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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 concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is MODERATE

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is MODERATE

Products with this Ingredient

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foundation82 products
brow liner12 products
concealer12 products
facial powder12 products
bronzer/highlighter11 products
eye liner11 products
blush7 products
lip liner6 products
mascara5 products
beach & sport sunscreen5 products
moisturizer with SPF4 products
serums & essences4 products
facial cleanser4 products
moisturizer4 products
facial moisturizer/treatment3 products
body wash/cleanser3 products
other eye makeup3 products
styling gel/lotion3 products
makeup primer2 products
hair styling aide2 products
anti-aging2 products
makeup remover2 products
foot cleansing1 products
shaving cream1 products
hair treatment/serum1 products
lip balm with SPF1 products
eye shadow1 products
mask1 products
around-eye cream1 products
fragrance for women1 products

Endocrine disruption

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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 evidenceEuropean 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 disruptionEuropean Commission on Endocrine Disruption
One or more studies show weak endocrine disruptionByford 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

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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

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Concern Reference
Human skin toxicant or allergen - strong evidenceentered 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

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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 - anyCosmetic 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

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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

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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 productIJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report)
Safety assessment was based on related chemicalIJT 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 chemicalNLM PubMed

Ecotoxicology

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

Multiple, additive exposure sources

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

Informational

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Concern Reference
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - anyIJT 27(S4): 1-82, 2008 JACT 3(5):147-209, 1984 (original report)

Organ system toxicity (non-reproductive)

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

Persistence and bioaccumulation

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

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