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DIBUTYL PHTHALATE


image source: PubChem
Health Concerns of the Ingredient:
Overall Hazard
 
 
Cancer
 
 
 
 

About DIBUTYL PHTHALATE: The State of California and other authoritative bodies have classified dibutyl phthalate (DBP) as a reproductive and developmental toxicant, and the European Union banned the use of this ingredient in ... read more

Function(s): Fragrance Ingredient; Plasticizer; Solvent

Synonym(s): 1,2-BENZENEDICARBOXYLIC ACID, DIBUTYL ESTER; BUTYL PHTHALATE; DBP; DI-N-BUTYLPHTHALATE; DIBUTYL 1,2-BENZENEDICARBOXYLATE; DIBUTYL ESTER 1,2-BENZENEDICARBOXYLIC ACID; DIBUTYL PHTHALATE; DIBUTYL PHTHALATE; DIBUTYL PHTHALATES; BENZENE-O-DICARBOXYLIC ACID DI-N-BUTYL ESTER; CELLUFLEX DPB; DBP (ESTER)

Use restrictions

Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCosIng

Endocrine disruption

Concern Reference
Human endocrine disruptor - strong evidenceEuropean Commission on Endocrine Disruption
Limited evidence of endocrine disruptionBKH/European Commission
endocrine - weight of evidence unknown/unassessed/unreview: published lit review or major tox studyIllinois EPA Chemicals Associated with Endocrine System
endocrine - weight of evidence unknown/unassessed/unreview: published lit review or major tox studyOur Stolen Future Endocrine Disruptors

Developmental/reproductive toxicity

Concern Reference
Possible human developmental toxicantCalifornia EPA Proposition 65
Limited evidence of reproductive toxicityEuropean Union - Classification & Labelling
Limited evidence of reproductive toxicityNational Library of Medicine HazMap
Limited evidence of developmental toxicityAgency for Toxic Substances and Disease Registry
Limited evidence of reproductive toxicityUS EPA

Organ system toxicity (non-reproductive)

Concern Reference
Known human respiratory toxicantEPA Hazardous Air Pollutants
One or more animal studies show effects at moderate doses (low dose studies may be unavailable for this ingredient)EPA Categorized List of Inert Pesticide Ingredients
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
reproductive - weight of evidence unknown/unassessed/unreview: published lit review or major tox studyNational Library of Medicine HazMap
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

Allergies/immunotoxicity

Concern Reference
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Persistence and bioaccumulation

Concern Reference
Persistent, bioaccumulative in wildlifeOSPAR PBTs - Substances of Possible Concern
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Ecotoxicology

Concern Reference
Wildlife and environmental toxicityEuropean Union - Classification & Labelling
Wildlife and environmental toxicityEPA Clean Water Act - Priority Pollutants
Wildlife and environmental toxicityIllinois EPA Chemicals Associated with Endocrine System
Suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Cancer

Concern Reference
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsEPA Integrated Risk Information System (IRIS)

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
Insufficient data to determine safetyEPA Integrated Risk Information System (IRIS)
13,018 studies in PubMed science library may include information on the toxicity of this chemical see search results ->NLM PubMed

Data Sources

Agency for Toxic Substances and Disease Registry. Minimal risk Levels for Hazardous Substances. January 2004. http://www.atsdr.cdc.gov/mrls.html, 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/, 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., Jankovic, J. A Screening Method for Occupational Reproductive Health Risk. American Industrial Hygiene Association Journal. 57: 641-649. 1996., Chapin, R.E. 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, Proposition 65 List of Carcinogens (July 2004) can be obtained from http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html.-CAND
BKH/European Commission. Towards the establishment of a priority list of substances for further evaluation of their role in endocrine disruption: - preparation of a candidate list of substances as a basis for priority setting. Final report-November 2000. http://europa.eu.int/comm/environment/docum/01262_en.htm#bkh. Category 1 chemicals from Annex 1: Candidate list of 553 substances. http://europa.eu.int/comm/environment/docum/bkh_annex_01.pdf, Japanese National Institute of Health Sciences. Lists of Paradigmatic Chemicals. http://www.nihs.go.jp/hse/endocrine-e/paradigm/paradigm.html, Keith, L.H. (ed.). Environmental Endocrine Disruptors. John Wiley & Sons, NY. 1997. http://www.wileyeurope.com/cda/product/0,,0471191450%7Cdesc%7C3037,00.html, World Wildlife Fund. Our Stolen Future. Widespread Pollutants with Endocrine-disrupting Effects. http://www.ourstolenfuture.org/Basics/chemlist.htm. The WWF list is derived from references detailed at http://www.ourstolenfuture.org/Sources/chemsources.htm and was originally published in: Colborn, T., F.S. vom Saal, and A.M. Soto. Developmental Effects of Endocrine-Disrupting Chemicals In Wildlife and Humans. Environmental Health Perspectives 101(5): 378-384. 1993.
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.
Colborn T, D Dumanoski, JP Myers. 2006. Widespread Pollutants with Endocrine-disrupting Effects. Updated from original listing in "Our Stolen Future" (1996).
EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
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.
EU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998.
European Commission. 2013. Cosing, the European Commission database with information on cosmetic substances and ingredients. Accessed on March 1, 2013 at http://ec.europa.eu/consumers/cosmetics/cosing/ .
IFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25
Illinois EPA (Illinois Environmental Protection Agency). 2000. Preliminary list of chemicals associated with endocrine system effects in animals and humans (*) or in vitro (+). In EPA (U.S. Environmental Protection Agency) 2000. Handbook for Non-Cancer Health Effects Valuation, Appendix C.
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). 2006. NTP Center for the Evaluation fo Risks to Human Reproduction (CERHR). NTP-CERHR Reports and Monographs.
OSPAR (Oslo-Paris). 2002. OSPAR List of Substances of Possible Concern. Secondary OSPAR List of Substances of Possible Concern. Secondary OSPAR. Place Published, OSPAR Convention for the Protection of the Marine Environement of North-East Atlanic.
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., Chapin, R.E. 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, Proposition 65 List of Carcinogens (July 2004) can be obtained from http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html.-CAND

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