SODIUM METHYLPARABEN || Skin Deep: Cosmetic Safety Reviews

SODIUM METHYLPARABEN

Preservative

SCORE

	8	high hazard
	65%	data gap
(why scores have changed)

Also listed as

BENZOIC ACID, 4-HYDROXY-, METHYL ESTER, SODIUM SALT; METHYLPARABEN, SODIUM SALT; SODIUM 4-CARBOMETHOXYPHENOLATE; SODIUM P-METHOXYCARBONYLPHENOXIDE; SODIUM METHYL P-HYDROXYBENZOATE; SODIUM SALT BENZOIC ACID, 4-HYDROXY-, METHYL ESTER; SODIUM SALT METHYLPARABEN; METHYL ESTER SODIUM SALT BENZOIC ACID, 4-HYDROXY-; BENZOIC ACID, 4HYDROXY, METHYL ESTER, SODIUM SALT; SODIUM 4- (METHOXYCARBONYL) PHENOLATE; BONOMOLD OMNA

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: Organ system toxicity (non-reproductive)
	Other moderate concerns for this ingredient: Biochemical or cellular level changes
	Lesser or emerging concerns for this ingredient: Neurotoxicity, Endocrine disruption, Data gaps
	See products containing SODIUM METHYLPARABEN

About SODIUM METHYLPARABEN: Sodium Methylparaben is the sodium salt of Methylparaben (q.v.) that conforms to theformula:

SODIUM METHYLPARABEN has reported used in the following product types: shampoo (51); facial moisturizer/treatment (21); anti-aging (17); conditioner (12); hair color and bleaching (8); mask (8); body wash/cleanser (6); sunscreen: moisturizer (6); dandruff/scalp treatment (5); facial cleanser (5)

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

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

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

Biochemical or cellular level changes

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

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
92 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

Persistence and bioaccumulation

type of concern

product conditions

reference

Not suspected to be persistent

Environmental Canada Domestic Substance List

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

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 Status	METHYLPARABEN	• 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 Assessments	METHYLPARABEN	•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
Environmental Canada Domestic Substance List	BENZOIC ACID, 4-HYDROXY-, METHYL ESTER, SODIUM SALT	•This chemical was NOT flagged by CEPA for further attention.
EU Banned and Restricted Fragrances	SODIUM METHYLPARABEN	Prohibited. Should not be used as a fragrance ingredient. Based on the depigmenting effect (pc to IFRA).
Nagel JE, Fuscaldo JT, Fireman P, 1977	METHYLPARABEN	•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, 1998	METHYLPARABEN	Methylparaben produced a positive uterotrophic response in vivo, approximately 100,000 times less potent than 17 beta-estradiol.
Pugazhendhi D, Sadler AJ, Darbre PD, 2007	METHYLPARABEN	The study identified genes which are upregulated or downregulated to a similar extent by methylparaben, n-butylparaben and 17beta-oestradiol.
Byford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD, 2002	PARABENS	•Hormonally active (parabens)
Harvell, J, 1994	PARABENS	•Skin or sense organ toxicity hazards: suspected
RTECS^®- Food and Chemical Toxicology 2002	SODIUM METHYLPARABEN	• brain and nervous system - Ataxia (mouse LD50) • broad systemic - Broad systemic toxicity (mouse LD50) • brain and nervous system - Flaccid paralysis with appropriate anesthesia (mouse TDLo)
RTECS^®- Journal of the American Pharmaceutical Association, Scientific Edition 1956	SODIUM METHYLPARABEN	• brain and nervous system - Ataxia (mouse LD50) • broad systemic - Broad systemic toxicity (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)

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.
Environmental Canada Domestic Substance List	EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
EU Banned and Restricted Fragrances	SCCPNFP (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 Literature	Nagel JE, Fuscaldo JT, Fireman P. Paraben allergy. JAMA. 1977, Apr 11; 237(15):1594-5.
Open scientific literature	Routledge 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 literature	Pugazhendhi 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.
EWG Assessment of Open Scientific Literature	Byford 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.
Scorecard.org Toxicity Information	Harvell, 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).
RTECS^®- Food and Chemical Toxicology 2002	RTECS^®- 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 1956	RTECS^®- Journal of the American Pharmaceutical Association, Scientific Edition. (Washington, DC) V.29-49, 1940-60. For publisher information, see JPMSAE. 45,260,1956

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