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FORMALDEHYDE SOLUTION (FORMALIN)

Health Concerns of the Ingredient:
Overall Hazard
 
 
 
 
 
 
Other HIGH concerns: Organ system toxicity (non-reproductive), Occupational hazards; Other LOW concerns: Data gaps, Irritation (skin, eyes, or lungs)

About FORMALDEHYDE SOLUTION (FORMALIN): Formalin is a solution of water, formaldehyde, and methanol.

Synoym(s): METHYLENE GLYCOL

Cancer

Concern Reference
Known human carcinogenInt'l Agency for Research on Cancer (IARC) - Carcinogens
Known human carcinogenNTP Report on Carcinogens, 11th Edition
Possible human carcinogenAmer Conf of Gov't Industrial Hygienists - Carcinogens
Possible human carcinogenEPA Integrated Risk Information System (IRIS)
Possible human carcinogenCalifornia EPA Proposition 65
Limited evidence of carcinogenicityEuropean Union - Classification & Labelling
Limited evidence of carcinogenicityNIOSH Occupational Carcinogens

Use restrictions

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) (only for products that may be aerosolized (airborne))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

Allergies/immunotoxicity

Concern Reference
Human immune and respiratory toxicant or allergen - strong evidence (only for )Association of Occupational and Environmental Clinics
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Limited evidence of immune system toxicity or allergies (only for products for use on skin)European Union - Classification & Labelling
Limited evidence of immune system toxicity or allergiesEuropean Economic Community
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Organ system toxicity (non-reproductive)

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 harmful (only for products for use on skin; products for use around the mouth; products for use on the lips; products that may be aerosolized (airborne))European Union - Classification & Labelling
Limited evidence of respiratory toxicityNational Library of Medicine HazMap
Limited evidence of gastrointestinal or liver toxicityAgency for Toxic Substances and Disease Registry
Limited evidence of respiratory toxicityAgency for Toxic Substances and Disease Registry
Limited evidence of sense organ toxicityEuropean Economic Community
Limited evidence of sense organ toxicityUS EPA, Air Risk Information Support Center
Limited evidence of kidney toxicityMerck & Co
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

Developmental/reproductive toxicity

Concern Reference
Limited evidence of reproductive toxicityUS EPA
Limited evidence of developmental toxicityNational Toxicology Program Center for the Evaluation of Risks to Human Reproduction

Occupational hazards

Concern Reference
Allowed workplace exposures restricted to low dosesEuropean Union - Classification & Labelling

Irritation (skin, eyes, or lungs)

Concern Reference
Limited evidence of skin irritationNational Library of Medicine HazMap

Multiple, additive exposure sources

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

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 productCosmetic Ingredient Review Assessments
16 studies in PubMed science library may include information on the toxicity of this chemical see search results ->NLM PubMed

Miscellaneous

Concern Reference
Occupational hazards related to handlingEuropean Union - Classification & Labelling

Data Sources

ACGIH (American Conference of Governmental Industrial Hygienists) 2008. ACGIH cancer classification system. www.acgih.org.
AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
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
Agency for Toxic Substances and Disease Registry. Minimal risk Levels for Hazardous Substances. January 2004. http://www.atsdr.cdc.gov/mrls.html, US EPA, Air Risk Information Support Center. Health Effects Notebook for Hazardous Air Pollutants. http://www.epa.gov/ttnatw01/hlthef/hapindex.html, A Relational Database of Hazardous Chemicals and Occupational Diseases. Browse Haz-Map by Adverse Effects http://hazmap.nlm.nih.gov/hazmapadv.html, California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
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.
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.
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.
EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
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). 2008. Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986-2005 guidelines.
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.
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, US EPA, Air Risk Information Support Center. Health Effects Notebook for Hazardous Air Pollutants. http://www.epa.gov/ttnatw01/hlthef/hapindex.html, 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)., A Relational Database of Hazardous Chemicals and Occupational Diseases. Browse Haz-Map by Adverse Effects http://hazmap.nlm.nih.gov/hazmapadv.html, Klaassen, C., M. Amdur and J. Doull (eds.). Casarett and Doull's Toxicology. The Basic Science of Poisons, 5th Ed. Pergamon Press, NY. 1996., LaDou, J. (ed.). Occupational Medicine. Appleton & Lange, Norwalk, CN. 1990., California EPA, Office of Environmental Health Hazard Assessment. Acute Reference Exposure Levels (RELs), Averaging Times, and Toxicologic Endpoints. Includes all Acute Reference Exposure Levels (ARELs) developed by OEHHA through May 2000http://www.oehha.org/air/acute_rels/allAcRELs.html, California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document 'Determination of Noncancer Chronic Reference Exposure Levels'. Includes all Chronic Reference Exposure Levels (CRELs) adopted by OEHHA as of August 2003 (http://www.oehha.ca.gov/air/chronic_rels/AllChrels.html, plus draft CRELS proposed through March 2004 (http://www.oehha.ca.gov/air/chronic_rels/index.html., National Institute for Occupational Safety and Health's Registry of Toxic Effects of Chemical Substances. See Environmental Defense's Suspect Hazard Identification documentation.
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.
Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
IARC (International Agency for Research on Cancer). 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99 (a total of 935 agents, mixtures and exposures).
Japan Ministry of Health, Labour and Welfare. 2006. Standards for Cosmetics. Evaluation and Licensing Division. Pharmaceutical and Food Safety Bureau.
Merck & Co. The Merck Manual of Diagnosis and Therapy. TABLE 226-1. Common Nephrotoxic Agents http://www.merck.com/pubs/mmanual/tables/226tb1.htm
NIOSH (National Institute for Occupational Safety and Health). 2006. NIOSH Carcinogens List (Potential occupational carcinogens). http://www.cdc.gov/niosh/npotocca.html.
NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program.
NTP (National Toxicology Program). 2006. NTP Center for the Evaluation fo Risks to Human Reproduction (CERHR). NTP-CERHR Reports and Monographs.
National Toxicology Program Center for the Evaluation of Risks to Human Reproduction. National Toxicology Program. 10th Report on Carcinogens (2002). http://ehis.niehs.nih.gov/roc/toc10.htmlERHR Briefs and Expert Panel Reports. http://cerhr.niehs.nih.gov/, Jankovic, J. A Screening Method for Occupational Reproductive Health Risk. American Industrial Hygiene Association Journal. 57: 641-649. 1996., California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document 'Determination of Noncancer Chronic Reference Exposure Levels'. Includes all Chronic Reference Exposure Levels (CRELs) adopted by OEHHA as of August 2003 (http://www.oehha.ca.gov/air/chronic_rels/AllChrels.html, plus draft CRELS proposed through March 2004 (http://www.oehha.ca.gov/air/chronic_rels/index.html.
US EPA, Air Risk Information Support Center. Health Effects Notebook for Hazardous Air Pollutants. http://www.epa.gov/ttnatw01/hlthef/hapindex.html, National Institute for Occupational Safety and Health's Registry of Toxic Effects of Chemical Substances. See Environmental Defense's Suspect Hazard Identification documentation.
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.

About the ratings

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer