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Response to ‘Dr Raymond David, BASF Corporation’

Journal of Perinatology volume 32, pages 393–394 (2012)Cite this article

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We thank Dr Raymond David from BASF for his letter and are pleased to address his concerns. Regarding Dr David's first point about the irrelevance of the kidney toxicity to humans due to the accumulation of the rat-specific protein alpha-2-u-microglobulin, please note that the EU SCENIHR report that was cited in our article, as well as the 2008 report, refers to alpha-2-macroglobulin (page 74 in the 2007 report; page 44 in the Table 12 footnote to which Dr David refers, and page 81 in the 2008 report), and unlike alpha-2-u-microglobulin, alpha-2-macroglobulin is a human protease inhibitor.1, 2 It is possible that this was a mistake by EU SCENIHR. However, it should be noted that the available literature regarding the health effects of DINCH was limited to summaries by BASF and the review in the EU SCENIHR report of unreferenced and unpublished animal studies submitted by BASF.1, 2 The publication of toxicological studies would enable independent evaluation of study results and prevent misinterpretation.

With regards to Dr David's second point regarding the adherence of the BASF studies to the OECD/GLP guidelines, while the 90-day oral toxicity rodent study seems indeed to have been performed under OECD guideline (no. 408), the adherence of the developmental study to OECD guidelines is unclear. In an unpublished but available draft document, BASF states that the pre-postnatal developmental toxicity study in Wistar rats ‘was roughly based on (OECD, EPA, EC) guidelines’.3

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References

  1. SCENIHR. Preliminary report on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. Scientific Committee on Emerging and Newly-Identified Health Risks, Health and Consumer Protection Directorate-General. European Commission, 2007, http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_cons_05_en.htm.

  2. SCENIHR. Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. Scientific Committee on Emerging and Newly-Identified Health and Consumer Protection Directorate-General. European Commission, 6 February 2008, http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_014.pdf.

  3. Robust Summary for DINCH. Unpublished data by BASF, US Consumer Product Safety Commission website, p 43 http://www.cpsc.gov/about/cpsia/docs/robustDINCH01062010.pdf (accessed 19 October 2011).

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Authors and Affiliations

  1. Mailman School of Public Health, Columbia University, New York, NY, USA

    E D S Van Vliet

  2. Clinical Environmental Health Sciences, Mailman School of Public Health,

    R M Whyatt

  3. Columbia University, New York, NY, USA

    R M Whyatt

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  1. E D S Van Vliet
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  2. R M Whyatt
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Correspondence to E D S Van Vliet.

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Van Vliet, E., Whyatt, R. Response to ‘Dr Raymond David, BASF Corporation’. J Perinatol 32, 393–394 (2012). https://doi.org/10.1038/jp.2011.165

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