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PHENONIP

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (moderate), Endocrine disruption (low), Non-reproductive organ system toxicity (low), Ecotoxicology (low), Irritation (skin, eyes, or lungs) (high), Occupational hazards (high), 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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Irritation (skin, eyes, or lungs)

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Concern Reference
Classified as irritantCPS&Q - Classification & Labelling

Occupational hazards

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Concern Reference
Allowed workplace exposures restricted to low dosesCPS&Q - Classification & Labelling

Allergies/immunotoxicity

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Concern Reference
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Human skin toxicant or allergen - strong evidenceCosmetics Ingredient Review

Use restrictions

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Concern Reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in cosmetics (concentration limit)Japan's Standards for Cosmetics
Determined safe for use in cosmetics, subject to concentration or use limitations - anyCosmetic Ingredient Review Assessments

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.

Developmental/reproductive toxicity

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Concern Reference
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.
Limited evidence of developmental toxicityChapin, RE. and R.A. Sloane. NIEHS/NTP Reproductive Assessment by Continuous Breeding: Evolving Study Design and Summaries of Ninety Studies. Environmental Health Perspectives 105, Supplement 1: 199-394. 1997. http://ehpnet1.niehs.nih.gov/docs/1997/Suppl-1/chapin.html

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as toxic or harmfulCPS&Q - Classification & Labelling
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List
Classified as a low human health priorityEnvironment Canada Domestic Substance List

Endocrine disruption

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Concern Reference
Isobutylparaben exhibited more potent estrogenic activity compared to butylparaben. In a mouse study, isobutylparaben at moderate doses of exposure caused an increase in uterine weight. 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.
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.
In a rat study, isobutylparaben 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.

Ecotoxicology

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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 toxinEnvironment Canada Domestic Substance List

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)
3 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

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)

Multiple, additive exposure sources

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Concern Reference
Designated as safe for general or specific, limited use in foodFDA Food Additive Status

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

  • CPS&Q (Consumer Products Safety & Quality) formely known as ECB (European Chemicals Bureau). 2008. Classification and Labelling: Chemicals: Annex VI of Directive 67/548/EEC through the 31st ATP.
  • CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
  • Cosmetics Ingredient Review
  • Japan Ministry of Health, Labour and Welfare. 2006. Standards for Cosmetics. Evaluation and Licensing Division. Pharmaceutical and Food Safety Bureau.
  • 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.
  • Oishi S, 2002 "Effects of propyl paraben on the male reproductive system." Food Chem Toxicol. 2002 Dec;40(12):1807-13.
  • Chapin, RE. and R.A. Sloane. NIEHS/NTP Reproductive Assessment by Continuous Breeding: Evolving Study Design and Summaries of Ninety Studies. Environmental Health Perspectives 105, Supplement 1: 199-394. 1997. http://ehpnet1.niehs.nih.gov/docs/1997/Suppl-1/chapin.html
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

About this Ingredient's Score Range

  • This ingredient’s score is higher if used in products intended for use around mouth due to increased risk of ingestion and absorption.
  • This ingredient’s score is higher if used in products intended for use on lips due to increased risk of ingestion and absorption.

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