42
Developed and Manufactured by: Distributed by: QuickVue® TLI Campylobacter Test Safety Data Sheet According to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR, Schedule 1 (WHMIS 2015) Standards & GHS Rev04 Revision Date: 04/26/2019 Date of Issue: 04/26/2019 Version: 2.0 04/26/2019 EN (English US) 1/4 SECTION 1: IDENTIFICATION 1.1. Product Identifier Product Name: QuickVue® TLI Campylobacter Test Product Code: 5047C, 5047D, 5047MD, 5047P, MS2, MW2 Cat. Number: 20344 1.2. Intended Use of the Product The QuickVue® TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue® TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history. 1.3. Name, Address, and Telephone of the Responsible Party Company, Manufacturer TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060 1-800-832-4522 Distributed by: Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA 1-800-874-1517 Emergency Telephone Number Emergency Number : 1-866-519-4752 SECTION 2: HAZARDS IDENTIFICATION 2.1. Classification of the Substance or Mixture GHS-US/CA Classification Skin Sens. 1 H317 Full text of hazard classes and H-statements : see section 16 2.2. Label Elements GHS-US/CA Labeling Hazard Pictograms (GHS-US/CA) : GHS07 Signal Word (GHS-US/CA) : Warning Hazard Statements (GHS-US/CA) : H317 - May cause an allergic skin reaction. Precautionary Statements (GHS-US/CA) : P261 - Avoid breathing vapors, mist, or spray. P272 - Contaminated work clothing should not be allowed out of the workplace. P280 - Wear protective gloves, protective clothing, and eye protection. P302+P352 - IF ON SKIN: Wash with plenty of water. P321 - Specific treatment (see section 4 on this SDS). P333+P313 - If skin irritation or rash occurs: Get medical advice/attention. P362+P364 - Take off contaminated clothing and wash it before reuse. P501 - Dispose of contents/container in accordance with local, regional, national, territorial, provincial, and international regulations. 2.3. Other Hazards No additional information available 2.4. Unknown Acute Toxicity (GHS-US/CA) No data available

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Page 1: Developed and Manufactured by: QuickVue® TLI …

Developed and Manufactured by:

Distributed by:

QuickVue® TLI Campylobacter Test Safety Data Sheet According to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR, Schedule 1 (WHMIS 2015) Standards & GHS Rev04 Revision Date: 04/26/2019 Date of Issue: 04/26/2019 Version: 2.0

04/26/2019 EN (English US) 1/4

SECTION 1: IDENTIFICATION 1.1. Product Identifier

Product Name: QuickVue® TLI Campylobacter Test Product Code: 5047C, 5047D, 5047MD, 5047P, MS2, MW2 Cat. Number: 20344

1.2. Intended Use of the Product

The QuickVue® TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue® TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

1.3. Name, Address, and Telephone of the Responsible Party

Company, Manufacturer TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060 1-800-832-4522

Distributed by: Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA 1-800-874-1517

Emergency Telephone Number

Emergency Number : 1-866-519-4752

SECTION 2: HAZARDS IDENTIFICATION 2.1. Classification of the Substance or Mixture GHS-US/CA Classification

Skin Sens. 1 H317

Full text of hazard classes and H-statements : see section 16

2.2. Label Elements

GHS-US/CA Labeling Hazard Pictograms (GHS-US/CA) :

GHS07

Signal Word (GHS-US/CA) : Warning Hazard Statements (GHS-US/CA) : H317 - May cause an allergic skin reaction.

Precautionary Statements (GHS-US/CA) : P261 - Avoid breathing vapors, mist, or spray. P272 - Contaminated work clothing should not be allowed out of the workplace. P280 - Wear protective gloves, protective clothing, and eye protection. P302+P352 - IF ON SKIN: Wash with plenty of water. P321 - Specific treatment (see section 4 on this SDS). P333+P313 - If skin irritation or rash occurs: Get medical advice/attention. P362+P364 - Take off contaminated clothing and wash it before reuse. P501 - Dispose of contents/container in accordance with local, regional, national, territorial, provincial, and international regulations.

2.3. Other Hazards No additional information available

2.4. Unknown Acute Toxicity (GHS-US/CA)

No data available

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QuickVue® TLI Campylobacter Test Safety Data Sheet According to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR, Schedule 1 (WHMIS 2015) Standards & GHS Rev04.

04/26/2019 EN (English US) 2/4

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

Refer to component Safety Data Sheets

SECTION 4: FIRST AID MEASURES Refer to component Safety Data Sheets

SECTION 5: FIRE-FIGHTING MEASURES Refer to component Safety Data Sheets

SECTION 6: ACCIDENTAL RELEASE MEASURES Refer to component Safety Data Sheets

SECTION 7: HANDLING AND STORAGE 7.1. Precautions for Safe Handling Not available

7.2. Conditions for Safe Storage, Including Any Incompatibilities

Storage Conditions: Store closed in a dry, cool and well-ventilated place. Protect from heat and direct sunlight. Store in the original container. Store refrigerated (2 - 8 °C).

7.3. Specific End Use(s)

The QuickVue® TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue® TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Refer to component Safety Data Sheets

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Refer to component Safety Data Sheets

SECTION 10: STABILITY AND REACTIVITY Refer to component Safety Data Sheets

SECTION 11: TOXICOLOGICAL INFORMATION Refer to component Safety Data Sheets

SECTION 12: ECOLOGICAL INFORMATION Refer to component Safety Data Sheets

SECTION 13: DISPOSAL CONSIDERATIONS Refer to component Safety Data Sheets

SECTION 14: TRANSPORT INFORMATION Refer to component Safety Data Sheets

SECTION 15: REGULATORY INFORMATION US Federal and State Regulations

Section 313 (Specific toxic chemical listings): 9016-45-9 Nonylphenoxypoly(ethyleneoxy)ethanol TSCA (Toxic Substances Control Act): 7647-14-5 Sodium Chloride ACTIVE 56-81-5 Glycerol ACTIVE 5704-04-1 N-(tri(hydroxymethyl)methyl)glycine ACTIVE 9002-93-1 Polyethylene glycol octylphenol ether ACTIVE 151-21-3 Sodium Dodecyl Sulphate 9016-45-9 Nonylphenoxypoly(ethyleneoxy)ethanol 9048-46-8 Albumins, bovine blood serum 69-65-8 D-Mannitol 64-17-5 Ethanol 1310-73-2 Sodium Hydroxide 7585-39-9 cycloheptapentylose

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QuickVue® TLI Campylobacter Test Safety Data Sheet According to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR, Schedule 1 (WHMIS 2015) Standards & GHS Rev04.

04/26/2019 EN (English US) 3/4

Chemicals known to cause developmental toxicity: 64-17-5 Ethanol New Jersey Right-to-Know List: 56-81-5 Glycerol 64-17-5 Ethanol 1310-73-2 Sodium Hydroxide New Jersey Special Hazardous Substance List: 64-17-5 Ethanol 1310-73-2 Sodium Hydroxide Pennsylvania Right-to-Know List: 56-81-5 Glycerol 64-17-5 Ethanol 1310-73-2 Sodium Hydroxide Pennsylvania Special Hazardous Substance List: 1310-73-2 Sodium Hydroxide TLV (Threshold Limit Value established by ACGIH): 64-17-5 Ethanol

Canadian Regulations

Canadian Domestic Substances List (DSL): 9048-46-8 Albumins, bovine blood serum 69-65-8 D-Mannitol 64-17-5 Ethanol 1310-73-2 Sodium Hydroxide 7585-39-9 cycloheptapentylose 55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2Hisothiazol- 3-one [EC no. 220-239-6] (3:1) Canadian Ingredient Disclosure list (limit 0.1%): 64-17-5 Ethanol Canadian Ingredient Disclosure list (limit 1%): None of the ingredients are listed. This product or its components are not listed on the Canadian Domestic Substances List (DSL) or the Non-Domestic Substances List (NDSL).

SECTION 16: OTHER INFORMATION, INCLUDING DATE OF PREPARATION OR LAST REVISION

Date of Preparation or Latest Revision

: 04/26/2019

Other Information : This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication Standard 29 CFR 1910.1200 and Canada’s Hazardous Products Regulations (HPR) SOR/2015-17.

Kit Components : Positive Control May cause an allergic skin reaction. Diluent May cause an allergic skin reaction. Conjugate May cause an allergic skin reaction. Membrane Device No known hazards OSHA/ HPR hazards. Substrate No known hazards OSHA/ HPR hazards.

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QuickVue® TLI Campylobacter Test Safety Data Sheet According to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR, Schedule 1 (WHMIS 2015) Standards & GHS Rev04.

04/26/2019 EN (English US) 4/4

Wash Solution May cause an allergic skin reaction.

GHS Full Text Phrases:

------ Skin Sens. 1 Skin sensitization, Category 1

------ H317 May cause an allergic skin reaction

Party Responsible for the Preparation of This Document TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060, USA ©2019 TECHLAB, Inc. All rights reserved. The TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc., under license. Quidel® and QuickVue® are registered trademarks of Quidel Corporation. This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product. NA GHS SDS 2015 (Can, US, Mex)

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Safety Data Sheet (SDS)acc. to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR,

Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

49.0.12

* 1 Product and Company Identification

· Product Identifier

· Trade Name: Conjugate· Product Number: 5047C, 5050C· Relevant identified uses of the substance or mixture and uses advised against:No further relevant information available.

· Application of the substance / the mixture: Kit Component

· Details of the Supplier of the Safety Data Sheet:· Manufacturer/Supplier:Company, Manufacturer:TECHLAB, Inc.2001 Kraft DriveBlacksburg, VA 24060, USA1-800-832-4522

Distributed by:Quidel Corporation10165 McKellar CourtSan Diego, CA 92121 [email protected]

· Emergency telephone number: 1.866.519.4752

2 Hazard(s) Identification

· Classification of the substance or mixture:

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

· Label elements:· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.

(Contd. on page 2)

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Safety Data Sheet (SDS)acc. to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR,

Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

P302+P352 If on skin: Wash with plenty of water.P362+P364 Take off contaminated clothing and wash it before reuse.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· Unknown acute toxicity:This value refers to knowledge of known, established toxicological or ecotoxicological values.1.4 % of the mixture consists of component(s) of unknown toxicity.

· Hazard(s) not otherwise classified (HNOC): None known

3 Composition/Information on ingredients:

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with non-hazardous additions.

· Dangerous Components:

CAS: 55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

Acute Tox. 3, H301; Acute Tox. 3, H311; Acute Tox. 3, H331; SkinCorr. 1B, H314; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; SkinSens. 1, H317

0.05%

CAS: 64-17-5RTECS: KQ 6300000

Ethanol

Flam. Liq. 2, H225; Skin Irrit. 2, H315; STOT SE 3, H335; Eye Irrit. 2B,H320

0.104%

CAS: 1310-73-2 Sodium Hydroxide

Skin Corr. 1A, H314; Acute Tox. 4, H302

0.203%

CAS: 69-65-8 D-Mannitol

Combustible Dust

0.347%

CAS: 6138-23-4 D-(+)-Trehalose dihydrate .733%

· Additional information: For the wording of the listed hazard phrases refer to section 16.

4 First-Aid Measures

· Description of first aid measures· After inhalation:Supply fresh air. If required, provide artificial respiration. Consult doctor if symptoms persist.In case of unconsciousness place patient stably in the side position for transportation.

· After skin contact:Remove contaminated clothes and shoes.Immediately wash with water and soap and rinse thoroughly.If skin irritation occurs, consult a doctor.

· After eye contact:Rinse opened eye for at least 15 minutes under running water. If symptoms persist, consult a doctor.

· After swallowing:Do not induce vomiting without medical advice.Seek immediate medical advice.

· Information for doctor· Most important symptoms and effects, both acute and delayed: No further relevant information available.· Indication of any immediate medical attention and special treatment needed:No further relevant information available.

(Contd. on page 3)

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Safety Data Sheet (SDS)acc. to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR,

Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

5 Fire-Fighting Measures

· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: Water with full jet· Special hazards arising from the substance or mixture: No further relevant information available.· Advice for firefightersAs in any fire, wear self-contained breathing apparatus pressure-demand and full protective gear to preventcontact with skin and eyes.

· Special protective equipment for firefighters:Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA)with a full face piece operated in positive pressure mode.

6 Accidental Release Measures:

· Personal precautions, protective equipment and emergency procedures:Do not breathe vapor.Avoid contact with skin, eyes and clothing.

· Environmental precautions: Do not allow to enter sewers/surface or ground water.· Methods and material for containment and cleaning up:Dispose of the collected material according to regulations.

· 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.

· Protective Action Criteria for Chemicals

· PAC-1:

64-17-5 Ethanol 1,800 ppm

1310-73-2 Sodium Hydroxide 0.5 mg/m³

7791-18-6 Magnesium Chloride 34 mg/m³

· PAC-2:

64-17-5 Ethanol 3300* ppm

1310-73-2 Sodium Hydroxide 5 mg/m³

7791-18-6 Magnesium Chloride 370 mg/m³

· PAC-3:

64-17-5 Ethanol 15000* ppm

1310-73-2 Sodium Hydroxide 50 mg/m³

7791-18-6 Magnesium Chloride 1,600 mg/m³

7 Handling and Storage

· Handling· Precautions for safe handling:Avoid contact with skin, eyes and clothingAvoid breathing fume/gas/mist/vapors/spray.Wear protective equipment.

· Information about protection against explosions and fires: No special measures required.(Contd. on page 4)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

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Trade Name: Conjugate

49.0.12

· Conditions for safe storage, including any incompatibilities· Storage· Requirements to be met by storerooms and receptacles:Protect from heat and direct sunlight.Store in a cool, dry place.Store in the original container.

· Information about storage in one common storage facility: Not required.· Further information about storage conditions: None.· Specific end use(s): No further relevant information available.

8 Exposure Controls/Personal Protection

· Additional information about design of technical systems: No further data; see section 7.

· Control parameters:· Components with occupational exposure limits:The product does not contain any relevant quantities of materials with critical values that have to be monitoredat the workplace.

· Additional information: The lists that were valid during the creation of this SDS were used as basis.

· Exposure controls:· Personal protective equipment· General protective and hygienic measures:Immediately remove all soiled and contaminated clothing and wash before reuse.Wash hands before breaks and at the end of work.

· Breathing equipment: Not required.· Protection of hands:

Protective gloves

· Material of gloves:Nitrile rubber, NBRThe selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material cannot be calculated in advance and has therefore to be checked prior to theapplication.

· Penetration time of glove material:The exact break-through time has to be determined and observed by the manufacturer of the protectivegloves.

· Eye protection:

Safety goggles

· Body protection:

Protective work clothing

(Contd. on page 5)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

9 Physical and chemical properties

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

Form: LiquidColor: Red

· Odor: Odorless· Odor threshold: Not determined.

· pH-value @ 20 °C (68 °F): 7.5-7.8

· Change in conditionMelting point/Melting range: Not determined.Boiling point/Boiling range: Not determined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not determined.

· Ignition temperature: Not applicable

· Decomposition temperature: Not determined.

· Auto igniting: Product is not self-igniting.

· Danger of explosion: Product does not present an explosion hazard.

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

· Vapor pressure: Not applicable.

· Density:Relative density: Not determined.Vapor density: Not applicable.Evaporation rate: Not applicable.

· Solubility in / Miscibility with:Water: Miscible

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

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

· Solvent content:Organic solvents: 0.2 %VOC content: 0.21 %

Solids content: 0.0 %· Other information: No further relevant information available.

10 Stability and reactivity

· Reactivity: Stable under normal conditions.· Chemical stability: Stable under normal conditions.· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.

(Contd. on page 6)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

· Possibility of hazardous reactions: No dangerous reactions known.· Conditions to avoid:Incompatibilities, flames, ignition sources.High temperatures.Keep out of direct sunlight.

· Incompatible materials: Strong acids, strong bases, strong oxidizing agents and strong reducing agents.· Hazardous decomposition products: Carbon oxides

11 Toxicological information

· Information on toxicological effects:· Acute toxicity:

· LD/LC50 values that are relevant for classification:

69-65-8 D-Mannitol

Oral LD50 13,500 mg/kg (Rat)

64-17-5 Ethanol

Oral LD50 7,060 mg/kg (Rat)Remarks: Lungs, Thorax, or Respiration: Other changes.Carcinogenicity - Mouse - OralTumorigenic: Equivocal tumorigenic agent by RTECS criteria. Liver: Tumors.Blood: Lymphomas including Hodgkin's disease.Central nervous system depression, narcosis, Damage to the heart., To the bestof our knowledge, the chemical, physical, and toxicological properties have notbeen thoroughly investigated.Heart - Irregularities - Based on Human EvidenceCentral nervous system - Breathing difficulties - Based on Human EvidenceStomach - Irregularities - Based on Human Evidence

Inhalative LC50/4 h 20,000 mg/l (Rat)

LC50/96 hours 12,900-15,300 mg/l (Trout)

1310-73-2 Sodium Hydroxide

Oral LD50 2,000 mg/kg (Rat)

· Primary irritant effect:· On the skin:May be irritating.May cause an allergic skin reaction.

· On the eye: May be irritating.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:The product shows the following dangers according to internally approved calculation methods forpreparations:Irritant

· Carcinogenic categories:· IARC (International Agency for Research on Cancer):The IARC (the International Agency for Research on Cancer) concluded that ethanol found alcoholicbeverages to be Group 1 - Carcinogenic to humans. All other instances it is not consider carcinogenic.Group 1 - Carcinogenic to humansGroup 2A - Probably carcinogenic to humansGroup 2B - Possibly carcinogenic to humansGroup 3 - Not classifiable as to its carcinogenicity to humansGroup 4 - Probably not carcinogenic to humans

(Contd. on page 7)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

64-17-5 Ethanol 1

· NTP (National Toxicology Program):

None of the ingredients are listed.

12 Ecological information

· Toxicity:

· Aquatic toxicity:

64-17-5 Ethanol

EC50 34,900 mg/l (Daphnia)

1310-73-2 Sodium Hydroxide

EC50 40 mg/l (Daphnia)

· Persistence and degradability: No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential: No further relevant information available.· Mobility in soil: No further relevant information available.· Additional ecological information:· General notes:Do not allow undiluted product or product that has not been neutralized to reach ground water, water course orsewage system.

· Results of PBT and vPvB assessment:· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects: No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation:Observe all federal, state and local environmental regulations when disposing of this material.

· Uncleaned packaging· Recommendation: Empty containers are consider hazardous.

14 Transport information

· UN-Number:· ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· UN proper shipping name:· DOT, ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· Transport hazard class(es):

· DOT, ADR/ADN, ADN, IMDG, IATA· Class: Non-Regulated Material· Packing group:· DOT, ADR/ADN, IMDG, IATA Non-Regulated Material· Environmental hazards: Not applicable.· Special precautions for user: Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code: Not applicable.

· UN "Model Regulation": Non-Regulated Material(Contd. on page 8)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture:· SARA (Superfund Amendments and Reauthorization):

· Section 355 (extremely hazardous substances):

None of the ingredients are listed.

· Section 313 (Specific toxic chemical listings):

None of the ingredients are listed.

· TSCA (Toxic Substances Control Act):

9048-46-8 Albumins, bovine blood serum

69-65-8 D-Mannitol

64-17-5 Ethanol

1310-73-2 Sodium Hydroxide

7585-39-9 cycloheptapentylose

· Hazardous Air Pollutants

None of the ingredients are listed.

· California Proposition 65:

· Chemicals known to cause cancer:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for females:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for males:

None of the ingredients are listed.

· Chemicals known to cause developmental toxicity:

64-17-5 Ethanol

· New Jersey Right-to-Know List:

64-17-5 Ethanol

1310-73-2 Sodium Hydroxide

· New Jersey Special Hazardous Substance List:

64-17-5 Ethanol CA, MU, TE, F3

1310-73-2 Sodium Hydroxide CO, R1

· Pennsylvania Right-to-Know List:

64-17-5 Ethanol

1310-73-2 Sodium Hydroxide

· Pennsylvania Special Hazardous Substance List:

1310-73-2 Sodium Hydroxide E

· Carcinogenic categories:

· EPA (Environmental Protection Agency):

None of the ingredients are listed.

· TLV (Threshold Limit Value established by ACGIH):

64-17-5 Ethanol A3

(Contd. on page 9)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

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· NIOSH-Ca (National Institute for Occupational Safety and Health):

None of the ingredients are listed.

· Canadian substance listings:

· Canadian Domestic Substances List (DSL):

9048-46-8 Albumins, bovine blood serum

69-65-8 D-Mannitol

64-17-5 Ethanol

1310-73-2 Sodium Hydroxide

7585-39-9 cycloheptapentylose

55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

· Canadian Ingredient Disclosure list (limit 0.1%):

64-17-5 Ethanol

· Canadian Ingredient Disclosure list (limit 1%):

None of the ingredients are listed.

· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P362+P364 Take off contaminated clothing and wash it before reuse.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· National regulations:

None of the ingredients are listed.

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

16 Other information:

The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate asof the date of issue. Nothing herein shall be deemed to create warranty, expressed or implied, and shall notestablish a legally valid contractual relationship. It is the responsibility of the user to determine applicability ofthis information and the suitability of the material or product for any particular purpose.

(Contd. on page 10)

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Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/08/2019

Trade Name: Conjugate

49.0.12

· Date of last revision/ revision number: 05/09/2019 / -· Abbreviations and acronyms:

ADR: The European Agreement concerning the International Carriage of Dangerous Goods by RoadADN: The European Agreement concerning the International Carriage of Dangerous Goods by Inland WaterwaysIMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)VOC: Volatile Organic Compounds (USA, EU)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational Safety and HealthFlam. Liq. 2: Flammable liquids – Category 2Acute Tox. 3: Acute toxicity – Category 3Acute Tox. 4: Acute toxicity – Category 4Skin Corr. 1A: Skin corrosion/irritation – Category 1ASkin Corr. 1B: Skin corrosion/irritation – Category 1BSkin Irrit. 2: Skin corrosion/irritation – Category 2Eye Irrit. 2B: Serious eye damage/eye irritation – Category 2BSkin Sens. 1: Skin sensitisation – Category 1STOT 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

· * Data compared to the previous version altered.© 2019 TECHLAB, Inc. All Rights Reserved.The TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc., under license.The Quidel Logo is a trademark of Quidel Corporation.

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* 1 Product and Company Identification

· Product Identifier

· Trade Name: Diluent 5047D· Product Number: 5047D· Relevant identified uses of the substance or mixture and uses advised against:No further relevant information available.

· Application of the substance / the mixture: Kit Component

· Details of the Supplier of the Safety Data Sheet:· Manufacturer/Supplier:Company, Manufacturer:TECHLAB, Inc.2001 Kraft DriveBlacksburg, VA 24060, USA1-800-832-4522

Distributed by:Quidel Corporation10165 McKellar CourtSan Diego, CA 92121 [email protected]

· Emergency telephone number: 1.866.519.4752

2 Hazard(s) Identification

· Classification of the substance or mixture:

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

· Label elements:· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)Sodium Dodecyl Sulphate

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.

(Contd. on page 2)

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P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P363 Wash contaminated clothing before reuse.P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· Unknown acute toxicity:This value refers to knowledge of known, established toxicological or ecotoxicological values.0 % of the mixture consists of component(s) of unknown toxicity.

· Hazard(s) not otherwise classified (HNOC): None known

3 Composition/Information on ingredients:

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with non-hazardous additions.

· Dangerous Components:

CAS: 9002-93-1 Polyethylene glycol octylphenol ether

Acute Tox. 3, H331; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Acute Tox. 4, H302; Eye Irrit. 2A, H319

≤2.5%

CAS: 151-21-3RTECS: WT 1050000

Sodium Dodecyl Sulphate

Acute Tox. 4, H302; Skin Irrit. 2, H315; Eye Irrit. 2A, H319; Skin Sens. 1,H317; STOT SE 3, H335

≤2.5%

CAS: 55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

Acute Tox. 3, H301; Acute Tox. 3, H311; Acute Tox. 3, H331; Skin Corr.1B, H314; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Skin Sens.1, H317

≤2.5%

· SVHC

9002-93-1 Polyethylene glycol octylphenol ether

· Additional information: For the wording of the listed hazard phrases refer to section 16.

4 First-Aid Measures

· Description of first aid measures· General information:Symptoms of poisoning may occur after exposure to dust, fumes or particulates; seek medical attention iffeeling unwell.

· After inhalation: In case of unconsciousness place patient stably in the side position for transportation.· After skin contact:Immediately wash with water and soap and rinse thoroughly.If skin irritation occurs, consult a doctor.

· After eye contact:If eye irritation occurs, consult a doctor.Rinse opened eye for several minutes under running water.If easy to do so, remove contact lenses if worn.

· After swallowing:If swallowed and symptoms occur, consult a doctor.Do not induce vomiting without medical advice.

· Information for doctor· Most important symptoms and effects, both acute and delayed: No further relevant information available.

(Contd. on page 3)

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· Indication of any immediate medical attention and special treatment needed:No further relevant information available.

5 Fire-Fighting Measures

· Extinguishing media· Suitable extinguishing agents: Use fire fighting measures that suit the environment.· For safety reasons unsuitable extinguishing agents: No further relevant information.· Special hazards arising from the substance or mixture: No further relevant information available.· Advice for firefighters· Special protective equipment for firefighters: Mouth respiratory protective device.

6 Accidental Release Measures:

· Personal precautions, protective equipment and emergency procedures: Not required.· Environmental precautions:Inform respective authorities in case of seepage into water course or sewage system.Do not allow to enter sewers/surface or ground water.

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (i.e. sand, diatomite, acid binders, universal binders, sawdust).Dispose contaminated material as waste according to section 13.Ensure adequate ventilation.Dispose of the collected material according to regulations.

· 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.

· Protective Action Criteria for Chemicals

· PAC-1:

151-21-3 Sodium Dodecyl Sulphate 3.9 mg/m³

· PAC-2:

151-21-3 Sodium Dodecyl Sulphate 43 mg/m³

· PAC-3:

151-21-3 Sodium Dodecyl Sulphate 260 mg/m³

7 Handling and Storage

· Handling· Precautions for safe handling:Ensure good ventilation/exhaustion at the workplace.Prevent formation of aerosols.

· Information about protection against explosions and fires: No special measures required.

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

(Contd. on page 4)

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8 Exposure Controls/Personal Protection

· Additional information about design of technical systems: No further data; see section 7.

· Control parameters:· Components with occupational exposure limits:The product does not contain any relevant quantities of materials with critical values that have to be monitoredat the workplace.

· Additional information: The lists that were valid during the creation of this SDS were used as basis.

· Exposure controls:· Personal protective equipment· General protective and hygienic measures:The usual precautionary measures for handling chemicals should be followed.Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing and wash before reuse.Wash hands before breaks and at the end of work.

· Breathing equipment: Not required.· Protection of hands:

Protective gloves

· Material of gloves:The selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material cannot be calculated in advance and has therefore to be checked prior to theapplication.

· Penetration time of glove material:The exact break-through time has to be determined and observed by the manufacturer of the protectivegloves.

· Eye protection:

Goggles recommended during refilling.

· Limitation and supervision of exposure into the environment:Keep away from drains, surface and ground waters.Avoid release into the environment.

9 Physical and chemical properties

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

Form: LiquidColor: Not determined.

· Odor: Not determined· Odor threshold: Not determined.

· pH-value: Not applicable.(Contd. on page 5)

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· Change in conditionMelting point/Melting range: Not determined.Boiling point/Boiling range: Not determined.

· Flash point: None

· Flammability (solid, gaseous): Not applicable.

· Ignition temperature: Not applicable

· Decomposition temperature: Not determined.

· Auto igniting: Product is not self-igniting.

· Danger of explosion: Product does not present an explosion hazard.

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

· Vapor pressure: Not determined.

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

· Solubility in / Miscibility with:Water: Miscible

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

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

· Solvent content:VOC content: 0.00 %

· Other information: No further relevant information available.

10 Stability and reactivity

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

11 Toxicological information

· Information on toxicological effects:· Acute toxicity:

· LD/LC50 values that are relevant for classification:

9002-93-1 Polyethylene glycol octylphenol ether

Oral LD50 1,800 mg/kg (Rat)

Dermal LD50 8,000 mg/kg (Rat)

(Contd. on page 6)

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Inhalative LC50/4 h 8.9 mg/l (Pimephales)

151-21-3 Sodium Dodecyl Sulphate

Oral LD50 1,288 mg/kg (Rat)

Inhalative LC50/4 h >3,900 mg/l (Rat)THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUREXPOSURE.

· Primary irritant effect:· On the skin: May cause an allergic skin reaction.· On the eye: No irritating effect.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:The product shows the following dangers according to internally approved calculation methods forpreparations:Irritant

· Carcinogenic categories:

· IARC (International Agency for Research on Cancer):

None of the ingredients are listed.

· NTP (National Toxicology Program):

None of the ingredients are listed.

12 Ecological information

· Toxicity:· Aquatic toxicity:Avoid release into the environment. Runoff from fire control or dilution water may cause pollution.

9002-93-1 Polyethylene glycol octylphenol ether

EC50 26 mg/l (Daphnia)

· Persistence and degradability: No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential: No further relevant information available.· Mobility in soil: No further relevant information available.· Ecotoxical effects:· Remark: Harmful to fish· Additional ecological information:· General notes:Do not allow undiluted product or product that has not been neutralized to reach ground water, water course orsewage system.Harmful to aquatic organisms

· Results of PBT and vPvB assessment:· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects: No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation:Must not be disposed of together with household garbage. Do not allow product to reach sewage system.Observe all federal, state and local environmental regulations when disposing of this material.

(Contd. on page 7)

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

14 Transport information

· UN-Number:· ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· UN proper shipping name:· DOT, ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· Transport hazard class(es):

· DOT, ADR/ADN, ADN, IMDG, IATA· Class: Non-Regulated Material· Packing group:· DOT, ADR/ADN, IMDG, IATA Non-Regulated Material· Environmental hazards: Not applicable.· Special precautions for user: Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code: Not applicable.

· UN "Model Regulation": Non-Regulated Material

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture:· SARA (Superfund Amendments and Reauthorization):

· Section 355 (extremely hazardous substances):

None of the ingredients are listed.

· Section 313 (Specific toxic chemical listings):

None of the ingredients are listed.

· TSCA (Toxic Substances Control Act):

9002-93-1 Polyethylene glycol octylphenol ether ACTIVE

151-21-3 Sodium Dodecyl Sulphate ACTIVE

· Hazardous Air Pollutants

None of the ingredients are listed.

· California Proposition 65:

· Chemicals known to cause cancer:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for females:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for males:

None of the ingredients are listed.

· Chemicals known to cause developmental toxicity:

None of the ingredients are listed.

· New Jersey Right-to-Know List:

None of the ingredients are listed.

· New Jersey Special Hazardous Substance List:

None of the ingredients are listed.

(Contd. on page 8)

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· Pennsylvania Right-to-Know List:

None of the ingredients are listed.

· Pennsylvania Special Hazardous Substance List:

None of the ingredients are listed.

· Carcinogenic categories:

· EPA (Environmental Protection Agency):

None of the ingredients are listed.

· TLV (Threshold Limit Value established by ACGIH):

None of the ingredients are listed.

· NIOSH-Ca (National Institute for Occupational Safety and Health):

None of the ingredients are listed.

· Canadian substance listings:

· Canadian Domestic Substances List (DSL):

All ingredients are listed.

· Canadian Ingredient Disclosure list (limit 0.1%):

None of the ingredients are listed.

· Canadian Ingredient Disclosure list (limit 1%):

None of the ingredients are listed.

· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)Sodium Dodecyl Sulphate

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P363 Wash contaminated clothing before reuse.P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· National regulations:

None of the ingredients are listed.

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.(Contd. on page 9)

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16 Other information:

The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate asof the date of issue. Nothing herein shall be deemed to create warranty, expressed or implied, and shall notestablish a legally valid contractual relationship. It is the responsibility of the user to determine applicability ofthis information and the suitability of the material or product for any particular purpose.

· Date of last revision/ revision number: 05/09/2019 / -· Abbreviations and acronyms:

ADR: The European Agreement concerning the International Carriage of Dangerous Goods by RoadADN: The European Agreement concerning the International Carriage of Dangerous Goods by Inland WaterwaysIMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)VOC: Volatile Organic Compounds (USA, EU)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicSVHC: Substances of Very High ConcernvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational Safety and HealthAcute Tox. 4: Acute toxicity – Category 4Acute Tox. 3: Acute toxicity – Category 3Skin Corr. 1B: Skin corrosion/irritation – Category 1BSkin Irrit. 2: Skin corrosion/irritation – Category 2Eye Irrit. 2A: Serious eye damage/eye irritation – Category 2ASkin Sens. 1: Skin sensitisation – Category 1STOT 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

· * Data compared to the previous version altered.© 2019 TECHLAB, Inc. All Rights Reserved.The TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc., under license.The Quidel Logo is a trademark of Quidel Corporation.

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* 1 Product and Company Identification

· Product Identifier

· Trade Name: Positive Control 5047P· Product Number: 5047P· Relevant identified uses of the substance or mixture and uses advised against:No further relevant information available.

· Application of the substance / the mixture: Kit Component

· Details of the Supplier of the Safety Data Sheet:· Manufacturer/Supplier:Company, Manufacturer:TECHLAB, Inc.2001 Kraft DriveBlacksburg, VA 24060, USA1-800-832-4522

Distributed by:Quidel Corporation10165 McKellar CourtSan Diego, CA 92121 [email protected]

· Emergency telephone number: 1.866.519.4752

2 Hazard(s) Identification

· Classification of the substance or mixture:

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

· Label elements:· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.

(Contd. on page 2)

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P302+P352 If on skin: Wash with plenty of water.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P363 Wash contaminated clothing before reuse.P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· Unknown acute toxicity:This value refers to knowledge of known, established toxicological or ecotoxicological values.0 % of the mixture consists of component(s) of unknown toxicity.

· Hazard(s) not otherwise classified (HNOC): None known

3 Composition/Information on ingredients:

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with non-hazardous additions.

· Dangerous Components:

55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

Acute Tox. 3, H301; Acute Tox. 3, H311; Acute Tox. 3, H331; Skin Corr. 1B, H314; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Skin Sens. 1, H317

≤2.5%

· Additional information:The exact percentages of the ingredients of this mixture are considered to be proprietary and are withheld inaccordance with the provisions of paragraph (i) of §1910.1200 of 29 CFR 1910.1200 Trade Secrets.For the wording of the listed hazard phrases refer to section 16.

4 First-Aid Measures

· Description of first aid measures· After inhalation:In case of unconsciousness place patient stably in the side position for transportation.Remove to fresh air and keep at rest in a position comfortable for breathing. Obtain medical attention ifbreathing difficulty persists.

· After skin contact:Immediately wash with water and soap and rinse thoroughly.If skin irritation occurs, consult a doctor.

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

· After swallowing:Call a doctor if irritation or symptoms develop.Do not induce vomiting without medical advice.

· Information for doctor· Most important symptoms and effects, both acute and delayed: No further relevant information available.· Indication of any immediate medical attention and special treatment needed:No further relevant information available.

5 Fire-Fighting Measures

· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: No further relevant information.· Special hazards arising from the substance or mixture: No further relevant information available.

(Contd. on page 3)

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· Advice for firefightersAs in any fire, wear self-contained breathing apparatus pressure-demand and full protective gear to preventcontact with skin and eyes.

· Special protective equipment for firefighters:As in any fire, wear self-contained breathing apparatus pressure-demand and full protective gear to preventcontact with skin and eyes.

6 Accidental Release Measures:

· Personal precautions, protective equipment and emergency procedures:Avoid contact with skin, eyes and clothing.

· Environmental precautions: Do not allow to enter sewers/surface or ground water.· Methods and material for containment and cleaning up:Absorb with liquid-binding material (i.e. sand, diatomite, acid binders, universal binders, sawdust).Ensure adequate ventilation.Dispose of the collected material according to regulations.

· 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.

· Protective Action Criteria for Chemicals

· PAC-1:

None of the ingredients are listed.

· PAC-2:

None of the ingredients are listed.

· PAC-3:

None of the ingredients are listed.

7 Handling and Storage

· Handling· Precautions for safe handling:Avoid contact with skin, eyes and clothingEnsure good ventilation/exhaustion at the workplace.Prevent formation of aerosols.

· Information about protection against explosions and fires: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage· Requirements to be met by storerooms and receptacles:Protect from heat and direct sunlight.Store in a cool, dry place.Store in the original container.

· Information about storage in one common storage facility: Not required.· Further information about storage conditions: None.· Specific end use(s): No further relevant information available.

8 Exposure Controls/Personal Protection

· Additional information about design of technical systems: No further data; see section 7.(Contd. on page 4)

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· Control parameters:· Components with occupational exposure limits:The product does not contain any relevant quantities of materials with critical values that have to be monitoredat the workplace.

· Additional information: The lists that were valid during the creation of this SDS were used as basis.

· Exposure controls:· Personal protective equipment· General protective and hygienic measures:The usual precautionary measures for handling chemicals should be followed.Immediately remove all soiled and contaminated clothing and wash before reuse.Wash hands before breaks and at the end of work.

· Breathing equipment:Have self-contained breathing apparatus, positive pressure, MSHA/NIOSH (approved or equivalent) availablein case of spillage or equipment failure.

· Protection of hands:

Protective gloves

· Material of gloves:The selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material cannot be calculated in advance and has therefore to be checked prior to theapplication.

· Penetration time of glove material:The exact break-through time has to be determined and observed by the manufacturer of the protectivegloves.

· Eye protection:

Goggles recommended during refilling.

· Body protection: Not required.· Limitation and supervision of exposure into the environment: None

9 Physical and chemical properties

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

Form: LiquidColor: Clear

· Odor: Odorless· Odor threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Not determined.Boiling point/Boiling range: Not determined.

· Flash point: Not applicable.(Contd. on page 5)

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· Flammability (solid, gaseous): Not applicable.

· Ignition temperature: Not applicable

· Decomposition temperature: Not determined.

· Auto igniting: Product is not self-igniting.

· Danger of explosion: Product does not present an explosion hazard.

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

· Vapor pressure: Not determined.

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

· Solubility in / Miscibility with:Water: Miscible

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

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

· Solvent content:VOC content: 0.00 %

Solids content: 0.0 %· Other information: No further relevant information available.

10 Stability and reactivity

· Reactivity: Stable under normal conditions.· Chemical stability: Stable under normal conditions.· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions: No dangerous reactions known.· Conditions to avoid: Keep out of direct sunlight.· Incompatible materials: Strong acids, strong bases, strong oxidizing agents and strong reducing agents.· Hazardous decomposition products: Oxides

11 Toxicological information

· Information on toxicological effects:· Acute toxicity:· LD/LC50 values that are relevant for classification: No data available.· Primary irritant effect:· On the skin:May be irritating.May cause an allergic skin reaction.

· On the eye: May be irritating.· Sensitization: Sensitization possible through skin contact.

(Contd. on page 6)

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· Additional toxicological information:The product shows the following dangers according to internally approved calculation methods forpreparations:Irritant

· Carcinogenic categories:

· IARC (International Agency for Research on Cancer):

None of the ingredients are listed.

· NTP (National Toxicology Program):

None of the ingredients are listed.

12 Ecological information

· Toxicity:· Aquatic toxicity: No further relevant information available.· Persistence and degradability: No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential: No further relevant information available.· Mobility in soil: No further relevant information available.· Additional ecological information:· General notes:Do not allow undiluted product or product that has not been neutralized to reach ground water, water course orsewage system.

· Results of PBT and vPvB assessment:· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects: No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation:Observe all federal, state and local environmental regulations when disposing of this material.

· Uncleaned packaging· Recommendation: Dispose of as unused product.

14 Transport information

· UN-Number:· ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· UN proper shipping name:· DOT, ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· Transport hazard class(es):

· DOT, ADR/ADN, ADN, IMDG, IATA· Class: Non-Regulated Material· Packing group:· DOT, ADR/ADN, IMDG, IATA Non-Regulated Material· Environmental hazards: Not applicable.· Special precautions for user: Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code: Not applicable.

(Contd. on page 7)

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· UN "Model Regulation": Non-Regulated Material

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture:· SARA (Superfund Amendments and Reauthorization):

· Section 355 (extremely hazardous substances):

None of the ingredients are listed.

· Section 313 (Specific toxic chemical listings):

None of the ingredients are listed.

· TSCA (Toxic Substances Control Act):

None of the ingredients are listed.

· Hazardous Air Pollutants

None of the ingredients are listed.

· California Proposition 65:

· Chemicals known to cause cancer:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for females:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for males:

None of the ingredients are listed.

· Chemicals known to cause developmental toxicity:

None of the ingredients are listed.

· New Jersey Right-to-Know List:

None of the ingredients are listed.

· New Jersey Special Hazardous Substance List:

None of the ingredients are listed.

· Pennsylvania Right-to-Know List:

None of the ingredients are listed.

· Pennsylvania Special Hazardous Substance List:

None of the ingredients are listed.

· Carcinogenic categories:

· EPA (Environmental Protection Agency):

None of the ingredients are listed.

· TLV (Threshold Limit Value established by ACGIH):

None of the ingredients are listed.

· NIOSH-Ca (National Institute for Occupational Safety and Health):

None of the ingredients are listed.

· Canadian substance listings:

· Canadian Domestic Substances List (DSL):

55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

(Contd. on page 8)

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· Canadian Ingredient Disclosure list (limit 0.1%):

None of the ingredients are listed.

· Canadian Ingredient Disclosure list (limit 1%):

None of the ingredients are listed.

· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P363 Wash contaminated clothing before reuse.P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· National regulations:

None of the ingredients are listed.

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

16 Other information:

The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate asof the date of issue. Nothing herein shall be deemed to create warranty, expressed or implied, and shall notestablish a legally valid contractual relationship. It is the responsibility of the user to determine applicability ofthis information and the suitability of the material or product for any particular purpose.

· Date of last revision/ revision number: 05/09/2019 / -· Abbreviations and acronyms:

ADR: The European Agreement concerning the International Carriage of Dangerous Goods by RoadADN: The European Agreement concerning the International Carriage of Dangerous Goods by Inland WaterwaysIMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)VOC: Volatile Organic Compounds (USA, EU)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational Safety and Health

(Contd. on page 9)

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Acute Tox. 3: Acute toxicity – Category 3Skin Corr. 1B: Skin corrosion/irritation – Category 1BSkin Sens. 1: Skin sensitisation – Category 1Aquatic 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

· * Data compared to the previous version altered.© 2019 TECHLAB, Inc. All Rights Reserved.The TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc., under license.The Quidel Logo is a trademark of Quidel Corporation.

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* 1 Product and Company Identification

· Product Identifier

· Trade Name: Wash Buffer MW2· Product Number: MW2· Relevant identified uses of the substance or mixture and uses advised against:No further relevant information available.

· Application of the substance / the mixture: Kit Component

· Details of the Supplier of the Safety Data Sheet:· Manufacturer/Supplier:Company, Manufacturer:TECHLAB, Inc.2001 Kraft DriveBlacksburg, VA 24060, USA1-800-832-4522

Distributed by:Quidel Corporation10165 McKellar CourtSan Diego, CA 92121 [email protected]

· Emergency telephone number: 1.866.519.4752

2 Hazard(s) Identification

· Classification of the substance or mixture:

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

· Label elements:· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)Sodium Dodecyl Sulphate

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.

(Contd. on page 2)

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P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P362+P364 Take off contaminated clothing and wash it before reuse.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· Unknown acute toxicity:This value refers to knowledge of known, established toxicological or ecotoxicological values.0 % of the mixture consists of component(s) of unknown toxicity.

· Hazard(s) not otherwise classified (HNOC): None known

3 Composition/Information on ingredients:

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with non-hazardous additions.

· Dangerous Components:

CAS: 9002-93-1 Polyethylene glycol octylphenol ether

Acute Tox. 3, H331; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Acute Tox. 4, H302; Eye Irrit. 2A, H319

0.5%

CAS: 151-21-3RTECS: WT 1050000

Sodium Dodecyl Sulphate

Acute Tox. 4, H302; Skin Irrit. 2, H315; Eye Irrit. 2A, H319; Skin Sens. 1,H317; STOT SE 3, H335

0.1%

CAS: 55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1)

Acute Tox. 3, H301; Acute Tox. 3, H311; Acute Tox. 3, H331; Skin Corr.1B, H314; Aquatic Acute 1, H400; Aquatic Chronic 1, H410; Skin Sens.1, H317

0.05%

· SVHC

9002-93-1 Polyethylene glycol octylphenol ether

· Additional information: For the wording of the listed hazard phrases refer to section 16.

4 First-Aid Measures

· Description of first aid measures· General information:Symptoms of poisoning may occur after exposure to dust, fumes or particulates; seek medical attention iffeeling unwell.

· After inhalation:In case of unconsciousness place patient stably in the side position for transportation.Remove to fresh air and keep at rest in a position comfortable for breathing. Obtain medical attention ifbreathing difficulty persists.

· After skin contact:Remove contaminated clothes and shoes.Immediately wash with water and soap and rinse thoroughly.If skin irritation occurs, consult a doctor.

· After eye contact:Rinse opened eye for several minutes under running water.Seek immediate medical advice.If eye irritation occurs, consult a doctor.

· After swallowing:Call a doctor immediately.Seek immediate medical advice.

(Contd. on page 3)

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Do not induce vomiting without medical advice.· Information for doctor· Most important symptoms and effects, both acute and delayed:Prolonged exposure may cause an allergic reaction.

· Indication of any immediate medical attention and special treatment needed:No further relevant information available.

5 Fire-Fighting Measures

· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: No further relevant information.· Special hazards arising from the substance or mixture: No further relevant information available.· Advice for firefightersAs in any fire, wear self-contained breathing apparatus pressure-demand and full protective gear to preventcontact with skin and eyes.

· Special protective equipment for firefighters: Mouth respiratory protective device.

6 Accidental Release Measures:

· Personal precautions, protective equipment and emergency procedures:Do not breathe vapor.Avoid contact with skin, eyes and clothing.

· Environmental precautions: Do not allow to enter sewers/surface or ground water.· Methods and material for containment and cleaning up:Dispose contaminated material as waste according to section 13.Ensure adequate ventilation.Dispose of the collected material according to regulations.

· 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.

· Protective Action Criteria for Chemicals

· PAC-1:

56-81-5 Glycerol 45 mg/m³

151-21-3 Sodium Dodecyl Sulphate 3.9 mg/m³

· PAC-2:

56-81-5 Glycerol 180 mg/m³

151-21-3 Sodium Dodecyl Sulphate 43 mg/m³

· PAC-3:

56-81-5 Glycerol 1,100 mg/m³

151-21-3 Sodium Dodecyl Sulphate 260 mg/m³

7 Handling and Storage

· Handling· Precautions for safe handling:Avoid contact with skin, eyes and clothingWear protective equipment.

(Contd. on page 4)

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Avoid creating and breathing dust/fume/gas/mist/vapors/spray.Ensure good ventilation/exhaustion at the workplace.

· Information about protection against explosions and fires: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage· Requirements to be met by storerooms and receptacles:Protect from heat and direct sunlight.Store in a cool, dry place.Store in the original container.

· Information about storage in one common storage facility: Not required.· Further information about storage conditions: Keep receptacle tightly sealed.· Specific end use(s): No further relevant information available.

8 Exposure Controls/Personal Protection

· Additional information about design of technical systems: No further data; see section 7.

· Control parameters:

· Components with occupational exposure limits:

56-81-5 Glycerol

PEL (USA) Long-term value: 15* 5** mg/m³mist; *total dust **respirable fraction

TLV (USA) TLV withdrawn-insufficient data human occup. exp.

EL (Canada) Long-term value: 10* 3** mg/m³*mist; **mist, respirable

EV (Canada) Long-term value: 10 mg/m³

· Additional information: The lists that were valid during the creation of this SDS were used as basis.

· Exposure controls:· Personal protective equipment· General protective and hygienic measures:Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing and wash before reuse.Wash hands before breaks and at the end of work.

· Breathing equipment:Have self-contained breathing apparatus, positive pressure, MSHA/NIOSH (approved or equivalent) availablein case of spillage or equipment failure.

· Protection of hands:

Protective gloves

· Material of gloves: Nitrile rubber, NBR· Penetration time of glove material: Not applicable.· Eye protection:

Safety goggles

(Contd. on page 5)

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· Body protection:

Protective work clothing

· Limitation and supervision of exposure into the environment: None

9 Physical and chemical properties

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

Form: LiquidColor: Clear

· Odor: Odorless· Odor threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Not determined.Boiling point/Boiling range: Not determined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not determined.

· Ignition temperature: Not applicable

· Decomposition temperature: Not determined.

· Auto igniting: Product is not self-igniting.

· Danger of explosion: Product does not present an explosion hazard.

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

· Vapor pressure: Not applicable.

· Density @ 20 °C (68 °F): 1.0143 g/cm³ (8.4643 lbs/gal)· Relative density: Not determined.· Vapor density: Not applicable.· Evaporation rate: Not applicable.

· Solubility in / Miscibility with:Water: Miscible

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

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

· Solvent content:Organic solvents: 1.6 %VOC content: 0.00 %

Solids content: 0.0 %(Contd. on page 6)

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· Other information: No further relevant information available.

10 Stability and reactivity

· Reactivity: Stable under normal conditions.· Chemical stability: Stable under normal conditions.· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions: No dangerous reactions known.· Conditions to avoid:Incompatibilities, flames, ignition sources.High temperatures.Keep out of direct sunlight.

· Incompatible materials: Strong acids, strong bases, strong oxidizing agents and strong reducing agents.· Hazardous decomposition products: Oxides

11 Toxicological information

· Information on toxicological effects:· Acute toxicity:

· LD/LC50 values that are relevant for classification:

9002-93-1 Polyethylene glycol octylphenol ether

Oral LD50 1,800 mg/kg (Rat)

Dermal LD50 8,000 mg/kg (Rat)

Inhalative LC50/4 h 8.9 mg/l (Pimephales)

151-21-3 Sodium Dodecyl Sulphate

Oral LD50 1,288 mg/kg (Rat)

Inhalative LC50/4 h >3,900 mg/l (Rat)THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE.

56-81-5 Glycerol

Oral LD50 12,600 mg/kg (Rat)

Dermal LD50 >10,000 mg/kg (Rabbit)

Inhalative LC50/96 hours >50,000 mg/l (Trout)

· Primary irritant effect:· On the skin: May be irritating.· On the eye: May be irritating.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:The product shows the following dangers according to internally approved calculation methods forpreparations:Irritant

· Carcinogenic categories:

· IARC (International Agency for Research on Cancer):

None of the ingredients are listed.

· NTP (National Toxicology Program):

None of the ingredients are listed.

(Contd. on page 7)

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12 Ecological information

· Toxicity:

· Aquatic toxicity:

9002-93-1 Polyethylene glycol octylphenol ether

EC50 26 mg/l (Daphnia)

· Persistence and degradability: No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential: No further relevant information available.· Mobility in soil: No further relevant information available.· Additional ecological information:· General notes:Do not allow undiluted product or product that has not been neutralized to reach ground water, water course orsewage system.

· Results of PBT and vPvB assessment:· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects: No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation:Observe all federal, state and local environmental regulations when disposing of this material.

· Uncleaned packaging· Recommendation: Dispose of as unused product.

14 Transport information

· UN-Number:· ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· UN proper shipping name:· DOT, ADR/ADN, ADN, IMDG, IATA Non-Regulated Material· Transport hazard class(es):

· DOT, ADR/ADN, ADN, IMDG, IATA· Class: Non-Regulated Material· Packing group:· DOT, ADR/ADN, IMDG, IATA Non-Regulated Material· Environmental hazards: Not applicable.· Special precautions for user: Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code: Not applicable.

· UN "Model Regulation": Non-Regulated Material

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture:· SARA (Superfund Amendments and Reauthorization):

· Section 355 (extremely hazardous substances):

None of the ingredients are listed.

(Contd. on page 8)

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· Section 313 (Specific toxic chemical listings):

None of the ingredients are listed.

· TSCA (Toxic Substances Control Act):

7647-14-5 Sodium Chloride ACTIVE

56-81-5 Glycerol ACTIVE

5704-04-1 N-(tri(hydroxymethyl)methyl)glycine ACTIVE

9002-93-1 Polyethylene glycol octylphenol ether ACTIVE

151-21-3 Sodium Dodecyl Sulphate ACTIVE

· Hazardous Air Pollutants

None of the ingredients are listed.

· California Proposition 65:

· Chemicals known to cause cancer:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for females:

None of the ingredients are listed.

· Chemicals known to cause reproductive toxicity for males:

None of the ingredients are listed.

· Chemicals known to cause developmental toxicity:

None of the ingredients are listed.

· New Jersey Right-to-Know List:

56-81-5 Glycerol

· New Jersey Special Hazardous Substance List:

None of the ingredients are listed.

· Pennsylvania Right-to-Know List:

56-81-5 Glycerol

· Pennsylvania Special Hazardous Substance List:

None of the ingredients are listed.

· Carcinogenic categories:

· EPA (Environmental Protection Agency):

None of the ingredients are listed.

· TLV (Threshold Limit Value established by ACGIH):

None of the ingredients are listed.

· NIOSH-Ca (National Institute for Occupational Safety and Health):

None of the ingredients are listed.

· Canadian substance listings:

· Canadian Domestic Substances List (DSL):

All ingredients are listed.

· Canadian Ingredient Disclosure list (limit 0.1%):

None of the ingredients are listed.

· Canadian Ingredient Disclosure list (limit 1%):

None of the ingredients are listed.

(Contd. on page 9)

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· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H-isothiazol-3-one[EC no. 220-239-6] (3:1)Sodium Dodecyl Sulphate

· Hazard statements:H317 May cause an allergic skin reaction.

· Precautionary statements:P261 Avoid breathing dust/fume/gas/mist/vapors/spray.P272 Contaminated work clothing must not be allowed out of the workplace.P280 Wear protective gloves.P302+P352 If on skin: Wash with plenty of water.P362+P364 Take off contaminated clothing and wash it before reuse.P333+P313 If skin irritation or rash occurs: Get medical advice/attention.P321 Specific treatment (see supplementary first aid instructions on this Safety Data Sheet).P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

· National regulations:

None of the ingredients are listed.

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

16 Other information:

The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate asof the date of issue. Nothing herein shall be deemed to create warranty, expressed or implied, and shall notestablish a legally valid contractual relationship. It is the responsibility of the user to determine applicability ofthis information and the suitability of the material or product for any particular purpose.

· Date of last revision/ revision number: 05/09/2019 / -· Abbreviations and acronyms:

ADR: The European Agreement concerning the International Carriage of Dangerous Goods by RoadADN: The European Agreement concerning the International Carriage of Dangerous Goods by Inland WaterwaysIMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsEINECS: European Inventory of Existing Commercial Chemical SubstancesELINCS: European List of Notified Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)VOC: Volatile Organic Compounds (USA, EU)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicSVHC: Substances of Very High ConcernvPvB: very Persistent and very BioaccumulativeNIOSH: National Institute for Occupational Safety and HealthAcute Tox. 4: Acute toxicity – Category 4Acute Tox. 3: Acute toxicity – Category 3Skin Corr. 1B: Skin corrosion/irritation – Category 1BSkin Irrit. 2: Skin corrosion/irritation – Category 2

(Contd. on page 10)

Page 42: Developed and Manufactured by: QuickVue® TLI …

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Safety Data Sheet (SDS)acc. to OSHA HazCom Standard 29 CFR 1910.1200(g) and according to HPR,

Schedule 1 (WHMIS 2015) Standards & GHS Rev04

Issue date 05/09/2019 Reviewed on 05/09/2019

Trade Name: Wash Buffer MW2

49.0.12

Eye Irrit. 2A: Serious eye damage/eye irritation – Category 2ASkin Sens. 1: Skin sensitisation – Category 1Skin Sens. 1B: Skin sensitisation – Category 1BSTOT 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

· * Data compared to the previous version altered.© 2019 TECHLAB, Inc. All Rights Reserved.The TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc., under license.The Quidel Logo is a trademark of Quidel Corporation.