SAFETYDATASHEET
MATERIAL
Strep A Extraction Reagent 2
OSOM@
IDENTIFICATION
AND COMPANY
1. PRODUCT
Strep A Extraction Reagent2
Product Name: OSOM@
Reagent2
Synonym(s): StrepA Extraction
StrepA Test kit (catalog 141 &
#
Use Only.Component OSOM@
of
Product Use: For ln Vitro Diagnostic
141E).For use in the qualitative antigen.
detection GroupA Streptococcal
of
acidicsolution.
Description:Aqueous,
Telephone
Manufacturer/Distributor Numbers
Emerqencv
CorporateHeadquarters
+1617-562-4555
(U.S.):
Genzyme
GenzymeDiagnostics
GenzymeCorporation
(U.S.): tBA0-424-9300
CHEMTREG
6659 Top Gun Street
500 KendallStreet
+1
(Outside U.S.): 703-527-3887
CHEMTREG
San Diego,C492121
M402142
Cambridge,
USA
USA
Phone: +1 858452-3198
Phone: +1617-252-7544
Distributor
Genzyme Diagnostics
50 GibsonDrive
KingsHill,WestMalling
Kent,ME194AF
UK
Phone: +44 (0) 1732220022
2. HAZARDSIDENTIFICATION
Precautionary Statements:
physical toxicological properties thispreparation notbeenthoroughly
Thechemical, and of have characterized.
lrritating theeyes.
to Maybe irritating skinandrespiratory
to system.
Avoidcontact eyesandskin.Do notingest
with
or inhale.Preparation
appearance: colorless
clear, liquid.
Routes Exposure:
of
Occupationalexposure mayinclude
routes inhalation, andskin
eye contact.
Potential HealthEffects:
Inhalation
may be irritating the nasalpassages
lnhalation to and throat.
Eye Eye exposure causeimmediate rednessand pain.
will irritation,
Prolonged
Skin skin contactmay causeskin irritation
with discomfort
and rash.
Ingestion lf largeamountsare ingested,
symptomsmay includedigestiveirritation
and discomfort.
GhronicEffects Prolonged repeated contact cause
or skin may chronic
irritation.
Target
Organs Eyesandskin.
Regulatory
Status:
Thispreparation
is classified hazardous
as under
U.S.OSHA CFR1910.1200; Directive
29 E.C. 1999/45/EC;
Canadian 1985, H-3;U.K.CHIPS
R.S. c. 2002No.1689;
and/or
U.N.
cHS ST/SG/AC
10/30.
present thispreparation concentrations to or greater
None thecomponents
of in at equal than0.1% listed
are by
IARC,
NTP,OSHA ACGIH a carcinogen.
or as
EffectiveDate: May 03, 2007 2074-2
Date Printed: May 03, 2007 Page1 of8
MATERIALSAFETYDATA SHEET
Strep A Extraction Reagent2
OSOM@
PotentialEnvironmentalEffects:
Noneexpected.
/ INFORMATION INGREDIENTS
ON
3. COMPOSITION
% (wuwt)
EC#
CAS #
lngredientName
231-791-2 98-99
7732-18-5
Water
Class:
ECHazard
None
ECR-Phrases:
200-580-7 1-2
64-19-7
Aceticacid
Glass:
ECHazard
R'!0,R35
ECR-Phrases:
AID MEASURES
4. FIRST
lnhalation:
becomesdifficult if coughor
or
if
area to fresh air. Seekmedicalattention breathing
movefrom exposure
lf inhaled,
develop.
othersymptoms
Eye Contact:
eyelidswith fingers.Removecontact
flusheyeswith plentyof tepidwaterfor 15 minuteswhileseparating
lmmediately
medicalattention.
immediate
if worn,Obtain
lenses
Skin Contact:
Obtainmedicalattention neededor
if
clothing.
flushskinwith cool waterand removecontaminated
In case of contact,
develop.
if irritation othersymptoms
or
Ingestion:
contacta poisoncontrolcenteror physician instructions.
for
In caseof ingestion,
MEASURES
5. FIREFIGHTING
FlammablePropefties:
solution considered fire hazard.
not a
Diluteaqueous
Media:
SuitableExtinguishing
foam,dry chemical water
or
chemical
dioxide,
mediasuitable surrounding suchas carbon
for fire,
Useextinguishing
spray.
Media:
Extinguishing
Unsuitable
Unknown.
Arising from the Chemical:
SpecificHazards
(CO).
Whenheated decomposition, produce (CO2)and carbonmonoxide
dioxide
may carbon
to
Standard ProtectiveEquipment and Precautionsfor Firefighters:
gear.
and full protective
Breathing
Apparatus
Self-Contained
shouldwear N|OSH-approved equivalent
or
Firefighters
MEASURES
RELEASE
6. ACCIDENTAL
PersonalPrecautions:
WearPersonal
adequateventilation.
Avoidphysical
contactwith materialand avoidaerosolinhalation.
Ensure
afterhandling.
thoroughly
(PPE)as indicated Section Washhands
in 8.
Equipment
Protective
Precautions:
Environmental
precautions required.
environmental
No special
2074-2
Date: May 03,2007
Effective
Page of 8
2
Date Printed: MaY03, 2007
MATERIALSAFETYDATA SHEET
Strep A Extraction Reagent2
OSOM@
Methods and Materialsfor Containmentand Clean'Up:
agent.Decontaminate spillsitefollowing
the
neutralizing
Absorbspillwith inertmaterial/sorbent appropriate
or
federal,state,localand provincial
with all applicable
procedures. Dispose materials accordance
in
of
standard
per
regulations, Section13.
environmental
AND STORAGE
7. HANDLING
Handling:
1
MixingStrepA ExtractionReagents
hygienepractices. Controls.
See Section8, Engineering
Followgood laboratory
decompose toxic nitrousgas, a short-term reactionby-product.
into
and 2 yieldsnitrousacid,which may immediately
Wash hands
contactand contamination personal and skin.Avoidvaporor aerosolinhalation.
clothing
of
Minimize
afterhandling.
thoroughly
Storage:
see
Storeat 15 to 30'C (59 to 86'F). Keep container
tightlyclosed.Do not storewith incompatible
substances;
Section 10.
CONTROLS PERSONAL
/ PROTECTION
8. EXPOSURE
Exposure
Guidelines:
LimitsValues. ShortTermExposure
. Limits(TLV-STEL)
ACGIH Threshold
15 ppmSTEL
Aceticacid 64-19-7
ACGIH . Threshold Limits Values - Time Weighted Averages (TLV-TWA)
10 ppm TWA
Aceticacid 64-19-7
Australia - Occupational Exposure Standards' STELs
15 ppm STEL;37 mg/m3STEL
Aceticacid 64-19-7
Australla - Occupatlonal Exposure Standards - TWAs
10ppmTWA; mg/m3 TWA
25
64-19-7
Aceticacid
Canada - Quebec . Occupational Exposure Limits - STEVS
15ppmSTEV;37 STEV
64-19-7 mg/m3
Aceticacid
- - Llmits. TWAEVS
Canada Quebec Occupatlonal
Exposure
10ppmTWAEV; mg/m3
64-19-7 25 TWAEV
Aceticacid
Ghina. OccupationalExposureLimits - PermissibleConcentration-Short Term (PC-STEL)
Aceticacid 20 mgh3 STEL
64-19-7
China- OccupationalExposureLimits - PermissibleConcentration-Time WeightedAverage(PC-TWA)
Aceticacid 10 mg/m3TWA
64-19-7
EU - Occupational IndicativeOccupationalExposureLimit Values (IOELV)- TWAs
ExposureDirective(2000/3g/EC)
10 ppm TWA;25 mg/m3TWA
Aceticacid 64-19-7
Germany . TRGS 900 - Occupational Exposure Limits . TWAs
'l)
10ppmTWA(exposure TWA(exposure
category 25 mg/m3
64-19-7 1); category
Aceticacid
- Limits- TWAS
Japan Recommended Exposure
10ppmOEL; mg/m3
25
64-19-7 OEL
Aceticacid
- Limits- STELs
Korea Occupational
Exposure
15ppmSTEL; mg/m3
64-19-7 37 STEL
Aceticacid
Korea- Occupational Limits- TWAS
Exposure
10ppmTWA; mg/m3
25 TWA
64-15-7
Acetic acid
OSHA - Final PELs - Time Weighted Averages (TWAs)
10ppmTWA; mg/m3
64-19-7 25 TWA
Aceticacid
EngineeringControls:
Provide adequate
ventilation means mechanical
by of exhaust, keepairborne
to concentrations Facilities
low. storing
or utilizing preparation
this should equipped aneyewash
be with fountain.
EffectiveDate: May 03, 2007 2074-2
Date Printed: May 03,2007 Page3 of 8
MATERIALSAFETYDATA SHEET
Strep A Extraction Reagent2
OSOM@
Equipment(PPE):
PersonalProtective
OSHA29 CFR 1910.134 ANSI
and
program thatmeetsU.S.Federal
protection
A respiratory
Respiratory
StandardCR 529,or otherapplicable
European
Z:94.4-93,
299.2,Canidian CSA Standard
(if
exposurelimitsmay be exceeded
whenever
must be followed
standards
regulatory
ventilation workplace
or
controls not feasible, if insufficient
or
are
engineering
ap-plicablb),
use.ln suchcasesan air purifying with an
respirator
equipped
warrantrespirator
conditions
gas cartridge recommended.
is
organicvapor/acid
safetygoggles.
protective
chemical
Wear appropriate
Eye/Face
clothingpromptly.
Wear lab coat or otherprotective
garments.
Removecontaminated
Skin
protective
gloves.
Wear chemicalresistant
Gloves
safetyprocedures.
Followcompany-specific
General
PROPERTIES
AND CHEMICAL
9. PHYSICAL
2.6 (approximate)
pH:
liquid
Clear,colorless
Appearance:
Solubility: Water-soluble
pungent odorlikevinegar
Sour,
Odor:
Density: Not applicable
Not available
Boiling Point:
VaporPressure: Not available
Not applicable
Melting Point:
PartitionCoefficient Notavailable
Not available
FreezingPoint:
(n-octanol/water):
VaporDensity: Notavailable
ChemicalFamily: Acidicsolution
Notavailable
Limits in Air, Lower:
Flammability/Explosivity
Notavailable
Limits in Air, Upper:
Flammability/Explosivity
Auto-lgnition Temperature: Not available
Not available
FlashPoint:
AND REACTIVITY
10. STABILITY
GhemicalStability:
and storageinformation Section7).
in
(see handling
conditions use and storage;
of
Stableunderordinary
Conditionsto Avoid:
Noneknown.
IncompatibleMaterials:
strongbasesand amines.
mostcommonmetals(except
aluminum),
agents,
Avoidstrongoxidizing
HazardousDecompositionProducts:
gasesand vapors.
Thermaldecomposition lead to releaseof irritating
may
Possibility of HazardousReactions:
polymerization not occur.
will
Hazardous
11. TOXICOLOGICAL
INFORMATION
2074-2
Date: May 03, 2007
Effective
Page of 8
4
Date Printed: May 43,2007
SAFEry DATASHEET
MATERIAL
Strep A Extraction Reagent2
OSOM@
Acute Effects:
Toxicology Data - Selected LD50s and LG50s
OralLD50Rat 3310
LC50Rat 11.4mglLl1H;
fnhalation
64-19-7
Acetic acid
mg/kg;DermalLD50 Rabbit 1060mg/kg
Local Effects:
tract irritation.
and may causeskin and respiratory
Causeseye irritation
Chronic Effects:
skin contactmay causedermatitis.
Prolonged repeated
or
Carcinogenicity:
equalto or greaterthan 0.1olo listedby
are
presentin this preparation concentrations
at
Noneof the components
NTP,OSHAorACG|Has a carcinogen.
IARC,
Mutagenicity:
No dataavailable.
Teratogenicity:
No dataavailable.
ReproductiveEffects:
No dataavailable.
Sensitization:
No data available.
INFORMATION
12.ECOLOGICAL
Ecotoxicity:
- Fish Data
Ecotoxicity Freshwater Species
promelas: mg/Llstatic]; Hr
96
Acetic 88
acid 64-19-7 96 Hr LC50Pimephales
75
macrochirus: mg/L
LC50Lepomis
-
Ecotoxicity MicrotoxData
phosphoreum: mg/L;15 min
Acetic 8.8
acid 5 min EC50Photobacterium
64-19-7
phosphoreum: mg/L:25 min EC50
EC50Photobacterium 8.8
phosphoreum: mg/L
Photobacterium 8.8
.
EcotoxicityWaterFleaData
magna: mg/L
95
Aceticacid 24 Hr EC50Daphnia
64-19-7
Persistanceand Degradability
:
No dataavailable.
BioaccumulativePotential:
No dataavailable.
Media:
Mobilityin Environmental
No data available.
CONSIDERATIONS
13. DISPOSAL
Methods Disposal:
of
product, with federal, local
and
of spilled
material waste accordance all applicable
in state,
Dispose unused and
provincial wasteregulations.
environmental hazardous
and
WasteGlassification:
California- 22 CCR - PresumedHazardousWastes
lgnitable
Toxic,Corrosive;
Aceticacid 64-19-7
2074-2
Date: May 03, 2007
Effective
Page5 of 8
Date Printed: May 03, 2007
MATERIALSAFETYDATA SHEET
Strep A Extraction Reagent2
OSOM@
INFORMATION
14.TRANSPORT
Basic ShippingDescriPtion:
GoodsClassification
(IATA)Dangerous
Association
Transport
InternationalAir
UN Number: 3316
UN
Kit
Name:Chemical
Shipping
Proper
Hazard Class:9
HazardLabel:Miscellaneous
Group: lll
PG
Packing
Y91
Instruction: 5
Packaging
quantities)
A44 (excepted
SpecialProvisions:
(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
-
CERCLATSARAHazardousSubstancesand their ReportableQuantities
5000lbfinalRQ; 2270k9finalRQ
64-19-7
Aceticacid
- UnitedStates - Section 8(b) Inventory(TSCA)
Inventory
Present
64-19-7
Acetic acid
US State Requlations:
California 8 CCRSection - Director's of Hazardous
- Substances
List
339
(Exempt solutions lessthan10% when
or
of
in
Present
64-19-7
Aceticacid
present foodor beverages)
in
2074-2
Date: May03,2007
Effective
Page of 8
6
DatePrinted: May03,2007
MATERIALSAFETYDATA SHEET
Strep A Extraction Reagent2
OSOM@
Requlations:
lnternational
Directive
Devices
Medical
under In VitroDiagnostic
Communities thisproduct regulated the
is
use,
lf approved European
for
(98/79/EC).
Canada- WHMIS- Glassificationsof Substances
80%,84%,92%), (30%,36%,56%);
E
83, E (including
64-19-7
Aceticacid
productaccording WHMISclassification
to
Uncontrolled
criteria
Canada- WHMIS- IngredientDisclosure List
1 o/o
64-19-7
Aceticacid
EU - Dangeroussubstances Directive(67/548/EEC)Annex I - Classification
-
R10 C;R35
64-19'7
Aceticacid
EU - DangerousSubstancesDirective(67/548/EEC)Annex | - ConcentrationLimits
-
Xi:
C; R34 10o/o<=C<25o/o:
90%<=C: R35 25o/o<=C<90o/o:
C;
64-19-7
Aceticacid
R36/38
EU - Dangeroussubstances Directive(67,548/EEC)Annex | - safety Phrases
-
3:112-23-2645
64-19-7
Acetic acid
Germany- Water Classification(VwVwS)- Annex 2'Water HazardGlasses
lD Number93, hazardclass 1 - low hazardto waters
64-19-7
Aceticacid
- Australia - lnventory of ChemicalSubstances(AICS)
Inventory
Present
64-19-7
Aceticacid
-
- Substances (DSL)
List
Inventory Canada Domestic
Present
64-19-7
Aceticacid
Inventory- Canada- Non-DomesticSubstancesList (NDSL)
Present
64-19-7
acid
Acetic
-
Inventory China
Present
64-19-7
acid
Acetic
(EINECS)
Union- European Substances
Chemical
- Commercial
Inventory Existing
of
Inventory European
200-580-7
64-19-7
Acetic acid
(ENCS)
- Substances
and NewChemical
Inventory JapanExisting
2-688
64-19-7
Acetic acid
Inventory- Korea - Existing and EvaluatedChemicalSubstances
KE-00013
64-19-7
Acetic acid
Products:
CanadianHazardous
Controlled
WHMTS Status
Glassification
E - Corosive
,rft,
#*-1
Ss
\..*/
Substances/Preparations:
Dangerous
Communities
European
Exempt
EC HazardGlass
Risk PhrasesNone
Safety PhrasesNone
16.OTHERINFORMATION
Information:
Further
criteria
made adhere thehazard
to
to
effort been
has
Every
format.
2400.1
prepared accordance theANSI
with
in
ThisMSDS been
has
Data9!9"t1 Directive,
Safety
Communities
European
Standard,
Hazard Communication
requirements USOSHA
of the
andcontent
Harmonized
Regulations, UNGlobally
and
Information Packaging
and
Hazard
Regulations, Chemical
UK
Products
Contiolled
Canadian
System Classification Labelling Chemicals.
of
and
of
2074-2
Date: May03,2007
Effective
Page of 8
7
DatePrinted: MaY 03,2007
MATERIALSAFETYDATA SHEET
Strep A ExtractionReagent2
OSOM@
MSDSOriginationDate: January07, 2005
Version #: 3
Revision Date: MaY03, 2007
Disclaimer:
to
currently available
information
tlg.b-qql
and repre_sents
aboveis provided good faith. lt is believed be accurate
to
in
The information
PURPOSE oF ANY
oR
FoR A PARTIcULAR
FITNESS
wE MAkE No wAfRANTy oF MERcHANTABILITv,
us. HowEVER,
DESCRIBED DATAOR INFORMATION
OR
WITHRESPECT PRODUCTS
TO
TYPE,EXPRESSED IMPLIED,
OR
OTHCN
FRoM THE usE oF sucH PRoDUcrs, DATAoR lNFoRMATloN.
Fnovroeo, nto we ASSUME LtABtLlryRESULTTNG
No
purposes, the user
Usersshouldmaketheirown investigations determine suitability the information theirparticular and
for
of
the
to
relating the
to
fromtheirusEof the material.The useris required complywith all laws and regulations
to
riskarising
all
assumes
procedures.
with and followgenerally safe handling
accepted
and mustbe familiar
and disposal the material,
purchase, of
use,storage
in no eventshallGenlymebe liablefor any claims,losses, damages any individual for lostprofitsor any special, indirect'
or
of
or
even if Genzymehas beenadvisedof the possibility such
of
howsoever arising,
damages,
consequential exemplary
or
incidental,
damages.
2074-2
Date: May 03,2007
Effective
Page8 of 8
DatePrinted: MaY03,2007
|