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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: 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 | 86 products |
| concealer | 16 products |
| eye liner | 15 products |
| facial powder | 12 products |
| brow liner | 12 products |
| bronzer/highlighter | 11 products |
| blush | 7 products |
| lip liner | 6 products |
| beach & sport sunscreen | 5 products |
| mascara | 5 products |
| moisturizer | 4 products |
| eye shadow | 4 products |
| facial cleanser | 4 products |
| moisturizer with SPF | 4 products |
| serums & essences | 4 products |
| styling gel/lotion | 3 products |
| makeup remover | 3 products |
| body wash/cleanser | 3 products |
| other eye makeup | 3 products |
| facial moisturizer/treatment | 3 products |
| anti-aging | 2 products |
| makeup primer | 2 products |
| hair styling aide | 2 products |
| around-eye cream | 1 products |
| fragrance for women | 1 products |
| mask | 1 products |
| after shave | 1 products |
| eye makeup remover | 1 products |
| foot cleansing | 1 products |
| shaving cream | 1 products |
| hair treatment/serum | 1 products |
| lip balm with SPF | 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.
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