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FORMALDEHYDE SOLUTION (FORMALIN)

Score:

Data: Limited

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

Cancer

Cancer concern is HIGH

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is MODERATE

Products with this Ingredient

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Cancer

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Concern Reference
Known human carcinogenWorld Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 88;2006
Known human carcinogenNTP Report on Carcinogens, 11th Edition
Possible human carcinogenAmer Conf of Gov't Industrial Hygienists - Carcinogens
Possible human carcinogenEPA (US. Environmental Protection Agency). Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986 guidelines.
Possible human carcinogenCalifornia EPA Proposition 65
Limited evidence of carcinogenicityCPS&Q - Classification & Labelling
Limited evidence of carcinogenicityNIOSH Occupational Carcinogens

Organ system toxicity (non-reproductive)

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Concern Reference
Known human respiratory toxicantEPA Hazardous Air Pollutants
One or more animal studies show classified as toxic effects at low dosesEPA Categorized List of Inert Pesticide Ingredients
Classified as toxic or harmfulCPS&Q - Classification & Labelling
Limited evidence of respiratory toxicityNational Library of Medicine HazMap
Limited evidence of gastrointestinal or liver toxicityAgency for Toxic Substances and Disease Registry Minimal risk Levels for Hazardous Substances. January 2004. http://www.atsdr.cdc.gov/mrls.html, DiPalma, J.A., J. Cunningham, J. Herrera, T. McCaffery, and D. Wolf. Occupational and Industrial Toxin Exposures and the Gastrointestinal Tract. American Journal of Gastroenterology. 86(9): 1107-1117. 1991. (Table 2: Selected Agents with Purported Digestive System Injury)., National Institute for Occupational Safety and Health
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

Use restrictions

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Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsJapan's Standards for Cosmetics
Violation of industry recommendations - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Not safe for use in products intended to be aerosolized, according to industry safety panel (Cosmetic Ingredient Review, CIR)Cosmetic Ingredient Review Assessments
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmeticsCanada - Prohibited and Restricted Cosmetics Ingredients
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualificationsCosmetic Ingredient Review Assessments
Recommendation to minimize use in cosmetics - Keep concentration to minimum: warning from industry safety panelCosmetic Ingredient Review Assessments

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 immune and respiratory toxicant or allergen - strong evidenceAssociation of Occupational and Environmental Clinics
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Limited evidence of immune system toxicity or allergiesCPS&Q - Classification & Labelling
Limited evidence of immune system toxicity or allergiesEuropean Economic Community Sensitizing Substances in the EEC List of Dangerous Substances. Annex I to Council Directive 67/548/EEC. http://www.kemi.se/default_eng.cfm?page=klass_mark/klasshem_eng.htm, A Relational Database of Hazardous Chemicals and Occupational Diseases. Browse Haz-Map by Adverse Effects http://hazmap.nlm.nih.gov/hazmapadv.html, Nordic Council of Ministers (Nordic Allergy Project). Kriteriedokumenter fra nordisk allergiprojekt - vurdering af 50 kemiske stoffers evne til at forarsage allergi, en litteraturgennemgang. Nord 1991:51. Copenhagen, 1991., Swedish National Chemicals Inspectorate. Labelling of chemical products, Swedish regulations and general advice with regard to the classification and labelling of chemical products hazardous to health, flammables and explosives. List of Allergenic Substances. National Chemicals Inspectorate, Solna, Sweden. 1987, 1990-1992.
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Developmental/reproductive toxicity

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Concern Reference
Limited evidence of reproductive toxicityUS EPA Roadmaps to Sources of Information on Chemicals Listed in the Emergency Planning Community and Community Right-to-Know Act (Also Known as SARA Title 3), Section 313 Toxic Release Inventory (for Microcomputers). (Report Number EPADFDK92040). 1991. Data file distributed in 2 diskettes by Office of Pollution, Prevention, and Toxics, Environmental Protection Agency, Washington, DC. NOTE: Datasource no longer being maintained by EPA; not currently available online., Frazier , L. and M. L. Hage (eds.). Reproductive Hazards of the Workplace, Wiley Europe, 1998. Table 10 (Partial List of Reproductive Toxicants) available at http://www.pharmacy.ohio-state.edu/homepage/safety/chemhygiene_table_repro.pdf.

Irritation (skin, eyes, or lungs)

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Concern Reference
Limited evidence of skin irritationNational Library of Medicine HazMap

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

Miscellaneous

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Concern Reference
Occupational hazards related to handlingCPS&Q - Classification & Labelling

Multiple, additive exposure sources

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Concern Reference
Designated as safe for general or specific, limited use in foodFDA Food Additive Status
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 - Not safe for use in products intended to be aerosolized, according to industry safety panel (Cosmetic Ingredient Review, CIR)Cosmetic Ingredient Review Assessments

Data Sources

  • World Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 88;2006
  • NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program.
  • ACGIH (American Conference of Governmental Industrial Hygienists) 2008. ACGIH cancer classification system. www.acgih.org.
  • EPA (US. Environmental Protection Agency). Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986 guidelines.
  • California EPA (California Environmental Protection Agency). 9/2008. Office of Environmental Health Hazard Assessment. Safe Drinking Water and Toxic Enforcement Act of 1986. Chemicals known to the State to cause cancer or reproductive toxicity.
  • 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.
  • NIOSH (National Institute for Occupational Safety and Health). 2006. NIOSH Carcinogens List (Potential occupational carcinogens). http://www.cdc.gov/niosh/npotocca.html.
  • EPA (U.S. Environmental Protection Agency). 2005. Office of Air. The 112(b)1 Hazardous Air Pollutants List (as modified). Last modified: 12 Dec 2005.
  • EPA (U.S. Environmental Protection Agency). 1987 & 2005. Office of Pesticide Programs. Inert (other) Pesticide Ingredients in Pesticide Products - Categorized List of Inert (other) Pesticide Ingredients.
  • NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
  • Agency for Toxic Substances and Disease Registry Minimal risk Levels for Hazardous Substances. January 2004. http://www.atsdr.cdc.gov/mrls.html, DiPalma, J.A., J. Cunningham, J. Herrera, T. McCaffery, and D. Wolf. Occupational and Industrial Toxin Exposures and the Gastrointestinal Tract. American Journal of Gastroenterology. 86(9): 1107-1117. 1991. (Table 2: Selected Agents with Purported Digestive System Injury)., National Institute for Occupational Safety and Health
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • Japan Ministry of Health, Labour and Welfare. 2006. Standards for Cosmetics. Evaluation and Licensing Division. Pharmaceutical and Food Safety Bureau.
  • CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
  • Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
  • AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
  • European Economic Community Sensitizing Substances in the EEC List of Dangerous Substances. Annex I to Council Directive 67/548/EEC. http://www.kemi.se/default_eng.cfm?page=klass_mark/klasshem_eng.htm, A Relational Database of Hazardous Chemicals and Occupational Diseases. Browse Haz-Map by Adverse Effects http://hazmap.nlm.nih.gov/hazmapadv.html, Nordic Council of Ministers (Nordic Allergy Project). Kriteriedokumenter fra nordisk allergiprojekt - vurdering af 50 kemiske stoffers evne til at forarsage allergi, en litteraturgennemgang. Nord 1991:51. Copenhagen, 1991., Swedish National Chemicals Inspectorate. Labelling of chemical products, Swedish regulations and general advice with regard to the classification and labelling of chemical products hazardous to health, flammables and explosives. List of Allergenic Substances. National Chemicals Inspectorate, Solna, Sweden. 1987, 1990-1992.
  • US EPA Roadmaps to Sources of Information on Chemicals Listed in the Emergency Planning Community and Community Right-to-Know Act (Also Known as SARA Title 3), Section 313 Toxic Release Inventory (for Microcomputers). (Report Number EPADFDK92040). 1991. Data file distributed in 2 diskettes by Office of Pollution, Prevention, and Toxics, Environmental Protection Agency, Washington, DC. NOTE: Datasource no longer being maintained by EPA; not currently available online., Frazier , L. and M. L. Hage (eds.). Reproductive Hazards of the Workplace, Wiley Europe, 1998. Table 10 (Partial List of Reproductive Toxicants) available at http://www.pharmacy.ohio-state.edu/homepage/safety/chemhygiene_table_repro.pdf.
  • 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.
  • 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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