BUTYLPARABEN

Fragrance Ingredient; Preservative; MASKING  

Also listed as

BENZOIC ACID, 4-HYDROXY-, BUTYL ESTER; BUTYL 4-HYDROXYBENZOATE; BUTYL P-HYDROXYBENZOATE; BUTYL P-HYDROXY BENZOATE; BUTYL PARAHYDROXYBENZOATE; PARAHYDROXYBENZOATE ESTER; BUTYL ESTER BENZOIC ACID, 4-HYDROXY-; 4-HYDROXY- BUTYL ESTER BENZOIC ACID; BENZOIC ACID, 4HYDROXY, BUTYL ESTER; P-HYDROXYBENZOIC ACID, BUTYL ESTER; ASEPTOFORM BUTYL


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
noViolations, restrictions & warnings
yes, moderateAllergies/immunotoxicity
noContamination concerns
noOther moderate concerns for this ingredient:
Endocrine disruption, Organ system toxicity (non-reproductive), Biochemical or cellular level changes
noLesser or emerging concerns for this ingredient:
Irritation (skin, eyes, or lungs), Data gaps
 
See products containing BUTYLPARABEN

About BUTYLPARABEN: Butylparaben is the ester of butyl alcohol and p-hydroxybenzoic acid. It conforms to theformula:

BUTYLPARABEN has reported used in the following product types: facial moisturizer/treatment (323); eye shadow (267); foundation (224); anti-aging (208); lipstick (157); sunscreen: makeup (156); moisturizer (143); mascara (136); sunscreen: moisturizer (123); blush (112)


Allergies/immunotoxicity

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

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
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Developmental/reproductive toxicity

type of concern product conditions reference
One or more animal studies show effects at very low doses    Oishi S, 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®- Mutation Research 2008

Biochemical or cellular level changes

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

Organ system toxicity (non-reproductive)

type of concern product conditions reference
Limited evidence of sense organ toxicity    Harvell, J, 1994
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Irritation (skin, eyes, or lungs)

type of concern product conditions reference
One or more animal studies show skin irritation at moderate doses    RTECS®- Journal of the Society of Cosmetic Chemists 1977

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be persistent     Environmental Canada Domestic Substance List
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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
99 studies in PubMed science library may include information on the toxicity of this chemical see search results ->   PubMed

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

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)
Cosmetic Ingredient Review AssessmentsBUTYLPARABEN•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 FoodBUTYL P-HYDROXYBENZOATE• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance ListBENZOIC ACID, 4-HYDROXY-, BUTYL ESTER•This chemical was NOT flagged by CEPA for further attention.
European Commission on Endocrine DisruptionN-BUTYL 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.
IFRA Fragrance Ingredient ListBENZOIC ACID, 4-HYDROXY-, BUTYL ESTER•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
Oishi S, 2002BUTYLPARABENA dose-dependent decrease of both round and elongated spermatid counts in stages VII-VIII seminiferous tubules was observed, and the elongated spermatid counts were significantly lower in all of the treated groups.
Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP, 1998BUTYLPARABENButylparaben produced a positive uterotrophic response in vivo, approximately 100,000 times less potent than 17 beta-estradiol.
Pugazhendhi D, Sadler AJ, Darbre PD, 2007BUTYLPARABENThe 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, 2002PARABENS•Hormonally active (parabens)
Harvell, J, 1994PARABENS•Skin or sense organ toxicity hazards: suspected
RTECS®- Archives of Toxicology 2002BUTYLPARABEN• reproductive - Spermatogenesis (mouse TDLo)
• reproductive - Testes, epididymis, sperm duct (mouse TDLo)
• endocrine system - Other changes (mouse TDLo)
RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition 1956BUTYLPARABEN• metabolic - Weight loss or decreased weight gain (rat TDLo)
RTECS®- Journal of the Society of Cosmetic Chemists 1977BUTYLPARABEN• sense organ - Lacrimation (mouse LD50)
• skin - Primary skin irritant (guinea pig )
RTECS®- Journal of the Society of Cosmetic Chemists 1977BUTYLPARABEN• skin - Primary skin irritant (guinea pig )
RTECS®- Mutation Research 2008BUTYLPARABEN• 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®- Nippon Eiseigaku Zasshi 1973BUTYLPARABEN• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS®- Toxicology and Applied Pharmacology 1998BUTYLPARABEN• endocrine system - Changes in uterine weight (rat TDLo)

references

government/industry list/academic study reference
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.
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
Open scientific literatureOishi S., 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9.
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.
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.
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).
RTECS®- Archives of Toxicology 2002RTECS®- Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.32- 1974- 76,423,2002
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®- Journal of the Society of Cosmetic Chemists 1977RTECS®- Journal of the Society of Cosmetic Chemists. (Soc. of Cosmetic Chemists, 1995 Broadway, Suite 1701, New York, NY 10023) V.1- 1947- 28,357,1977
RTECS®- Journal of the Society of Cosmetic Chemists 1977RTECS®- Journal of the Society of Cosmetic Chemists. (Soc. of Cosmetic Chemists, 1995 Broadway, Suite 1701, New York, NY 10023) V.1- 28,357,1977
RTECS®- Mutation Research 2008RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 649,114,2008
RTECS®- Nippon Eiseigaku Zasshi 1973RTECS®- 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
RTECS®- Toxicology and Applied Pharmacology 1998RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 153,12,1998

"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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