Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
Soil Generic Assessment Criteria for Human Health Risk ... - ESdat
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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948<br />
Barium CASNumber: 7440393 AssessorA: CherylDavies,Delta<br />
Simons<br />
AssessorB:<br />
JenniferStothert,<br />
EntecUKLtd<br />
Finalreview:<br />
Panel/SF<br />
Date 27/03/2009 Date 29/04/2009 Date 25/08/2009<br />
Oral Dermal Inhalation CombineOraland<br />
InhalationTDIs<br />
Justification<br />
ApplyTDIoraltoexposureroutes<br />
ApplyIDoraltoexposureroutes<br />
Yes Yes Yes<br />
No No No<br />
Insufficientdatatoassessnonthresholdeffectsso<br />
HCVbasedonthresholdeffects.<br />
ApplyTDIinhtoexposureroutes<br />
ApplyIDinhtoexposureroutes<br />
No No No<br />
No No No<br />
NR<br />
Insufficientdatatoassessnonthresholdeffectsso<br />
HCVbasedonthresholdeffects.Insufficientdata<br />
withsufficientdetailonderivationtoderiveHCVinh,<br />
useroutetorouteextrapolationfromoralHCV<br />
TDIoral<br />
Recommended<br />
TDIoral<br />
Units<br />
20 ug.kg1.d1<br />
Justification<br />
FSA,COT,CICADsrecommendation<br />
Organisation WebLink LastUpdated DateWebChecked <strong>Health</strong>criteriatype Value InitialUnits CLEAunitsug.kg Confidencerating Basis Value Units UF UFdescription Studytype Description<br />
1.d1<br />
FoodStandardsAgency(FSA) http://www.food.gov.uk/ 01/11/2008 27/03/2009 TDIoral 20 ug.kgbw1.d1 20 NOAEL 0.21 mg.kgbw1.d1 10 10toallow<strong>for</strong>databasedeficiencies<br />
anddifferencesbetweenhumans<br />
Shortterm 11healthymalevolunteerswereadministereddrinkingwater<br />
containingbariumchloride(0mg/l<strong>for</strong>2weeks,5mg/l<strong>for</strong>the<br />
next4weeksand10mg/l<strong>for</strong>thelast4weeks)<br />
CommitteeontheToxicityofChemicalsin<br />
Food,ConsumerProductsandthe<br />
Environment(COT)<br />
http://cot.food.gov.uk/ Draft2008 27/03/2009 TDIoral(samedataasFSA) 20 ug.kgbw1.d1 20 DraftReport NOAEL 0.21 mg.kgbw1.d1 10 10toallow<strong>for</strong>databasedeficiencies<br />
anddifferencesbetweenhumans<br />
Shortterm<br />
11healthymalevolunteerswereadministereddrinkingwater<br />
containingbariumchloride(0mg/l<strong>for</strong>2weeks,5mg/l<strong>for</strong>the<br />
next4weeksand10mg/l<strong>for</strong>thelast4weeks)<br />
IPCSconciseInternationalChemical<br />
<strong>Assessment</strong>Documents(CICADs)<br />
http://inchem.org/pages/cicads.html 2001 27/03/2009 TDIoral 0.02 mg.kgbw1.d1 20 Theuseofa<br />
NOAELfrom<br />
humanstudies<br />
increasesthe<br />
confidenceinthe<br />
derivationofthe<br />
TDI.Theoverall<br />
confidenceis<br />
medium,<br />
reflectingmedium<br />
confidenceinthe<br />
principalstudies<br />
andinthe<br />
database.<br />
NOAEL 0.21 mg.kgbw1.d1 10 10toallow<strong>for</strong>databasedeficiencies<br />
anddifferencesbetweenhumans<br />
Shortterm<br />
Wonesetal.(1990)administered1.5litres/dayofdistilled<br />
drinkingwatercontainingvariouslevelsofbariumchlorideto<br />
11healthymalevolunteersaged27–61years(mean39.5years,<br />
median41years).Bariumconcentrationsinthedrinkingwater<br />
consumedbythesubjectspriortothestudywereknowntobe<br />
verylow.Nobariumwasadded<strong>for</strong>thefirst2weeks,which<br />
servedasacontrolperiod;drinkingwatercontaining5mg<br />
barium/litre(0.14mgbarium/kgbodyweightperdayusing<br />
referencevaluesof2litres/day<strong>for</strong>waterconsumptionand70<br />
kg<strong>for</strong>bodyweight)wasadministered<strong>for</strong>thenext4weeks,and<br />
drinkingwatercontaining10mgbarium/litre(0.21mg<br />
barium/kgbodyweightperday)wasadministered<strong>for</strong>thelast4<br />
weeksofthestudy.DietswerecontrolledtomimicUSdietary<br />
practices.Systolic&diastolicbloodpressuresweremeasured<br />
inthemorningandevening.Bloodwascollectedatthe<br />
beginningandperiodically.Twentyfourhoururinecollections<br />
wereper<strong>for</strong>medattheendofeachstudyperiod.<br />
Organisation<strong>for</strong>EconomicCooperation<br />
andDevelopment(OECD)Screening<br />
In<strong>for</strong>mationDataSet(SIDS)<strong>for</strong>High<br />
ProductionVolumeChemicals<br />
DutchNationalInstitute<strong>for</strong>Public<strong>Health</strong><br />
andtheEnvironment(RIVM)Maximum<br />
Permissible<strong>Risk</strong>(MPR)levels.<br />
http://inchem.org/pages/sids.html 01/07/1999 27/03/2009 In<strong>for</strong>mationonC.I.Pigment<br />
Red53:1DandCredNo.9<br />
http://www.rivm.nl/en/ 01/12/1992 27/03/2009 NoHCV Lowestchronic<br />
NOEC<br />
2900 ug.l1 Chronictoxicity Toxicitystudyoffreshwaterorganisms<br />
<strong>Health</strong>CanadaToxicologicalValues http://www.hcsc.gc.ca/index_e.html 12/09/2008 03/04/2009 MaximumAcceptable<br />
ConcentrationMACindrinking<br />
water<br />
1 mg.l1 28.57 (Roundedupfrom NOAEL 7.3 mg.l1 10 Intraspeciesvariation Epidemiological<br />
0.73mg.l1)<br />
study<br />
Epidemiologicalstudyofpopulationingestingwatercontaining<br />
Ba<br />
USAgency<strong>for</strong>ToxicSubstancesandDiseasehttp://www.atsdr.cdc.gov/ 01/08/2007 26/03/2009 MRL 0.2 mg.kgbw1.d1 200 BMDL5 61.13 mg.kgbw1.d1 300 10<strong>for</strong>extrapolationofanimalsto<br />
Registry(ATDSR)ToxicologicalProfilesand<br />
Minimal<strong>Risk</strong>levels<br />
humans<br />
10<strong>for</strong>humanvariability<br />
3<strong>for</strong>databasedeficiencies<br />
USEPA<strong>Health</strong>Advisors<br />
USEPAIntegrated<strong>Risk</strong>In<strong>for</strong>mationSystem<br />
(IRIS)<br />
http://www.epa.gov/waterscience/criteria/<br />
drinking<br />
Summer2006 08/04/2009 RfDindrinkingwater<strong>for</strong>Child 0.2 mg.kg1.d1 200 DataisfromIris<br />
http://epa.gov/iris/ 11/07/2005 08/04/2009 OralRfD 0.2 mg.kg1.d1 200 Medium BMD05<br />
84<br />
mg.kg1.d1<br />
BMDL05 63<br />
mg.kg1.d1<br />
300 10<strong>for</strong>extrapolation<strong>for</strong>interspecies Chronicand<br />
differences(UFA:animaltohuman); subchronicoral<br />
10<strong>for</strong>considerationofintraspecies<br />
variation(UFH:humanvariability);<br />
and3<strong>for</strong>deficienciesinthedatabase<br />
(UFD).<br />
Chronicoralstudy Mousestudy.Groupsof60maleand60femaleB6C3F1mice<br />
wereadministered0,500,1,250,or2,500ppmbariumchloride<br />
dehydrateindrinkingwater<strong>for</strong>2years.Usingmeasuredbody<br />
weightsandwaterconsumption,theinvestigatorsestimated<br />
thedailybariumdosestobe0,30,75,and160mg<br />
barium/kg/day<strong>for</strong>malesand0,40,90,and200mg<br />
barium/kg/day<strong>for</strong>females.<br />
NTP(1994)exposedbothsexesofF344/Nratsandbothsexes<br />
ofB6C3F1micetobariumchloridedihydrate(BaCl2×2H2O)in<br />
drinkingwater<strong>for</strong>13weeksor2years.Drinkingwater<br />
concentrationsinthechronicstudy(60animals/sex/group)<br />
wereand0,500,1250,and2500ppm.Thestudyauthors<br />
estimateddoses,usingwaterconsumptionandbodyweight<br />
data,as0,15,30,and60mgBa/kgday<strong>for</strong>maleratsand0,15,<br />
45,and75mgBa/kgday<strong>for</strong>femalerats.Theestimateddoses<br />
<strong>for</strong>micewere30,75,and160mgBa/kgday<strong>for</strong>malesand40,<br />
90,and200mgBa/kgday<strong>for</strong>females.Inthesubchronicstudy<br />
(10animals/sex/group),drinkingwaterconcentrationswere0,<br />
125,500,1000,2000,and4000ppm.Estimateddoseswere0,<br />
10,30,65,110,and200mgBa/kgday<strong>for</strong>maleratsand0,10,<br />
35,65,115,and180mgBa/kgday<strong>for</strong>femalerats.Formice,<br />
thecorrespondingestimateddoseswere0,15,55,100,205,<br />
and450mgBa/kgday<strong>for</strong>themalesand0,15,60,110,200,<br />
and495mgBa/kgday<strong>for</strong>thefemales.Theanimalswerefed<br />
anNIH07diet.Bariumwasnotreportedasacontaminantof<br />
thefeed.<br />
Page 1 of 8<br />
EIC Pro<strong>for</strong>ma barium.xls 17/11/2009
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