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BUTYL BENZYL PHTHALATE

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Endocrine disruption (moderate), Persistence and bioaccumulation (moderate), Non-reproductive organ system toxicity (moderate), and Ecotoxicology (low)

Cancer

Cancer concern is LOW_MODERATE

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is MODERATE

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW_MODERATE

Products with this Ingredient

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Use restrictions

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

Developmental/reproductive toxicity

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Concern Reference
Possible human developmental toxicantCalifornia EPA Proposition 65
Limited evidence of developmental toxicityCPS&Q - Classification & Labelling
One or more animal studies show reproductive effects at low dosesWang JX, Xi YL, Hu K, Liu XB Effect of butyl benzyl phthalate on life table-demography of two successive generations of cladoceran Moina macrocopa Straus. J Environ Biol. 2011 Jan;32(1):17-22.
Limited evidence of developmental toxicityLyche JL, Gutleb AC, Bergman A, Eriksen GS, Murk AJ, Ropstad E, Saunders M, Skaare JU Reproductive and developmental toxicity of phthalates. J Toxicol Environ Health B Crit Rev. 2009 Apr;12(4):225-49.
Limited evidence of reproductive toxicityNational 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/

Endocrine disruption

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Concern Reference
Human endocrine disruptor - strong evidenceEuropean Commission on Endocrine Disruption
Limited evidence of endocrine disruptionBKH/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.
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 studyJobling et al 1995

Persistence and bioaccumulation

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Concern Reference
Persistent or bioaccumulative and moderate to high toxicity concern in humansEnvironment Canada Domestic Substance List
Persistent, bioaccumulative in wildlifeOSPAR PBTs - Substances of Possible Concern
Not suspected to be persistentEnvironment Canada Domestic Substance List

Cancer

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Concern Reference
Limited evidence of carcinogenicityEPA (US. Environmental Protection Agency). Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986 guidelines.
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsWorld 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 73;1999

Allergies/immunotoxicity

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Concern Reference
One or more human case studies show significant immune or allergenic effectsJust AC, Whyatt RM, Perzanowski MS, Calafat AM, Perera FP, Goldstein IF, Chen Q, Rundle AG, Miller RL Prenatal exposure to butylbenzyl phthalate and early eczema in an urban cohort. Environ Health Perspect. 2012 Oct;120(10):1475-80

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as expected to be toxic or harmfulEnvironment Canada Domestic Substance List
One or more animal studies show any 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
Classified as a low human health priorityEnvironment Canada Domestic Substance List

Ecotoxicology

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Concern Reference
Wildlife and environmental toxicityCPS&Q - 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 toxin and be persistent or bioaccumulativeEnvironment Canada Domestic Substance List
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 productJACT 11(1):1-23, 1992
544 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 - anyJACT 11(1):1-23, 1992

Data Sources

  • 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/ .
  • 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.
  • Wang JX, Xi YL, Hu K, Liu XB Effect of butyl benzyl phthalate on life table-demography of two successive generations of cladoceran Moina macrocopa Straus. J Environ Biol. 2011 Jan;32(1):17-22.
  • Lyche JL, Gutleb AC, Bergman A, Eriksen GS, Murk AJ, Ropstad E, Saunders M, Skaare JU Reproductive and developmental toxicity of phthalates. J Toxicol Environ Health B Crit Rev. 2009 Apr;12(4):225-49.
  • 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/
  • EU (European Union)- Strategy for Endocrine Disrupters 2007. Commision on endocrin disruption requested by the European Parliament in 1998.
  • 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.
  • 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.
  • Jobling et al 1995
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • EPA (US. Environmental Protection Agency). Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986 guidelines.
  • 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 73;1999
  • Just AC, Whyatt RM, Perzanowski MS, Calafat AM, Perera FP, Goldstein IF, Chen Q, Rundle AG, Miller RL Prenatal exposure to butylbenzyl phthalate and early eczema in an urban cohort. Environ Health Perspect. 2012 Oct;120(10):1475-80
  • 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.
  • JACT 11(1):1-23, 1992
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.

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