METHYLPARABEN

Fragrance Ingredient; Preservative  

Also listed as

BENZOIC ACID, 4-HYDROXY-, METHYL ESTER; P-CARBOMRYHOXYPHENOL; 4-HYDROXYBENZOIC ACID, METHYL ESTER; P-METHOXYCARBONYLPHENOL; METHYL 4-HYDROXYBENZOATE; METHYL P-HYDROXYBENZOATE; METHYL PARAHYDROXYBENZOATE; METHYL ESTER BENZOIC ACID, 4-HYDROXY-; METHYL ESTER 4-HYDROXYBENZOIC ACID; 4-HYDROXY- METHYL ESTER BENZOIC ACID; METHYLPARABE


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
noDevelopmental/reproductive toxicity
yes, strongViolations, restrictions & warnings
yes, moderateAllergies/immunotoxicity
noContamination concerns
noOther strong concerns for this ingredient:
Organ system toxicity (non-reproductive)
noOther moderate concerns for this ingredient:
Irritation (skin, eyes, or lungs), Biochemical or cellular level changes
noLesser or emerging concerns for this ingredient:
Neurotoxicity, Endocrine disruption, Data gaps
 
See products containing METHYLPARABEN
See ingredients that may have METHYLPARABEN as an impurity

See products that may have METHYLPARABEN as an impurity

About METHYLPARABEN: Methylparaben is the ester of methyl alcohol and p-hydroxybenzoic acid. It conforms to theformula:

METHYLPARABEN has reported used in the following product types: facial moisturizer/treatment (2299); moisturizer (1828); anti-aging (1436); foundation (1322); mascara (1016); hair color and bleaching (1015); eye shadow (1011); facial cleanser (1010); conditioner (824); sunscreen: SPF 15-30 (724)


Violations, restrictions & warnings

type of concern product conditions reference
Violation of government restrictions - Banned or found unsafe for use in cosmetics   EU Banned and Restricted Fragrances

Allergies/immunotoxicity

type of concern product conditions reference
Human skin toxicant - strong evidence    Nagel JE, Fuscaldo JT, Fireman P, 1977

Organ system toxicity (non-reproductive)

type of concern product conditions reference
Known human toxicant    EU Banned and Restricted Fragrances
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Neurotoxicity

type of concern product conditions reference
One or more animal studies show brain and nervous system effects at moderate doses    RTECS®- Food and Chemical Toxicology 2002
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Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Food and Chemical Toxicology 2002
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Endocrine disruption

type of concern product conditions reference
One or more studies show weak endocrine disruption    Byford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD, 2002
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Biochemical or cellular level changes

type of concern product conditions reference
Interferes with gene expresion    Pugazhendhi D, Sadler AJ, Darbre PD, 2007

Irritation (skin, eyes, or lungs)

type of concern product conditions reference
One or more animal studies show skin irritation at low doses    RTECS®- Food and Chemical Toxicology 2002
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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
176 studies on toxicity in PubMed see search results ->   PubMed

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be persistent     Environmental Canada Domestic Substance List
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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

Ecotoxicology

type of concern product conditions reference
Not suspected to be an environmental toxin     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 StatusMETHYLPARABEN• Food additive: chemical preservative
• GRAS/ Food additive: permitted as optional ingredient in a standardized food - CFR184.1490
• less than 0.1% by weight - refers to part number under Title 21 Code of Federal Regulations 150
• Art Sw Jelly (150.141) and Preserves (150.161)
• Food additive: food additive for which a petition has been filed and a regulation issued
• ZERO - Res in milk from dairy cows treated with mastitis formulations -556.390
• Use and Info - CFR526.820
Cosmetic Ingredient Review AssessmentsMETHYLPARABEN•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 FoodMETHYL P-HYDROXYBENZOATE• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance ListBENZOIC ACID, 4-HYDROXY-, METHYL ESTER•This chemical was NOT flagged by CEPA for further attention.
European Commission on Endocrine DisruptionMETHYL P-HYDROXYBENZOATEHH-CAT1;WF-CAT3b
EU Banned and Restricted FragrancesSODIUM METHYLPARABENProhibited. Should not be used as a fragrance ingredient. Based on the depigmenting effect (pc to IFRA).
Nagel JE, Fuscaldo JT, Fireman P, 1977METHYLPARABEN•Skin sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin
Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP, 1998METHYLPARABENMethylparaben produced a positive uterotrophic response in vivo, approximately 100,000 times less potent than 17 beta-estradiol.
Pugazhendhi D, Sadler AJ, Darbre PD, 2007METHYLPARABENThe study identified genes which are upregulated or downregulated to a similar extent by methylparaben, n-butylparaben and 17beta-oestradiol.
Harvell, J, 1994PARABENS•Skin or sense organ toxicity hazards: suspected
Byford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD, 2002PARABENS•Hormonally active (parabens)
RTECS®- Eisei Shikenjo Hokoku 1978METHYLPARABEN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Eisei Shikenjo Hokoku 1978METHYLPARABEN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- FAO Nutrition Meetings Report Series 1974METHYLPARABEN• broad systemic - Broad systemic toxicity (guinea pig LD50)
RTECS®- Food and Chemical Toxicology 2002METHYLPARABEN• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse orl)
• skin - Primary skin irritant (rabbit )
RTECS®- Food and Chemical Toxicology 2002METHYLPARABEN• metabolic - Weight loss or decreased weight gain (rat TDLo)
• brain and nervous system - Ataxia (mouse TDLo)
• broad systemic - Broad systemic toxicity (mouse LD50)
• blood - Other changes (rat TDLo)
• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse orl)
• skin - Primary irritation (guinea pig TDLo)
• skin - Primary skin irritant (rabbit )
• respiratory - Respiratory depression (mouse TDLo)
• cardiovascular - Shock (mouse TDLo)
• respiratory - Tumors (mouse TDLo)
RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition 1956METHYLPARABEN• brain and nervous system - Ataxia (mouse LD50)
• brain and nervous system - Flaccid paralysis without anesthesia (usually neuromuscular blockage) (mouse LD50)
• brain and nervous system - Somnolence (general depressed activity) (mouse LD50)
RTECS®- Mutation Research 1979METHYLPARABEN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Mutation Research 1979METHYLPARABEN• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)

references

government/industry list/academic study reference
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.
Cosmetic Ingredient Review AssessmentsCIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
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.
Environmental Canada Domestic Substance ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
European Commission on Endocrine DisruptionEU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998.
EU Banned and Restricted FragrancesSCCPNFP (Scientific Committee On Cosmetic Products And Non-Food Products). 1999. Opinion Concerning Fragrance Allergy In Consumers. . SCCNFP/0017/98 Final, December 1999; and SCCPNFP (Scientific Committee On Cosmetic Products And Non-Food Products). 2000. An Initial List Of Perfumery Materials Which Must Not Form Part Of Fragrances Compounds Used In Cosmetic Products. SCCNFP/0320/00, final May 2000.
EWG Assessment of Open Scientific LiteratureNagel JE, Fuscaldo JT, Fireman P. Paraben allergy. JAMA. 1977, Apr 11; 237(15):1594-5.
Open scientific literatureRoutledge EJ, Parker J, Odum J, Ashby J, Sumpter JP, 1998. "Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic.," Toxicol Appl Pharmacol. 1998 Nov;153(1):12-9.
Open scientific literaturePugazhendhi D, Sadler AJ, Darbre PD, 2007. "Comparison of the global gene expression profiles produced by methylparaben, n-butylparaben and 17beta-oestradiol in MCF7 human breast cancer cells," J Appl Toxicol. 2007 Jan-Feb;27(1):67-77.
Scorecard.org Toxicity InformationHarvell, J., M. Bason and H. Maibach. Contact Urticaria and its Mechanisms. Food Chemistry and Toxicology 32(2): 103-112. 1994. (Table 2: Substances identified as capable of causing contact urticaria).
EWG Assessment of Open Scientific LiteratureByford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD. Oestrogenic activity of parabens in MCF7 human breast cancer cells. J Steroid Biochem Mol Biol. 2002 Jan;80(1):49-60.
RTECS®- Eisei Shikenjo Hokoku 1978RTECS®- Eisei Shikenjo Hokoku. Bulletin of the Institute of Hygienic Sciences. (Kokuritsu Eisei Shikenjo Kagaku, 18-1 Bushitsu Johobu, Setagaya-ku, Tokyo 158, Japan) V.1- 1886- (96),55,1978
RTECS®- Eisei Shikenjo Hokoku 1978RTECS®- Eisei Shikenjo Hokoku. Bulletin of the Institute of Hygienic Sciences. (Kokuritsu Eisei Shikenjo Kagaku, 18-1 Bushitsu Johobu, Setagaya-ku, Tokyo 158, Japan) V.1- (96),55,1978
RTECS®- FAO Nutrition Meetings Report Series 1974RTECS®- FAO Nutrition Meetings Report Series. (Rome, Italy) No.?-57, 1948-77. Discontinued. 53A,81,1974
RTECS®- Food and Chemical Toxicology 2002RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 40,1335,2002
RTECS®- Food and Chemical Toxicology 2002RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 40,1335,2002
RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition 1956RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition. (Washington, DC) V.29-49, 1940-60. For publisher information, see JPMSAE. 45,260,1956
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 66,277,1979
RTECS®- Mutation Research 1979RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 66,277,1979

"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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