No Observed Adverse Effect Levels of Phthalate Esters on Reproductive and Developmental Toxicity, the Differences with Age and Species in Testicular Toxicity, and Tolerable Daily Intake of DEHP

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  • Koizumi Mutsuko
    Biological Safety Research Center, National Institute of Health Sciences
  • Ema Makoto
    Division of Biological Evaluation, National Institute of Health Sciences Osaka Branch
  • Hirose Akihiko
    Biological Safety Research Center, National Institute of Health Sciences
  • Kurokawa Yuji
    Biological Safety Research Center, National Institute of Health Sciences
  • Hasegawa Ryuichi
    Biological Safety Research Center, National Institute of Health Sciences

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Other Title
  • フタル酸エステルの生殖・発生無毒性量、精巣毒性の週齢差、種差およびDEHPの1日耐容摂取量
  • フタルサン エステル ノ セイショク ハッセイ ムドクセイリョウ セイソウ ドクセイ ノ シュウレイサ シュサ オヨビ DEHP ノ 1ニチ タイヨウセッシュリョウ

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Abstract

It is well known that some species of phthalate esters have reproductive and developmental toxicity, monoesters being active metabolites. In June 2000, the Japanese Government established a tolerable daily intake (TDI) for di(2-ethylhexyl) phthalate (DEHP) based on data for testicular and reproductive toxicity because of the report that certain cooked foods had been relatively high contaminated, caused by the use of polyvinyl chloride gloves containing DEHP in the final stage of food packing. In the present paper, first of all, no observed adverse effect levels (NOAELs) or lowest observed adverse effect levels (LOAELs) of various kinds of phthalate esters in terms of reproductive and developmental toxicity endpoints, and the differences with age and species in testicular toxicity are examined and summarized. Then the rationale for establishing a TDI for DEHP and the exposure problem are discussed. This article also includes new information from a draft of the Toxicological Profile for DEHP published in September 2000 by the US Agency for Toxic Substances and Disease Registry, and assessment reports made available in October 2000 from the Center for the Evaluation of Risks to Human Reproduction, US National Toxicology Program.

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