alkylphenols

1. Alkylphenols Reliable and Effective Products

2. Alkylphenols & Ethoxylates Research Council

3. Alkylphenols & Ethoxylates Research Council 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

4. Alkylphenols & Ethoxylates Research Council Product Applications Surfactants Primarily nonylphenol ethoxylates and octylphenol ethoxylates Excellent wetting, emulsifying and dispersant properties Good chemical stability Cost-effective “Workhorse” surfactant

5. Alkylphenols & Ethoxylates Research Council Product Applications Nonylphenol Ethoxylates Applications: Household, industrial and institutional cleaners Textile manufacturing Pulp and paper processing Emulsion polymerization Industrial additive

6. Alkylphenols & Ethoxylates Research Council 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

7. Alkylphenols & Ethoxylates Research Council Product Applications Other Applications pharmaceuticals corrosion inhibitors dyestuffs insecticides/bactericides chemical stabilizers lube oils and fuels personal care products

8. Alkylphenols & Ethoxylates Research Council Environmental Safety of APEs Environmental Exposure Environmental Effects Environmental Treatment Risk Assessment NPE Environmental Management Program

9. Alkylphenols & Ethoxylates Research Council 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

10. Alkylphenols & Ethoxylates Research Council 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

11. Alkylphenols & Ethoxylates Research Council 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

12. Alkylphenols & Ethoxylates Research Council 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.”

13. Alkylphenols & Ethoxylates Research Council 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

14. Alkylphenols & Ethoxylates Research Council Human Safety of Nonylphenol Human Exposure of Nonylphenol Human Safety of Nonylphenol Human Health Risk Assessment

15. Alkylphenols & Ethoxylates Research Council 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

16. Alkylphenols & Ethoxylates Research Council 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

17. Alkylphenols & Ethoxylates Research Council 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

18. Alkylphenols & Ethoxylates Research Council The Endocrine Hypothesis What is the Endocrine Hypothesis? Wildlife Effects Human Health Effects Hormone Activity of Alkylphenols

19. Alkylphenols & Ethoxylates Research Council 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, Japan’s Environment Agency and others

20. Alkylphenols & Ethoxylates Research Council 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

21. Alkylphenols & Ethoxylates Research Council 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”

22. Alkylphenols & Ethoxylates Research Council 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

23. Alkylphenols & Ethoxylates Research Council 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

24. Alkylphenols & Ethoxylates Research Council Regulatory Issues United States Canada European Union Japan

25. Alkylphenols & Ethoxylates Research Council 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

26. Alkylphenols & Ethoxylates Research Council U.S. Regulatory Status FDA has regulatory authority for food-contact materials TNPP, nonylphenol ethoxylates and others approved for food-contact uses

27. Alkylphenols & Ethoxylates Research Council 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

28. Alkylphenols & Ethoxylates Research Council 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

29. Alkylphenols & Ethoxylates Research Council Japanese Regulatory Status Japan’s Environment Agency is monitoring chemicals in the environment, including APEs

30. Alkylphenols & Ethoxylates Research Council 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

31. Alkylphenols & Ethoxylates Research Council For More Information: Alkylphenols & Ethoxylates Research Council www.aperc.org