Menu
BUTYLPARABEN
Score:
Data: Fair
- Other Concerns
- Functions
- About the Chemical
- Synonyms
-
Use restrictions (moderate), Endocrine disruption (high), and Biochemical or cellular level changes (moderate)
Cancer 
Cancer: Ingredients linked to cancer in government, industry or academic studies or assessments.
Developmental & Reproductive Toxicity
Developmental and reproductive toxicity: Ingredients linked to developmental and reproductive toxicity, a broad class of health effects that range from infertility and reproductive organ cancers to birth defects and developmental delays in children.
Allergies & Immunotoxicity
Allergies and immunotoxicity: Ingredients linked to harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissue in the body.
Products with this Ingredient
| foundation | 89 products |
| eye liner | 28 products |
| concealer | 22 products |
| facial powder | 17 products |
| brow liner | 14 products |
| bronzer/highlighter | 11 products |
| blush | 9 products |
| moisturizer with SPF | 8 products |
| lip liner | 7 products |
| eye shadow | 6 products |
| mascara | 6 products |
| moisturizer | 5 products |
| beach & sport sunscreen | 5 products |
| styling gel/lotion | 4 products |
| makeup remover | 4 products |
| serums & essences | 4 products |
| facial cleanser | 4 products |
| facial moisturizer/treatment | 4 products |
| hair styling aide | 4 products |
| body wash/cleanser | 3 products |
| makeup primer | 3 products |
| other eye makeup | 3 products |
| anti-aging | 2 products |
| around-eye cream | 1 products |
| fragrance for women | 1 products |
| exfoliant/scrub | 1 products |
| mask | 1 products |
| foot cleansing | 1 products |
| shaving cream | 1 products |
| body firming lotion | 1 products |
| hair relaxer | 1 products |
| hair treatment/serum | 1 products |
| lip balm with SPF | 1 products |
| eye makeup remover | 1 products |
| lip gloss | 1 products |
| after shave | 1 products |
Endocrine disruption
| Concern | Reference |
|---|---|
| The European Chemicals Agency classifies butylparaben as a substance of very high concern due to endocrine disrupting properties and associated effects on male fertility. | European Chemicals Agency (ECHA) 2020. Substance of very high concern (SVHC). |
| Human endocrine disruptor - strong evidence | European Commission on Endocrine Disruption |
| The European Commission SCCP reports this substances causes endocrine effects in animals. | 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 |
| One or more studies show significant wildlife and the environment disruption | European Commission on Endocrine Disruption |
| One or more studies show weak endocrine disruption | 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. |
| Butylparaben produced a positive uterotrophic response in vivo, approximately 100,000 times less potent than 17 beta-estradiol. | 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. |
Developmental/reproductive toxicity
| Concern | Reference |
|---|---|
| The European Chemicals Agency classifies butylparaben as a substance of very high concern due to endocrine disrupting properties and associated effects on male fertility. | European Chemicals Agency (ECHA) 2020. Substance of very high concern (SVHC). |
| A 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. | Oishi S, 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9. |
| 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. | Oishi S, 2002 "Effects of propyl paraben on the male reproductive system." Food Chem Toxicol. 2002 Dec;40(12):1807-13. |
Allergies/immunotoxicity
| Concern | Reference |
|---|---|
| Human skin toxicant or allergen - strong evidence | entered by Kristan from CIR review |
| Parabens listed as one of the agents capable of causing contact urticaria by immunological pathogenetic mechanism. | 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). |
Use restrictions
| Concern | Reference |
|---|---|
| Restricted in EU cosmetics (concentration limit 0.19% for butyl and propyl parabens) | 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 |
| Determined safe for use in cosmetics, subject to concentration or use limitations - any | Cosmetic Ingredient Review Assessments |
| Safe except for diaper ointments used on very young children. | 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 |
Biochemical or cellular level changes
| Concern | Reference |
|---|---|
| The study identified genes which are upregulated or downregulated to a similar extent by methylparaben, n-butylparaben and 17beta-oestradiol. | 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. |
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 product | IJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report) |
| Safety assessment was based on related chemical | IJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report) |
| 308 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Ecotoxicology
| Concern | Reference |
|---|---|
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
Multiple, additive exposure sources
| Concern | Reference |
|---|---|
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any | IJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report) |
Organ system toxicity (non-reproductive)
| Concern | Reference |
|---|---|
| Classified as not expected to be potentially toxic or harmful | Environment Canada Domestic Substance List |
Persistence and bioaccumulation
| Concern | Reference |
|---|---|
| Not suspected to be persistent | Environment Canada Domestic Substance List |
| Not suspected to be bioaccumulative | Environment Canada Domestic Substance List |
Data Sources
- European Chemicals Agency (ECHA) 2020. Substance of very high concern (SVHC).
- EU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998.
- 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
- 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.
- 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.
- Oishi S, 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9.
- Oishi S, 2002 "Effects of propyl paraben on the male reproductive system." Food Chem Toxicol. 2002 Dec;40(12):1807-13.
- entered by Kristan from CIR review
- 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).
- 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
- CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
- 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
- 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.
- IJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report)
- NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
- EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
- 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.
ABOUT THE SKIN DEEP® 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
ABOUT EWG VERIFIED™
Beyond providing Skin Deep® as an educational tool for consumers, EWG offers its EWG VERIFIED™ mark as a quick and easily identifiable way of conveying personal care products that meet EWG's strict health criteria. Before a company can use EWG VERIFIED™ on such products, the company must show that it fully discloses the products' ingredients on their labels or packaging, they do not contain EWG ingredients of concern, and are made with good manufacturing practices, among other criteria. Note that EWG receives licensing fees from all EWG VERIFIED™ member companies that help to support the important work we do. Learn more | Legal Disclaimer
