ISOBUTYLPARABEN || Skin Deep: Cosmetic Safety Reviews

ISOBUTYLPARABEN

Preservative

SCORE

	3	moderate hazard
	81%	data gap
(why scores have changed)

Also listed as

BENZOIC ACID, 4-HYDROXY-, 2-METHYLPROPYL ESTER; 4-HYDROXYBENZOIC ACID, 2-METHYLPROPYL ESTER; ISOBUTYL P-HYDROXYBENZOATE; ISOBUTYL PARAHYDROXYBENZOATE; PARAHYDROXYBENZOIC ACID, ISOBUTYL ESTER; 2-METHYLPROPYL ESTER BENZOIC ACID, 4-HYDROXY-; 2-METHYLPROPYL ESTER 4-HYDROXYBENZOIC ACID; ISOBUTYL ESTER PARAHYDROXYBENZOIC ACID; 4-HYDROXY- 2-METHYLPROPYL ESTER BENZOIC ACID; SODIUM ISOBUTYLPARABEN; BENZOIC ACID, 4HYDROXY, 2METHYLPROPYL 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
	Restrictions & warnings
	Allergies/immunotoxicity
	Contamination concerns
	Lesser or emerging concerns for this ingredient: Endocrine disruption, Organ system toxicity (non-reproductive), Data gaps
	See products containing ISOBUTYLPARABEN

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 disruptors, and were found in the breast cancer tumors of 19 of 20 women studied (Darbre 2004). The Centers for Disease Control and Prevention (CDC) tested urine from a group of 2,548 Americans over the age of 6 and found parabens in over 99% of samples (Calafat 2010). Isobutylparaben is closely rela ... read more

ISOBUTYLPARABEN has reported used in the following product types: facial moisturizer/treatment (212); anti-aging (158); foundation (123); eye shadow (111); moisturizer (99); lipstick (96); hair color and bleaching (87); mascara (85); lip gloss (76); around-eye cream (70)

Allergies/immunotoxicity

type of concern

product conditions

reference

Human skin toxicant - strong evidence

Cosmetic Ingredient Review Assessments

Endocrine disruption

type of concern

product conditions

reference

One or more animal studies show endocrine disruption at moderate doses

Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ, 2002

Organ system toxicity (non-reproductive)

type of concern

product conditions

reference

One or more animal studies show broad systemic effects at high doses (low dose studies may be unavailable for this ingredient)

RTECS^®- Archives Internationales de Pharmacodynamie et de Therapie 1960

Data gaps

type of concern	product conditions	reference
Safety assessment was based on related chemical		Cosmetic Ingredient Review Assessments
10 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 bioaccumulative

Environment Canada Domestic Substance List

Ecotoxicology

type of concern	product conditions	reference
Not suspected to be an environmental toxin		Environment Canada Domestic Substance List

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
Cosmetic Ingredient Review Assessments	ISOBUTYLPARABEN	•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR) •Determined safe for use in cosmetics based on concentrations of surrogate, related chemical in cosmetics, by industry safety panel (Cosmetic Ingredient Review, CIR) • •Safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) is based on safety or product use data for a different, related ingredient •Sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin
Environment Canada Domestic Substance List	BENZOIC ACID, 4-HYDROXY-, 2-METHYLPROPYL ESTER	•This chemical was NOT flagged by CEPA for further attention.
Vo TT, Jeung EB, 2009	ISOBUTYLPARABEN	In a rat study, isobutylparaben increased the uterine weight and changed the expression of estrogen and progesterone receptors, thus exhibiting estrogen-like properties in vivo.
Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ, 2002	ISOBUTYLPARABEN	Isobutylparaben exhibited more potent estrogenic activity compared to butylparaben. In a mouse study, isobutylparaben at moderate doses of exposure caused an increase in uterine weight.
Calafat AM, Ye X, Wong LY, Bishop AM, Needham LL, 2010	ISOBUTYLPARABEN
Darbre PD, Aljarrah A, Miller WR, Coldham NG, Sauer MJ, Pope GS, 2004	ISOBUTYLPARABEN
Darbre PD, Byford JR, Shaw LE, Horton RA, Pope GS, Sauer MJ, 2002	ISOBUTYLPARABEN
EU (European Union)- Community Strategy for Endocrine Disrupters 2007	ISOBUTYLPARABEN
Vo TT, Yoo YM, Choi KC, Jeung EB, 2010	ISOBUTYLPARABEN
Byford JR, Shaw LE, Drew MG, Pope GS, Sauer MJ, Darbre PD, 2002	PARABENS	•Hormonally active (parabens)
Harvell, J, 1994	PARABENS	Parabens listed as one of the agents capable of causing contact urticaria by immunological pathogenetic mechanism.
RTECS^®- Archives Internationales de Pharmacodynamie et de Therapie 1960	ISOBUTYLPARABEN	• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS^®- JAT, Journal of Applied Toxicology 2002	ISOBUTYLPARABEN	• endocrine system - Changes in uterine weight (mouse TDLo) • endocrine system - Estrogenic (mouse TDLo)
RTECS^®- Journal of Applied Toxicology (John Wiley & Sons, Ltd 2003	ISOBUTYLPARABEN	• endocrine system - Changes in uterine weight (mouse TDLo)

references

government/industry list/academic study	reference
Cosmetic Ingredient Review Assessments	CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
Environment Canada Domestic Substance List	EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
Open scientific literature	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.
Open scientific literature	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.
Open scientific literature	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.
Open scientific literature	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.
Open scientific literature	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.
Open scientific literature	EU (European Union)- Community Strategy for Endocrine Disrupters 2007. Commission on endocrine disruption requested by the European Parliament in 1998. SEC (2007) 1635.
Open scientific literature	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.
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.
Open scientific literature	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^®- 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^®- JAT, Journal of Applied Toxicology 2002	RTECS^®- JAT, Journal of Applied Toxicology. (John Wiley & Sons Ltd., Baffins Lane, Chichester, W. Sussex PO19 1UD, UK) V.1- 1981- 22,219,2002
RTECS^®- Journal of Applied Toxicology (John Wiley & Sons, Ltd 2003	RTECS^®- Journal of Applied Toxicology (John Wiley & Sons, Ltd., Oldlands Way Bognor Regis West Sussex, PO22 9SA England) V.1- 1981- 23,285,2003

"RTECS®" is a United States trademark owned and licensed under authority of the U.S. Government, by and through MDL Information Systems, Inc.