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Letter on ‘A review of alternatives to di(2-ethylhexyl)phthalate-containing medical devices in the neonatal intensive care unit’

Journal of Perinatology volume 32, page 393 (2012)Cite this article

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I am writing to correct some misrepresentations of the toxicity of Hexamoll DINCH that were presented by Van Vliet et al.1 Unfortunately, the authors relied on the Preliminary SCENIHR report on the safety of medical devices containing di(2-ethylhexyl)phthalate-plasticized polyvinylchloride or other plasticizers on neonates and other groups possibly at risk (2007). The final version, published in 2008, clearly indicates the correct information. The following summarizes what needs correction.

  • The authors indicate that DINCH causes nephrotoxicity following repeated oral exposure (Table 1, page 553). This is incorrect. The SCENIHR report clearly indicates the kidney as the critical endpoint (page 44, Table 12), but this is based on increased kidney weight not nephrotoxicity (it is noteworthy that SCENIHR was an independent review and did not rely solely on the conclusions of the study authors). The report indicates that relative kidney-to-body weights were increased relative to controls resulting from accumulation of alpha-2-u microglobulin, a rat-specific protein that has no relevance for humans.

  • The authors state that for studies conducted on Hexamoll DINCH, the ‘experimental design does not conform to the guidelines of the Organisation of Economic Co-operation and Development (OECD)’ (paragraph 2, second column, page 553). This is incorrect. As stated in the SCENIHR report, ‘all studies were performed under GLP conditions according to OECD guidelines’ (page 81). Indeed, all studies were conducted for submission to regulatory agencies for approval of manufacture and sale, and therefore needed to follow OECD guidelines.

  • The authors state that ‘In the multigenerational study, although there was a significant decrease in male anogenital index and anogenital distance in the high-dose group, these were not considered biologically significant by study authors as other parameters like descending testes, testes weight and sperm were not affected’ (paragraph 2, second column, page 553). This is misleading and incomplete. The SCENIHR report states that high-dose males and females in a pre- and postnatal developmental toxicity study had lower anogenital index relative to controls. Thus, the effect is not gender-specific and is inconsistent with anti-androgenic properties. This is also stated in the SCENIHR report (page 82), but was omitted by the authors.

The authors indicate that DINCH causes nephrotoxicity following repeated oral exposure (Table 1, page 553). This is incorrect. The SCENIHR report clearly indicates the kidney as the critical endpoint (page 44, Table 12), but this is based on increased kidney weight not nephrotoxicity (it is noteworthy that SCENIHR was an independent review and did not rely solely on the conclusions of the study authors). The report indicates that relative kidney-to-body weights were increased relative to controls resulting from accumulation of alpha-2-u microglobulin, a rat-specific protein that has no relevance for humans.

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References

  1. Van Vliet EDS, Reitano EM, Chhabra JS, Bergen GP, Whyatt RM . A review of alternatives to di (2-ethylhexyl) phthalate-containing medical devices in the neonatal intensive care unit. J Perinatol 2011; 31: 551–560.

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  1. Department of Toxicology, BASF Corporation, Florham Park, NJ, USA

    R M David

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  1. R M David
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Correspondence to R M David.

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Competing interests

The author is employed by a company that manufactures plasticizers, including Hexamoll DINCH.

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David, R. Letter on ‘A review of alternatives to di(2-ethylhexyl)phthalate-containing medical devices in the neonatal intensive care unit’. J Perinatol 32, 393 (2012). https://doi.org/10.1038/jp.2011.169

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  • DOI: https://doi.org/10.1038/jp.2011.169

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