1 - Pro Advantage by NDC



DOCVARIABLE GMSDS000000000000701 \* MERGEFORMATSECTION 1: DOCVARIABLE GMSDSEU000000HH00200 \* MERGEFORMATIDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING1.1DOCVARIABLE GMSDSEU000000HH00201 \* MERGEFORMATProduct identifierDOCVARIABLE GMSD00056AA0282 \* MERGEFORMATTrade namePro Advantage HCG Pregnacy TestsReference No.P080063, P080023, P0800211.2DOCVARIABLE GMSDSEU000000HH00202 \* MERGEFORMATRelevant identified uses of the substance or mixture and uses advised againstDOCVARIABLE GMSDSEUCSR0000000008 \* MERGEFORMATIdentified use(s)DOCVARIABLE IECHE01231092 \* MERGEFORMATIn vitro diagnostic reagent. DOCVARIABLE IECHE01231095 \* MERGEFORMATFor professional use only.1.3DOCVARIABLE GMSDSEU000000HH00203 \* MERGEFORMATDetails of the supplier of the safety data sheetDOCVARIABLE GMSD00056AA0284 \* MERGEFORMATCompany IdentificationNDC, Inc.407 New Sanford RoadLaVergne, TN 37086, USADOCVARIABLE GMSDSBDI000000000128 \* MERGEFORMATTelephone615-366-32301.4DOCVARIABLE GMSDSEU000000HH00204 \* MERGEFORMATEmergency telephone numberDOCVARIABLE GMSD00056AA0005 \* MERGEFORMATEmergency Phone No.ChemTel Inc. International access: + (0)1-813-248-0585ChemTel Inc. Free phone (North America only): 1-(800)-255-3924DOCVARIABLE GMSDS000000000000702 \* MERGEFORMATSECTION 2: DOCVARIABLE GMSD00056AA0017 \* MERGEFORMATHAZARDS IDENTIFICATION2.1DOCVARIABLE GMSDSEU000000HH00205 \* MERGEFORMATClassification of the substance or mixtureDOCVARIABLE GMSDSBDI000000000135 \* MERGEFORMATRegulation (EC) No. 1272/2008 (CLP)DOCVARIABLE GMSDSEU000000CLP0071 \* MERGEFORMATEye Irrit. 2DOCVARIABLE GMSDSGHS000000000406 \* MERGEFORMATHazard statement(s)DOCVARIABLE GMSDSGHS0CEUH319A \* MERGEFORMATH319: Causes serious eye irritation.DOCVARIABLE GMSDS00000000000430A \* MERGEFORMATDirective 67/548/EEC & Directive 1999/45/ECDOCVARIABLE GMSD00030AC0001 \* MERGEFORMATNot classified as dangerous for supply/use.OSHA Hazard Communication Standard 29 CFR 1910.1200 (HazCom 2012) / GHSDOCVARIABLE GMSDSEU000000CLP0071 \* MERGEFORMATEye Irrit. 2DOCVARIABLE GMSDSGHS000000000406 \* MERGEFORMATHazard statement(s)DOCVARIABLE GMSDSGHS00EUH205 \* MERGEFORMATCauses serious eye irritation.2.2DOCVARIABLE GMSDSEU000000HH00206 \* MERGEFORMATLabel elementsDOCVARIABLE GMSDSEU000000ES00087 \* MERGEFORMATNo measures required. DOCVARIABLE IECHE01251279 \* MERGEFORMATThe product is placed on the market in the form of an article, which contains insignificant quantities of hazardous chemicals that are not intended to be released from the device.2.3DOCVARIABLE GMSDSGHS000000000426 \* MERGEFORMATOther hazardsDOCVARIABLE GMSD00050AA0004 \* MERGEFORMATNone anticipated.DOCVARIABLE GMSDS000000000000703 \* MERGEFORMATSECTION 3: DOCVARIABLE GMSD00056AA0008 \* MERGEFORMATCOMPOSITION/INFORMATION ON INGREDIENTS3.2DOCVARIABLE GMSDSEU000000HH00209 \* MERGEFORMATMixturesDOCVARIABLE IECHE01231239 \* MERGEFORMATDescription:DOCVARIABLE IECHE01231273 \* MERGEFORMATIn vitro diagnostic reagent test device. DOCVARIABLE IECHE01231275 \* MERGEFORMATPreparation. DOCVARIABLE IECHE01231277 \* MERGEFORMATLaminated test strip consisting of solid support materials impregnated with dried chemical / biochemical reagents.DOCVARIABLE IECHE01231241 \* MERGEFORMATDangerous components:DOCVARIABLE GMSD00030AE0002 \* MERGEFORMATEC Classification No. 1272/2008 / GHSDOCVARIABLE GMSDA000000000000340 \* MERGEFORMATHazardous ingredient(s)DOCVARIABLE GMSD00050AA0071 \* MERGEFORMAT%W/WDOCVARIABLE GMSDA000000000000335 \* MERGEFORMATEC No.CAS DOCVARIABLE GMSDA000000000000398 \* MERGEFORMATNo.DOCVARIABLE GMSDS000000000000614 \* MERGEFORMATClassification code: DOCVARIABLE GMSDSGHS000000000406 \* MERGEFORMATHazard statement(s)Sodium carbonate1 - 2207-838-8497-19-8DOCVARIABLE GMSDSEU000000CLP0071 \* MERGEFORMATEye Irrit. 2; H319Triton X100*1 - 2-9002-93-1DOCVARIABLE GMSDSEU000000CLP0063 \* MERGEFORMATAcute Tox. 4; H302DOCVARIABLE GMSDSEU000000CLP0070 \* MERGEFORMATEye Dam. 1; H318DOCVARIABLE GMSDSEU000000CLP0100 \* MERGEFORMATAquatic Chronic 2; H411Sodium azide**< 0.1247-852-126628-22-8DOCVARIABLE GMSDSEU000000CLP0061 \* MERGEFORMATAcute Tox. 2; H300DOCVARIABLE GMSDSEU000000CLP0098 \* MERGEFORMATAquatic Acute 1; H400DOCVARIABLE GMSDSEU000000CLP0099 \* MERGEFORMATAquatic Chronic 1; H410EUH032DOCVARIABLE GMSD00030AE0002 \* MERGEFORMATEC Classification No. 67/548/EEC DOCVARIABLE GMSDA000000000000340 \* MERGEFORMATHazardous ingredient(s)DOCVARIABLE GMSD00050AA0071 \* MERGEFORMAT%W/WDOCVARIABLE GMSDA000000000000335 \* MERGEFORMATEC No.CAS DOCVARIABLE GMSDA000000000000398 \* MERGEFORMATNo.DOCVARIABLE GMSD00030AE0002 \* MERGEFORMATEC Classification DOCVARIABLE GMSD00050AD0001 \* MERGEFORMATand DOCVARIABLE GMSD00056AA0125 \* MERGEFORMATRisk PhrasesSodium carbonate1 - 2207-838-8497-19-8Xi; R36Triton X100*1 - 2-9002-93-1Xn; R22-41-51/53Sodium azide**< 0.1247-852-126628-22-8T+, N; R28-32-50/53* candidate substance of very high concern (SVHC)** DOCVARIABLE GMSDSGHS000000000453 \* MERGEFORMATSubstance with a community exposure limit3.3 DOCVARIABLE GMSD00056AA0147 \* MERGEFORMATAdditional InformationDOCVARIABLE IECHE01231106 \* MERGEFORMATFor full text of R/H phrases see section 16.DOCVARIABLE IECHE01231115 \* MERGEFORMATEach device is packaged in a foil pouch.DOCVARIABLE GMSDS000000000000704 \* MERGEFORMATSECTION 4: DOCVARIABLE GMSD00056AA0018 \* MERGEFORMATFIRST AID MEASURES4.1DOCVARIABLE GMSDSEU000000HH00210 \* MERGEFORMATDescription of first aid measuresDOCVARIABLE GMSDSEUSDS0000000509 \* MERGEFORMATGeneral informationDOCVARIABLE IECHE01231281 \* MERGEFORMATThe following first aid measures are only relevant in the event of serious misuse, whereby the device is disassembled and there is exposure to the chemicals in the test strip.DOCVARIABLE GMSD00056AA0021 \* MERGEFORMATInhalationDOCVARIABLE IECHE01231156 \* MERGEFORMATSupply fresh air; consult doctor in case of complaint.DOCVARIABLE GMSD00056AA0022 \* MERGEFORMATSkin ContactDOCVARIABLE GMSD00005AD0003 \* MERGEFORMATWash skin with soap and water. DOCVARIABLE GMSD00056AA0023 \* MERGEFORMATEye ContactDOCVARIABLE GMSDSGHS00EUP351 \* MERGEFORMATRinse cautiously with water for several minutes. DOCVARIABLE GMSDSGHS00EUP338 \* MERGEFORMATRemove contact lenses, if present and easy to do. Continue rinsing. DOCVARIABLE GMSDSGHS000000000292 \* MERGEFORMATIf eye irritation persists, get medical advice/attention.DOCVARIABLE GMSD00056AA0024 \* MERGEFORMATIngestionDOCVARIABLE GMSD00007AB0001 \* MERGEFORMATWash out mouth with water. DOCVARIABLE IECHE01231332 \* MERGEFORMATConsult a doctor.4.2DOCVARIABLE GMSDSEU000000HH00211 \* MERGEFORMATMost important symptoms and effects, both acute and delayedDOCVARIABLE GMSD00050AA0001 \* MERGEFORMATNone. 4.3DOCVARIABLE GMSDSEU000000HH00212 \* MERGEFORMATIndication of the immediate medical attention and special treatment neededDOCVARIABLE GMSD00050AA0001 \* MERGEFORMATNone.DOCVARIABLE GMSDS000000000000705 \* MERGEFORMATSECTION 5: DOCVARIABLE GMSD00056AA0026 \* MERGEFORMATFIRE-FIGHTING MEASURES5.1DOCVARIABLE GMSD00056AA0027 \* MERGEFORMATExtinguishing mediaDOCVARIABLE GMSDS000000000000478 \* MERGEFORMATSuitable Extinguishing MediaDOCVARIABLE IECHE01231160 \* MERGEFORMATCO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. 5.2DOCVARIABLE GMSDSEU000000HH00213 \* MERGEFORMATSpecial hazards arising from the substance or mixtureDOCVARIABLE IECHE01231162 \* MERGEFORMATIn case of fire, the following can be released: DOCVARIABLE IECHE01231287 \* MERGEFORMATHazardous fumes, DOCVARIABLE IECHE01231192 \* MERGEFORMATCarbon oxides (COx), DOCVARIABLE IECHE01231194 \* MERGEFORMATnitrogen oxides (NOx).5.3DOCVARIABLE GMSDSEU000000HH00214 \* MERGEFORMATAdvice for fire-fightersDOCVARIABLE IECHE01231243 \* MERGEFORMATUse fire-extinguishing methods suitable to surrounding conditions.DOCVARIABLE IECHE01231189 \* MERGEFORMAT DOCVARIABLE IECHE01231164 \* MERGEFORMATWear full protective suit and self-contained breathing aparatus (SCBA) when extinguishing fires. DOCVARIABLE GMSDS000000000000706 \* MERGEFORMATSECTION 6: DOCVARIABLE GMSD00056AA0029 \* MERGEFORMATACCIDENTAL RELEASE MEASURES6.1DOCVARIABLE GMSDSGHS000000000430 \* MERGEFORMATPersonal precautions, protective equipment and emergency proceduresDOCVARIABLE IECHE01231166 \* MERGEFORMATRefer to Section 8 for protective measures when handling the spillage.6.2DOCVARIABLE GMSD00056AA0149 \* MERGEFORMATEnvironmental precautionsDOCVARIABLE GMSD00030AG0077 \* MERGEFORMATAvoid release to the environment.6.3DOCVARIABLE GMSDSEU000000HH00215 \* MERGEFORMATMethods and material for containment and cleaning upDOCVARIABLE IECHE01231291 \* MERGEFORMATCollect material and dispose of as waste according to Section 13.6.4DOCVARIABLE GMSDS000000000000641 \* MERGEFORMATReference to other sections8, 13 DOCVARIABLE GMSDS000000000000707 \* MERGEFORMATSECTION 7: DOCVARIABLE GMSD00056AA0030 \* MERGEFORMATHANDLING AND STORAGE7.1DOCVARIABLE GMSDSEU000000HH00216 \* MERGEFORMATPrecautions for safe handlingDOCVARIABLE IECHE01231326 \* MERGEFORMATSpecimens should be handled as potentially infectious materials. DOCVARIABLE IECHE01251290 \* MERGEFORMATRefer to EU directive 2000/54EC or US regulation 29 CFR 1910.1030 for information on handling biohazardous materials.DOCVARIABLE IECHE01231295 \* MERGEFORMATAvoid contact with the eyes, skin and mucous membranes.DOCVARIABLE GMSDSGHS00EUP102 \* MERGEFORMATKeep out of reach of children.DOCVARIABLE GMSDSEU0000000PP0462 \* MERGEFORMATWash hands before breaks and after work. DOCVARIABLE IECHE01231300 \* MERGEFORMATClean work areas with hypochlorite or other disinfecting agent.7.2DOCVARIABLE GMSDSEU000000HH00217 \* MERGEFORMATConditions for safe storage, including any incompatibilitiesDOCVARIABLE IECHE01231245 \* MERGEFORMATStore in the original container at 2 to 30°C. 7.3DOCVARIABLE GMSDSEU000000HH00218 \* MERGEFORMATSpecific end use(s)DOCVARIABLE IECHE01231247 \* MERGEFORMATUse as per instructions for use.DOCVARIABLE GMSDS000000000000708 \* MERGEFORMATSECTION 8: DOCVARIABLE GMSD00056AA0036 \* MERGEFORMATEXPOSURE CONTROLS/PERSONAL PROTECTION 8.1DOCVARIABLE GMSDSGHS000000000411 \* MERGEFORMATControl parameters8.1.1DOCVARIABLE GMSD00056AA0042 \* MERGEFORMATOccupational Exposure LimitsEU IOELV / UK WEL / Irl OELV DOCVARIABLE GMSDA000000000000308 \* MERGEFORMATSUBSTANCE.DOCVARIABLE GMSD00056AA0011 \* MERGEFORMATCAS No.DOCVARIABLE GMSD00050AD0106 \* MERGEFORMATLTEL (8 hr TWA ppm)DOCVARIABLE GMSDA000000000000101 \* MERGEFORMATLTEL (8 hr TWA mg/m?)DOCVARIABLE GMSDA000000000000102 \* MERGEFORMATSTEL (ppm)DOCVARIABLE GMSDA000000000000103 \* MERGEFORMATSTEL (mg/m?)DOCVARIABLE GMSD00056AB0021 \* MERGEFORMATNote:Sodium Azide26628-22-80.10.3SkDOCVARIABLE GMSD00019AC0030 \* MERGEFORMATSk - Can be absorbed through skin.8.2DOCVARIABLE GMSDSEUSDS0000000507 \* MERGEFORMATExposure controls8.2.1DOCVARIABLE GMSDSGHS000000000414 \* MERGEFORMATAppropriate engineering controlsDOCVARIABLE GMSDA000000000000296 \* MERGEFORMATNot relevant for this material. 8.2.2DOCVARIABLE GMSDSBDI000000000057 \* MERGEFORMATPersonal protection equipmentDOCVARIABLE GMSDSGHS000000000392 \* MERGEFORMATEye/face protectionDOCVARIABLE IECHE01231304 \* MERGEFORMATSafety glasses recommended. (EN166)DOCVARIABLE GMSDSEUSDS0000000510 \* MERGEFORMATHand protectionDOCVARIABLE IECHE01231149 \* MERGEFORMATDisposable gloves. (EN374).DOCVARIABLE IECHE01231217 \* MERGEFORMATMaterial of gloves:DOCVARIABLE IECHE01231229 \* MERGEFORMATLatex / natural rubber, DOCVARIABLE GMSD00034AA0104 \* MERGEFORMATNitrile rubber.DOCVARIABLE IECHE01231223 \* MERGEFORMATPenetration time of glove material:DOCVARIABLE IECHE01231221 \* MERGEFORMATGloves resistance is not critical when the product is handled according to the instructions for use.DOCVARIABLE GMSDSBDI000000000041 \* MERGEFORMATBody protectionDOCVARIABLE GMSDA000000000000174 \* MERGEFORMATLaboratory coat.DOCVARIABLE GMSDSEUSDS0000000525 \* MERGEFORMATRespiratory protectionDOCVARIABLE GMSD0X050AA0011 \* MERGEFORMATNot normally required.8.2.3DOCVARIABLE GMSDA000000000000100 \* MERGEFORMATEnvironmental Exposure ControlsDOCVARIABLE GMSDSEU000000EC00031 \* MERGEFORMATNo special measures are required.DOCVARIABLE GMSDS000000000000709 \* MERGEFORMATSECTION 9: DOCVARIABLE GMSD00056AA0043 \* MERGEFORMATPHYSICAL AND CHEMICAL PROPERTIES9.1DOCVARIABLE GMSDSEU000000HH00219 \* MERGEFORMATInformation on basic physical and chemical propertiesDOCVARIABLE GMSDSEUSDS0000000526 \* MERGEFORMATAppearance Laminated test strip, which may be housed in a plastic holder.DOCVARIABLE GMSD00016AB0036 \* MERGEFORMATColourVariable depending on product.DOCVARIABLE GMSD00056AA0045 \* MERGEFORMATOdourDOCVARIABLE GMSD00016AC0001 \* MERGEFORMATNo odour.DOCVARIABLE GMSD00056AA0046 \* MERGEFORMATOdour Threshold (ppm)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSD00056AA0047 \* MERGEFORMATpH (Value)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0049 \* MERGEFORMATMelting Point (°C) / DOCVARIABLE GMSD00056AA0073 \* MERGEFORMATFreezing Point (°C) DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSDSEUSDS0000000538 \* MERGEFORMATBoiling point/boiling range (°C):DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0050 \* MERGEFORMATFlash Point (°C)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSDSEUSDS0000000543 \* MERGEFORMATEvaporation rate (BA = 1)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSDSEUSDS0000000540 \* MERGEFORMATFlammability (solid, gas)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSDSGHS000000000071 \* MERGEFORMATExplosive limit rangesDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSD00056AA0061 \* MERGEFORMATVapour Pressure (mm Hg)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSD00056AA0082 \* MERGEFORMATVapour Density (Air=1)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSD00056AA0063 \* MERGEFORMATDensity (g/ml)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSD00056AA0064 \* MERGEFORMATSolubility (Water)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0065 \* MERGEFORMATSolubility (Other)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0066 \* MERGEFORMATPartition Coefficient DOCVARIABLE GMSD00016AQ0001 \* MERGEFORMAT(n-Octanol/water)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0054 \* MERGEFORMATAuto Ignition Temperature (°C)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00017AM0021 \* MERGEFORMATDecomposition Temperature (°C)DOCVARIABLE GMSD0X050AA0009 \* MERGEFORMATNot determined.DOCVARIABLE GMSD00056AA0086 \* MERGEFORMATViscosity (mPa.s)DOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSDSEUSDS0000000541 \* MERGEFORMATExplosive propertiesDOCVARIABLE GMSD00016AJ0001 \* MERGEFORMATNot explosive. DOCVARIABLE GMSDSEUSDS0000000542 \* MERGEFORMATOxidising propertiesDOCVARIABLE GMSD0X016AK0002 \* MERGEFORMATNot oxidising9.2DOCVARIABLE GMSDSEUSDS0000000516 \* MERGEFORMATOther informationDOCVARIABLE GMSD0X050AA0008 \* MERGEFORMATNot available.DOCVARIABLE GMSDS000000000000710 \* MERGEFORMATSECTION 10: DOCVARIABLE GMSD00056AA0087 \* MERGEFORMATSTABILITY AND REACTIVITY10.1DOCVARIABLE GMSD00056AA0309 \* MERGEFORMATReactivityDOCVARIABLE GMSD00050AA0006 \* MERGEFORMATNone known.10.2DOCVARIABLE GMSDSEU000000HH00222 \* MERGEFORMATChemical stabilityDOCVARIABLE IECHE01231179 \* MERGEFORMATThe product is stable in accordance with the recommended storage conditions. 10.3DOCVARIABLE GMSDSEU000000HH00223 \* MERGEFORMATPossibility of hazardous reactionsDOCVARIABLE IECHE01231308 \* MERGEFORMATContact with acids may liberate trace amounts of toxic gas (hydrazoic acid). DOCVARIABLE IECHE01231233 \* MERGEFORMATHazardous polymerisation will not occur.10.4DOCVARIABLE GMSDSEUSDS0000000502 \* MERGEFORMATConditions to avoidDOCVARIABLE GMSD0X050AA0001 \* MERGEFORMATNone.10.5DOCVARIABLE GMSD00014AD0003A \* MERGEFORMATIncompatible materialsDOCVARIABLE GMSD0X050AA0001 \* MERGEFORMATNone.10.6DOCVARIABLE GMSD00056AA0089 \* MERGEFORMATHazardous Decomposition Product(s)DOCVARIABLE GMSD00050AA0006 \* MERGEFORMATNone known.DOCVARIABLE GMSDS000000000000711 \* MERGEFORMATSECTION 11: DOCVARIABLE GMSD00056AA0090 \* MERGEFORMATTOXICOLOGICAL INFORMATION11.1DOCVARIABLE GMSDSEU000000HH00224 \* MERGEFORMATInformation on toxicological effects11.1.2DOCVARIABLE GMSDSEU000000HH00209 \* MERGEFORMATMixturesDOCVARIABLE GMSDS000000000000376 \* MERGEFORMATAcute toxicityDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSEUCSR0000000019 \* MERGEFORMATIrritationDOCVARIABLE GMSDSGHS00EUH205 \* MERGEFORMATCauses serious eye irritation.DOCVARIABLE GMSDSEUCSR0000000023 \* MERGEFORMATCorrosivityDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met. DOCVARIABLE GMSDSEUSDS0000000529 \* MERGEFORMATSensitisationDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSEUSDS0000000517 \* MERGEFORMATRepeated dose toxicityDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSEUCSR0000000029 \* MERGEFORMATCarcinogenicityDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met. DOCVARIABLE GMSDSEUCSR0000000028 \* MERGEFORMATMutagenicityDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSEUCSR0000000030 \* MERGEFORMATToxicity for reproductionDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSGHS000000000386 \* MERGEFORMATSTOT-single exposureDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSGHS000000000390 \* MERGEFORMATSTOT-repeated exposureDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.DOCVARIABLE GMSDSGHS000000000442 \* MERGEFORMATAspiration hazardDOCVARIABLE GMSDSGHS000000000456 \* MERGEFORMATBased upon the available data, the classification criteria are not met.11.2DOCVARIABLE GMSDSEUSDS0000000516 \* MERGEFORMATOther informationDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicableDOCVARIABLE GMSDS000000000000712 \* MERGEFORMATSECTION 12: DOCVARIABLE GMSD00056AA0092 \* MERGEFORMATECOLOGICAL INFORMATION12.1DOCVARIABLE GMSD00056AA0095 \* MERGEFORMATToxicityDOCVARIABLE IECHE01231253 \* MERGEFORMATThe product does not contain significant quantities of ingredients that are environmentally toxic.12.2DOCVARIABLE GMSDSEUSDS0000000534 \* MERGEFORMATPersistence and degradabilityDOCVARIABLE IECHE01231125 \* MERGEFORMATThe device contains plastic and other components that are not readily degradable.12.3DOCVARIABLE GMSDSEUSDS0000000535 \* MERGEFORMATBioaccumulative potentialDOCVARIABLE GMSD00050AA0004 \* MERGEFORMATNone anticipated. 12.4DOCVARIABLE GMSDSGHS000000000429 \* MERGEFORMATMobility in soilDOCVARIABLE GMSD00024AB0004 \* MERGEFORMATThe product is predicted to have low mobility in soil.12.5DOCVARIABLE GMSDSEUSDS0000000544 \* MERGEFORMATResults of PBT and vPvB assessmentDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.12.6DOCVARIABLE GMSDSEUSDS0000000536 \* MERGEFORMATOther adverse effectsDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSDS000000000000713 \* MERGEFORMATSECTION 13: DOCVARIABLE GMSD00056AA0097 \* MERGEFORMATDISPOSAL CONSIDERATIONS13.1DOCVARIABLE GMSDSEU000000HH00225 \* MERGEFORMATWaste treatment methodsDOCVARIABLE IECHE01231255 \* MERGEFORMATProduct:DOCVARIABLE IECHE01231314 \* MERGEFORMATUsed devices and other contaminated materials should be disposed of as potentially biohazardous waste. DOCVARIABLE GMSD00028AA0033 \* MERGEFORMATDisposal should be in accordance with local, state or national legislation. DOCVARIABLE IECHE01231316 \* MERGEFORMATTo ensure compliance we recommend that you contact the relevant (local) authorities and/or an approved waste-disposal company for information.DOCVARIABLE IECHE01231237 \* MERGEFORMATEuropean waste catalogue:18 01 03.DOCVARIABLE IECHE01231257 \* MERGEFORMATPackaging:DOCVARIABLE GMSD00028AA0033 \* MERGEFORMATDisposal should be in accordance with local, state or national legislation. DOCVARIABLE IECHE01231324 \* MERGEFORMATContaminated packaging must be disposed of in the same manner as the product.DOCVARIABLE IECHE01231320 \* MERGEFORMATNon-contaminated packaging materials may be recycled. Contact your local service providers for further information.DOCVARIABLE GMSDS000000000000714 \* MERGEFORMATSECTION 14: DOCVARIABLE GMSD00056AA0098 \* MERGEFORMATTRANSPORT INFORMATION14.1DOCVARIABLE GMSDSEUSDS0000000521 \* MERGEFORMATUN numberDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable14.2DOCVARIABLE GMSD00056AA0107 \* MERGEFORMATUN Proper Shipping NameDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable14.3DOCVARIABLE GMSDSEU000000HH00226 \* MERGEFORMATTransport hazard class(es)DOCVARIABLE GMSD00029AD0021 \* MERGEFORMATNot classified as dangerous for transport.14.4DOCVARIABLE GMSDA000000000000346 \* MERGEFORMATPacking GroupDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable14.5DOCVARIABLE GMSDSEU000000HH00227 \* MERGEFORMATEnvironmental hazardsDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable14.6DOCVARIABLE GMSDSEU000000HH00228 \* MERGEFORMATSpecial precautions for userDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicable14.7DOCVARIABLE GMSDSEU000000HH00231 \* MERGEFORMATTransport in bulk according to Annex II of MARPOL73/78 and the IBC CodeDOCVARIABLE GMSD0X050AA0007 \* MERGEFORMATNot applicableDOCVARIABLE GMSDS000000000000715 \* MERGEFORMATSECTION 15: DOCVARIABLE GMSD00056AA0123 \* MERGEFORMATREGULATORY INFORMATION15.1DOCVARIABLE GMSDSEU000000HH00229 \* MERGEFORMATSafety, health and environmental regulations/legislation specific for the substance or mixtureDOCVARIABLE IECHE01231259 \* MERGEFORMATIn Vitro diagnostics medical devices directive 98/79/EC. OSHA Hazard Communication Standard 29 CFR 1910.1200Consumer Product Safety Regulations 16 CFR 1600IVD Product Labelling 21 CFR 809Carcinogen listingsIARC:None of the ingredients is listed.NTP:None of the ingredients is listed.ACGIH:None of the ingredients is listed.OSHA:None of the ingredients is listed.EPA:None of the ingredients is listed.Californian Proposition 65Chemicals known to cause cancer:None of the ingredients is listed.Chemicals known to cause reproductive toxicity:None of the ingredients is listed.SARASection 355 (extremely hazardous substances):Sodium azide (trace).Section 313 (specific toxic chemical listings):Sodium azide (trace).15.2DOCVARIABLE GMSDSEU000000HH00230 \* MERGEFORMATChemical Safety AssessmentDOCVARIABLE GMSD00050AA0007 \* MERGEFORMATNot applicable.DOCVARIABLE GMSDS000000000000716 \* MERGEFORMATSECTION 16: DOCVARIABLE GMSD00056AA0127 \* MERGEFORMATOTHER INFORMATIONDOCVARIABLE GMSDSGHS000000000380 \* MERGEFORMATLEGEND STOTDOCVARIABLE GMSDS000000000000646 \* MERGEFORMATSpecific Target Organ ToxicitySTELShort Term Exposure LimitLTELLong Term Exposure limitTWATime Weighted AverageDOCVARIABLE GMSDS000000000000614 \* MERGEFORMATClassification code:DOCVARIABLE GMSDSEU000000CLP0063 \* MERGEFORMATAcute Tox. 4DOCVARIABLE GMSDS000000000000376 \* MERGEFORMATAcute toxicity; DOCVARIABLE GMSDSGHS000000000450 \* MERGEFORMATCategory 4DOCVARIABLE GMSDSEU000000CLP0061 \* MERGEFORMATAcute Tox. 2DOCVARIABLE GMSDS000000000000376 \* MERGEFORMATAcute toxicity: DOCVARIABLE GMSDSGHS000000000438 \* MERGEFORMATCategory 2DOCVARIABLE GMSDSEU000000CLP0070 \* MERGEFORMATEye Dam. 1DOCVARIABLE GMSD0X022AA0051 \* MERGEFORMATEye damage; DOCVARIABLE GMSDSGHS000000000437 \* MERGEFORMATCategory 1DOCVARIABLE GMSDSEU000000CLP0071 \* MERGEFORMATEye Irrit. 2DOCVARIABLE GMSD0X022AA0051 \* MERGEFORMATEye DOCVARIABLE GMSDSEUCSR0000000019 \* MERGEFORMATIrritation: DOCVARIABLE GMSDSGHS000000000438 \* MERGEFORMATCategory 2DOCVARIABLE GMSDSEU000000CLP0098 \* MERGEFORMATAquatic Acute 1DOCVARIABLE GMSDSGHS000000000417 \* MERGEFORMATHazardous to the aquatic environment DOCVARIABLE GMSD00056AA0306 \* MERGEFORMATAcute: DOCVARIABLE GMSDS000000000000626 \* MERGEFORMATDOCVARIABLE GMSDSGHS000000000437 \* MERGEFORMATCategory 1DOCVARIABLE GMSDSEU000000CLP0099 \* MERGEFORMATAquatic Chronic 1DOCVARIABLE GMSDSGHS000000000417 \* MERGEFORMATHazardous to the aquatic environment DOCVARIABLE GMSD00056AA0304 \* MERGEFORMATChronic: DOCVARIABLE GMSDSGHS000000000437 \* MERGEFORMATCategory 1DOCVARIABLE GMSDSEU000000CLP0100 \* MERGEFORMATAquatic Chronic 2DOCVARIABLE GMSDSGHS000000000417 \* MERGEFORMATHazardous to the aquatic environment DOCVARIABLE GMSD00056AA0304 \* MERGEFORMATChronic: DOCVARIABLE GMSDSGHS000000000438 \* MERGEFORMATCategory 2XiDOCVARIABLE GMSD0X023AC0031 \* MERGEFORMATIrritantXnDOCVARIABLE GMSD00023AD0031 \* MERGEFORMATHarmful.T+DOCVARIABLE GMSD00023AD0037 \* MERGEFORMATVery toxic.NDOCVARIABLE GMSD00030AC0002 \* MERGEFORMATDangerous for the environment.DOCVARIABLE GMSDSGHS000000000406 \* MERGEFORMATHazard statement(s)DOCVARIABLE GMSDSGHS0CEUH300 \* MERGEFORMATH300: Fatal if swallowed. DOCVARIABLE GMSDSGHS0CEUH302A \* MERGEFORMATH302: Harmful if swallowed.DOCVARIABLE GMSDSGHS0CEUH318 \* MERGEFORMATH318: Causes serious eye damage.DOCVARIABLE GMSDSGHS0CEUH319A \* MERGEFORMATH319: Causes serious eye irritation.DOCVARIABLE GMSDSGHS0CEUH400A \* MERGEFORMATH400: Very toxic to aquatic life.DOCVARIABLE GMSDSGHS0CEUH410A \* MERGEFORMATH410: Very toxic to aquatic life with long lasting effects.DOCVARIABLE GMSDSGHS0CEUH411 \* MERGEFORMATH411: Toxic to aquatic life with long lasting effects.DOCVARIABLE GMSDSGHS0CEUH032A \* MERGEFORMATEUH032: Contact with acids liberates very toxic gas.DOCVARIABLE GMSD00056AA0125 \* MERGEFORMATRisk PhrasesDOCVARIABLE GMSD00030BF0021 \* MERGEFORMATR22: Harmful if swallowed.DOCVARIABLE GMSD00030BF0035 \* MERGEFORMATR28: Very toxic if swallowed.DOCVARIABLE GMSD00030BF0040 \* MERGEFORMATR32: Contact with acids liberates very toxic gas.DOCVARIABLE GMSD00030BF0044 \* MERGEFORMATR36: Irritating to eyes.DOCVARIABLE GMSD00030BF0075 \* MERGEFORMATR41: Risk of serious damage to eyes.DOCVARIABLE GMSD00030BF0100 \* MERGEFORMATR50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.DOCVARIABLE GMSD00030BF0102 \* MERGEFORMATR51/53: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.DOCVARIABLE GMSD00030BF0021 \* MERGEFORMATDOCVARIABLE GMSDS000000000000509 \* MERGEFORMATReferences:DOCVARIABLE IECHE01231269 \* MERGEFORMATRaw material safety data sheets.DOCVARIABLE GMSD00056AA0147 \* MERGEFORMATAdditional InformationDOCVARIABLE IECHE01231263 \* MERGEFORMATReason for update:DOCVARIABLE IECHE01231267 \* MERGEFORMATUpdate in accordance with Regulation (EU) No 453/2010. DOCVARIABLE GMSDSBDI000000000135 \* MERGEFORMATRegulation (EC) No. 1272/2008 (CLP) & GHSDOCVARIABLE IECHE01231265 \* MERGEFORMATChanges to all sections.DOCVARIABLE IECHE01231261 \* MERGEFORMATSupersedes:DOCVARIABLE IECHE01231097 \* MERGEFORMATVersion: 2DOCVARIABLE GMSD00029AC0047 \* MERGEFORMATPrepared by:Dr. J. J. Tobin, ChemHaz Solutions, Email: info@ DOCVARIABLE IECHE01231084 \* MERGEFORMATTo the best of our knowledge, the information contained herein is accurate. However, neither the above named supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. ................
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