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QUATERNIUM-15 (FORMALDEHYDE RELEASER)

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (moderate), Non-reproductive organ system toxicity (moderate), Irritation (skin, eyes, or lungs) (moderate), and Contamination concerns (high)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is HIGH

Products with this Ingredient

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eye liner3 products
body wash/cleanser1 products
makeup remover1 products

Contamination concerns

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Chemical
FORMALDEHYDE

Allergies/immunotoxicity

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Concern Reference
Known human any toxicant or allergenAOEC (Association of Occupational and Environmental Clinics) 2012. Asthmagen compilation - AEOC exposures codes.
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Irritation (skin, eyes, or lungs)

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Concern Reference
Possible human eye, skin irritantScientific Committee on Consumer Safety (SCCS) OPINION ON Quaternium-15 (cis-isomer), COLIPA n° P63 December 2011.

Use restrictions

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Concern Reference
Recommended restricted in cosmetics - use, concentration, or manufacturing restrictions - anyScientific Committee on Consumer Safety (SCCS) OPINION ON Quaternium-15 (cis-isomer), COLIPA n° P63 December 2011.
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualificationsCosmetic Ingredient Review Assessments

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as expected to be toxic or harmfulEnvironment Canada Domestic Substance List
Classified as medium human health priorityEnvironment Canada Domestic Substance List
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)EPA Toxic Release Inventory PBTs

Cancer

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Concern Reference
Cancer - limited evidenceIARC (International Agency for Research on Cancer) 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99.

Developmental/reproductive toxicity

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Concern Reference
One or more animal studies show any effects at moderate dosesVanessa E Melin, Haritha Potineni, Patricia Hunt, Jodi Griswold, Bill Siems, Stephen R. Werre & Terry C. Hrubec. 2014. Exposure to common quaternary ammonium disinfectants decreases fertility in mice. Reproductive toxicology (Elmsford, N.Y.) 50, 163-70

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
94 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

Informational

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Concern Reference
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Determined safe for use in cosmetics up to a specified concentration limitJACT 5(3):61-101, 1986 (original report); IJT 29(Suppl 2):98-114, 2010; IJT 36(Suppl 2):14-58, 2017

Persistence and bioaccumulation

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Concern Reference
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Data Sources

  • AOEC (Association of Occupational and Environmental Clinics) 2012. Asthmagen compilation - AEOC exposures codes.
  • CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
  • NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
  • Scientific Committee on Consumer Safety (SCCS) OPINION ON Quaternium-15 (cis-isomer), COLIPA n° P63 December 2011.
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • IARC (International Agency for Research on Cancer) 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99.
  • Vanessa E Melin, Haritha Potineni, Patricia Hunt, Jodi Griswold, Bill Siems, Stephen R. Werre & Terry C. Hrubec. 2014. Exposure to common quaternary ammonium disinfectants decreases fertility in mice. Reproductive toxicology (Elmsford, N.Y.) 50, 163-70
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • JACT 5(3):61-101, 1986 (original report); IJT 29(Suppl 2):98-114, 2010; IJT 36(Suppl 2):14-58, 2017

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