SAFETYDATASHEET
MATERIAL
hGG Urine Control - Positive | & ll
OSOM@
IDENTIFICATION
AND COMPANY
1. PRODUCT
hGG Urine Control - Positive| & ll
ProductName: OSOM@
Controlll
Controll; hCG UrinePositive
Synonym(s): hCG UrinePositive
hCG UrineControl (Catalog 134).For use in quality control_
#
Set
ProductUse: Component OSOM@
of _
hCG
Test,and OSOM@
CardPregnancy
Test,OSOM@
hCG-Urine
withthe OSOM@
testing
Test.For ln VitroDiagnostic Only.
Use
Urine/Serum
salt,and preservative.
purifiedhCG (gtycoprotein
hormone),
containing
solution
Description: Aqueous
EmerqencvTelephoneNumbers
butor
Manufacturer/Distri
CorporateHeadquarters
GenzymeCorporation: 617-562-4555
GenzymeDiagnostics
GenzymeCorporation
(NorthAmerica):800-424-9300
CHEMTREC
6659 Top Gun Street
500 KendallStreet
(lnternational):703"527-3887
CHEMTREC
San Diego, 92121USA
CA
Cambridge, 02142USA
MA
Fax: 858-452-3258
617-252-7500
Phone:
98
Phone: 858-452-31
Fax: 617-252-7600
IDENTIFICATION
2. HAZARDS
EmergencyOverview:
have
pertaining exposures,
directlyto occupational
properties this preparation,
of
physicaland toxicological
The chemical,
characterized.
not beenthoroughly
PrecautionaryStatements:
The humanhCG in thispreparation testedby
was
witheyesand skin.Do not ingestor inhale.
Avoidcontact
and foundto be negative the presence hepatitis virussurfaceantigen(HBsAg),
B
of
for
methbds
FDA-approved
becauseno test methodcan
virus (HlV) 1 & 2 and hepatitis virus(HCV) However,
C
humanimmunodeficiency
agentsare absent,this productshouldbe handledas a potentially
infectious
providecomplete thai
assurahce
clear,colorless
appearance:
Preparation
Precautions.
with Universal/Standard
material accordance
in
biohazardous
liquid.
Routes of Exposure:
Typicaloccupationalexposure are eye and skincontact.
routes
PotentialHealthEffects:
passages throat.
and
coughing irritation thenasal
of
or
sneezing,
may
inhalation cause
Aerosol
lnhalation
redness tearing'
and
irritation,
Eyeexposure cause
may
Eye
dryness redness'
and
irritation,
contact cause
may
Skin
Skin
or
Ingestion produce irritation discomfort.
digestive
may
Ingestion
exposure this preparation
are
to
oceupational
Chroniceffectsfrom repeated long-term
or
Chronic Effects
unKnown.
Unknown.
TargetOrgans
RegulatoryStatus:
1999/45/EC;
E.C.Directive
underU.S.OSHA29 CFR 1910.1200;
Thispreparation notclassified hazardous
as
is
10/30.
2002No.1689, U.N.GHSST/SG/AC
or
R.S.1985, H-3;U.K.CHIPS
c.
Canadian
equalto or greaterthan 0.1% are listedby
presentin this preparation concentrations
at
Noneof the components
OSHAorACG|Has a carcinogen.
IARC,NTP,
/ INFORMATION INGREDIENTS
ON
3. COMPOSITION
2079-0
14,2005
Date: January
Effective
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Page of6
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Printed: January
Date
SAFETYDATASHEET
MATERIAL
hCG UrineControl- Positivel& ll
OSOM@
ec#
cAs # %
IngredientName
>97
231-791-2
7732-18-5
Water
Class: None
EGHazard
None
EGR-Phrases:
NotAssigned < 1
NotAssigned
(hCG)
Gonadotropin
HumanChorionic
Glass:None
Hazard
EG
None
ECR-Phrases:
0.88
231-598-3
7647-14-5
chloride
Sodium
Class: Xi
ECHazard
R36/38
ECR-Phrases:
0.2
247-852-1
26628-22-8
azide
Sodium
Class:T+,N
ECHazard
R28,R32'R50'R53
ECR-Phrases:
4. FIRSTAID MEASURES
GeneralAdvice:
Precautions treatment
and
Universallstandard
lN THE EVENTOF OVERTExposuRE, followyour employer's
guidelines.
Inhalation:
becomesdifficult if coughor
or
area to fresh air. seek medicalattention breathing
if
movefrom exposure
lf inhaled,
develoP.
othersymPtoms
Eye Gontact:
contactlensesif
removing
fingers.,
eyelids-with
flusheyeswith plentyof tepidwaterwhileseparating
lmmediately or
obtain medicalatterition neededor if symptoms'suchas redness
if
worn.continueto flushfor at least 15 minutes.
persist.
irritation
Skin Contact:
Wash material
ctothing'
flushskinwith copiousamountsof coolwaterand removecontaminated
ln caseof contact,
obtain medicalattention neededor if irritation
if
*ith cteanwater.
from skinwith soapand waterand rinseilrorougftly
develoP.
or othersYmPtoms
Ingestion:
and alert,rinsemouthout with water'obtain
contacta physician instructions. conscious
lf
for
In caseof ingestion,
attention necessary'
if
medical
MEASURES
5. FIREFIGHTING
ProPerties:
Flammable
non-flammable'
solutions typically
are
Aqueous
Suitable ExtinguishingMedia:
foam,dry chemical waterspray'
or
chemical
Carbondioxide,
Specific HazardsArising from the Chemical:
Noneexpected.
standard ProtectiveEquipment and Precautionsfor Firefighters:
and full
Apparatus
self-containedBreathing
shouldwear NlosH-approved equivalent
or
As in any fire,firefighters
gear.
protective
2079-0
Date: January14,2005
Effective
Page of 6
2
14,2005
DatePrinted: January
MATERIALSAFETYDATA SHEET
hCG UrineControl'Positive | & ll
OSOM@
MEASURES
RELEASE
6. ACCIDENTAL
PersonalPrecautions:
wash
contactwith material'
(ppE) as indicated Section8. Avoid physical
in
Wear personalprotective Equipment
afterhandling.
thoroughlY
hands
EnvironmentalPrecautions:
contains smallamountof sodiumazidewhichcan reactwith copper,lead,brassor solderin
a
This preparation
entersdrain,flushwith a largevolume
metalazides. lf preparation
pifi[ilg lyri"rr ano rorm potentiatty
exptosive
of waterto preventazidebuild-up.
Materials Containmentand Glean'Up:
for
Methodsand
time
contact
sufficient
allowing
solution
bleach
hypochlorite
prepared sodium
10%
Disinfect spillsitewitha freshly
the to
paper
pickup com.ptbte, spillsitewithwater-moistened towels
wipe
is
nftLi miteriat
up.
wiping
,i.,jt"rl ueiore
[e'o of
Dispose
container.
waste
in'anappropriate
waste
towets tre spiiled
wit'n
Discard
mJteiiat.
remove remarnrng
any
andprovincial
local
state,
federal,
*"it" in accordance attapplicable
with
,pirr"omaterial c6niamin"t"a
ano
per 13.
regulations, Section
environmental
AND STORAGE
7. HANDLING
Handling:
when preparing handli!9this
or
Precautions
FollowUniversal/Standard
hygienepractices.
Followgood laboratory
controls indicated section8'
in
as
exposure
perionathrotective (PPE)and employ
Equipment
wear proper
material.
handling'
after
iontact.Wash handsthoroughly
Avoidphysical
Storage:
at
storagetemperature(s)
The recommended
storage_co_ndition-s.
Referto producttabetand/orliterature specific
for
or
substances
preparation/revision siore at2 to ti'"c (so to 46'F). Do not storewith incompatible
is:
ir.,"iir" bt MSos
10.
in
identified Section
conditions
underavoidable
PROTECTION
CONTROLS PERSONAL
/
8. EXPOSURE
ExposureGuidelines;
for
limitsglrigltly established
exposure
occupational
Thereare no ACGIH,NIOSH,OSHAor country-specific
(0J% tf carcinogen)'
greaterlhan 1o/o
equalto or
present'in pieparation conienirations
at
iliis
components
EngineeringControls:
measures'
specialventilation
This preparation aqueousand non-volatile is not expected necessitate
to_
and
is
eyewashfountainand a safetyshower'
with an
shouldbe equipped
storingor utitti;g this pieparation
Facilities
Equipment(PPE):
PersonalProtective
undernormalconditions use.
of
A respirator not required
is
Respiratory
787.1-2003'
safety wearas described theANSIstandard
in
protective eye
Wearappropriate
Eye/Face
garmentoveryour
suchas a lab coat or other long-sleeved
protective
clothing,
Wear appropriate
Skin
Changeinto cleanclothespromptlyif
contactand co-niamination clothing.
of
clothes, minimize
to
clothingbeforereuse.
Wash contaminated
clothingbecomescontaminated.
glovesimpermeable this material/preparation'
to
preventskin exposureby wearingprotective
Gloves or
gloves regularly
Change
handling.
gtoves r5commended incidental
for
are
MeObjtgraOe nitrite
or punctured'
torn
immedia[e[ if they are contaminated,
2079-0
Date: January14,2005
Effective
Page3 of 6
14,2005
DatePrinted: January
SAFETYDATASHEET
MATERIAL
hCG Urine Control - Positive l & ll
OSOM@
PersonalProtectiveEquipment (PPE):
the
follow
solution,
bleach
instruments spillsiteswithsodiumhypochlorite
or
lf disinfecting
General
safetymanager/industrial
yourcompany's
handling PPE guidelines. Consult
and
manufacture-r's
with your selection
of
6ygienist your safetyiequipmenthanufacturer/supplierassistance
for
or
PPE.
appropriate
PROPERTIES
AND CHEMICAL
9. PHYSICAL
7.1 (approx.)
pH:
liquid
Clear,colorless
Appearance:
Water-soluble
Solubility:
Notavailable
Odor:
Not available
Vapor Pressure:
Not avaitable
Boiling Point:
Partition Goefficient Not available
Notapplicable
MeltingPoint:
(n-octanol/water):
Not available
FreezingPoint:
Notavailable
Vapor Density:
AND REACTIVITY
10. STABTLITY
StabilitY:
Ghemical
and storageinformation Section7).
in
conditions use and storage;(see handling
of
Stableunderordinary
Conditionsto Avoid:
exposure directsunlight'
Avoidprolonged to
Materials:
Incompatible
agents,acids,heavymetalsand their salts.
Avoidstrongoxidizing
Products:
Decomposition
Hazardous
gasesand vapours.
Thermaldecomposition leadto releaseof irritating
can
Possibility of HazardousReactions:
polymerization not occur.
will
Hazardous
INFORMATION
11. TOXICOLOGICAL
Acute Effects:
to
agents. be irritating
May
presents riskfor exposure infectious
to
material thispreparation a
in
source
Thehuman
theeyesandskin.
Effects:
Ghronic
exposure this
to
occupational
fromrepeated long-term
or
effects
Dataindicating presence absence chronic
of
or
the
available.
preparationnotYet
is
INFORMATION
12. ECOLOGICAL
Ecotoxicity:
available product.
for
No information
2079-O
Date: January 2005
14,
Effective
Page4 of 6
14,2005
January
Printed:
Date
SAFEW DATASHEET
MATERIAL
hCG UrineControl- Positivel& ll
OSOM@
CONSIDERATIONS
13. DISPOSAL
Methods of Disposal:
in
contains smallamountof sodiumazidewhichcan reactwith copper,lead,brassor solder
a
This preparation
entersdrain,flushwith a largevolumeof
metalazides. lf preparation
ano form potentially
explosive
plumbing systems
wasteshouldbe treatedas
and product
nemiining unusedmaterial
il"ifito"pr"uent azidebuild-up. with
in
shouldbe disinfected accordance
instruments surfaces
and
biohazardous/infectious and contaminated
waste
Precautions'
Universal/Standard
your employer's
Packaging:
packaging the sameway as the
in
Handlecontaminated
may retainproductresidues.
Containers this material
of
non-contaminated
differently'
specified
to instructions. not officiatly
lf
itselfand oisfose atcording
substance
wasteor recycled'
be treatedlike household
packagingmay
Waste Classification:
and accurate
wasteregulations ensurecomplete
to
must referto the relevanthazardous
chemicalwastegenerators
may vary according geographic location'
to
regulations
J".iitit"tion. Dijposal
INFORMATION
{ 4. TRANSPORT
:
AdditionalInformation
information'
Genzyme shipping
for
Contact
INFORMATION
15. REGULATORY
US FederalRequlations:
device.
diagnostic
in vitro
Thispreparationa component an FDA-regulated
of
is
Requlations:
lnternational
Directive
Devices
Medical
under ln VitroDiagnostic
the
communities thisproduct regulated
is
use,
lf approved European
for
(98/7elEC).
GanadianHazardousProducts:
Non-controlled
Status
WHMIS
EuropeanCommunitiesDangerousSubstances/Preparations:
ClassNone
ECHazard
None
RiskPhrases
16.OTHERINFORMATION
Use:
Recommended
tn VitroDiagnostic Only' Not for humanor drug use'
Use
For
2079-0
14,2005
Date: January
Effective
Page of 6
5
14,2005
DatePrinted: January
SAFETYDATASHEET
MATERIAL
hCG Urine Control ' Positive l & ll
OSOM@
lnformation:
Further
criteria
effort been.made adhere thehazard
to
to
has
Every
format.
prepared accordance theANSI Z4oo.1
with
in
ThisMSDS been
has
D.irective'
safetyData
communities
Euiopean
Standard,
Communication
osHA Hazard
requirements US
of the 9lq"tg
andcontent Harmonized
Regulations, UNGlobally
and
Information Packaging
prooucti and
Hazard
Regulations, chemical
uK
controlled
canadian
andLabelling Chemicals.
of
System Classification
of
Materials.ldentification (HMIS@) a or
System
using Hazardous
a
workers
trained
ratings thisMSDS for appropriately
are
on
Thehazard rating
(NFpAi projram. ratings estimates should treated such. hazard The
as
be
and
proiection are
The
70i
nstoii"iion
Fire
Nailonal
in theHMls@
lr9-q[r^effects indicated
are
(longterm)
hazards ri-sxs.Chronic
or
to signiRcint
.""i".irng" from(0)minimat hazards 1+;
ratings www.paint.org/hmis'
visit
mark theNPCA. details HMIS@
on
For
of
service
irao"-ano
fl. i-rfurrso a relistereo
is
ov
"n-"Jt"iiir,
Fordetails NFPA visitwww.nfpa.org.
704
on
NFPARATINGS
RATINGS
HMIS@
14,2005
Date: January
Origination
MSDS
#: 1
Version
Date: NotAPPlicable
Revision
Disclaimer:
to
available
currently
information
above provided goodfaith.lt is believed be accurate represents u_qgl tlg
and
to
in
is
Theinformation PURPOSE oF ANY
oR
FITNESS A PARTICULAR
FoR
oF MlRCHANrnetLtrY,
us. Ho\A/EVER, MAKE wnnlnnr.rry
ruo
wE
wrrH REsFEcrro pRobucrs DEScRtBED DATA INFORMATION oR
oR
orHERTypE,EXpREss-D rMpLrED,
oR
DATAOR INFORMATION'
THEUSEOF SUCHPRODUCTS'
NESUTIUC FROM
LIABILITY
NO
PROVIDED, WE NSSUHNC
AND purposes, the.
and user
of theinformation theirparticular
for
to oetermine suitabili$
the
owninvestigations
their
make
should
Users relating the
to
fromtheiruseof therateriai. rhe uslr is req'uired comply all lawsandregulations
with
to
assumes riskarising
all procedures
accepted handling
safe
generally
andmustbefamiliar andfollow
with
purchase, storage oisposat themateriai
of
and
use, indirect'
orfor lostprofits anyspecial,
or
Genzyme liable anyctaims,'toiJes,damages anyindividual
of
or
for
be
shall
In no event
evenif Genzyme beenadvised thepossibility such of
of
has
arisingl
howsoever
damages,
or exemplary
consequential
incidental,
damages.
2079-0
14,2005
Date: January
Effective
Page of 6
6
Printed: January 2005
14,
Date
|