition (rat TDLo)
RTECS^®- Kenkyu Nenpo--Tokyo-toritsu Eisei Kenkyusho 1976	POTASSIUM SORBATE	• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS^®- Mutation Research 1977	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS^®- Mutation Research 1977	POTASSIUM SORBATE	• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)

references

government/industry list/academic study	reference
FDA Food Additive Status	FDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.
Cosmetic Ingredient Review Assessments	CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
FDA Everything Added to Food	FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
Environment Canada Domestic Substance List	EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
RTECS^®- Archives of Toxicology, Supplement 1980	RTECS^®- Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) No.1- 1978- 4,41,1980
RTECS^®- Archives of Toxicology, Supplement 1980	RTECS^®- Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) No.1- 4,41,1980
RTECS^®- FAO Nutrition Meetings Report Series 1967	RTECS^®- FAO Nutrition Meetings Report Series. (Rome, Italy) No.?-57, 1948-77. Discontinued. 40,1,1967
RTECS^®- FAO Nutrition Meetings Report Series 1974	RTECS^®- FAO Nutrition Meetings Report Series. (Rome, Italy) No.?-57, 1948-77. Discontinued. 53A,121,1974
RTECS^®- Food and Chemical Toxicology 1984	RTECS^®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 22,501,1984
RTECS^®- Food and Chemical Toxicology 1984	RTECS^®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 22,501,1984
RTECS^®- Food and Chemical Toxicology 2002	RTECS^®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 40,1799,2002
RTECS^®- Kenkyu Nenpo--Tokyo-toritsu Eisei Kenkyusho 1976	RTECS^®- Kenkyu Nenpo--Tokyo-toritsu Eisei Kenkyusho. Annual Report of Tokyo Metropolitan Research Laboratory of Public Health. (Tokyo-toritsu Eisei Kenkyusho, 24-1, 3-chome, Hyakunin-cho, Shin-juku-ku, Tokyo 160, Japan) V.1- 1949/50- 27,159,1976
RTECS^®- Mutation Research 1977	RTECS^®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 48,337,1977
RTECS^®- Mutation Research 1977	RTECS^®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 48,337,1977

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