GLYCERYL MONOSTEARATE || Skin Deep: Cosmetic Safety Reviews

GLYCERYL MONOSTEARATE

Fragrance Ingredient; Skin-Conditioning Agent - Emollient; Surfactant - Emulsifying Agent

SCORE

	1	low hazard
	88%	data gap
(why scores have changed)

Also listed as

GLYCERYL STEARATE, GLYCEROL ISOSTEARATE; GLYCERYL ISOSTEARATE; GLYCERYL MONOISOSTEARATE; ISOSTEARIC ACID MONOGLYCERIDE; ISOSTEARIC AICD MONOGLYCERIDE; 2,3-DIHYDROXYPROPYL OCTADECANOATE; GLYCERIN 1-STEARATE; GYCEROL 1-STEARATE; JEECHEM HMS; MONOSTEARIN; OCTADECANOIC ACID, 2,3-DIHYDROXYPROPYL ESTER

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
	Lesser or emerging concerns for this ingredient: Organ system toxicity (non-reproductive), Ecotoxicology, Data gaps
	See products containing GLYCERYL MONOSTEARATE

About GLYCERYL MONOSTEARATE: Glyceryl Stearate is the monoester of glycerin and stearic acid. It conforms generally to theformula:

GLYCERYL MONOSTEARATE has reported used in the following product types: facial moisturizer/treatment (663); moisturizer (565); anti-aging (309); mascara (254); sunscreen: moisturizer (200); facial cleanser (148); foundation (140); exfoliant/scrub (129); conditioner (121); hand cream (117)

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^®- National Technical Information Service

Ecotoxicology

type of concern	product conditions	reference
Suspected to be an environmental toxin		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
55 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

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	GLYCERYL MONOSTEARATE	• miscellaneous • Substances generally recognized as safe in foods but limited in standardized foods where the standard provides for its use • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required • 184.1324 • <2% of product - Macaroni products - CFR139.110 • <3% of product - Noodle products -139.150
Cosmetic Ingredient Review Assessments	GLYCERYL STEARATE	•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	GLYCERYL MONOSTEARATE	• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List	OCTADECANOIC ACID, MONOESTER WITH 1,2,3-PROPANETRIOL	•This chemical was NOT flagged by CEPA for further attention. The chemical was flagged as a low human health priority and for suspected aquatic toxicity.
RTECS^®- National Technical Information Service	GLYCERYL MONOSTEARATE	• broad systemic - Broad systemic toxicity (mouse LD50)

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.
RTECS^®- National Technical Information Service	RTECS^®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. AD277-689

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