al204c alphalisa® insulin kit

Kit components07.04.2020

Product code Description

AL204C AlphaLISA® Insulin Kit

Components:AL204S AlphaLISA® human Insulin (0.01 IU; 0.38 µg)AL204AC AlphaLISA® anti-Insulin Acceptor Beads (50 µL)AL204BC AlphaLISA® Biotinylated Antibody Anti-Insulin (50 µL)AL000C Immunoassay buffer, 10X, 10 mL6760002S Streptavidin Donor Beads

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Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 07.04.2020 Revision: 07.04.2020

51.0.2

SECTION 1: Identification of the substance/mixture and of the company/undertaking

· 1.1 Product identifier

· Trade name: AlphaLISA® human Insulin (0.01 IU; 0.38 µg)

· Product number: AL204S· 1.2 Relevant identified uses of the substance or mixture and uses advised against

No further relevant information available.· Application of the substance / the mixture Laboratory chemicals

· 1.3 Details of the supplier of the safety data sheet· Manufacturer/Supplier:

PerkinElmer Inc549 Albany StBoston, MA 02118

· Further information obtainable from:US Technical Support800-762-4000

· 1.4 Emergency telephone number:If inside USA, call CHEMTREC at 1-800-424-9300If outside USA, call CHEMTREC at 1-703-527-3887

SECTION 2: Hazards identification

· 2.1 Classification of the substance or mixture· 2.1.1 Classification according to Regulation (EC) No 1272/2008

Skin Irrit. 2 H315 Causes skin irritation.

Eye Dam. 1 H318 Causes serious eye damage.

Skin Sens. 1 H317 May cause an allergic skin reaction.

Aquatic Acute 1 H400 Very toxic to aquatic life.

Aquatic Chronic 1 H410 Very toxic to aquatic life with long lasting effects.· 2.1.3 Additional information: For the wording of the relevant risk phrases refer to section 16.

· 2.2 Label elements· Labelling according to Regulation (EC) No 1272/2008

The product is classified and labelled according to the CLP regulation.· Hazard pictograms

GHS05 GHS07 GHS09

· Signal word Danger

· Hazard-determining components of labelling:hydrochloric acidProclin-300

· Hazard statementsH315 Causes skin irritation.H318 Causes serious eye damage.H317 May cause an allergic skin reaction.H410 Very toxic to aquatic life with long lasting effects.

· Precautionary statementsP261 Avoid breathing dust/fume/gas/mist/vapours/spray.

(Contd. on page 2) EU

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Trade name: AlphaLISA® human Insulin (0.01 IU; 0.38 µg)

(Contd. of page 1)

51.0.2

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, ifpresent and easy to do. Continue rinsing.

P310 Immediately call a POISON CENTER/doctor.P321 Specific treatment (see on this label).P362+P364 Take off contaminated clothing and wash it before reuse.P501 Dispose of contents/container in accordance with local/regional/national/international

regulations.· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

SECTION 3: Composition/information on ingredients

· 3.2 Chemical characterisation: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:

CAS: 7647-01-0EINECS: 231-595-7Index number: 017-002-01-X

hydrochloric acid Skin Corr. 1B, H314; Eye Dam. 1, H318; Acute Tox. 4, H302;

STOT SE 3, H335

1-2.5%

CAS: 55965-84-9Index number: 613-167-00-5

Proclin-300 Acute Tox. 3, H301; Acute Tox. 2, H310; Acute Tox. 2, H330; Skin

Corr. 1C, H314; Eye Dam. 1, H318; Aquatic Acute 1, H400; AquaticChronic 1, H410; Skin Sens. 1A, H317

<1%

· Additional information: For the wording of the relevant risk phrases refer to section 16.

SECTION 4: First aid measures

· 4.1 Description of first aid measures· General information: Immediately remove any clothing soiled by the product.· After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.

· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.· After swallowing: If symptoms persist consult doctor.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.· 4.3 Indication of any immediate medical attention and special treatment needed

No further relevant information available.

SECTION 5: Firefighting measures

· 5.1 Extinguishing media· Suitable extinguishing agents: Use fire extinguishing methods suitable to surrounding conditions.· 5.2 Special hazards arising from the substance or mixture No further relevant information available.· 5.3 Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.

EU

(Contd. on page 3)

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(Contd. of page 2)

51.0.2

SECTION 6: Accidental release measures

· 6.1 Personal precautions, protective equipment and emergency proceduresWear protective equipment. Keep unprotected persons away.

· 6.2 Environmental precautions:Do not allow product to reach sewage system or any water course.Inform respective authorities in case of seepage into water course or sewage system.Do not allow to enter sewers/ surface or ground water.

· 6.3 Methods and material for containment and cleaning up:Use neutralising agent.Dispose contaminated material as waste according to item 13.Ensure adequate ventilation.

· 6.4 Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

SECTION 7: Handling and storage

· 7.1 Precautions for safe handlingThorough dedusting.Ensure good ventilation/exhaustion at the workplace.

· Information about fire - and explosion protection: No special measures required.

· 7.2 Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and containers: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: Keep container tightly sealed.· 7.3 Specific end use(s) No further relevant information available.

SECTION 8: Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· 8.1 Control parameters

· Ingredients with limit values that require monitoring at the workplace:

7647-01-0 hydrochloric acid (1-2.5%)

IOELV Short-term value: 15 mg/m³, 10 ppmLong-term value: 8 mg/m³, 5 ppm

· 8.2 Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothingWash hands before breaks and at the end of work.Avoid contact with the skin.Avoid contact with the eyes and skin.

· Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure useself-contained respiratory protective device.


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(Contd. of page 3)

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Suitable respiratory protective device recommended.· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of quality andvaries from manufacturer to manufacturer. As the product is a preparation of several substances, the resistanceof the glove material can not be calculated in advance and has therefore to be checked prior to the application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Eye protection:

Tightly sealed goggles

SECTION 9: Physical and chemical properties

· 9.1 Information on basic physical and chemical properties· General Information· Appearance:

Form: SolidColour: According to product specification

· Odour: Characteristic· Odour threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/freezing point: Undetermined.Initial boiling point and boiling range: 100 °C

· Flash point: Not applicable.

· Flammability (solid, gas): Not determined.

· Decomposition temperature: Not determined.

· Auto-ignition temperature: Product is not selfigniting.

· Explosive properties: Product does not present an explosion hazard.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapour pressure at 20 °C: 23 hPa

· Density: Not determined.· Relative density Not determined.· Vapour density Not applicable.


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(Contd. of page 4)

51.0.2

· Evaporation rate Not applicable.

· Solubility in / Miscibility withwater: Insoluble.

· Partition coefficient: n-octanol/water: Not determined.

· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

· Solvent content:Water: 32.5 %

Solids content: 14.8 %· 9.2 Other information No further relevant information available.

SECTION 10: Stability and reactivity

· 10.1 Reactivity No further relevant information available.· 10.2 Chemical stability· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· 10.3 Possibility of hazardous reactions No dangerous reactions known.· 10.4 Conditions to avoid No further relevant information available.· 10.5 Incompatible materials: No further relevant information available.· 10.6 Hazardous decomposition products: No dangerous decomposition products known.

SECTION 11: Toxicological information

· 11.1 Information on toxicological effects· Acute toxicity Based on available data, the classification criteria are not met.· Primary irritant effect:· Skin corrosion/irritation

Causes skin irritation.· Serious eye damage/irritation

Causes serious eye damage.· Respiratory or skin sensitisation

May cause an allergic skin reaction.· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)· Germ cell mutagenicity Based on available data, the classification criteria are not met.· Carcinogenicity Based on available data, the classification criteria are not met.· Reproductive toxicity Based on available data, the classification criteria are not met.· STOT-single exposure Based on available data, the classification criteria are not met.· STOT-repeated exposure Based on available data, the classification criteria are not met.· Aspiration hazard Based on available data, the classification criteria are not met.

SECTION 12: Ecological information

· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.


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(Contd. of page 5)

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· Ecotoxical effects:· Remark: Very toxic for fish· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.

SECTION 13: Disposal considerations

· 13.1 Waste treatment methods· Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.Hand over to hazardous waste disposers.Must be specially treated adhering to official regulations.

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

SECTION 14: Transport information

· 14.1 UN-Number· ADR, IMDG, IATA UN1759

· 14.2 UN proper shipping name· ADR 17 59 CO RROS IVE S OLI D, N . O . S . (P ro c l in - 30 0 ,

H Y D R O C H L O R I C A C I D ) , E N V I R O N M E N T A L L YHAZARDOUS

· IMDG, IATA CORROSIVE SOLID, N.O.S. (Proclin-300, HYDROCHLORICACID)

· 14.3 Transport hazard class(es)

· ADR

· Class 8 Corrosive substances.· Label 8

· IMDG, IATA

· Class 8 Corrosive substances.· Label 8

· 14.4 Packing group· ADR, IMDG, IATA III

· 14.5 Environmental hazards:· Special marking (ADR): Symbol (fish and tree)


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(Contd. of page 6)

51.0.2

· 14.6 Special precautions for user Warning: Corrosive substances.· Hazard identification number (Kemler code): 80· EMS Number: F-A,S-B· Segregation groups Acids· Stowage Category A

· 14.7 Transport in bulk according to Annex II ofMarpol and the IBC Code Not applicable.

· Transport/Additional information:

· ADR· Limited quantities (LQ) 5 kg· Excepted quantities (EQ) Code: E1

Maximum net quantity per inner packaging: 30 gMaximum net quantity per outer packaging: 1000 g

· Transport category 3 · Tunnel restriction code E

· IMDG· Limited quantities (LQ) 5 kg· Excepted quantities (EQ) Code: E1

Maximum net quantity per inner packaging: 30 gMaximum net quantity per outer packaging: 1000 g

· UN "Model Regulation": UN 1759 CORROSIVE SOLID, N.O.S. (PROCLIN-300,HYDROCHLORIC ACID), 8, III, ENVIRONMENTALLYHAZARDOUS

SECTION 15: Regulatory information

· 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

· Directive 2012/18/EU· Named dangerous substances - ANNEX I None of the ingredients is listed.· Seveso category E1 Hazardous to the Aquatic Environment· Qualifying quantity (tonnes) for the application of lower-tier requirements 100 t· Qualifying quantity (tonnes) for the application of upper-tier requirements 200 t· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

SECTION 16: Other informationThe information provided in this Safety Data Sheet is based on our present knowledge,and believed to be correct at the date of publication. However, no representation is madeconcerning its accuracy and completeness. It is intended as guidance only, and is not to beconsidered a warranty or quality specification. All materials may present unknown hazards, andshould be used with caution. Although certain hazards are described, we cannot guarantee thatthese are the only hazards which exist. PerkinElmer, Inc. shall not be heldliable for any damage resulting from handling or from contact with the product.

· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of Chemicals


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(Contd. of page 7)

51.0.2

EINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeAcute Tox. 3: Acute toxicity - oral – Category 3Acute Tox. 4: Acute toxicity - oral – Category 4Acute Tox. 2: Acute toxicity - dermal – Category 2Skin Corr. 1B: Skin corrosion/irritation – Category 1BSkin Corr. 1C: Skin corrosion/irritation – Category 1CSkin Irrit. 2: Skin corrosion/irritation – Category 2Eye Dam. 1: Serious eye damage/eye irritation – Category 1Skin Sens. 1: Skin sensitisation – Category 1Skin Sens. 1A: Skin sensitisation – Category 1ASTOT SE 3: Specific target organ toxicity (single exposure) – Category 3Aquatic Acute 1: Hazardous to the aquatic environment - acute aquatic hazard – Category 1Aquatic Chronic 1: Hazardous to the aquatic environment - long-term aquatic hazard – Category 1

EU

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51.0.2



· Trade name: AlphaLISA® anti-Insulin Acceptor Beads (50 µL)

· Product number: AL204AC· 1.2 Relevant identified uses of the substance or mixture and uses advised against









Aquatic Chronic 2 H411 Toxic to aquatic life with long lasting effects.· 2.1.3 Additional information: For the wording of the relevant risk phrases refer to section 16.



GHS07 GHS09

· Signal word Warning

· Hazard-determining components of labelling:Proclin-300

· Hazard statementsH317 May cause an allergic skin reaction.H411 Toxic to aquatic life with long lasting effects.

· Precautionary statementsP261 Avoid breathing dust/fume/gas/mist/vapours/spray.P273 Avoid release to the environment.P280 Wear protective gloves.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see on this label).P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.


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Trade name: AlphaLISA® anti-Insulin Acceptor Beads (50 µL)

(Contd. of page 1)

51.0.2

· vPvB: Not applicable.




CAS: 55965-84-9Index number: 613-167-00-5

Proclin-300 Acute Tox. 3, H301; Acute Tox. 2, H310; Acute Tox. 2, H330; Skin

Corr. 1C, H314; Eye Dam. 1, H318; Aquatic Acute 1, H400; AquaticChronic 1, H410; Skin Sens. 1A, H317

<0.1%



· 4.1 Description of first aid measures· General information: Immediately remove any clothing soiled by the product.· After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.

· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: If symptoms persist consult doctor.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.· 4.3 Indication of any immediate medical attention and special treatment needed





· 6.1 Personal precautions, protective equipment and emergency procedures Not required.· 6.2 Environmental precautions:

Do not allow product to reach sewage system or any water course.Inform respective authorities in case of seepage into water course or sewage system.

· 6.3 Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).Dispose contaminated material as waste according to item 13.Ensure adequate ventilation.

· 6.4 Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.


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(Contd. of page 2)

51.0.2

See Section 13 for disposal information.


· 7.1 Precautions for safe handlingEnsure good ventilation/exhaustion at the workplace.Prevent formation of aerosols.

· Information about fire - and explosion protection: No special measures required.

· 7.2 Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and containers: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: None.· 7.3 Specific end use(s) No further relevant information available.



· 8.1 Control parameters· Ingredients with limit values that require monitoring at the workplace:

The product does not contain any relevant quantities of materials with critical values that have to be monitored atthe workplace.


Immediately remove all soiled and contaminated clothingWash hands before breaks and at the end of work.

· Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure useself-contained respiratory protective device.Suitable respiratory protective device recommended.

· Protection of hands:

Protective gloves




· Eye protection: Goggles recommended during refilling EU

(Contd. on page 4)

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(Contd. of page 3)

51.0.2



Form: FluidColour: According to product specification


· pH-value: Not determined.

· Change in conditionMelting point/freezing point: 0 °CInitial boiling point and boiling range: 100 °C


· Flammability (solid, gas): Not applicable.






· Density at 20 °C: 1 g/cm³· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Not miscible or difficult to mix.


· Viscosity:Dynamic: Not determined.Kinematic: Not determined.


· 9.2 Other information No further relevant information available.


· 10.1 Reactivity No further relevant information available.· 10.2 Chemical stability· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· 10.3 Possibility of hazardous reactions No dangerous reactions known.· 10.4 Conditions to avoid No further relevant information available.· 10.5 Incompatible materials: No further relevant information available.


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(Contd. of page 4)

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· 10.6 Hazardous decomposition products: No dangerous decomposition products known.


· 11.1 Information on toxicological effects· Acute toxicity Based on available data, the classification criteria are not met.· Primary irritant effect:· Skin corrosion/irritation Based on available data, the classification criteria are not met.· Serious eye damage/irritation Based on available data, the classification criteria are not met.· Respiratory or skin sensitisation



· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.· Ecotoxical effects:· Remark: Toxic for fish· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.



Must not be disposed together with household garbage. Do not allow product to reach sewage system.Hand over to hazardous waste disposers.Must be specially treated adhering to official regulations.



· 14.1 UN-Number· ADR, ADN, IMDG, IATA Void


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(Contd. of page 5)

51.0.2

· 14.2 UN proper shipping name· ADR, ADN, IMDG, IATA Void


· ADR, ADN, IMDG, IATA· Class Void

· 14.4 Packing group· ADR, IMDG, IATA Void

· 14.5 Environmental hazards: Not applicable.

· 14.6 Special precautions for user Not applicable.


· UN "Model Regulation": Void



· Directive 2012/18/EU· Named dangerous substances - ANNEX I None of the ingredients is listed.· Seveso category E2 Hazardous to the Aquatic Environment· Qualifying quantity (tonnes) for the application of lower-tier requirements 200 t· Qualifying quantity (tonnes) for the application of upper-tier requirements 500 t· REGULATION (EC) No 1907/2006 ANNEX XVII Conditions of restriction: 3· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeAcute Tox. 3: Acute toxicity - oral – Category 3Acute Tox. 2: Acute toxicity - dermal – Category 2Skin Corr. 1C: Skin corrosion/irritation – Category 1CEye Dam. 1: Serious eye damage/eye irritation – Category 1Skin Sens. 1: Skin sensitisation – Category 1Skin Sens. 1A: Skin sensitisation – Category 1A


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(Contd. of page 6)

51.0.2

Aquatic Acute 1: Hazardous to the aquatic environment - acute aquatic hazard – Category 1Aquatic Chronic 1: Hazardous to the aquatic environment - long-term aquatic hazard – Category 1Aquatic Chronic 2: Hazardous to the aquatic environment - long-term aquatic hazard – Category 2

EU

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51.0.2



· Trade name: AlphaLISA® Biotinylated Antibody Anti-Insulin (50 µL)

· Product number: AL204BC· 1.2 Relevant identified uses of the substance or mixture and uses advised against








The product is not classified, according to the CLP regulation.

· 2.2 Label elements· Labelling according to Regulation (EC) No 1272/2008 Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.



· Dangerous components: Void· Additional information: For the wording of the relevant risk phrases refer to section 16.


· 4.1 Description of first aid measures· General information: No special measures required.· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: If skin irritation continues, consult a doctor.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: If symptoms persist consult doctor.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.


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Trade name: AlphaLISA® Biotinylated Antibody Anti-Insulin (50 µL)

(Contd. of page 1)

51.0.2

· 4.3 Indication of any immediate medical attention and special treatment neededNo further relevant information available.




· 6.1 Personal precautions, protective equipment and emergency procedures Not required.· 6.2 Environmental precautions: Do not allow to enter sewers/ surface or ground water.· 6.3 Methods and material for containment and cleaning up:

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).· 6.4 Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.


· 7.1 Precautions for safe handling No special measures required.· Information about fire - and explosion protection: No special measures required.







The usual precautionary measures are to be adhered to when handling chemicals.· Respiratory protection: Not required.· Protection of hands:



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(Contd. of page 2)

51.0.2



· Eye protection: Goggles recommended during refilling














· Density: Not determined.· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.






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(Contd. of page 3)

51.0.2





· 11.1 Information on toxicological effects· Acute toxicity Based on available data, the classification criteria are not met.

· LD/LC50 values relevant for classification:

26628-22-8 sodium azide

Oral LD50 27 mg/kg (rat)

Dermal LD50 20 mg/kg (rabbit)

· Primary irritant effect:· Skin corrosion/irritation Based on available data, the classification criteria are not met.· Serious eye damage/irritation Based on available data, the classification criteria are not met.· Respiratory or skin sensitisation Based on available data, the classification criteria are not met.· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)· Germ cell mutagenicity Based on available data, the classification criteria are not met.· Carcinogenicity Based on available data, the classification criteria are not met.· Reproductive toxicity Based on available data, the classification criteria are not met.· STOT-single exposure Based on available data, the classification criteria are not met.· STOT-repeated exposure Based on available data, the classification criteria are not met.· Aspiration hazard Based on available data, the classification criteria are not met.


· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.

EU

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(Contd. of page 4)

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Smaller quantities can be disposed of with household waste.Must be specially treated adhering to official regulations.



· 14.1 UN-Number· ADR, ADN, IMDG, IATA Void

· 14.2 UN proper shipping name· ADR, ADN, IMDG, IATA Void










· Directive 2012/18/EU· Named dangerous substances - ANNEX I None of the ingredients is listed.· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous Goods


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(Contd. of page 5)

51.0.2

IATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulative

EU

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51.0.2



· Trade name: Immunoassay buffer, 10X, 10 mL

· Product number: AL000C· 1.2 Relevant identified uses of the substance or mixture and uses advised against








Acute Tox. 3 H331 Toxic if inhaled.

Skin Irrit. 2 H315 Causes skin irritation.

Eye Irrit. 2 H319 Causes serious eye irritation.


Aquatic Acute 1 H400 Very toxic to aquatic life.

Aquatic Chronic 1 H410 Very toxic to aquatic life with long lasting effects.· 2.1.3 Additional information: For the wording of the relevant risk phrases refer to section 16.



GHS06 GHS09

· Signal word Danger

· Hazard-determining components of labelling:Proclin-300

· Hazard statementsH331 Toxic if inhaled.H315 Causes skin irritation.H319 Causes serious eye irritation.H317 May cause an allergic skin reaction.H410 Very toxic to aquatic life with long lasting effects.

· Precautionary statementsP261 Avoid breathing dust/fume/gas/mist/vapours/spray.


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Trade name: Immunoassay buffer, 10X, 10 mL

(Contd. of page 1)

51.0.2

P280 Wear protective gloves / eye protection / face protection.P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.P403+P233 Store in a well-ventilated place. Keep container tightly closed.P501 Dispose of contents/container in accordance with local/regional/national/international

regulations.· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.




CAS: 9002-93-1 Polyethylene glycol octylphenol ether Eye Irrit. 2, H319; Aquatic Chronic 3, H412

2.5-10%

CAS: 55965-84-9Index number: 613-167-00-5

Proclin-300 Acute Tox. 3, H301; Acute Tox. 2, H310; Acute Tox. 2, H330; Skin Corr. 1C, H314; Eye Dam. 1, H318; Aquatic Acute 1, H400;

Aquatic Chronic 1, H410; Skin Sens. 1A, H317

<1%

· SVHC

9002-93-1 Polyethylene glycol octylphenol ether



· 4.1 Description of first aid measures· General information:

Immediately remove any clothing soiled by the product.Remove breathing equipment only after contaminated clothing have been completely removed.In case of irregular breathing or respiratory arrest provide artificial respiration.

· After inhalation:Supply fresh air or oxygen; call for doctor.In case of unconsciousness place patient stably in side position for transportation.

· After eye contact:Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

· After swallowing: If symptoms persist consult doctor.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.· 4.3 Indication of any immediate medical attention and special treatment needed



· 5.1 Extinguishing media· Suitable extinguishing agents: Use fire extinguishing methods suitable to surrounding conditions.· 5.2 Special hazards arising from the substance or mixture No further relevant information available.


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51.0.2

· 5.3 Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.


· 6.1 Personal precautions, protective equipment and emergency procedures Not required.· 6.2 Environmental precautions:

Do not allow product to reach sewage system or any water course.Inform respective authorities in case of seepage into water course or sewage system.Do not allow to enter sewers/ surface or ground water.

· 6.3 Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).Dispose contaminated material as waste according to item 13.Ensure adequate ventilation.

· 6.4 Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.


· 7.1 Precautions for safe handlingEnsure good ventilation/exhaustion at the workplace.Open and handle receptacle with care.Prevent formation of aerosols.

· Information about fire - and explosion protection: Keep respiratory protective device available.

· 7.2 Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and containers: No special requirements.· Information about storage in one common storage facility: Not required.· Further information about storage conditions: Keep container tightly sealed.· 7.3 Specific end use(s) No further relevant information available.






Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothingWash hands before breaks and at the end of work.Store protective clothing separately.Avoid contact with the eyes and skin.


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· Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure useself-contained respiratory protective device.Suitable respiratory protective device recommended.

· Protection of hands:

Protective gloves




· Eye protection:

Tightly sealed goggles















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(Contd. of page 4)

51.0.2

· Density: Not determined.· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.





Solids content: 1.0 %· 9.2 Other information No further relevant information available.




· 11.1 Information on toxicological effects· Acute toxicity

Toxic if inhaled.· Primary irritant effect:· Skin corrosion/irritation

Causes skin irritation.· Serious eye damage/irritation

Causes serious eye irritation.· Respiratory or skin sensitisation


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(Contd. on page 6)

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(Contd. of page 5)

51.0.2


· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.· Ecotoxical effects:· Remark: Very toxic for fish· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.



Hand over to hazardous waste disposers.Must be specially treated adhering to official regulations.Must not be disposed together with household garbage. Do not allow product to reach sewage system.



· 14.1 UN-Number· ADR, IMDG, IATA UN2810

· 14.2 UN proper shipping name· ADR 2810 TOXIC LIQUID, ORGANIC, N.O.S. (Proclin-300,

Polyethylene glycol octylphenol ether), ENVIRONMENTALLYHAZARDOUS

· IMDG TOXIC LIQUID, ORGANIC, N.O.S . (Procl in-300,Polyethylene glycol octylphenol ether), MARINE POLLUTANT

· IATA TOXIC LIQUID, ORGANIC, N.O.S . (Procl in-300,Polyethylene glycol octylphenol ether)


· ADR, IMDG

· Class 6.1 Toxic substances.


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· Label 6.1

· IATA

· Class 6.1 Toxic substances.· Label 6.1

· 14.4 Packing group· ADR, IMDG, IATA III

· 14.5 Environmental hazards: Product contains environmentally hazardous substances:Proclin-300

· Marine pollutant: Symbol (fish and tree)· Special marking (ADR): Symbol (fish and tree)

· 14.6 Special precautions for user Warning: Toxic substances.· Hazard identification number (Kemler code): 60· EMS Number: F-A,S-A· Stowage Category A · Stowage Code SW2 Clear of living quarters.


· Transport/Additional information:

· ADR· Limited quantities (LQ) 5L· Excepted quantities (EQ) Code: E1

Maximum net quantity per inner packaging: 30 mlMaximum net quantity per outer packaging: 1000 ml

· Transport category 2 · Tunnel restriction code E

· IMDG· Limited quantities (LQ) 5L· Excepted quantities (EQ) Code: E1

Maximum net quantity per inner packaging: 30 mlMaximum net quantity per outer packaging: 1000 ml

· UN "Model Regulation": UN 2810 TOXIC LIQUID, ORGANIC, N.O.S. (PROCLIN-300,POLYETHYLENE GLYCOL OCTYLPHENOL ETHER), 6.1,III, ENVIRONMENTALLY HAZARDOUS



· Directive 2012/18/EU· Named dangerous substances - ANNEX I None of the ingredients is listed.· Seveso category

H2 ACUTE TOXICE1 Hazardous to the Aquatic Environment

· Qualifying quantity (tonnes) for the application of lower-tier requirements 50 t(Contd. on page 8)

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(Contd. of page 7)

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· Qualifying quantity (tonnes) for the application of upper-tier requirements 200 t

· LIST OF SUBSTANCES SUBJECT TO AUTHORISATION (ANNEX XIV)

9002-93-1 Polyethylene glycol octylphenol ether Sunset date: 2021-01-04

· REGULATION (EC) No 1907/2006 ANNEX XVII Conditions of restriction: 3

· National regulations:

· Other regulations, limitations and prohibitive regulations

· Substances of very high concern (SVHC) according to REACH, Article 57

9002-93-1 Polyethylene glycol octylphenol ether

· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicSVHC: Substances of Very High ConcernvPvB: very Persistent and very BioaccumulativeAcute Tox. 3: Acute toxicity - oral – Category 3Acute Tox. 2: Acute toxicity - dermal – Category 2Skin Corr. 1C: Skin corrosion/irritation – Category 1CSkin Irrit. 2: Skin corrosion/irritation – Category 2Eye Dam. 1: Serious eye damage/eye irritation – Category 1Eye Irrit. 2: Serious eye damage/eye irritation – Category 2Skin Sens. 1: Skin sensitisation – Category 1Skin Sens. 1A: Skin sensitisation – Category 1AAquatic Acute 1: Hazardous to the aquatic environment - acute aquatic hazard – Category 1Aquatic Chronic 1: Hazardous to the aquatic environment - long-term aquatic hazard – Category 1Aquatic Chronic 3: Hazardous to the aquatic environment - long-term aquatic hazard – Category 3

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51.0.2



· Trade name: Streptavidin Donor Beads

· Product number: 6760002S, 6760002S2· 1.2 Relevant identified uses of the substance or mixture and uses advised against








The product is not classified, according to the CLP regulation.

· 2.2 Label elements· Labelling according to Regulation (EC) No 1272/2008 Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· 2.3 Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.



· Dangerous components: Void· Additional information: For the wording of the relevant risk phrases refer to section 16.


· 4.1 Description of first aid measures· General information: No special measures required.· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: If skin irritation continues, consult a doctor.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing: If symptoms persist consult doctor.· 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available.


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Trade name: Streptavidin Donor Beads

(Contd. of page 1)

51.0.2

· 4.3 Indication of any immediate medical attention and special treatment neededNo further relevant information available.




· 6.1 Personal precautions, protective equipment and emergency procedures Not required.· 6.2 Environmental precautions: No special measures required.· 6.3 Methods and material for containment and cleaning up:

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).· 6.4 Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.


· 7.1 Precautions for safe handling No special measures required.· Information about fire - and explosion protection: No special measures required.







The usual precautionary measures are to be adhered to when handling chemicals.· Respiratory protection: Not required.· Protection of hands:



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· Eye protection: Goggles recommended during refilling






· Change in conditionMelting point/freezing point: 0 °CInitial boiling point and boiling range: 100 °C








· Density at 20 °C: 1 g/cm³· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.





Solids content: 0.6 %


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· 11.1 Information on toxicological effects· Acute toxicity Based on available data, the classification criteria are not met.· Primary irritant effect:· Skin corrosion/irritation Based on available data, the classification criteria are not met.· Serious eye damage/irritation Based on available data, the classification criteria are not met.· Respiratory or skin sensitisation Based on available data, the classification criteria are not met.· CMR effects (carcinogenity, mutagenicity and toxicity for reproduction)· Germ cell mutagenicity Based on available data, the classification criteria are not met.· Carcinogenicity Based on available data, the classification criteria are not met.· Reproductive toxicity Based on available data, the classification criteria are not met.· STOT-single exposure Based on available data, the classification criteria are not met.· STOT-repeated exposure Based on available data, the classification criteria are not met.· Aspiration hazard Based on available data, the classification criteria are not met.


· 12.1 Toxicity· Aquatic toxicity: No further relevant information available.· 12.2 Persistence and degradability No further relevant information available.· 12.3 Bioaccumulative potential No further relevant information available.· 12.4 Mobility in soil No further relevant information available.· 12.5 Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· 12.6 Other adverse effects No further relevant information available.



Smaller quantities can be disposed of with household waste.Must be specially treated adhering to official regulations.


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· 14.1 UN-Number· ADR, IMDG, IATA Void

· 14.2 UN proper shipping name· ADR, IMDG, IATA Void










· Directive 2012/18/EU· Named dangerous substances - ANNEX I None of the ingredients is listed.· 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out.


· Abbreviations and acronyms:ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the InternationalCarriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)PBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulative

EU

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