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Citation |
Craan AG, Myres AW, Green DW. Regul. Toxicol. Pharmacol. 1997; 26(3): 271-280. |
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Affiliation |
Product Safety Laboratory, Health Protection Branch, Health Canada, Ottawa, Ontario, Canada. |
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Copyright |
(Copyright © 1997, Elsevier Publishing) |
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DOI |
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PMID |
9441917 |
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Abstract |
Boric acid (H3BO3) has been used in a wide variety of applications--medication, pesticides, and household products. Reports of child poisoning by H3BO3 were common in the clinical literature before 1975. However, a decline in its use as a bacteriostatic agent coupled with increased regulatory control has almost eliminated poisonings by accidental ingestion. Schedule I (Part I, Item 8) of the Hazardous Products Act of Canada, proclaimed in the late 1960s, followed in the wake of concerns about accidental poisoning and prohibits its use in toys. Since that time, scientific knowledge has increased and has led to a reevaluation of the hazard associated with H3BO3. A maximum tolerated dose (MTD) was sought for children in the most susceptible age range, with a view to determine a maximum acceptable concentration (MAC) in toys. The effects of H3BO3 in a variety of exposure scenarios were evaluated. Precedence was given to clinical data in humans, particularly children, since there is no suitable animal model of boric acid intoxication. An extensive search of the pediatric literature was conducted to find a no-observed-adverse-effect level (NOAEL) or a lowest-observed-adverse-effect level (LOAEL). An analysis of the pivotal study to the present assessment resulted in the application of an uncertainty factor of 100 to account for variations in sensitivity among children and for the use of a LOAEL. Based on a pediatric LOAEL of 300 mg/kg body wt, we derived a MTD of 3 mg H3BO3/ kg body wt and a MAC of 9.1 mg H3BO3/g of toy. These results compared favorably with calculations from other human and animal NOAELs/LOAELs. Language: en |