Determination of an acute no-observed-adverse-effect level (NOAEL) for copper in water

M Araya, MC McGoldrick, LM Klevay, JJ Strain, P Robson, F Nielsen, M Olivares, F Pizarro, L Johnson, KA Poirier

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Abstract

A prospective, double-blind controlled study was designed to determine the acute no-observed-adverse-effect level (NOAEL) of nausea in an apparently healthy population of 179 individuals who drank copper-containing water as the sulfate salt. Subjects were recruited at three different international sites and given a blind, randomly selected dose (0, 2, 4, 6, or 8 mg Cu/L) in a bolus of 200 ml (final total copper dose was equivalent to 0, 0.4,0.8,1.2, and 1.6 mg) once weekly over a consecutive 5-week period. Gastrointestinal (GI) symptoms of nausea, abdominal pain, vomiting, or diarrhea were screened for a period of up to 24 h. Nausea was the most frequently reported effect and was reported within the first 15 min of ingestion. For the combined trisite population (n=179),8,9,14,25, and 44 subjects responded positively to one or more GI symptoms at 0, 2, 4, 6, and 8 mg Cu/L, respectively. Analysis of the data demonstrated a clear dose response to the combined positive GI effects and to nausea alone. Statistically significant greater reporting of effects occurred at 6 and 8 mg Cu/L. Therefore, an acute NOAEL and lowest-observed-adverse-effect level of 4 and 6 mg Cu/L (0.8 and 1.2 mg Cu), respectively, were determined in drinking water for a combined international human population. (C) 2001 Academic Press.
LanguageEnglish
Pages137-145
JournalRegulatory Toxicology and Pharmacology
Volume34
Issue number2
DOIs
Publication statusPublished - Oct 2001

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No-Observed-Adverse-Effect Level
Nausea
Copper
Water
Population
Double-Blind Method
Drinking Water
Abdominal Pain
Sulfates
Vomiting
Diarrhea
Salts
Eating

Cite this

Araya, M ; McGoldrick, MC ; Klevay, LM ; Strain, JJ ; Robson, P ; Nielsen, F ; Olivares, M ; Pizarro, F ; Johnson, L ; Poirier, KA. / Determination of an acute no-observed-adverse-effect level (NOAEL) for copper in water. In: Regulatory Toxicology and Pharmacology. 2001 ; Vol. 34, No. 2. pp. 137-145.
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Araya, M, McGoldrick, MC, Klevay, LM, Strain, JJ, Robson, P, Nielsen, F, Olivares, M, Pizarro, F, Johnson, L & Poirier, KA 2001, 'Determination of an acute no-observed-adverse-effect level (NOAEL) for copper in water', Regulatory Toxicology and Pharmacology, vol. 34, no. 2, pp. 137-145. https://doi.org/10.1006/rtph.2001.1492

Determination of an acute no-observed-adverse-effect level (NOAEL) for copper in water. / Araya, M; McGoldrick, MC; Klevay, LM; Strain, JJ; Robson, P; Nielsen, F; Olivares, M; Pizarro, F; Johnson, L; Poirier, KA.

In: Regulatory Toxicology and Pharmacology, Vol. 34, No. 2, 10.2001, p. 137-145.

Research output: Contribution to journalArticle

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T1 - Determination of an acute no-observed-adverse-effect level (NOAEL) for copper in water

AU - Araya, M

AU - McGoldrick, MC

AU - Klevay, LM

AU - Strain, JJ

AU - Robson, P

AU - Nielsen, F

AU - Olivares, M

AU - Pizarro, F

AU - Johnson, L

AU - Poirier, KA

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N2 - A prospective, double-blind controlled study was designed to determine the acute no-observed-adverse-effect level (NOAEL) of nausea in an apparently healthy population of 179 individuals who drank copper-containing water as the sulfate salt. Subjects were recruited at three different international sites and given a blind, randomly selected dose (0, 2, 4, 6, or 8 mg Cu/L) in a bolus of 200 ml (final total copper dose was equivalent to 0, 0.4,0.8,1.2, and 1.6 mg) once weekly over a consecutive 5-week period. Gastrointestinal (GI) symptoms of nausea, abdominal pain, vomiting, or diarrhea were screened for a period of up to 24 h. Nausea was the most frequently reported effect and was reported within the first 15 min of ingestion. For the combined trisite population (n=179),8,9,14,25, and 44 subjects responded positively to one or more GI symptoms at 0, 2, 4, 6, and 8 mg Cu/L, respectively. Analysis of the data demonstrated a clear dose response to the combined positive GI effects and to nausea alone. Statistically significant greater reporting of effects occurred at 6 and 8 mg Cu/L. Therefore, an acute NOAEL and lowest-observed-adverse-effect level of 4 and 6 mg Cu/L (0.8 and 1.2 mg Cu), respectively, were determined in drinking water for a combined international human population. (C) 2001 Academic Press.

AB - A prospective, double-blind controlled study was designed to determine the acute no-observed-adverse-effect level (NOAEL) of nausea in an apparently healthy population of 179 individuals who drank copper-containing water as the sulfate salt. Subjects were recruited at three different international sites and given a blind, randomly selected dose (0, 2, 4, 6, or 8 mg Cu/L) in a bolus of 200 ml (final total copper dose was equivalent to 0, 0.4,0.8,1.2, and 1.6 mg) once weekly over a consecutive 5-week period. Gastrointestinal (GI) symptoms of nausea, abdominal pain, vomiting, or diarrhea were screened for a period of up to 24 h. Nausea was the most frequently reported effect and was reported within the first 15 min of ingestion. For the combined trisite population (n=179),8,9,14,25, and 44 subjects responded positively to one or more GI symptoms at 0, 2, 4, 6, and 8 mg Cu/L, respectively. Analysis of the data demonstrated a clear dose response to the combined positive GI effects and to nausea alone. Statistically significant greater reporting of effects occurred at 6 and 8 mg Cu/L. Therefore, an acute NOAEL and lowest-observed-adverse-effect level of 4 and 6 mg Cu/L (0.8 and 1.2 mg Cu), respectively, were determined in drinking water for a combined international human population. (C) 2001 Academic Press.

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DO - 10.1006/rtph.2001.1492

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