Alkylphenols

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Alkylphenols

• Reliable and Effective Products

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Presentation Overview

• Product Uses and Benefits
• Environmental Safety
• Human Safety
• The Endocrine Hypothesis
• Regulatory Status
• APERC contact information

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Effective Products and the Science of Safety

• Alkylphenol (AP) based products are high
  performance, cost effective compounds with broad
  regulatory acceptance worldwide
• Alkylphenol based products are safe for the
  environment when used as intended and handled and
  disposed of properly
• Normal exposures to alkylphenols, with
  responsible handling, do not pose a significant
  human health risk

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Product Applications

• Surfactants
• Primarily nonylphenol ethoxylates and octylphenol
  ethoxylates
• Excellent wetting, emulsifying and dispersant
  properties
• Good chemical stability
• Cost-effective
• Workhorse surfactant

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Product Applications

• Nonylphenol Ethoxylates Applications
• Household, industrial and institutional cleaners
• Textile manufacturing
• Pulp and paper processing
• Emulsion polymerization
• Industrial additive

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Product Applications

• Nonylphenol Applications
• Phosphite antioxidants for a wide range of
  polymer systems (TNPP)
• Reclaiming agent for synthetic rubber
• Hardeners for epoxy resins
• PVC plasticizer intermediates

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Product Applications

• Other Applications
• pharmaceuticals
• corrosion inhibitors
• dyestuffs
• insecticides/bactericides
• chemical stabilizers
• lube oils and fuels
• personal care products

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Environmental Safety of APEs

• Environmental Exposure
• Environmental Effects
• Environmental Treatment
• Risk Assessment
• NPE Environmental Management Program

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Environmental Exposure

• North American studies show that environmental
  concentrations of NP and NPEs are low
• In 70 of US waterways NP and NPEs are below
  detectable limits
• In 30 of US sediment samples, NPEs are below
  detectable limits
• NP and NPEs are biodegradable and do not build up
  in the environment

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Environmental Effects

• Aquatic toxicity of nonylphenol occurs at high
  exposure concentrations
• A U.S. EPA study found no effects from
  nonylphenol below 76 parts per billion
• In a major U.S. study of 30 rivers, nonylphenol
  concentrations were all measured well below 1
  part per billion
• Nonylphenol has a low potential for
  bioaccumulation

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Environmental Treatment

• Wastewater treatment facilities can effectively
  and efficiently remove nonylphenols and
  nonylphenol ethoxylates from water prior to
  discharge
• Studies in the US show removal rates of 95 and
  greater under normally recommended operating
  conditions

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Environmental Risk Assessment

• North American monitoring studies show that, in
  general, the levels of nonylphenol found in the
  environment-even in industrial rivers-are well
  below levels that may harm aquatic organisms
• U.S. EPA
• Nationwide, nonylphenol does not pose a
  significant risk to aquatic organisms.

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NPE Environmental Management Program

• Program Goals
• Promote the responsible environmental management
  of NP and NPE among users
• Provide guidance on pollution prevention and
  control
• Visit www.aperc.org for more information

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Human Safety of Nonylphenol

• Human Exposure of Nonylphenol
• Human Safety of Nonylphenol
• Human Health Risk Assessment

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Exposure to Nonylphenol

• Limited human exposure to nonylphenol through use
• Estimated daily intake is very low
• Animal studies show that nonylphenol is
• Rapidly metabolized and excreted from the body
• Not accumulated in the body
• Not readily absorbed through skin
• Studies in humans are consistent with the animal
  data

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Effects of Nonylphenol

• Animal studies using Nonylphenol conclude
• Not a selective, reproductive or developmental
  toxicants
• No effect on the fetus at doses below maternal
  toxicity
• No significant toxicity

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Human Health Risk Assessment

• Human exposure to NP is very low
• Under conditions of normal use, exposure levels
  to NP are less than levels known to cause effects
  in animal studies
• Normal exposure to NP based products does not
  pose a significant risk to human health

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The Endocrine Hypothesis

• What is the Endocrine Hypothesis?
• Wildlife Effects
• Human Health Effects
• Hormone Activity of Alkylphenols

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The Endocrine Disruption Hypothesis

• Theory that hormonally active agents may
  interfere with the natural activity of hormones
  in the body
• Popularized by 1996 publication of Our Stolen
  Future
• Under review by US EPA, European Commission,
  Japans Environment Agency and others

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Endocrine EffectsWildlife

• Endocrine modulated effects have been observed
  in wildlife populations in areas where the
  environment is very contaminated
• Cause-and-effect relationship has not been
  established between exposure to endocrine
  chemicals and adverse effects in wildlife
• Biomarker versus endocrine disruption

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Endocrine EffectsHuman Health

• NIEHS - Little evidence of harm to humans at
  environmental levels
• EPA - A causal relationship between exposure to
  environmental substances and effects on human
  health via endocrine disruption have not been
  established
• NAS - More research is needed to draw any
  conclusions

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Endocrine Activity of Alkylphenols

• Nonylphenol and octylphenol have
  estrogen-receptor binding activity in vitro that
  is 100,000 times less active than real estrogen
• Commercially available ethoxylates of nonylphenol
  and octylphenol do not have estrogenic properties
  in vitro or in vivo
• Nonylphenol is estrogenic in vivo only at high
  doses ( 50mg/kg/day), 500 times higher than the
  highest estimated daily intake

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Endocrine Activity of Alkylphenols

• No adverse effects due to endocrine disruption in
  NIEHS study of rats exposed to nonylphenol and
  octylphenol for three generations
• Toxicity not endocrine issues - drive
  regulatory risk assessment conclusions about
  nonylphenol and nonylphenol ethoxylates in North
  America

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Regulatory Issues

• United States
• Canada
• European Union
• Japan

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U.S. Regulatory Status

• No present or pending regulatory restrictions on
  use
• EPA review of nonylphenol concluded no widespread
  risk to aquatic organisms
• EPA to establish water quality criteria for
  nonylphenol

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U.S. Regulatory Status

• FDA has regulatory authority for food-contact
  materials
• TNPP, nonylphenol ethoxylates and others approved
  for food-contact uses

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Canadian Regulatory Status

• Environment Canada and Health Canada assessment
  of nonylphenol and its ethoxylates
• Draft assessment issued April 1, 2000
• No danger to the environment on which life
  depends
• No danger to human health from environmental
  exposure
• CEPA toxic due to untreated or partially
  treated discharge at a limited number of sites
• Final assessment expected late 2000
• Risk Management discussions with stakeholders

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European Regulatory Status

• EU Risk Assessment of nonylphenol near completion
• Theoretical, worst-case , environmental
  exposure assessments in lieu of monitoring
• Highly conservative assessment of effects
• Draft proposal restricts nonylphenol ethoxylates
  use in some applications
• No restrictions on the use of TNPP
• Few unilateral actions by member states

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Japanese Regulatory Status

• Japans Environment Agency is monitoring
  chemicals in the environment, including APEs

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Conclusion

• Alkylphenol-based products are high performance,
  cost-effective compounds with broad regulatory
  acceptance
• Alkylphenol-based products are safe for the
  environment when used as intended and handled and
  disposed of properly
• Normal exposures to alkylphenol-based products do
  not pose a significant human health risk

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For More Information

• Alkylphenols Ethoxylates Research Council
• www.aperc.org