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ISOPROPYLPARABEN
Score:
Data: Fair
- Other Concerns
- Functions
- About the Chemical
- Synonyms
-
Use restrictions (high), Endocrine disruption (high), and Ecotoxicology (low)
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
| eye liner | 5 products |
| recreational sunscreen | 3 products |
| daily use with SPF | 2 products |
| styling gel/lotion | 1 products |
| conditioner | 1 products |
| body oil | 1 products |
| eye shadow | 1 products |
| makeup primer | 1 products |
| hair treatment/serum | 1 products |
Use restrictions
| Concern | Reference |
|---|---|
| Violation of government restrictions - Banned or found unsafe for use in cosmetics | European Union - Banned or Restricted in Cosmetics |
| 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 |
Endocrine disruption
| Concern | Reference |
|---|---|
| The European Chemicals Agency classifies a closely related chemical 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 |
| A review article reports parabens cause endocrine disruption in animals. | Boberg J, Taxvig C, Christiansen S, Hass U Possible endocrine disrupting effects of parabens and their metabolites. Reprod Toxicol. 2010 Sep;30(2):301-12. Epub 2010 Apr 8. |
| 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. |
| Propylparaben 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. |
| In a rat study, isopropylparaben increased the uterine weight and changed the expression of estrogen and progesterone receptors, thus exhibiting estrogen-like properties in vivo. | 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. |
Allergies/immunotoxicity
| Concern | Reference |
|---|---|
| Human skin toxicant or allergen - strong evidence | Cosmetic Ingredient Review Assessments |
| A review article reports propylparaben causes allergies in people. | Soni MG, Burdock GA, Taylor SL, Greenberg NA Safety assessment of propyl paraben: a review of the published literature. Food Chem Toxicol. 2001 Jun;39(6):513-32. |
| A review article reports parabens cause skin allergies. | 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). |
| 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). |
Developmental/reproductive toxicity
| Concern | Reference |
|---|---|
| The European Chemicals Agency classifies a closely related chemical 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). |
| 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. |
Ecotoxicology
| Concern | Reference |
|---|---|
| Results suggest an antiestrogenic potential of propylparaben tested in vivo in juvenile zebrafish (Danio rerio). | Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006 "Evaluation of xenoestrogenic potential of propylparaben in zebrafish (Danio rerio)." Neuro Endocrinol Lett. 2006 Dec;27 Suppl 2:104-7. |
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
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 | Cosmetic Ingredient Review Assessments |
| Safety assessment was based on related chemical | Cosmetic Ingredient Review Assessments |
| 16 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Multiple, additive exposure sources
| Concern | Reference |
|---|---|
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
| Designated as safe for general or specific, limited use in food | FDA Food Additive Status |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any | Cosmetic Ingredient Review Assessments |
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
- 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
- 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
- Boberg J, Taxvig C, Christiansen S, Hass U Possible endocrine disrupting effects of parabens and their metabolites. Reprod Toxicol. 2010 Sep;30(2):301-12. Epub 2010 Apr 8.
- 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.
- Soni MG, Burdock GA, Taylor SL, Greenberg NA Safety assessment of propyl paraben: a review of the published literature. Food Chem Toxicol. 2001 Jun;39(6):513-32.
- 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).
- 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).
- Oishi S, 2002 "Effects of propyl paraben on the male reproductive system." Food Chem Toxicol. 2002 Dec;40(12):1807-13.
- Mikula P, Dobsikova R, Svobodova Z, Jarkovsky J, 2006 "Evaluation of xenoestrogenic potential of propylparaben in zebrafish (Danio rerio)." Neuro Endocrinol Lett. 2006 Dec;27 Suppl 2:104-7.
- EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
- NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
- 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.
- FDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.
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