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ISOBUTYLPARABEN


image source: PubChem
Health Concerns of the Ingredient:
Overall Hazard
 
 
Cancer
 
 
 
 
Other HIGH concerns: Endocrine disruption; Other MODERATE concerns: Biochemical or cellular level changes; Other LOW concerns: Data gaps

About ISOBUTYLPARABEN: Isobutylparaben is in the parabens family of preservatives used by the food, pharmaceutical, and personal care product industries. Parabens mimic estrogen, are potential hormone (endocrine) system dis ... read more

Function(s): Preservative

Synonym(s): 2-METHYLPROPYL ESTER 4-HYDROXYBENZOIC ACID; 2-METHYLPROPYL ESTER BENZOIC ACID, 4-HYDROXY-; 4-HYDROXY- 2-METHYLPROPYL ESTER BENZOIC ACID; 4-HYDROXYBENZOIC ACID, 2-METHYLPROPYL ESTER; BENZOIC ACID, 4-HYDROXY-, 2-METHYLPROPYL ESTER; BENZOIC ACID, 4HYDROXY, 2METHYLPROPYL ESTER; ISOBUTYL 4-HYDROXYBENZOATE; ISOBUTYL ESTER PARAHYDROXYBENZOIC ACID; ISOBUTYL P-HYDROXYBENZOATE; ISOBUTYL PARAHYDROXYBENZOATE; PARAHYDROXYBENZOIC ACID, ISOBUTYL ESTER

Allergies/immunotoxicity

Concern Reference
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
One or more human case studies show possible immune or allergenic effectsHarvell, J

Endocrine disruption

Concern Reference
Human endocrine disruptor - strong evidenceEuropean Commission on Endocrine Disruption
Limited evidence of endocrine disruption
One or more studies show significant wildlife and the environment disruptionEuropean Commission on Endocrine Disruption
One or more animal studies show endocrine disruption at moderate dosesDarbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ
One or more studies show weak endocrine disruptionByford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD
One or more studies show weak endocrine disruptionRoutledge EJ, Parker J, Odum J, Ashby J, Sumpter JP, 1998
One or more animal studies show endocrine disruption at high dosesVo TT, Jeung EB

Use restrictions

Concern Reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Scientific Committee on Consumer Safety (SCCS) OPINION ON Parabens, COLIPA n P82
Determined safe for use in cosmetics, subject to concentration or use limitations - Cosmetic Ingredient Review Assessments
Determined safe for use in cosmetics, subject to concentration or use limitations - Scientific Committee on Consumer Safety SCCS)

Developmental/reproductive toxicity

Concern Reference
One or more animal studies show effects at very low dosesOishi S

Biochemical or cellular level changes

Concern Reference
Interferes with gene expresionPugazhendhi D, Sadler AJ, Darbre PD, 2007

Data gaps

Concern 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 productCosmetic Ingredient Review Assessments
Safety assessment was based on related chemicalCosmetic Ingredient Review Assessments
27 studies in PubMed science library may include information on the toxicity of this chemical see search results ->NLM PubMed

Ecotoxicology

Concern Reference
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Multiple, additive exposure sources

Concern Reference
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Organ system toxicity (non-reproductive)

Concern Reference
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Persistence and bioaccumulation

Concern Reference
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Data Sources

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.
CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
Calafat AM, Ye X, Wong LY, Bishop AM, Needham LL. 2010. Urinary concentrations of four parabens in the U.S. population: NHANES 2005-2006. Environ Health Perspect 118(5): 679-85.
Darbre PD, Aljarrah A, Miller WR, Coldham NG, Sauer MJ, Pope GS. 2004. Concentrations of parabens in human breast tumours. J Appl Toxicol 24(1): 5-13.
Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ. 2002. Oestrogenic activity of isobutylparaben in vitro and in vivo. J Appl Toxicol 22(4): 219-26.
Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ. 2002. Oestrogenic activity of isobutylparaben in vitro and in vivo. J Appl Toxicol 22(4): 219-26.
EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
EU (European Union)- Community Strategy for Endocrine Disrupters 2007. Commission on endocrine disruption requested by the European Parliament in 1998. SEC (2007) 1635.
EU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998.
European Commission. 2013. Cosing, the European Commission database with information on cosmetic substances and ingredients. Accessed on March 1, 2013 at http://ec.europa.eu/consumers/cosmetics/cosing/ .
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.
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).
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
NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
Oishi S., 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9.
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.
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.
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS SCCP Extended Opinion on the Safety Evaluation of Parabens Adopted by the SCCP by written procedure on 28 January 2005
Scientific Committee on Consumer Safety (SCCS) OPINION ON Parabens, COLIPA n P82. December 2010. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf
Scientific Committee on Consumer Safety SCCS). 2011. Clarification on Opinion SCCS/1348/10 in the light of the Danish clause of safeguard banning the use of parabens in cosmetic products intended for children under three years of age. October 2011. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_069.pdf
Vo TT, Jeung EB. 2009. An evaluation of estrogenic activity of parabens using uterine calbindin-d9k gene in an immature rat model. Toxicol Sci 112(1): 68-77.
Vo TT, Yoo YM, Choi KC, Jeung EB. 2010. Potential estrogenic effect(s) of parabens at the prepubertal stage of a postnatal female rat model. Reprod Toxicol 29(3): 306-16.

About the ratings

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer