TOCOPHERYL ACETATE || Skin Deep: Cosmetic Safety Reviews

TOCOPHERYL ACETATE

Antioxidant; Skin-Conditioning Agent - Miscellaneous; SKIN CONDITIONING

SCORE

	4	moderate hazard
	81%	data gap
(why scores have changed)

Also listed as

3,4-DIHYDRO-2,5,7,8-TETRAMETHYL-2- (4,8,12-TRIMETHYLTRIDECYL-2H-BENZOPYRAN-6-OL, ACETATE; D-A-TOCOPHERYL ACETATE; D-ALPHA-TOCOPHERYL ACETATE; DL-A -TOCOPHERYL ACETATE; DL-ALPHA-TOCOPHERYL ACETATE; VITAMIN E ACETATE; ACETATE 3,4-DIHYDRO-2,5,7,8-TETRAMETHYL-2- (4,8,12-TRIMETHYLTRIDECYL-2H-BENZOPYRAN-6-OL; TOCOPHEROL ACETATE; TOCOPHERYL ACETATE, DL-ALPHA; ALPHA-TOCOPHERYL ACETATE; DL-ALPHA TOCOPHERYL ACETATE

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
	Violations, restrictions & warnings
	Allergies/immunotoxicity
	Contamination concerns - HYDROQUINONE
	Lesser or emerging concerns for this ingredient: Organ system toxicity (non-reproductive), Ecotoxicology, Data gaps
	See products containing TOCOPHERYL ACETATE

About TOCOPHERYL ACETATE: Tocopheryl Acetate is the ester of Tocopherol (q.v.) and acetic acid.

TOCOPHERYL ACETATE has reported used in the following product types: facial moisturizer/treatment (813); lipstick (712); moisturizer (494); anti-aging (486); foundation (452); lip gloss (375); sunscreen: makeup (373); sunscreen: moisturizer (263); sunscreen: SPF 15-30 (227); conditioner (214)

Allergies/immunotoxicity

type of concern	product conditions	reference
Human skin toxicant - strong evidence		Cosmetic Ingredient Review Assessments

Cancer

type of concern

product conditions

reference

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

RTECS^®- Cancer Letters (Shannon, Ireland) 1984

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^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V 2002

Ecotoxicology

type of concern

product conditions

reference

Suspected to be an environmental toxin and be persistent or bioaccumulative (uncertainty in environmental toxicity or persistence/bioaccumulation)

Environmental Canada Domestic Substance List

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

Multiple, additive exposure sources

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

Persistence and bioaccumulation

type of concern	product conditions	reference
Not suspected to be bioaccumulative		Environmental 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	TOCOPHEROL ACETATE	• DS/NUTR • GRAS (generally recognized as safe) - use in food presumed safe based either on a history of use before 1958 or on published scientific evidence; need not be approved by the FDA prior to use in food; most have not limit for use but must conform to good manufacturing practices; some GRAS substances have quantitative limit for use in foods; by definition under Sec 201(s) of FD&C Act, not food additives • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required - CFR182.5892; 182.8892
Cosmetic Ingredient Review Assessments	TOCOPHERYL ACETATE	•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 •May contain harmful impurities •Sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin
FDA Everything Added to Food	ALPHA-TOCOPHEROL ACETATE	• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List	2H-1-BENZOPYRAN-6-OL, 3,4-DIHYDRO-2,5,7,8-TETRAMETHYL- 2-(4,8,12-TRIMETHYLTRIDECYL)-, ACETATE, [2R-[2R(4R,8R)]]-	•This chemical was deemed a low human health priority and was NOT flagged by CEPA for further attention. The chemical was flagged for suspected persistence, and uncertain aquatic toxicity.
Gensler HL, Aickin M, Peng YM, Xu M, 1996	TOCOPHERYL ACETATE	tocopheryl acetate enhanced photocarcinogenesis in an animal study
RTECS^®- Cancer Letters (Shannon, Ireland) 1984	TOCOPHERYL ACETATE	• mutagenic - Positive mutation assay: DNA Damage (rat ipr)
RTECS^®- Food and Chemical Toxicology 1986	TOCOPHERYL ACETATE	• liver - Changes in liver weight (rat TDLo) • blood - Changes in other cell count (unspecified) (rat TDLo) • blood - Pigmented or nucleated red blood cells (rat TDLo)
RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V 2002	TOCOPHERYL ACETATE	• broad systemic - Broad systemic toxicity (rat LD50)
RTECS^®- Japanese Journal of Cancer Research 1991	TOCOPHERYL ACETATE	• cancer - Tumors at site of application (rat TDLo)

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.
Environmental Canada Domestic Substance List	EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
Open scientific literature	Gensler HL, Aickin M, Peng YM, Xu M. 1996. Importance of the form of topical vitamin E for prevention of photocarcinogenesis. Nutr Cancer 26(2): 183-91.
RTECS^®- Cancer Letters (Shannon, Ireland) 1984	RTECS^®- Cancer Letters (Shannon, Ireland). (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 25,163,1984
RTECS^®- Food and Chemical Toxicology 1986	RTECS^®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 24,1043,1986
RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V 2002	RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V.16- 1997- 21,51,2002
RTECS^®- Japanese Journal of Cancer Research 1991	RTECS^®- Japanese Journal of Cancer Research. (Elsevier Science Pub. BV, POB 211, 1000 AE Amsterdam, Netherlands) V.76- 1985- 82,511,1991

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