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ISOBUTYLPARABEN

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Endocrine disruption (moderate), and Biochemical or cellular level changes (moderate)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW_MODERATE

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is MODERATE

Products with this Ingredient

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eye liner10 products
beach & sport sunscreen7 products
blush3 products
moisturizer with SPF3 products
brow liner1 products
makeup remover1 products
makeup primer1 products
serums & essences1 products
moisturizer1 products
exfoliant/scrub1 products
around-eye cream1 products
bronzer/highlighter1 products

Use restrictions

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Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsEuropean Union - Banned or Restricted in Cosmetics
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - anyScientific 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
Determined safe for use in cosmetics, subject to concentration or use limitations - anyScientific 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

Endocrine disruption

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Concern Reference
Human endocrine disruptor - strong evidenceEuropean Commission on Endocrine Disruption
Limited evidence of endocrine disruptionSCIENTIFIC 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 animal studies show endocrine disruption at moderate dosesDarbre 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.
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.
One or more studies show weak endocrine disruptionRoutledge 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.
One or more animal studies show endocrine disruption at high dosesVo 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.

Allergies/immunotoxicity

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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, 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).

Biochemical or cellular level changes

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Concern Reference
Interferes with gene expresionPugazhendhi 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.

Developmental/reproductive toxicity

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Concern Reference
One or more animal studies show any effects at very low dosesOishi S, 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9.

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 productCosmetic Ingredient Review Assessments
Safety assessment was based on related chemicalCosmetic Ingredient Review Assessments
29 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 - anyCosmetic Ingredient Review Assessments

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

  • EC (European Commission of the European Union). 1999-2006. Enterprise Directorate-General Pharmaceuticals and Cosmetics. The rules governing cosmetic products in the European Union, Volume 1, "Cosmetics legislation."
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • Oishi S, 2002. "Effects of butyl paraben on the male reproductive system in mice," Arch Toxicol. 2002 Jul;76(7):423-9.
  • 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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