Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices

, such as availability and safety of alternatives to DEHP and PVC should be ….. regarding the safety of DEHP from PVC medical devices are released. Uni-Bell ….

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Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released
TABLE OF CONTENTS

  • Executive Summary … 3
  • 1.0 Introduction … 8
  • 2.0 Exposure Assessment … 10
  • 2.1 Parenteral Exposure to DEHP … 10
  • 2.2 Oral Exposure …17
  • 2.3 Inhalation Exposure … 18
  • 2.4 Dermal/Mucosal Exposure … 19
  • 2.5 Aggregate Exposure to DEHP from Multiple Medical Devices …20
  • 3.0 Derivation of Tolerable Intake (TI) Values for DEHP …21
  • 3.1 Selection of Appropriate NOAEL and/or LOAEL Values from Critical Studies (Step 1) …21
  • 3.2 Derivation of a Modifying Factor (Step 2) …30
  • 3.3 Application of Modifying Factors to Derive Parenteral and Oral TI Values (Step 3)… 42
  • 4.0 Risk Characterization …44
  • 4.1 Conclusions Based on TI/Dose Ratios …44
  • 4.2 Conclusions Based on Other Considerations …48
  • 4.3 Aggregate Exposure to DEHP and MEHP …48
  • 5.0 References …49
  • Annex A: Exposure Assessment
  • Annex B: Summary of Results of Parenteral Toxicity Studies of DEHP
  • Annex C: Aggregate Safety Assessment for Coexposure to DEHP and MEHP
  • Annex D: Nonsystemic Effects

TABLE OF TABLES

  • Table 2-1 PVC medical devices known to release DEHP …10
  • Table 2-2 Estimated upper-bound dose of DEHP received by adult and neonatal patients undergoing various medical procedures …11
  • Table 2-3 Dose of DEHP received by neonates undergoing IV drug therapy …13
  • Table 2-4 Dose of DEHP received from replacement transfusion in neonates … 15
  • Table 2-5 Dose of DEHP received during cardiac surgery …16
  • Table 2-6 Dose of DEHP received by infants undergoing ECMO …16
  • Table 2-7 Aggregate exposure of neonates to DEHP in the NICU environment …20
  • Table 3-1 Critical toxicity studies for DEHP …22
  • Table 3-2 Criteria to determine appropriateness of study for TI derivation …23
  • Table 3-3 Evaluation of critical toxicity studies (parental route) for DEHP …29
  • Table 3-4 Uncertainty Factors for TI derivation …30
  • Table 3-5 Comparison of the potency of DEHP in rats and nonhuman primates following oral exposure (based on testicular effects) …35
  • Table 3-6 In vitro hydrolysis of phthalate diesters by intestinal cell preparations ..36
  • Table 3-7 Comparison of experimental conditions used in Advamed (2001) study and conditions in the clinical setting for neonates in a NICU and adults undergoing hemodialysis …39
  • Table 3-8 Modifying Factors for derivation of TI values for DEHP …42
  • Table 3-9 TI values for DEHP …43
  • Table 3-10 Existing health-based exposure limits for DEHP based on noncancer effects (oral exposure) …43
  • Table 4-1 Comparison of Tolerable Intake (TI) values for DEHP to the dose of DEHP received by adult and neonatal patients undergoing various medical procedures …47
Download Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices pdf from www.fda.gov, 119 pages, 618.65KB.
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