Safety assessment of boron by application of new uncertainty factors and their subdivision

Regulatory Toxicology and Pharmacology

Volumn 65, Issue 1, 2013, Pages 108-114

  Hasegawa, Ryuichi ^a   Hirata Koizumi, Mutsuko ^a   Dourson, Michael L ^b   Parker, Ann ^b   Ono, Atsushi ^a   Hirose, Akihiko ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^b Toxicology Excellence for Risk Assessment   (United States)

Author keywords

Application of new uncertainty factor (UF); Chemical risk assessment; Derivation of boron TDI; Subdivision of new uncertainty factor (UF)

Indexed keywords

BORON; DRINKING WATER;

ARTICLE; CALCULATION; DEVELOPMENTAL TOXICITY; DOG; FEEDING; FETUS WEIGHT; GLOMERULUS FILTRATION RATE; HUMAN; NONHUMAN; PREGNANT WOMAN; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; TESTIS DISEASE; TOXICITY TESTING; TOXICOKINETICS; UNCERTAINTY; UNCERTAINTY FACTOR; WATER QUALITY; WORLD HEALTH ORGANIZATION;

ANIMALS; BENCHMARKING; BORON; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; MALE; MICE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PREGNANCY; RATS; RISK ASSESSMENT; SPECIES SPECIFICITY; UNCERTAINTY;

CANIS FAMILIARIS; RATTUS;

EID: 84871411209     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.10.013     Document Type: Article

References (44)

1. Allen B.C., Strong P.L., Price C.J., Hubbard S.A., Daston G.P. Benchmark dose analysis of developmental toxicity in rats exposed to boric acid. Fundam. Appl. Toxicol. 1996, 32:194-204.
2. Chapin, R., Dourson, M., Gomes, J., Hales, B., submitted for publication. Boric acid and its salts: third party review. Pesticide Management Regulatory Authority (PMRA) of Health Canada.
3. Connelly J.C., Hasegawa R., McArdle J.V., Tucker M.L. ICH guideline residual solvents. Pharmaeuropa 1997, 9(Suppl. 1):S1-S68.
4. Dieter M.P. Toxicity and carcinogenicity studies of boric acid in male and female B6C3F1 mice. Environ. Health Perspect. 1994, 102(Suppl. 7):93-97.
5. Dourson M., Maier A., Meek B., Renwick A., Ohanian E., Poirier K. Boron tolerable intake: re-evaluation of toxicokinetics for data-derived uncertainty factors. Biol. Trace Elem. Res. 1998, 66:453-463.
6. Dourson M.L., Stara J.F. Regulatory history and experimental support of uncertainty (safety) factors. Regul. Toxicol. Pharmacol. 1983, 3:224-238.
7. Duydu Y., Başaran N., üstündaĝ A., Aydin S., ündeĝer ü., Ataman O.Y., Aydos K., Düker Y., Ickstadt K., Waltrup B.S., Golka K., Bolt H.M. Reproductive toxicity parameters and biological monitoring in occupationally and environmentally boron-exposed persons in Bandirma, Turkey. Arch. Toxicol. 2011, 85:589-600.
8. Dunlop W. Serial changes in renal haemodynamics during normal human pregnancy. Br. J. Obstet. Gynaecol. 1981, 88:1-9.
9. EFSA Opinion of the scientific panel on dietetic products, nutrition and allergies on a request from the commission related to the tolerable upper intake level of boron (sodium borate and boric acid). EFSA J. 2004, 80:1-22.
10. Falk-Filipsson A., Hanberg A., Victorin K., Warholm M., Wallen M. Assessment factors-applications in health risk assessment of chemicals. Environ. Res. 2007, 104:108-127.
11. Freireich E.J., Gehan E.A., Rall D.P., Schmidt L.H., Skipper H.E. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man. Cancer Chemother. Rep. 1966, 50:219-244.
12. Hasegawa R., Hirata-Koizumi M., Dourson M., Parker A., Hirose A., Nakai S., Kamata E., Ema M. Pediatric susceptibility to 18 industrial chemicals: a comparative analysis of newborn with young animals. Regul. Toxicol. Pharmacol. 2007, 47:296-307.
13. Hasegawa R., Hirata-Koizumi M., Dourson M.L., Parker A., Sweeney L.M., Nishikawa A., Yoshida M., Ono A., Hirose A. Proposal of new uncertainty factor application to derive tolerable daily intake. Regul. Toxicol. Pharmacol. 2010, 58:237-242.
14. Heindel J.J., Price C.J., Field E.A., Marr M.C., Myers C.B., Morrissey R.E., Schwetz B.A. Developmental toxicity of boric acid in mice and rats. Fundam. Appl. Toxicol. 1992, 18:266-277.
15. IPCS (International Programme on Chemical Safety) Assessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-Based Exposure Limits, Environmental Health Criteria, No. 170 1994, World Health Organization, Geneva.
16. Jansen J.A., Andersen J., Schou J.S. Boric acid single dose pharmacokinetics after intravenous administration to man. Arch. Toxicol. 1984, 55:64-67.
17. Krutzen E., Olofsson P., Back S.E., Nilsson-Ehle P. Glomerular filtration rate in pregnancy: a study in normal subjects and in patients with hypertension, preeclampsia and diabetes. Scand. J. Clin. Lab. Invest. 1992, 52:387-392.
18. Ku W.W., Chapin R.E., Moseman R.F., Brink R.E., Pierce K.D., Adams K.Y. Tissue disposition of boron in male Fischer rats. Toxicol. Appl. Pharmacol. 1991, 111:145-151.
19. Lee I.P., Sherins R.J., Dixon R.L. Evidence for induction of germinal aplasia in male rats by environmental exposure to boron. Toxicol. Appl. Pharmacol. 1978, 45:577-590.
20. Lehman A.J., Fitzhugh O.G. 100-fold margin of safety. Assoc. Food Drug Off. US Quant. Bull. 1954, 18:33-35.
21. Meek M.E., Newhook R., Liteplo R.G., Armstrong A.C. Approach to assessment of risk to human health for priority substances under the Canadian environmental protection act. J. Environ. Sci. Health C Environ. Carcinog. Ecotoxicol. Rev. 1994, 12:105-134.
22. NTP (National Toxicology Program), 1987. Toxicology and carcinogenesis studies of boric acid (CAS No. 10043-35-3) in B6C3F1 mice (food studies). NTP Technical Report Series No. 324.
23. Pahl M.V., Culver B.D., Strong P.L., Murray F.J., Vaziri N.D. The effect of pregnancy on renal clearance of boron in humans: a study based on normal dietary intake of boron. Toxicol. Sci. 2001, 60:252-256.
24. Price C.J., Marr M.C., Myers C.B., Seely J.C., Heindel J.J., Schwetz B.A. The developmental toxicity of boric acid in rabbits. Fundam. Appl. Toxicol. 1996, 34:176-187.
25. Price C.J., Strong P.L., Marr M.C., Myers C.B., Murray F.J. Developmental toxicity NOAEL and postnatal recovery in rats fed boric acid during gestation. Fundam. Appl. Toxicol. 1996, 32:179-193.
26. Renwick A.G. Data-derived safety factors for the evaluation of food additives and environmental contaminants. Food Addit. Contam. 1993, 10:275-305.
27. Robbins W.A., Xun L., Jia J., Kennedy N., Elashoff D.A., Ping L. Chronic boron exposure and human semen parameters. Reprod. Toxicol. 2010, 29:184-190.
28. Sayli B.S. Assessment of fertility and infertility in boron-exposed Turkish subpopulations. 3. Evaluation of fertility among sibs and in " borate families" Biol. Trace Elem. Res. 2001, 81:255-267.
29. Sayli B.S. Low frequency of infertility among workers in a borate processing facility. Biol. Trace Elem. Res. 2003, 93:19-29.
30. Schneider K., Oltmanns J., Hassauer M. Allometric principles for interspecies extrapolation in toxicological risk assessment-empirical investigations. Regul. Toxicol. Pharmacol. 2004, 39:334-347.
31. Schou J.S., Jansen J.A., Aggerbeck B. Human pharmacokinetics and safety of boric acid. Arch. Toxicol. Suppl. 1984, 7:232-235.
32. Sturgiss S.N., Wilkinson R., Davison J.M. Renal reserve during human pregnancy. Am. J. Physiol. 1996, 271:F16-F20.
33. Treinen K.A., Chapin R.E. Development of testicular lesions in F344 rats after treatment with boric acid. Toxicol. Appl. Pharmacol. 1991, 107:325-335.
34. US Borax, 2000. UCI Boric acid clearance study reports and associated data: rat and human studies, April 4, 2000.
35. US EPA, 2004. Toxicological review of boron and compounds (CAS No. 7440-42-8) in support of summary information on the Integrated Risk, Information System (IRIS), US EPA.
36. US IOM Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc 2001, National Academy Press, Washington, DC.
37. Usuda K., Kono K., Orita Y., Dote T., Iguchi K., Nishiura H., Tominaga M., Tagawa T., Goto E., Shirai Y. Serum and urinary boron levels in rats after single administration of sodium tetraborate. Arch. Toxicol. 1998, 72:468-474.
38. Vanderpool R.A., Hof D., Johnson P.E. Use of inductively coupled plasma-mass spectrometry in boron-10 stable isotope experiments with plans, rats, and humans. Environ. Health Perspect. 1994, 102(Suppl. 7):13-20.
39. Vaziri N.D., Oveisi F., Culver B.D., Pahl M.V., Andersen M.E., Strong P.L., Murray F.J. The effect of pregnancy on renal clearance of boron in rats given boric acid orally. Toxicol. Sci. 2001, 60:257-263.
40. Weir R.J., Fisher R.S. Toxicologic studies on borax and boric acid. Toxicol. Appl. Pharmacol. 1972, 23:351-364.
41. WHO Harmonization Project Document No. 2: Chemical-Specific Adjustment Factors for Interspecies Differences and Human Variability: Guidance Document for use of Data in Dose/Concentration-Response Assessment 2005, World Health Organization, Geneva.
42. WHO Boron in Drinking-Water, Background Document for Development of WHO Guidelines for Drinking-Water Quality 2009, World Health Organization, Geneva.
43. Whorton M.D., Haas J.L., Trent L., Wong O. Reproductive effects of sodium borates on male employees: birth rate assessment. Occup. Environ. Med. 1994, 51:761-767.
44. Yazbeck C., Kloppmann W., Cottier R., Sahuquillo J., Debotte G., Huel G. Health impact evaluation of boron in drinking water: a geographical risk assessment in Northern France. Environ. Geochem. Health 2005, 27:419-427.