ZINC OXIDE

Bulking Agent; Colorant; Skin Protectant; Sunscreen Agent  

SCORE

2

low hazard to moderate hazard depending on product usage

5

 

81%

data gap

(why scores have changed)

Also listed as

FLOWERS OF ZINC; PHILOSOPHER'S WOOL; PIGMENT WHITE 4; CI 77947; LOW TEMPERATURE BURNED ZINC OXIDE; ZINC WHITE; ZINC FLOWERS; ZINC OXIDE (NON-NANO)


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
yes, moderateDevelopmental/reproductive toxicity
noRestrictions & warnings
yes, moderateAllergies/immunotoxicity
noContamination concerns
noOther strong concerns for this ingredient:
Occupational hazards
noOther moderate concerns for this ingredient:
Persistence and bioaccumulation, Organ system toxicity (non-reproductive)
noLesser or emerging concerns for this ingredient:
Neurotoxicity, Ecotoxicology, Irritation (skin, eyes, or lungs)
 
See products containing ZINC OXIDE

About ZINC OXIDE: To identify the colorant allowed for use in the European Union (EU), the INCI Name CI 77947 must be used, except for hair dye products. See "Regulatory and Ingredient Use Information," for Colorants in Volume 1, Introduction, Part A.

ingredient UV blocking strength

Sunscreens: What
common sunscreen
concentrations
UV blocking strength

2.0%


3.0%


20.0%


25.0%


ZINC OXIDE has reported used in the following product types: foundation (553); eye shadow (174); facial powder (152); concealer (123); blush (110); sunscreen: makeup (95); lip liner (93); facial moisturizer/treatment (60); diaper cream (60); bronzer/highlighter (52)


Allergies/immunotoxicity

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

Persistence and bioaccumulation

type of concern product conditions reference
Persistent or bioaccumulative and moderate to high toxicity concern in humans    Environment Canada Domestic Substance List
Persistent, bioaccumulative in wildlife    Canada PBTs - Accelerated Reduction/Elimination of Toxics (ARET)
show more

Occupational hazards

type of concern product conditions reference
Allowed workplace exposures restricted to low doses    RTECS®- TLV/BEI,2007
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 products that may be aerosolized (airborne)  National Library of Medicine HazMap
Allowed workplace exposures restricted to moderate doses    RTECS®- TLV/BEI,2005

Organ system toxicity (non-reproductive)

type of concern product conditions reference
Classified as expected to be toxic or harmful    Environment Canada Domestic Substance List
show more

Developmental/reproductive toxicity

type of concern product conditions reference
Limited evidence of reproductive toxicity    Zhu X, Zhu L, Duan Z, Qi R, Li Y, Lang Y, 2008
show more

Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Toxicology and Applied Pharmacology 1985
show more

Neurotoxicity

type of concern product conditions reference
One or more animal studies show brain, nervous system, or behavioral 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
Suspected to be an environmental toxin and be persistent or bioaccumulative    Environment Canada Domestic Substance List
show more

Decreased skin absorption

type of concern product conditions reference
Limited potential to absorb into the skin.    Gulson B, McCall MJ, Gomez L, Korsch M, Casey P, Kinsley L, 2010

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

Data gaps

type of concern product conditions reference
2,143 studies in PubMed science library may include information on the toxicity of this chemical see search results ->   PubMed

Enhanced skin absorption

type of concern product conditions reference
Does not cause enhanced penetration    SCCNFP, 2003



Government, industry, academic studies and classifications

government/industry list/academic study appears on list as classification(s)
European Union - Classification & LabellingZINC OXIDE•Dangerous for the environment
•Very toxic to aquatic organisms
FDA Food Additive StatusZINC 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 ClinicsZINC• Asthmagen sensitizer
FDA Color Additive StatusZINC OXIDE•Color additive approved by FDA for use in cosmetics
•Color additive approved by FDA for cosmetics used around eyes
FDA Everything Added to FoodZINC OXIDE• Fully up-to-date toxicology information has been sought.
Environment Canada Domestic Substance ListZINC 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 HandbookZINC OXIDE•Color Additives - Exempt from Batch Certification by the U.S. Food and Drug Administration
IFRA Fragrance Ingredient ListZINC OXIDE (ZNO)•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
National Library of Medicine HazMapZINC 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);
EPA Toxic Release Inventory PBTsZINC COMPOUNDS•Toxic, U.S. Environmental Protection Agency Toxics Release Inventory programs
Gordon T, Fine JM, 1993ZINC OXIDEZinc inhalation causes metal fume fever, an acute self-limited illness. Zinc oxide is the most common cause.
Ketcheson MR, Barron GP, Cox DH, 1969ZINC OXIDEIn oral exposure study, 200 mg/kg ZnO induced a complete fetal resorption (100% prenatal death) in all treated dams
Adams, L, 2006ZINC OXIDE
Borgå K, Campbell L, Gabrielsen GW, Norstrom RJ, Muir DC, Fisk AT, 2006ZINCZinc found to be bioaccumulative in Arctic seabirds
Sayes CM, Reed KL, Warheit DB, 2007ZINC OXIDENano- and fine-sized zinc oxide produced potent but reversible inflammation of the lungs, which was resolved by 1 month post-instillation exposure.
Zhu X, Zhu L, Duan Z, Qi R, Li Y, Lang Y, 2008
European_Chemicals_Bureau, 2004ZINC OXIDE (NON-NANO)
SCCNFP, 2003ZINC OXIDE (NON-NANO)Bulk size zinc oxide does not appear to penetrate healthy or psoriatic skin, results of in-vitro and in-vivo studies indicate absorbance of <1%
Gulson B, McCall MJ, Gomez L, Korsch M, Casey P, Kinsley L, 2010ZINC OXIDE (NON-NANO)Human study showed about 0.4% of zinc oxide penetrated to bloodstream
California EPA, Office of Environmental Health Hazard AssessmentZINC COMPOUNDS•Respiratory toxicity hazards: suspected
California EPA, Office of Environmental Health Hazard AssessmentZINC COMPOUNDS•Immunotoxicity hazards: suspected
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
RTECS®- TLV/BEI,2005ZINC OXIDE• occupationally related - ACGIH TLV (human TWA)
RTECS®- TLV/BEI,2006ZINC OXIDE• occupationally related - ACGIH TLV (human TWA)
RTECS®- TLV/BEI,2007ZINC OXIDE• occupationally related - ACGIH TLV (human TWA)
RTECS®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972ZINC OXIDE• sense organ - Primary eye irritant (rabbit )
• skin - Primary skin irritant (rabbit )
RTECS®- Cytology and Genetics (English Translation) 1978ZINC OXIDE• mutagenic - Positive mutation assay: Cytogenetic Analysis (rat ihl)
RTECS®- Cytology and Genetics (English Translation) 1978ZINC OXIDE• mutagenic - Positive mutation assay: Cytogenetic Analysis (rat ihl)
RTECS®- Gekkan Yakuji 1980ZINC OXIDE• broad systemic - Broad systemic toxicity ( human LDLo)
RTECS®- Mutation Research 2008ZINC OXIDE• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human oth)
RTECS®- Mutation Research 1981ZINC OXIDE• mutagenic - Positive mutation assay: DNA Adduct (Escherichia coli )
RTECS®- Mutation Research 1981ZINC OXIDE• mutagenic - Positive mutation assay: DNA Adduct (Escherichia coli )
RTECS®- Shigaku 1987ZINC OXIDE• 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®- Shigaku 1987ZINC OXIDE• 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 1997ZINC OXIDE• brain, nervous system, or behavioral effect - Changes in motor activity (specific assay) (rat TDLo)
RTECS®- Toxicology and Applied Pharmacology 1985ZINC OXIDE• mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (guinea pig ihl)

references

government/industry list/academic study reference
European Union - Classification & LabellingCPS&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 StatusFDA (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 ClinicsAOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
FDA Color Additive StatusFDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
FDA Everything Added to FoodFDA (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 ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
CTFA International Cosmetic Ingredient Dictionary and HandbookCTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
IFRA Fragrance Ingredient ListIFRA (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 HazMapNLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
EPA Toxic Release Inventory PBTsEPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
Open scientific literatureGordon T, Fine JM. 1993. Metal fume fever. Occup Med. Jul-Sep;8(3):504-17. Review.
Open scientific literatureKetcheson 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
Open scientific literatureAdams, 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 literatureBorgå 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 literatureSayes 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 literatureZhu X, Zhu L, Duan Z, Qi R, Li Y, Lang Y. 2008. Comparative toxicity of several metal oxide nanoparticle aqueous suspensions to Zebrafish (Danio rerio) early developmental stage. J Environ Sci Health A Tox Hazard Subst Environ Eng 43(3): 278-84.
Open scientific literatureEuropean_Chemicals_Bureau. 2004. ZINC OXIDE Part II – Human Health, CAS No: 1314-13-2, EINECS No: 215-222-5; Summary Risk Assessment Report Addendum to the Part II (Human Health) I-21020 Ispra (VA) Italy.
Open scientific literatureSCCNFP. 2003. Opinion concerning Zinc Oxide: European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. Available: http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm
Open scientific literatureGulson B, McCall MJ, Gomez L, Korsch M, Casey P, Kinsley L. 2010. Dermal absorption of ZnO particles from sunscreens applied to humans at the beach. realizebeauty.files.wordpress.com/2010/02/iconn2010-abstract-gulson1.pdf
Scorecard.org Toxicity InformationCalifornia EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
Scorecard.org Toxicity InformationCalifornia EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
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.
RTECS®- TLV/BEI,2005RTECS®- TLV/BEI,2005
RTECS®- TLV/BEI,2006RTECS®- TLV/BEI,2006
RTECS®- TLV/BEI,2007RTECS®- TLV/BEI,2007
RTECS®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972RTECS®- "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) 1978RTECS®- 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®- Cytology and Genetics (English Translation) 1978RTECS®- Cytology and Genetics (English Translation). Translation of TGANAK. (Allerton Press Inc., 150 Fifth Ave., New York, NY 10011) V.8- 12(3),46,1978
RTECS®- Gekkan Yakuji 1980RTECS®- 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®- Mutation Research 2008RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 650,39,2008
RTECS®- Mutation Research 1981RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 89,95,1981
RTECS®- Mutation Research 1981RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 89,95,1981
RTECS®- Shigaku 1987RTECS®- Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20 Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 74,1385,1987
RTECS®- Shigaku 1987RTECS®- Shigaku. Ondotology. (Nippon Shika Daigaku Shigakkai, 1-9-20 Fujimi, Chiyodaku, Tokyo 102, Japan) V.38- 1949- 74,1385,1987
RTECS®- Toxicologist 1997RTECS®- 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 1985RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 78,29,1985

"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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