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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

Substance

Structure

Safety Issues

Wax esters (found on the external surface of leaves and stems; 0.1% w/w of fresh leaf weight by steam distillation): alkyl esters (C48–C56), fatty acids (C48–C56) (Bohnstedt, 1979; Mabry et al., 1977; Waller and Gisvold, 1945)

Sterols: campesterol, β-sitosterol, stigmasterol, cholesterol (Habermehl and Christ, 1974; Konno et al., 1987; Xue et al., 1988)

2-Ketones (probably contribute to the odor of L. tridentata): 2-dodecanone, 2-undecanone, 2-tridecanone; traces of 2-tetradecanone, 2-pentadecanone, 3-hexanone, 2-heptanone, 2-nonanone (Bohnstedt, 1979; Brinker, 1993–1994; Mabry et al., 1977)

Vinyl ketones (probably contribute to odor of chaparral of L. tridentata): 1-hexen-3-one, 1-octen-3-one; traces of 1-hepten-3-one (Bohnstedt, 1979; Brinker, 1993–1994; Mabry et al., 1977)

Fatty alcohols (C22–C32) (Bohnstedt, 1979)

Other hydrocarbons: n-tridecane, n-tetradecane; traces of 3-methylbutanal, 3-hexanol, hexanal, 3-hexen-1-yl acetate, isobutyric acid (Bohnstedt, 1979; Brinker, 1993–1994; Mabry et al., 1977)

NOTE: IC50 = Concentration at which the response has decreased to 50% of the original response, CYP = cytochrome P450, MAO = monoamine oxidase.

Page
419
Front Matter (R1-R20)
Executive Summary (1-18)
1 Introduction and Background (19-42)
2 Approaches Used by Others and Existing Safety Frameworks (43-84)
3 The Framework (85-125)
4 Categories of Scientific Evidence--Human Information and Data (126-155)
5 Categories of Scientific Evidence--Animal Data (156-174)
6 Categories of Scientific Evidence--Information About Related Substances (175-216)
7 Categories of Scientific Evidence--In Vitro Data (217-234)
8 Interactions (235-246)
9 Vulnerable Groups and Prevalance of Use (247-252)
10 Scientific Principles for Integrating and Evaluating the Available Data (253-268)
11 Applying the Framework: Case Studies Using the Prototype Safety Monographs (269-291)
12 Factors Influencing Use of the Safety Framework (292-296)
13 Findings and Recommendations (297-306)
Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances (307-315)
Appendix B: Scope of Work and Comments to Initial July 2002 Framework (316-321)
Appendix C: Plant Family Information (322-355)
Appendix D: Chaparral: Prototype Monograph Summary (356-362)
Appendix E: Glucosamine: Prototype Monograph Summary (363-366)
Appendix F: Melatonin: Prototype Monograph Summary (367-371)
Appendix G: Chromium Picolinate: Prototype Monograph Summary (372-375)
Appendix H: Saw Palmetto: Prototype Monograph Summary (376-379)
Appendix I: Shark Cartilage: Prototype Monograph Summary (380-384)
Appendix J: Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral (385-449)
Appendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by Women (450-477)
Appendix L: Acknowledgements (478-480)
Appendix M: Biographical Sketches of Commitee Members (481-488)
Index (489-506)