Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study
In a double blind, 3 × 3 factorial (volume × dose) study, 70 adult females (18–60 years of age) at four different international sites (total pooled n=269) were given 100, 150, or 200 ml of bottled drinking water with 0.4, 0.8, or 1.2 mg of copper (Cu) as the sulfate salt once each week. Two addition...
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| Veröffentlicht in: | Regulatory toxicology and pharmacology 2003-12, Vol.38 (3), p.389-399 |
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| creator | Araya, Magdalena Chen, Bingheng Klevay, Leslie M Strain, J.J Johnson, LuAnn Robson, Paula Shi, Wei Nielsen, Forrest Zhu, Huigang Olivares, Manuel Pizarro, Fernando Haber, Lynne T |
| description | In a double blind, 3
×
3 factorial (volume
×
dose) study, 70 adult females (18–60 years of age) at four different international sites (total pooled
n=269) were given 100, 150, or 200
ml of bottled drinking water with 0.4, 0.8, or 1.2
mg of copper (Cu) as the sulfate salt once each week. Two additional doses (0 and 1.6
mg Cu) were added at the 200
ml volume to determine a dose–response relationship and corroborate previously reported results. All subjects completed a questionnaire at 0, 0.25, and 1
h post-dosing that screened for positive gastrointestinal (GI) effects (nausea, vomiting, abdominal pain, and diarrhea). Nausea was the most prevalent symptom reported and was generally reported within the first 15
min (water volume,
p |
| doi_str_mv | 10.1016/j.yrtph.2003.08.001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_16168315</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0273230003001041</els_id><sourcerecordid>16168315</sourcerecordid><originalsourceid>FETCH-LOGICAL-c327t-386154b843f6a283dcee19eb75220532bfc2b635e6ad252aaa3cfce564c2d3a53</originalsourceid><addsrcrecordid>eNp9kU2P0zAQhi0EYsvCL0ACn7gl-CNxnQMHVPElrcQB9mw59nhxSexiO1317_BLcTeVOMHJkud5Z0bzIPSSkpYSKt7u21Mqhx8tI4S3RLaE0EdoQ8kgGsKG_jHaELblDeOEXKFnOe8JIUzK7VN0RTvBeCflBv3exeB8mnXxMeDosA5Ym6UADrGJY4Z0BNtoe4SUoQHnwJTKWDzF-3_WJzjChF1M2MTDARL2AY-xlAkstsmHnz7c4Xtd1orG8zIV32Rfp_pQf8PDNnrCuSz29Bw9cXrK8OLyXqPbjx--7z43N18_fdm9v2kMZ9vScClo342y405oJrk1AHSAcdszRnrORmfYKHgPQlvWM601N85ALzrDLNc9v0Zv1r6HFH8tkIuafTYwTTpAXLKiggrJ6RnkK2hSzDmBU4fkZ51OihJ1VqP26kGNOqtRRKqqpqZeXdov4wz2b-biogKvV8DpqPRd8lndfmM1SehQZ9OhEu9WAuoZjh6SysZDMGB9qndXNvr_rvAHgcuuTg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>16168315</pqid></control><display><type>article</type><title>Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><creator>Araya, Magdalena ; Chen, Bingheng ; Klevay, Leslie M ; Strain, J.J ; Johnson, LuAnn ; Robson, Paula ; Shi, Wei ; Nielsen, Forrest ; Zhu, Huigang ; Olivares, Manuel ; Pizarro, Fernando ; Haber, Lynne T</creator><creatorcontrib>Araya, Magdalena ; Chen, Bingheng ; Klevay, Leslie M ; Strain, J.J ; Johnson, LuAnn ; Robson, Paula ; Shi, Wei ; Nielsen, Forrest ; Zhu, Huigang ; Olivares, Manuel ; Pizarro, Fernando ; Haber, Lynne T</creatorcontrib><description>In a double blind, 3
×
3 factorial (volume
×
dose) study, 70 adult females (18–60 years of age) at four different international sites (total pooled
n=269) were given 100, 150, or 200
ml of bottled drinking water with 0.4, 0.8, or 1.2
mg of copper (Cu) as the sulfate salt once each week. Two additional doses (0 and 1.6
mg Cu) were added at the 200
ml volume to determine a dose–response relationship and corroborate previously reported results. All subjects completed a questionnaire at 0, 0.25, and 1
h post-dosing that screened for positive gastrointestinal (GI) effects (nausea, vomiting, abdominal pain, and diarrhea). Nausea was the most prevalent symptom reported and was generally reported within the first 15
min (water volume,
p<0.032; copper dose,
p<0.0001; and water volume
×
copper interaction,
p<0.97). As volume increased, the effect of Cu-induced nausea decreased; as Cu dose increased, the incidence of nausea increased. At 200
ml, a significant increase in reported incidence of nausea at 0.25
h occurred at 1.2 mg Cu (6
mg Cu/L), indicating a NOAEL of 0.8
mg Cu (4
mg Cu/L) for adult females. These data confirm a previously determined human acute NOAEL for Cu added to distilled water, and provide additional, controlled human data for determining safe concentrations of Cu in drinking water.</description><identifier>ISSN: 0273-2300</identifier><identifier>ISSN: 1096-0295</identifier><identifier>EISSN: 1096-0295</identifier><identifier>DOI: 10.1016/j.yrtph.2003.08.001</identifier><identifier>PMID: 14623488</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Acute exposure ; Administration, Oral ; Adolescent ; Adult ; adults ; Aged ; Bottled water ; chemical risk assessment ; Copper ; Copper Sulfate - administration & dosage ; Copper Sulfate - adverse effects ; Copper Sulfate - pharmacokinetics ; diarrhea ; Dose-Response Relationship, Drug ; Dose–response ; Double-Blind Method ; double-blind studies ; Drinking ; drinking water ; Female ; gastrointestinal system ; heavy metals ; Humans ; International Cooperation ; lowest observed effect level ; Middle Aged ; Mineral Waters - administration & dosage ; Mineral Waters - adverse effects ; Mineral Waters - analysis ; Nausea ; Nausea - chemically induced ; No-Observed-Adverse-Effect Level ; NOAEL ; questionnaires ; Reproducibility of Results ; Risk assessment ; signs and symptoms (animals and humans) ; Stomach - drug effects ; Upper Safe Limit ; vomiting ; Water - chemistry ; women</subject><ispartof>Regulatory toxicology and pharmacology, 2003-12, Vol.38 (3), p.389-399</ispartof><rights>2003 Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c327t-386154b843f6a283dcee19eb75220532bfc2b635e6ad252aaa3cfce564c2d3a53</citedby><cites>FETCH-LOGICAL-c327t-386154b843f6a283dcee19eb75220532bfc2b635e6ad252aaa3cfce564c2d3a53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.yrtph.2003.08.001$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14623488$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Araya, Magdalena</creatorcontrib><creatorcontrib>Chen, Bingheng</creatorcontrib><creatorcontrib>Klevay, Leslie M</creatorcontrib><creatorcontrib>Strain, J.J</creatorcontrib><creatorcontrib>Johnson, LuAnn</creatorcontrib><creatorcontrib>Robson, Paula</creatorcontrib><creatorcontrib>Shi, Wei</creatorcontrib><creatorcontrib>Nielsen, Forrest</creatorcontrib><creatorcontrib>Zhu, Huigang</creatorcontrib><creatorcontrib>Olivares, Manuel</creatorcontrib><creatorcontrib>Pizarro, Fernando</creatorcontrib><creatorcontrib>Haber, Lynne T</creatorcontrib><title>Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study</title><title>Regulatory toxicology and pharmacology</title><addtitle>Regul Toxicol Pharmacol</addtitle><description>In a double blind, 3
×
3 factorial (volume
×
dose) study, 70 adult females (18–60 years of age) at four different international sites (total pooled
n=269) were given 100, 150, or 200
ml of bottled drinking water with 0.4, 0.8, or 1.2
mg of copper (Cu) as the sulfate salt once each week. Two additional doses (0 and 1.6
mg Cu) were added at the 200
ml volume to determine a dose–response relationship and corroborate previously reported results. All subjects completed a questionnaire at 0, 0.25, and 1
h post-dosing that screened for positive gastrointestinal (GI) effects (nausea, vomiting, abdominal pain, and diarrhea). Nausea was the most prevalent symptom reported and was generally reported within the first 15
min (water volume,
p<0.032; copper dose,
p<0.0001; and water volume
×
copper interaction,
p<0.97). As volume increased, the effect of Cu-induced nausea decreased; as Cu dose increased, the incidence of nausea increased. At 200
ml, a significant increase in reported incidence of nausea at 0.25
h occurred at 1.2 mg Cu (6
mg Cu/L), indicating a NOAEL of 0.8
mg Cu (4
mg Cu/L) for adult females. These data confirm a previously determined human acute NOAEL for Cu added to distilled water, and provide additional, controlled human data for determining safe concentrations of Cu in drinking water.</description><subject>Acute exposure</subject><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>adults</subject><subject>Aged</subject><subject>Bottled water</subject><subject>chemical risk assessment</subject><subject>Copper</subject><subject>Copper Sulfate - administration & dosage</subject><subject>Copper Sulfate - adverse effects</subject><subject>Copper Sulfate - pharmacokinetics</subject><subject>diarrhea</subject><subject>Dose-Response Relationship, Drug</subject><subject>Dose–response</subject><subject>Double-Blind Method</subject><subject>double-blind studies</subject><subject>Drinking</subject><subject>drinking water</subject><subject>Female</subject><subject>gastrointestinal system</subject><subject>heavy metals</subject><subject>Humans</subject><subject>International Cooperation</subject><subject>lowest observed effect level</subject><subject>Middle Aged</subject><subject>Mineral Waters - administration & dosage</subject><subject>Mineral Waters - adverse effects</subject><subject>Mineral Waters - analysis</subject><subject>Nausea</subject><subject>Nausea - chemically induced</subject><subject>No-Observed-Adverse-Effect Level</subject><subject>NOAEL</subject><subject>questionnaires</subject><subject>Reproducibility of Results</subject><subject>Risk assessment</subject><subject>signs and symptoms (animals and humans)</subject><subject>Stomach - drug effects</subject><subject>Upper Safe Limit</subject><subject>vomiting</subject><subject>Water - chemistry</subject><subject>women</subject><issn>0273-2300</issn><issn>1096-0295</issn><issn>1096-0295</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU2P0zAQhi0EYsvCL0ACn7gl-CNxnQMHVPElrcQB9mw59nhxSexiO1317_BLcTeVOMHJkud5Z0bzIPSSkpYSKt7u21Mqhx8tI4S3RLaE0EdoQ8kgGsKG_jHaELblDeOEXKFnOe8JIUzK7VN0RTvBeCflBv3exeB8mnXxMeDosA5Ym6UADrGJY4Z0BNtoe4SUoQHnwJTKWDzF-3_WJzjChF1M2MTDARL2AY-xlAkstsmHnz7c4Xtd1orG8zIV32Rfp_pQf8PDNnrCuSz29Bw9cXrK8OLyXqPbjx--7z43N18_fdm9v2kMZ9vScClo342y405oJrk1AHSAcdszRnrORmfYKHgPQlvWM601N85ALzrDLNc9v0Zv1r6HFH8tkIuafTYwTTpAXLKiggrJ6RnkK2hSzDmBU4fkZ51OihJ1VqP26kGNOqtRRKqqpqZeXdov4wz2b-biogKvV8DpqPRd8lndfmM1SehQZ9OhEu9WAuoZjh6SysZDMGB9qndXNvr_rvAHgcuuTg</recordid><startdate>200312</startdate><enddate>200312</enddate><creator>Araya, Magdalena</creator><creator>Chen, Bingheng</creator><creator>Klevay, Leslie M</creator><creator>Strain, J.J</creator><creator>Johnson, LuAnn</creator><creator>Robson, Paula</creator><creator>Shi, Wei</creator><creator>Nielsen, Forrest</creator><creator>Zhu, Huigang</creator><creator>Olivares, Manuel</creator><creator>Pizarro, Fernando</creator><creator>Haber, Lynne T</creator><general>Elsevier Inc</general><scope>FBQ</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QH</scope><scope>7T2</scope><scope>7TV</scope><scope>7U2</scope><scope>7U7</scope><scope>7UA</scope><scope>C1K</scope></search><sort><creationdate>200312</creationdate><title>Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study</title><author>Araya, Magdalena ; Chen, Bingheng ; Klevay, Leslie M ; Strain, J.J ; Johnson, LuAnn ; Robson, Paula ; Shi, Wei ; Nielsen, Forrest ; Zhu, Huigang ; Olivares, Manuel ; Pizarro, Fernando ; Haber, Lynne T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c327t-386154b843f6a283dcee19eb75220532bfc2b635e6ad252aaa3cfce564c2d3a53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Acute exposure</topic><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>adults</topic><topic>Aged</topic><topic>Bottled water</topic><topic>chemical risk assessment</topic><topic>Copper</topic><topic>Copper Sulfate - administration & dosage</topic><topic>Copper Sulfate - adverse effects</topic><topic>Copper Sulfate - pharmacokinetics</topic><topic>diarrhea</topic><topic>Dose-Response Relationship, Drug</topic><topic>Dose–response</topic><topic>Double-Blind Method</topic><topic>double-blind studies</topic><topic>Drinking</topic><topic>drinking water</topic><topic>Female</topic><topic>gastrointestinal system</topic><topic>heavy metals</topic><topic>Humans</topic><topic>International Cooperation</topic><topic>lowest observed effect level</topic><topic>Middle Aged</topic><topic>Mineral Waters - administration & dosage</topic><topic>Mineral Waters - adverse effects</topic><topic>Mineral Waters - analysis</topic><topic>Nausea</topic><topic>Nausea - chemically induced</topic><topic>No-Observed-Adverse-Effect Level</topic><topic>NOAEL</topic><topic>questionnaires</topic><topic>Reproducibility of Results</topic><topic>Risk assessment</topic><topic>signs and symptoms (animals and humans)</topic><topic>Stomach - drug effects</topic><topic>Upper Safe Limit</topic><topic>vomiting</topic><topic>Water - chemistry</topic><topic>women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Araya, Magdalena</creatorcontrib><creatorcontrib>Chen, Bingheng</creatorcontrib><creatorcontrib>Klevay, Leslie M</creatorcontrib><creatorcontrib>Strain, J.J</creatorcontrib><creatorcontrib>Johnson, LuAnn</creatorcontrib><creatorcontrib>Robson, Paula</creatorcontrib><creatorcontrib>Shi, Wei</creatorcontrib><creatorcontrib>Nielsen, Forrest</creatorcontrib><creatorcontrib>Zhu, Huigang</creatorcontrib><creatorcontrib>Olivares, Manuel</creatorcontrib><creatorcontrib>Pizarro, Fernando</creatorcontrib><creatorcontrib>Haber, Lynne T</creatorcontrib><collection>AGRIS</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Aqualine</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Pollution Abstracts</collection><collection>Safety Science and Risk</collection><collection>Toxicology Abstracts</collection><collection>Water Resources Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Regulatory toxicology and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Araya, Magdalena</au><au>Chen, Bingheng</au><au>Klevay, Leslie M</au><au>Strain, J.J</au><au>Johnson, LuAnn</au><au>Robson, Paula</au><au>Shi, Wei</au><au>Nielsen, Forrest</au><au>Zhu, Huigang</au><au>Olivares, Manuel</au><au>Pizarro, Fernando</au><au>Haber, Lynne T</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study</atitle><jtitle>Regulatory toxicology and pharmacology</jtitle><addtitle>Regul Toxicol Pharmacol</addtitle><date>2003-12</date><risdate>2003</risdate><volume>38</volume><issue>3</issue><spage>389</spage><epage>399</epage><pages>389-399</pages><issn>0273-2300</issn><issn>1096-0295</issn><eissn>1096-0295</eissn><abstract>In a double blind, 3
×
3 factorial (volume
×
dose) study, 70 adult females (18–60 years of age) at four different international sites (total pooled
n=269) were given 100, 150, or 200
ml of bottled drinking water with 0.4, 0.8, or 1.2
mg of copper (Cu) as the sulfate salt once each week. Two additional doses (0 and 1.6
mg Cu) were added at the 200
ml volume to determine a dose–response relationship and corroborate previously reported results. All subjects completed a questionnaire at 0, 0.25, and 1
h post-dosing that screened for positive gastrointestinal (GI) effects (nausea, vomiting, abdominal pain, and diarrhea). Nausea was the most prevalent symptom reported and was generally reported within the first 15
min (water volume,
p<0.032; copper dose,
p<0.0001; and water volume
×
copper interaction,
p<0.97). As volume increased, the effect of Cu-induced nausea decreased; as Cu dose increased, the incidence of nausea increased. At 200
ml, a significant increase in reported incidence of nausea at 0.25
h occurred at 1.2 mg Cu (6
mg Cu/L), indicating a NOAEL of 0.8
mg Cu (4
mg Cu/L) for adult females. These data confirm a previously determined human acute NOAEL for Cu added to distilled water, and provide additional, controlled human data for determining safe concentrations of Cu in drinking water.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>14623488</pmid><doi>10.1016/j.yrtph.2003.08.001</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0273-2300 |
| ispartof | Regulatory toxicology and pharmacology, 2003-12, Vol.38 (3), p.389-399 |
| issn | 0273-2300 1096-0295 1096-0295 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_16168315 |
| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Acute exposure Administration, Oral Adolescent Adult adults Aged Bottled water chemical risk assessment Copper Copper Sulfate - administration & dosage Copper Sulfate - adverse effects Copper Sulfate - pharmacokinetics diarrhea Dose-Response Relationship, Drug Dose–response Double-Blind Method double-blind studies Drinking drinking water Female gastrointestinal system heavy metals Humans International Cooperation lowest observed effect level Middle Aged Mineral Waters - administration & dosage Mineral Waters - adverse effects Mineral Waters - analysis Nausea Nausea - chemically induced No-Observed-Adverse-Effect Level NOAEL questionnaires Reproducibility of Results Risk assessment signs and symptoms (animals and humans) Stomach - drug effects Upper Safe Limit vomiting Water - chemistry women |
| title | Confirmation of an acute no-observed-adverse-effect and low-observed-adverse-effect level for copper in bottled drinking water in a multi-site international study |
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