MATERIALSAFETYDATA SHEET
Strep A PositiveControl
OSOM@
AND COMPANY
IDENTIFICATION
1. PRODUCT
Strep A Positive Control
Product Name: OSOM@
Control;UltraStrepA PositiveControl
Synonym(s): StrepA Positive
StrepA Test kit (catalog 141 &
#
Only.Component OSOM@
of
Product Use: For In Vitro Diagnostic
Use
UltraStrepA Testkit (catalog 147, 149& 149E).For externalquality
#
141E)and OSOM@
controltesting.
and preservative.
heat-inactivated
bacteria
containing
Description: Aqueoussolution
Manufacturer/Distributor TelephoneNumbers
Emerqencv
GorporateHeadq uarters
(U.S.):+1 617-562-4555
Genzyme
GenzymeDiagnostics
GenzymeGorporation
(U.S.):1-800424-9300
CHEMTREC
6659 Top Gun Street
500 KendallStreet
(Outside U.S.):+1 703-527-3887
CHEMTREC
San Diego,C492121
Cambridge,M402142
USA
USA
Phone: +1 858-452-3198
Phone: +1617-252-7500
Distributor
GenzymeDiagnostics
50 GibsonDrive
KingsHill,WestMalling
Kent,ME194AF
UK
Phone: +44 (0) 1732220022
2. HAZARDSIDENTIFICATION
PrecautionaryStatements:
properties thispreparation notbeen
physical toxicological
The of have thoroughly
CAUTION! chemical, and
Preparation
characterized. contact eyesandskin.Do notingest inhale. Harmful ingestion.
by
Avoid with or
appearance: colorless liquid.
clear,
Routes Exposure:
of
mayinclude contact, contact skinabsorption.
eye and
Occupational
exposureroutes skin
Potential
HealthEffects:
inhalation cause
may coughing sorethroat.
and
Aerosol
lnhalation
irritation,
redness watering.
Eyeexposure cause
may and
Eye
may irritation,
dryness redness. Sodium azide
maybeabsorbed
through
Skincontact cause and
Skin
theskinandresult systemic
in effects.
pressure,
Ingestion cause
may nausea, vomiting,headache, lowering blood
slight of
diarrhea,
Ingestion
pain,and a general
feeling apprehension unwellness.
of and
abdominal
No data available.
Chronic Effects
Sodiumazide: Cardiovascular centralnervoussystem.
Target Organs and
2075-2
EffectiveDate: May 03, 2007
Page of8
1
Date Printed: May 03,2007
MATERIALSAFETYDATA SHEET
Strep A PositiveControl
OSOM@
RegulatoryStatus:
E.C.Directive
19991451EC;
underU.S.OSHA29 CFR 1910.1200;
Thispreparation classified hazardous
as
is
10/30'
R.S.1985.c. H-3:U.K.CHIPS2002No, 1689;and/orU.N.GHS ST/SG/AC
Canadian
equalto or greaterthan 0.1% are listedby
presentin this preparation concentrations
at
Noneof the components
IARC,NTP,OSHAor ACGIHas a carcinogen.
PotentialEnvironmentalEffects:
Unknown.
I INFORMATION INGREDIENTS
ON
3. COMPOSITION
cAs# % (wt/wt)
EC#
Name
Ingredient
93 - 96
231-791-2
7732-18-5
Water
Glass: None
None ECHazard
EGR-Phrases:
1- 5
NotAssigned
Non-viable
GroupA Streptococci Not Assigned
Class:None
ECR-Phrases:None ECHazard
azide
Sodium 26628-22-8 247-852-1 0.1
R28,R32,R50,R53 Class: T+,N
ECR-Phrases: ECHazard
4, FIRSTAID MEASURES
lnhalation:
movefrom exposure
lf inhaled, area to fresh air. Seek medicalattention breathing
if becomesdifficult if coughor
or
othersymptoms develop.
Eye Contact:
flusheyeswith plentyof tepidwaterfor 15 minutes
lmmediately whileseparatingeyelidswith fingers.Removecontact
persist.
lensesif worn.Obtainmedicalattention neededor if symptoms,
if suchas rednessor irritation
Skin Contact:
In caseof contact,
flushskinwith copiousamountsof coolwaterand removecontaminated
clothing.
Obtainmedical
attention neededor if irritation othersymptoms
if or develop.
Ingestion:
contacta poisoncontrolcenteror physician instructions.
ln caseof ingestion, for
5. FIREFIGHTING
MEASURES
FlammableProperties:
Dilute
aqueous solution consideredfirehazard.
not a
Suitable
Extinguishing Media:
Useextinguishing suitable surrounding such carbon
media for fire, as dioxide, foam, chemical water
chemical dry or
spray.
Extinguishing
Unsuitable Media:
Unknown.
Specific Arisingfromthe Chemical:
Hazards
Whenheated decomposition, produce
to may hydrazoic fumes.
acid
EffectiveDate: May 03, 2007 2075-2
Date Printed: May 03,2007 2
Page of 8
DATASHEET
SAFETY
MATERIAL
Strep A PositiveControl
OSOM@
StandardProtectiveEquipment and Precautionsfor Firefighters:
gear.
and full protective
Apparatus
Breathing
Self-Contained
shouldwear N1OSH-approved equivalent
or
Firefighters
MEASURES
RELEASE
6. ACCIDENTAL
PersonalPrecautions:
(PPE)as indicated Section8. Avoid physical Wash
contactwith material.
in
ProtectiveEquipment
Wear Personal
afterhandling.
handsthoroughly
Precautions:
Environmental
contains smallamountof sodiumazidewhichcan reactwith copper,lead,brassor solderin
preparation a
This
metalazides.Followproperdisposalprocedures.
and form potentially
plumbing explosive
systems
Methodsand Materials Containmentand Clean-Up:
for
standardprocedures.
Dispose of
Decontaminate spillsitefollowing
the
Absorbspillwith inertmaterial/sorbent.
per
federal,state,localand provincial regulations, Section
environmental
with all applicable
materials accordance
in
13.
AND STORAGE
7. HANDLING
Handling:
hygienepractices.
Followgood laboratory Controls.
Minimizecontactand contamination
See Section8, Engineering
of personal and skin.Wash handsthoroughly
afterhandling.
clothing
Storage:
Storeat 15 to 30"C (59 to B6'F). Keepcontainer
tightlyclosed.Do not storewith incompatible
substances;
see
10.
Section
PROTECTION
/
8. EXPOSURE
CONTROLS PERSONAL
Exposure
Guidelines:
Canada- Quebec - Occupational Exposure Limils - Ceilings
26628-22-g 0.11ppm Ceiling; mg/m3Ceiling
0.3
Sodium azide
lndicative Occupational Exposure Limit Values 0OELV) - Skin Notations
EU - Occupational Exposure Directive (20001391EC't
26628-22-g possibility significant
of uptakethroughthe skin
Sodium azide
lndicative Occupational Exposure Limit Values (IOELV)- STELs
EU . Occupational Exposure Directive (2000/39/EC)
26628-22-8 0.3 mg/m3STEL
Sodium azide
-
EU- Occupational (2000/3g/EC) LimitValues(IOELV) TWAs
Indicative
Exposure Occupational
Exposure
Directive
26628-22-8 0.1mg/m3 TWA
Sodiumazide
Germany - DFG - Recommended Exposure Limits - Ceilings (Peak Limitations)
26628-22-8 0.4 mg/m3Peak (inhalable fraction)
Sodiumazide
- - Limits. MAKValues
GermanyDFG Recommended
Exposure
26628-22-A 0.2 mg/m3MAK (inhalablefraction)
azide
Sodium
-
Germany TRGS - Occupational Limits- TWAs
900 Exposure
26628-22-8 0.2mg/m3TWA
Sodiumazide
ExposureLimits - Geilings
lsrael . Occupational
26628-22^8 0.29mg/m3Ceiling NaN3);0.11 ppm Ceiling(as Hydrazoic
(as
azide acid,vapor)
Sodium
Korea- Occupational ExposureLimits - Geilings
26628-22-g 0.1 ppm Ceiling; mg/m3Ceiling
azide 0.3
Sodium
Controls:
Engineering
Thispreparationaqueous non-volatile is notexpected require
is and and to ventilation
measures.
Facilities
special
storing utilizing preparation
or this should equipped an eyewash
be with fountain.
(PPE):
Protective
Personal Equipment
Respiratory A respirator not required
is undernormalconditions use.
of
protective safetyglasses.
Eye/Face Wear appropriate chemical
2075-2
Effective
Date: May03,2007
Page of 8
3
DatePrinted: May03,2007
MATERIALSAFETYDATA SHEET
Strep A PositiveGontrol
OSOM@
PersonalProtectiveEquipment (PPE):
clothingpromptly'
Wear lab coat or otherprotective
garments.
Removecontaminated
Skin
protective
gloves.
Wear chemicalresistant
Gloves
safetyprocedures.
Followcompany-specific
General
PROPERTIES
AND GHEMICAL
9. PHYSICAL
7.2 (approximate)
pH:
liquid
Clear,colorless
Appearance:
Water-soluble
Solubility:
Not available
Odor:
Not available
Vapor Pressure:
Not available
Boiling Point:
Not available
Partition Coefficient
Not applicable
MeltingPoint:
(n-octanol/water):
Not available
FreezingPoint:
Not available
Vapor Density:
Limitsi n Air, Lower:
lity/Explosivity
Flammabi Not available
Flammability/Explosivity in Air, Upper:
Limits Notavailable
Temperature:Notavailable
Auto-lgnition
Not available
FlashPoint:
AND REACTIVITY
10. STABILITY
ChemicalStability:
(see handlingand storageinformation Section7).
in
conditions use and storage;
of
Stableunderordinary
Conditionsto Avoid:
Avoidprolongedexposure directsunlight.
to
IncompatibleMaterials:
agents,acids,heavymetalsand theirsalts.
Avoid strongoxidizing
HazardousDecompositionProducts:
undernormalconditions use.
of
Noneexpected
Possibility of HazardousReactions:
polymerization not occur.
will
Hazardous
INFORMATION
11. TOXICOLOGICAL
Acute Effects:
Toxicology - Selected
Data LD50s LG50s
and
Sodiumazide Oral LD50 Rat:27 mg/kg, DermalLD50 Rabbil 20 mglkg
26628-22-8
Local Effects:
No dataavailable.
Chronic Effects:
No dataavailable.
2075-2
EffectiveDate: May 03,2007
Page4 of 8
Date Printed: May 03, 2007
MATERIALSAFETYDATA SHEET
Strep A PositiveControl
OSOM@
Garcinogenicity:
equalto or greaterthan 0.1%are listedby
presentin this preparation concentrations
at
Noneof the components
IARC,NTP,OSHAorACG|Has a carcinogen.
-
- LimitsValues Carcinogens
ACGIH Threshold
(as
26628-22-8 44 - NotClassifiable a Human Carcinogen sodium
as
Sodiumazide
azide hYdrazoic vaPor)
acid
and
Mutagenicity:
No dataavailable.
Teratogenicity:
No data available.
ReproductiveEffects:
No data available.
Sensitization:
No dataavailable.
INFORMATION
12. ECOLOGICAL
Ecotoxicity:
Ecotoxicity - Freshwater Fish Species Data
mykiss:0.8 mg/L;96 Hr LC50
96 Hr LC50Oncorhynchus
26628-22-8
Sodiumazide
macrochirus: mg/L;96 Hr LC50 Pimephales
0.7
Lepomis
promelas:5.46mg/L[flow-through]
Persistance Degradability:
and
Nodataavailable.
Potential:
Bioaccumulative
Nodataavailable.
Media:
Mobility Environmental
in
Nodataavailable.
CONSIDERATIONS
13. DISPOSAL
Methodsof Disposal:
contains smallamountof sodiumazidewhichcan reactwith copper,lead,brassor solderin
This preparation a
entersdrain,flushwith a largevolumeof
metalazides. lf preparation
and form potentially
explosive
ptumbinisystems
with all applicable
and waste in accordance
Disposeof unusedproduct, spilledmaterial
pr6vent azidebuild-up.
waterto
federal,state,localand provincial wasteregulations.
environmental hazardous
and
Waste Classification:
California 22CCR- Presumed
- Hazardous
Wastes
lgnitable;Reactive
26628-22-8
Sodiumazide
-
Act)- P Series ToxicWastes
Wastes Acutely
(Resource
Conservation Recovery
&
RCRA
P105
26628-22-8 wastenumber
Sodiumazide
INFORMATION
14.TRANSPORT
2075-2
Date: May03,2007
Effective
Page of I
5
DatePrinted: MaY 2007
03,
SAFETYDATASHEET
MATERIAL
Strep A PositiveGontrol
OSOM@
:
Basic ShippingDescriPtion
GoodsClassification
(IATA)Dangerous
Association
International Transport
Air
UN Number: 3316
UN
Kit
Name:Chemical
Shipping
Proper
Class:9
Hazard
HazardLabel:Miscellaneous
Group: lll
PG
Packing
Instruction: 5
Y91
Packaging
quantities)
SpecialProvisions: (excepted
A44
(DOT)
U.S. Department Transportation
of
ORM-D
Commodity,
Consumer
INFORMATION
15. REGULATORY
US Federal Requlations:
device.
This preparation a component an FDA-regulated vitrodiagnostic
in
of
is
-
CERCLA/SARA HazardousSubstancesand their ReportableQuantities
26628-22-8 1000lb finalRQ; 454kg final RQ
Sodiumazide
-
CERCLA/SARA Section 302 ExtremelyHazardousSubstancesEPCRARQs
RQ
26628-22-8 1000Ib EPCRA
Sodiumazide
- Section Extremely TPQs
Substances
Hazardous
302
CERCLA/SARA
26628-22-8 500lb TPQ(Thismaterial a reactive
solid.TheTPQdoes
is
Sodiumazide
pounds non-powder, non-molten,
for
notdefault 10000
to
form)
non-solvent
CERCLATSAM- Section 313 - Emission Reporting
1.0 % de minimisconcentration
26628-22-8
Sodiumazide
-
- 8(b)lnventory
States Section
Inventory United OSCA)
Present
26628-22-g
Sodiumazide
USStateRequlations:
California- 8 CCRSection 339 - Director's List of HazardousSubstances
26628-22-A Present
Sodiumazide
2075-2
Date: May 03, 2007
Effective
Page6 of 8
Date Printed: MaY03, 2007
MATERIALSAFETYDATA SHEET
Strep A PositiveControl
OSOM@
lnternational Requlations:
MedicalDevicesDirective
use,this productis regulated
underthe In Vitro Diagnostic
Communities
lf approved European
for
(98/79/EC).
Canada- WHMIS- Classificationsof Substances
26628-22-8 D1A
Sodiumazide
Canada- WHMIS- IngredientDisclosure List
26628-22-8 1o/o
Sodiumazide
EU - Dangeroussubstances Directive(67/548/EEC)Annex | - classification
-
26628-22-g f+;R28 R32 N;R50-53
Sodiumazide
EU - DangerousSubstancesDirective(67l548lEECl Annex | 'Safety Phrases
-
26628-22-8 S:1/2-28-45-60-61
azide
Sodium
Germany- Water Classification(VwVwS)- Annex 2 'Water HazardClasses
636, hazardclass2 - hazardto waters
26628-22-8 lD Number
Sodiumazide
- Australia - Inventoryof GhemicalSubstances(AICS)
Inventory
26628-22-8 Present
azide
Sodium
Inventory'Canada - DomesticSubstancesList (DSL)
26628-22-8 Present
azide
Sodium
-
Inventory China
26628-22-8 Present
azide
Sodium
(EINECS)
Union- European
- Chemical
Substances
Commercial
Inventory Existing
of
lnventory European
247-852-1
26628-22-8
Sodiumazide
Inventory- Japan Existing and New ChemicalSubstances(ENCS)
1-482
26628-22-8
Sodiumazide
Inventory- Korea - Existing and EvaluatedGhemicalSubstances
26628-22-8 KE-31357
azide
Sodium
Canad ian Hazardous Prod ucts:
WHMIS Status Non-controlled
Substances/Preparations:
Dangerous
Communities
European
x
Xn - Harmful
EG HazardGlass
Symbols
RiskPhrases
verytoxicgas.
with acidsliberates
R32 Contact
R22 Harmful swallowed.
if
SafetyPhrases
mustbe disposed in a safeway.
of
and its container
s35 This material
16.OTHERINFORMATION
Use:
Recommended
Diagnostic Only. for human druguse.
Not or
ForIn Vitro Use
Information:
Further
effort beenmade adhere thehazard
to criteria
to
prepared accordance theANSI has
format.
Every
with 2400.1
in
ThisMSDS been
has
Data Directive,
Safety Sheets
Standard,
European Communities
Hazard
requirements USOSHA Communication
of the
andcontent
Harmonized
Regulations, UNGlobally
and
Information Packaging
and
Hazard
Regulations, Chemical
UK
Products
Canadian Controlled
System Classification Labelling Chemicals.
of
of and
2075-2
Date: May 03, 2007
Effective
Page7 of I
Date Printed: May 03,2007
SAFETYDATASHEET
MATERIAL
OSOM@ A Positive
Control
Strep
MSDSOriginationDate: January07, 2005
Version #: 3
Revision Date: May 03,2007
Disclaimer:
to
and represents best information currently available
the
aboveis provided good faith. lt is believed be accurate
to
in
The information
PURPOSE OF ANY
OR
FORA PARTICULAR
FITNESS
US.HOWEVER, MAKENO WARRANTY MERCHANTABILIry,OF
WE
DESCRIBED DATAOR INFORMATION
OR
WITHRESPECT PRODUCTS
TO
TYPE,EXPRESSED IMPLIED,
OR
OTHER
DATAOR INFORMATION.
FROMTHE USEOF SUCHPRODUCTS,
ANDWE ASSUME LIABILITY RESULTING
NO
PROVIDED.
purposes, the user
Usersshouldmaketheirown investigations determine suitability the information their particular and
for
of
the
to
relating the
to
assumes riskarisingfromtheiruse of the material.The useris required complywith all lawsand regulations
to
all
procedures.
with and followgenerally safe handling
accepted
and mustbe familiar
and disposal the material,
of
purchase, use,storage
in no eventshallGen2yme liablefor any claims,losses, damages any individual for lost profitsor any special, indirect,
or
or of
be
has been advisedof the possibility such
of
evenif Genzyme
arising,
darirages,howsoever
consequential exemplary
or
incidental,
damages.
2075-2
Date: May03,2007
Effective
Page of 8
8
DatePrinted: May03,2007
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