PROPYLPARABEN
Fragrance Ingredient; Preservative; PERFUMING
Also listed as
BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER; 4-HYDROXYBENZOIC ACID, PROPYL ESTER; PROPYL P-HYDROXYBENZOATE; PROPYL PARAHYDROXYBENZOATE; PROPYL ESTER BENZOIC ACID, 4-HYDROXY-; PROPYL ESTER 4-HYDROXYBENZOIC ACID; 4-HYDROXY- PROPYL ESTER BENZOIC ACID; BENZOIC ACID, 4HYDROXY, PROPYL ESTER; PROPYL 4-HYDROXYBENZOATE; ASEPTOFORM P; BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER
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: Endocrine disruption, Organ system toxicity (non-reproductive) |
| Lesser or emerging concerns for this ingredient: Ecotoxicology, Data gaps |
|
See products containing PROPYLPARABEN | |
About PROPYLPARABEN: Propylparaben is the ester of n-propyl alcohol and p-hydroxybenzoic acid. It conforms to theformula:
PROPYLPARABEN has reported used in the following product types: facial moisturizer/treatment (832); foundation (829); lipstick (637); eye shadow (529); moisturizer (519); mascara (499); anti-aging (494); sunscreen: makeup (410); lip gloss (361); facial cleanser (292)
Endocrine disruption
| type of concern | product conditions | reference |
| Human disruptor - strong evidence | European Commission on Endocrine Disruption | |
| One or more studies show significant wildlife and the environment disruption | European Commission on Endocrine Disruption | |
| show more | ||
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 | |
| show more | ||
Cancer
| type of concern | product conditions | reference |
| One or more in vitro tests on mammalian cells show positive mutation results | RTECS®- Mutation Research 2008 |
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| Limited evidence of sense organ toxicity | Harvell, J, 1994 | |
| show more | ||
Ecotoxicology
| type of concern | product conditions | reference |
| Wildlife and environmental toxicity | Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006 | |
| show more | ||
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 | |
| 272 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 | |
| show more | ||
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 |
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 |
| FDA Everything Added to Food | PROPYL P-HYDROXYBENZOATE | • Fully up-to-date toxicology information has been sought. |
| Cosmetics Industry Review | PROPYLPARABEN | •Skin sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin |
| Inui, 2003 | PROPYL PARABEN | Increased VTG concerntration, mRNA expression of VTG-1, VTG-2, CHG-L, CHG-H and ERa in male medaka |
| 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. |
| Harvell, J, 1994 | PARABENS | •Skin or sense organ toxicity hazards: suspected |
| European Commission on Endocrine Disruption | N-PROPYL P-HYDROXYBENZOATE | •Evidence of endocrine disrupting activity in at least one species using intact animals, high human health concern. •Evidence of endocrine disrupting activity in at least one species using intact animals, high human concern. |
| Environmental Canada Domestic Substance List | BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER | •This chemical was NOT flagged by CEPA for further attention. |
| IFRA Fragrance Ingredient List | PROPYL P-HYDROXYBENZOATE | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| Byford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD, 2002 | PARABENS | •Hormonally active (parabens) |
| RTECS®- Archives Internationales de Pharmacodynamie et de Therapie 1960 | PROPYLPARABEN | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- Food and Chemical Toxicology 2002 | PROPYLPARABEN | • reproductive - Testes, epididymis, sperm duct (rat TDLo) • metabolic - Weight loss or decreased weight gain (rat TDLo) • endocrine system - Androgenic (rat TDLo) |
| RTECS®- Mutation Research 2008 | PROPYLPARABEN | • mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster ovr) • mutagenic - Positive mutation assay: DNA Damage (hamster ovr) • mutagenic - Positive mutation assay: Sister Chromatid Exchange (hamster ovr) |
| RTECS®- National Technical Information Service | PROPYLPARABEN | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie 1929 | PROPYLPARABEN | • broad systemic - Broad systemic toxicity (rabbit LDLo) |
| RTECS®- Nippon Eiseigaku Zasshi 1973 | PROPYLPARABEN | • broad systemic - Broad systemic toxicity (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. |
| 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. |
| EWG Assessment of Open Scientific Literature | Cosmetics Industry Review |
| Open scientific literature | {Inui, 2003} |
| 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. |
| 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). |
| European Commission on Endocrine Disruption | EU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998. |
| Environmental Canada Domestic Substance List | EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry. |
| 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 |
| 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. |
| RTECS®- Archives Internationales de Pharmacodynamie et de Therapie 1960 | RTECS®- Archives Internationales de Pharmacodynamie et de Therapie. (Heymans Institute of Pharmacology, De Pintelaan 185, B-9000 Ghent, Belgium) V.4- 1898- 128,135,1960 |
| RTECS®- Food and Chemical Toxicology 2002 | RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 40,1807,2002 |
| RTECS®- Mutation Research 2008 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 649,114,2008 |
| RTECS®- National Technical Information Service | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. AD691-490 |
| RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie 1929 | RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie. (Berlin, Ger.) V.110-253, 1925-66. For publisher information, see NSAPCC. 146,208,1929 |
| RTECS®- Nippon Eiseigaku Zasshi 1973 | RTECS®- Nippon Eiseigaku Zasshi. Japanese Journal of Hygiene. (Nippon Eisei Gakkai, c/o Kyoto Daigaku Igakubu, Konoe-cho, Yoshida, Sakyo-ku, Kyoto 606, Japan) V.1- 1946- 28,463,1973 |
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