About DINP and California Proposition 65

With more than 100+ years of healthcare experience, Medline is committed to quality and safety. Our priority is to make sure our customers know they can trust our products and their use.

The California Safe Drinking Water and Toxic Enforcement Act of 1986 commonly referred to Prop 65 is a California voter initiative designed to protect drinking water from harmful chemicals and all persons from exposure to such chemicals. Prop 65 requires companies with ten or more employees who do business in California to provide warnings to consumers about exposure to chemicals that have been identified by the state to cause cancer, birth defects or reproductive harm. In 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) promulgated new “safe harbor” consumer warning regulations that take effect on Aug. 30, 2018 (27 Cal. Code Reg. Section 25600 et seq.). While the regulations themselves provide that the content and methods of transmission they include are not the only clear and reasonable warnings, they also provide that warnings in compliance with the regulations will be deemed clear and reasonable without need for further inquiry.

Importantly, the California Office of Environmental Health Hazard Assessment group itself has stated that the listing of a chemical does not necessarily mean a product containing the chemical is in “violation of any product-safety standards.” The listing of a chemical means that customers need to be notified that they are being exposed to the chemical.

Many of the products are also subject to the United States Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and international quality and manufacturing standards. Warning requirements under Proposition 65 apply when the products are used in California, and do not affect the status of these products under other laws and in other geographic areas.

These products are considered safe when used as directed.

For more information go to www.P65Warnings.ca.gov.

California Proposition 65 – About DINP
DINP, an ingredient used in the manufacturing of vinyl exam gloves, has been added to the California Office of Environmental Health Hazard Assessment Proposition 65 list. The following information is provided to help you understand this important issue, so you can make an informed decision about your exam gloves purchase. Additional information on CA Proposition 65 can also be found here.

What Is DINP
DINP (Diisononyl phthalate) is a phthalate plasticizer used in the manufacture of many vinyl (polyvinyl chloride/PVC) products, including electrical wire, coated fabrics, automotive parts, vinyl flooring, footwear, and medical examination gloves, to make them pliable.

CA Prop 65 - DINP
The California Office of Environmental Health Hazard Assessment has added DINP to the Proposition 65 list of chemicals “known to the State of California to cause cancer.” As stated above, the listing of a chemical does not necessarily mean a product containing the chemical is in “violation of any product-safety standards.” As a result of Prop 65, manufacturers selling products containing DINP in California are required to either remove DINP from their products or provide a clear and reasonable warning to customers prior to purchase and/or use. In response to this law, Medline is adding warning labels to our vinyl glove products sold in California.

Medline has also evaluated any potential health risks to nurses and other care providers using the gloves. Based on extensive research by independent scientific review bodies in the U.S. and Europe, the health assessment concludes that any leaching DINP would not pose any significant health risks to nurses and other care providers using the gloves.¹

For customers looking for alternative exam glove options that do not contain DINP, Medline offers a wide selection of latex and nitrile gloves. We are also aggressively exploring viable alternatives to DINP that would deliver users a high level of quality, safety and performance, at the same cost.

Additional Information

References

BASF SE et al. (2013). REACH Registration Dossier for di-“isononyl” phthalate, joint submission to the European Chemicals Agency. Last updated in September 2013.

CERHR (2003). US National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction, Research Triangle Park, NC, USA. Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). NIH Publication No. 03-4484.

CPSC (2010). US Consumer Product Safety Commission, Bethesda, MD, USA. Memorandum: Overview of Phthalates Toxicity.

Dow Benelux B.V. and ExxonMobil Chemical Holland B.V. (2013). REACH Registration Dossier for 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich. Last updated in August 2013.

ECHA (2013). European Chemicals Agency. Evaluation of new scientific evidence concerning DINP and DIDP. In relation to entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006. Final review report. August 2013. ECHA-13-R-07-EN.

EFSA (2005). European Food Safety Authority, Parma, Italy. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to Di-isononylphthalate (DINP) for use in food contact materials. The EFSA Journal 244, 1–18.

 

Exxon Biomedical Sciences (1986). Chronic Toxicity/Oncogenicity Study in F-344 Rats. Test Material: MRD-83-260. Project No 326075 performed at Exxon Biomedical Sciences, Inc., Unpublished Laboratory Report, January 13, 1986 (cited in EFSA, 2005).

NICNAS (2008). Australia National Industrial Chemicals Notification and Assessment Scheme. Existing Chemical Hazard Assessment Report. Diisononyl Phthalate.

NICNAS (2012). Australia National Industrial Chemicals Notification and Assessment Scheme. Diisononyl phthalate. Priority Existing Chemical Assessment Report No. 35. September 2012. Available via eChemPortal.

NICNAS (2013). Australia National Industrial Chemicals Notification and Assessment Scheme. Diisononyl phthalate (DINP) Fact Sheet.

US EPA (2010). US Environmental Protection Agency. Screening-level hazard characterization, phthalate esters category. Dated April 2010.

MEDLINE LATEX AND NITRILE GLOVES DO NOT INCLUDE DINP.
For product alternatives, contact your Medline representative or call 1-800-MEDLINE.

© Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc.

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