NANO ZINC OXIDE (20-60nm) || Skin Deep: Cosmetic Safety Reviews

NANO ZINC OXIDE (20-60nm)

SCORE

	3	moderate hazard to high hazard depending on product usage
	9	moderate hazard to high hazard depending on product usage
	70%	data gap
(why scores have changed)

Also listed as

NANO ZINC OXIDE; NANOZN

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
	Other strong concerns for this ingredient: Enhanced skin absorption, Occupational hazards
	Other moderate concerns for this ingredient: Persistence and bioaccumulation, Organ system toxicity (non-reproductive)
	Lesser or emerging concerns for this ingredient: Neurotoxicity, Ecotoxicology, Irritation (skin, eyes, or lungs), Data gaps
	See products containing NANO ZINC OXIDE (20-60nm)

About NANO ZINC OXIDE (20-60nm): Nano zinc oxide offers greater sun protection than larger zinc particles. Comparatively little is known regarding potential health effects of nanoparticles. They do not penetrate healthy skin, and thus appear to pose a low health risk in lotions. Inhalation of powders and sprays is a concern.

ingredient UV blocking strength

common sunscreen
concentrations

UV blocking strength

2.0%

2.1%

3.0%

5.0%

6.0%

20.0%

25.0%

NANO ZINC OXIDE (20-60nm) has reported used in the following product types: sunscreen: makeup (181); foundation (168); sunscreen: SPF 15-30 (86); sunscreen: SPF greater than 30 (80); facial moisturizer/treatment (78); sunscreen: moisturizer (73); anti-aging (34); concealer (17); sunscreen: lip balm (17); baby sunscreen (17)

Allergies/immunotoxicity

type of concern	product conditions	reference
Human immune and respiratory toxicant - strong evidence		Association of Occupational and Environmental Clinics
Limited evidence of immune system toxicity	products that may be aerosolized (airborne)	California EPA, Office of Environmental Health Hazard Assessment
One or more animal studies show effects at very low doses	products that may be aerosolized (airborne)	Sayes CM, Reed KL, Warheit DB, 2007

Violations, restrictions & warnings

type of concern	product conditions	reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions -		SCCNFP (2003)

Persistence and bioaccumulation

type of concern

product conditions

reference

Persistent or bioaccumulative and moderate to high toxicity concern in humans

Environmental Canada Domestic Substance List

Persistent, bioaccumulative in wildlife

Canada PBTs - Accelerated Reduction/Elimination of Toxics (ARET)

Occupational hazards

type of concern	product conditions	reference
Allowed workplace exposures restricted to low doses		RTECS^®- TLV/BEI,2006
Strong evidence of occupational hazards	products that may be aerosolized (airborne)	Gordon T, Fine JM, 1993
Allowed workplace exposures restricted to moderate doses		National Library of Medicine HazMap
Allowed workplace exposures restricted to moderate doses		RTECS^®- TLV/BEI,2005
Moderate evidence of occupational hazards	products that may be aerosolized (airborne)	Gordon T, Fine JM, 1993

Organ system toxicity (non-reproductive)

type of concern

product conditions

reference

Classified as expected to be toxic or harmful

Environmental Canada Domestic Substance List

Cancer

type of concern

product conditions

reference

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

COLIPA, 2003; COLIPA, 1995; Brendler-Schwaab, 2001

Developmental/reproductive toxicity

type of concern

product conditions

reference

One or more animal studies show developmental effects at high doses

Schlicker, 1968

Neurotoxicity

type of concern	product conditions	reference
One or more animal studies show brain and nervous system effects at high doses		RTECS^®- Toxicologist 1997

Irritation (skin, eyes, or lungs)

type of concern	product conditions	reference
One or more animal studies show skin irritation at moderate doses		RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972

Ecotoxicology

type of concern

product conditions

reference

Wildlife and environmental toxicity

European Union - Classification & Labelling

Decreased skin absorption

type of concern	product conditions	reference
Limited potential to absorb into the skin.		Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997

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

Enhanced skin absorption

type of concern	product conditions	reference
Nano-scale ingredients with potential to absorb into the skin		Nanomaterial Database
Nano-scale ingredients with potential to absorb into the skin		FDA (U, 2006

Data gaps

type of concern	product conditions	reference
Not assessed for safety in cosmetics by industry panel
Insufficient data to determine safety		SCCNFP (2003)
1,786 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
European Union - Classification & Labelling	ZINC OXIDE	•Dangerous for the environment •Very toxic to aquatic organisms
FDA Food Additive Status	ZINC OXIDE	• NUTR/DS • 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 - CFR182.5991; 182.8991
Association of Occupational and Environmental Clinics	ZINC	• Asthmagen sensitizer
FDA Color Additive Status	ZINC OXIDE	•Color additive approved by FDA for use in cosmetics •Color additive approved by FDA for cosmetics used around eyes
FDA Everything Added to Food	ZINC OXIDE	• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List	ZINC OXIDE (ZNO)	•This chemical was flagged for further attention by CEPA due to suspected aquatic toxicity and persistence. The chemical was also flagged as a low human health priority.
CTFA International Cosmetic Ingredient Dictionary and Handbook	ZINC OXIDE	•Color Additives - Exempt from Batch Certification by the U.S. Food and Drug Administration
IFRA Fragrance Ingredient List	ZINC OXIDE (ZNO)	•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
National Library of Medicine HazMap	ZINC OXIDE	•PEL (OSHA) - Permissible exposure limit (OSHA): 5 mg/m3(fume and respirable dust), 15 mg/m3(total dust); •STEL (ACGIH) - Short-term exposure limits (ACGIH): 10 mg/m3, respirable fraction; •TLV (ACGIH) - Threshold limit value (ACGIH): 2 mg/m3, respirable fraction ; •IDLH (NIOSH) - Immediately Dangerous to Life or Health: 500 mg/m3; •MAK - Maximum Allowable Concentration (Federal Republic of Germany): 1 mg/m3, respirable fraction(fume);
Nanomaterial Database	NANO-SCALE INGREDIENT	•nano-scale ingredient
Canada PBTs - Accelerated Reduction/Elimination of Toxics (ARET)	ZINC COMPOUNDS	•Persistent toxicant under Canada's Accelerated Reduction/Elimination of Toxics program - targeted for elimination or reduction
EPA Toxic Release Inventory PBTs	ZINC COMPOUNDS	•Toxic, U.S. Environmental Protection Agency Toxics Release Inventory programs
COLIPA, 2003; COLIPA, 1995; Brendler-Schwaab, 2001	MICRONIZED ZINC OXIDE	Clastogenic (and aneugenic) in Chinese hamster cells
Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997	MICRONIZED ZINC OXIDE	Zinc oxide (micronized or ACS grade) is not absorbed by intact or injured skin
Schlicker, 1968	MICRONIZED ZINC OXIDE	No observed adverse effects on reproduction or development in rats at 100mg/kg/day orally, resorption of fetuses at 200 mg/kg/day
Brunner, 2006	MICRONIZED ZINC OXIDE	micronized zinc oxide (188nm effective particle size) found to damage DNA and mitochondria in human (MSTO-211H) and rat (3T3) cells
Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997	ZINC OXIDE	Zinc oxide (micronized or ACS grade) is not absorbed by intact or injured skin
COLIPA, 2003; COLIPA, 1995; Brendler-Schwaab, 2001	MICRONIZED ZINC OXIDE	Clastogenic (and aneugenic) in Chinese hamster cells
Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997	MICRONIZED ZINC OXIDE	Zinc oxide (micronized or ACS grade) is not absorbed by intact or injured skin
Schlicker, 1968	MICRONIZED ZINC OXIDE	No observed adverse effects on reproduction or development in rats at 100mg/kg/day orally, resorption of fetuses at 200 mg/kg/day
FDA (U, 2006	NANO-SCALE INGREDIENTS	Nano scale (<100 nm primary particle size) ingredients may absorb into skin
Cross SE, Innes B, Roberts MS, Tsuzuki T, Robertson TA, McCormick P, 2007	MICRONIZED ZINC OXIDE	In vitro study did not detect penetration of nanoparticulate zinc oxide into lower stratum corneum or viable epidermis
Gojova A, Guo B, Kota RS, Rutledge JC, Kennedy IM, Barakat AI, 2007	ZINC OXIDE (ZNO) NANOPARTICLES	Zinc oxide nanoparticles are cytotoxic when applied directly to cultured human aortic endothelial cells and cause considerable cell death.
SCCNFP (2003)	MICRONIZED ZINC OXIDE	More information is needed to enable a proper safety evaluation of micronised ZnO for use as a UV filter in cosmetic products. An appropriate safety dossier on micronised ZnO itself, including possible skin penetration and systemic including possible path
Adams, L, 2006	NANO-SCALE ZINC OXIDE	Zinc oxide demonstrated increased antibacterial activity increasing with particle concentration
SCCNFP (2003)	MICRONIZED ZINC OXIDE	Outstanding questions on micronized zinc oxide in sunscreens led the SCCP to request a full and complete safety dossier on the ingredient.
SCCNFP (2003)	MICRONZED ZINC OXIDE	Outstanding questions on micronized zinc oxide in sunscreens led the SCCP to request a full and complete safety dossier on the ingredient.
Sayes CM, Reed KL, Warheit DB, 2007	NANO ZINC OXIDE	Nano- and fine-sized zinc oxide produced potent but reversible inflammation of the lungs, which was resolved by 1 month post-instillation exposure.
Gordon T, Fine JM, 1993	ZINC OXIDE	Inhalation causes acute but reversible health effects--fever, intense shaking, chills, fever, and body pain.
Gordon T, Fine JM, 1993	ZINC OXIDE	Zinc inhalation causes metal fume fever, an acute self-limited illness. Zinc oxide is the most common cause.
BorgÃ¥ K, Campbell L, Gabrielsen GW, Norstrom RJ, Muir DC, Fisk AT, 2006	ZINC	Zinc found to be bioaccumulative in Arctic seabirds
Ketcheson MR, Barron GP, Cox DH, 1969	ZINC OXIDE	In oral exposure study, 200 mg/kg ZnO induced a complete fetal resorption (100% prenatal death) in all treated dams
California EPA, Office of Environmental Health Hazard Assessment	ZINC COMPOUNDS	•Respiratory toxicity hazards: suspected
California EPA, Office of Environmental Health Hazard Assessment	ZINC COMPOUNDS	•Immunotoxicity hazards: suspected
RTECS^®- TLV/BEI,2005	NANO ZINC OXIDE (20-60NM)	• occupationally related - ACGIH TLV (human TWA)
RTECS^®- TLV/BEI,2006	NANO ZINC OXIDE (20-60NM)	• occupationally related - ACGIH TLV (human TWA)
RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972	NANO ZINC OXIDE (20-60NM)	• sense organ - Primary eye irritant (rabbit ) • skin - Primary skin irritant (rabbit )
RTECS^®- Cytology and Genetics (English Translation) 1978	NANO ZINC OXIDE (20-60NM)	• mutagenic - Positive mutation assay: Cytogenetic Analysis (rat ihl)
RTECS^®- Gekkan Yakuji 1980	NANO ZINC OXIDE (20-60NM)	• broad systemic - Broad systemic toxicity ( human LDLo)
RTECS^®- Journal of Nutrition 1969	NANO ZINC OXIDE (20-60NM)	• developmental - Growth statistics (rat TDLo) • reproductive - Homeostasis (rat TDLo)
RTECS^®- Mutation Research 1981	NANO ZINC OXIDE (20-60NM)	• mutagenic - Positive mutation assay: DNA Adduct (Escherichia coli )
RTECS^®- Shigaku 1987	NANO ZINC OXIDE (20-60NM)	• mutagenic - Positive mutation assay: Morphological Transform (hamster emb) • mutagenic - Positive mutation assay: Sister Chromatid Exchange (hamster emb) • mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (hamster emb)
RTECS^®- Toxicologist 1997	NANO ZINC OXIDE (20-60NM)	• brain and nervous system - Changes in motor activity (specific assay) (rat TDLo)
RTECS^®- Toxicology and Applied Pharmacology 1985	NANO ZINC OXIDE (20-60NM)	• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (guinea pig ihl)

references

government/industry list/academic study	reference
European Union - Classification & Labelling	CPS&Q (Consumer Products Safety & Quality) formely known as ECB (European Chemicals Bureau). 2008. Classification and Labelling: Chemicals: Annex VI of Directive 67/548/EEC through the 31st ATP.
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.
Association of Occupational and Environmental Clinics	AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
FDA Color Additive Status	FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
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.
CTFA International Cosmetic Ingredient Dictionary and Handbook	CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
IFRA Fragrance Ingredient List	IFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25
National Library of Medicine HazMap	NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
Nanomaterial Database	NanoWerk. 2007. Nanomaterial Database. Available online: http://www.nanowerk.com/phpscripts/n_dbsearch.php
Canada PBTs - Accelerated Reduction/Elimination of Toxics (ARET)	EC (Environment Canada). 1994. Accelerated Reduction/Elimination of Toxics (ARET). ARET substance list of persistent, bioaccumulative and toxic chemicals.
EPA Toxic Release Inventory PBTs	EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
Open scientific literature	{COLIPA, 2003; COLIPA, 1995; Brendler-Schwaab, 2001}
Open scientific literature	{Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997}
Open scientific literature	{Schlicker, 1968}
Open scientific literature	{Brunner, 2006}
Open scientific literature	{Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997}
Open scientific literature	{COLIPA, 2003; COLIPA, 1995; Brendler-Schwaab, 2001}
Open scientific literature	{Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997}
Open scientific literature	{Schlicker, 1968}
Open scientific literature	FDA (U.S. Food and Drug Administration). 2006. FDA Considerations for Regulation of Nanomaterial Containing Products. Presentation by Nakissa Sadrieh, Ph.D., Office of Pharmaceutical Science, CDER, FDA. Available online at http://www.fda.gov/nanotechnology/.
Open scientific literature	Cross SE, Innes B, Roberts MS, Tsuzuki T, Robertson TA, McCormick P. 2007. Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation. Skin Pharmacol Physiol 20(3): 148-154.
Open scientific literature	Gojova A, Guo B, Kota RS, Rutledge JC, Kennedy IM, Barakat AI. 2007. Induction of inflammation in vascular endothelial cells by metal oxide nanoparticles: effect of particle composition. Environ Health Perspect 115(3): 403-409.
Open scientific literature	SCCNFP (2003). "Opinion concerning Zinc Oxide." European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.
Open scientific literature	Adams, L. K., D. Y. Lyon, et al. (2006). "Comparative eco-toxicity of nanoscale TiO2, SiO2, and ZnO water suspensions." Water Research Article in Press.
Open scientific literature	SCCNFP (2003). "Opinion concerning Zinc Oxide." European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.
Open scientific literature	SCCNFP (2003). "Opinion concerning Zinc Oxide." European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.
Open scientific literature	Sayes CM, Reed KL, Warheit DB. 2007. Assessing toxicity of fine and nanoparticles: comparing in vitro measurements to in vivo pulmonary toxicity profiles. Toxicol Sci 97(1): 163-80.
Open scientific literature	Gordon T, Fine JM. 1993. Metal fume fever. Occup Med. Jul-Sep;8(3):504-17. Review.
Open scientific literature	Gordon T, Fine JM. 1993. Metal fume fever. Occup Med. Jul-Sep;8(3):504-17. Review.
Open scientific literature	BorgÃ¥ K, Campbell L, Gabrielsen GW, Norstrom RJ, Muir DC, Fisk AT. 2006. Regional and species specific bioaccumulation of major and trace elements in Arctic seabirds. Environ Toxicol Chem. 2006 Nov;25(11):2927-36.
Open scientific literature	Ketcheson MR, Barron GP, Cox DH. 1969. Relationship of Maternal Dietary Zinc during Gestation and Lactation to Development and Zinc, Iron and Copper Content of the Postnatal Rat. J Nutr 98: 303-311
Scorecard.org Toxicity Information	California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
Scorecard.org Toxicity Information	California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
RTECS^®- TLV/BEI,2005	RTECS^®- TLV/BEI,2005
RTECS^®- TLV/BEI,2006	RTECS^®- TLV/BEI,2006
RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972	RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J.V., Institut Pro Vychovu Vedoucicn Pracovniku Chemickeho Prumyclu Praha, Czechoslovakia, 1972 -,10,1972
RTECS^®- Cytology and Genetics (English Translation) 1978	RTECS^®- Cytology and Genetics (English Translation). Translation of TGANAK. (Allerton Press Inc., 150 Fifth Ave., New York, NY 10011) V.8- 1974- 12(3),46,1978
RTECS^®- Gekkan Yakuji 1980	RTECS^®- Gekkan Yakuji. Pharmaceuticals Monthly. (Yakugyo Jihosha, Inaoka Bldg., 2-36 Jinbo-cho, Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1959- 22,291,1980
RTECS^®- Journal of Nutrition 1969	RTECS^®- Journal of Nutrition. (Subscription Dept., 9650 Rockville Pike, Bethesda, MD 20014) V.1- -1928 98,303,1969
RTECS^®- Mutation Research 1981	RTECS^®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 89,95,1981
RTECS^®- Shigaku 1987	RTECS^®- Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20 Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 1949- 74,1385,1987
RTECS^®- Toxicologist 1997	RTECS^®- Toxicologist. (Soc. of Toxicology, Inc., 475 Wolf Ledge Parkway, Akron, OH 44311) V.1- -1981 36(1,pt2),183,1997
RTECS^®- Toxicology and Applied Pharmacology 1985	RTECS^®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 78,29,1985

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