SODIUM PROPYLPARABEN || Skin Deep: Cosmetic Safety Reviews

SODIUM PROPYLPARABEN

Preservative

SCORE

	4	moderate hazard
	79%	data gap
(why scores have changed)

Also listed as

BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER, SODIUM SALT; 4-HYDROXYBENZOIC ACID, PROPYL ESTER, SODIUM SALT; PROPYL P-HYDROXYBENZOATE SODIUM SALT; PROPYLPARABEN, SODIUM SALT; SODIUM SALT BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER; SODIUM SALT 4-HYDROXYBENZOIC ACID, PROPYL ESTER; SODIUM SALT PROPYLPARABEN; PROPYL ESTER SODIUM SALT BENZOIC ACID, 4-HYDROXY-; PROPYL ESTER SODIUM SALT 4-HYDROXYBENZOIC ACID; BENZOIC ACID, 4HYDROXY, PROPYL ESTER, SODIUM SALT; SODIUM 4-PROPOXYCARBONYLPHENOXIDE

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 moderate concerns for this ingredient: Organ system toxicity (non-reproductive)
	Lesser or emerging concerns for this ingredient: Neurotoxicity, Endocrine disruption, Ecotoxicology, Data gaps
	See products containing SODIUM PROPYLPARABEN

About SODIUM PROPYLPARABEN: Sodium Propylparaben is the sodium salt of Propylparaben (q.v.).

SODIUM PROPYLPARABEN has reported used in the following product types: brow liner (2); personal cleansing (1); moisturizer (1); liquid hand soap (1); sunless tanning (1); shampoo (1); anti-aging (1); no match (1); mascara (1); sunscreen: SPF greater than 30 (1)

Allergies/immunotoxicity

type of concern	product conditions	reference
Human skin toxicant - strong evidence		Cosmetics Industry Review

Developmental/reproductive toxicity

type of concern	product conditions	reference
One or more animal studies show effects at low doses		Oishi S, 2002

Neurotoxicity

type of concern	product conditions	reference
One or more animal studies show brain and nervous system effects at moderate doses		RTECS^®- Journal of the American Pharmaceutical Association, Scientific Edition 1956

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

Organ system toxicity (non-reproductive)

type of concern

product conditions

reference

One or more animal studies show broad systemic effects at low doses

RTECS^®- Journal of the American Pharmaceutical Association, Scientific Edition 1956

Ecotoxicology

type of concern

product conditions

reference

Wildlife and environmental toxicity

Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006

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
69 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

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
FDA Food Additive Status	PROPYLPARABEN	• Food additive: chemical preservative • 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 - CFR184.1670 • less than 0.1% • refers to part number under Title 21 Code of Federal Regulations 150 • 150.141; 150.161) • Art Sw Jelly and Preserves • Food additive: food additive for which a petition has been filed and a regulation issued • 0.025% • In mastitis formulations - CFR526.820 • Food additive: food additive for which a petition has been filed and a regulation issued • ZERO - In milk from dairy animals - CFR556.550
Cosmetic Ingredient Review Assessments	PROPYLPARABEN	•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-, PROPYL ESTER, SODIUM SALT	•This chemical was NOT flagged by CEPA for further attention.
Cosmetics Industry Review	PROPYLPARABEN	•Skin sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin
IFRA Fragrance Ingredient List	SODIUM 4 - PROPOXYCARBONYLPHENOXIDE	•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP, 1998	PROPYLPARABEN	Propylparaben produced a positive uterotrophic response in vivo, approximately 100,000 times less potent than 17 beta-estradiol.
Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006	PROPYLPARABEN	Results suggest an antiestrogenic potential of propylparaben tested in vivo in juvenile zebrafish (Danio rerio).
Oishi S, 2002	PROPYLPARABEN	The cauda epididymal sperm reserves and concentrations decreased in a dose-dependent manner and the difference was significant at dose of 0.10% and above.
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^®- Journal of the American Pharmaceutical Association, Scientific Edition 1956	SODIUM PROPYLPARABEN	• broad systemic - Broad systemic toxicity (mouse LD50) • brain and nervous system - Changes in motor activity (specific assay) (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.
EWG Assessment of Open Scientific Literature	Cosmetics Industry Review
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
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	Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006. "Evaluation of xenoestrogenic potential of propylparaben in zebrafish (Danio rerio)." Neuro Endocrinol Lett. 2006 Dec;27 Suppl 2:104-7.
Open scientific literature	Oishi S, 2002. "Effects of propyl paraben on the male reproductive system." Food Chem Toxicol. 2002 Dec;40(12):1807-13.
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^®- 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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