37 of 40 SDS Combined.pdf

Page 1/9 Safety Data Sheet acc. to OSHA HCS

Version 5 Printing date 01/20/2021 Reviewed on 01/20/2021

Product identifier Trade name: Liquid Polibar Plus

Article number: L168; P650PPS; 900203; 705667 Application of the substance / the mixture:

Radiopaque contrast media for diagnostic imaging of the gastrointestinal tract White suspension having a sweet odor and no grittiness.

Route of Administration:

Oral and Rectal.

Oral: 1900mL Rectal: 650mL & 1900mL

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

E-Z-EM Canada Inc.

11065 boulevard L-H. Lafontaine Montréal, QC, Canada H1J 2Z4 tel: (514) 353-5820 Information department:

B-Lands Consulting WTC, 5 Place Robert Schuman, BP 1516 38025 Grenoble, FRANCE Tel: +33 476 295 869 Fax: +33 476 295 870 Email: clients@reachteam.eu www.reachteam.eu Emergency telephone number:

EMERGENCY CONTACT:

Health: 1-800-257-5181 U.S. Transport - Chemtrec: 1-800-424-9300 International Transport - Chemtrec: 1-703-527-3887

Classification of the substance or mixture The product is not classified according to the Globally Harmonized System (GHS).

Label elements GHS label elements Not applicable.

Hazard pictograms Not applicable.

Signal word Not applicable.

Hazard statements Not applicable.

Additional Information:

WHMIS-symbols:

Not Hazardous.

Not controlled under WHIMS (Canada).

Classification system:

NFPA ratings (scale 0 - 4)

Health = 0 Fire = 0 Reactivity = 0

43.0

1 Identification

2 Hazard(s) identification

0 0 mailto:clients@reachteam.eu http://www.reachteam.eu/

ITEM# 009180

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HMIS-ratings (scale 0 - 4)

Health = 0 Fire = 0 Reactivity = 0

Chemical characterization: Mixtures Description: Mixture: consisting of the following components.

Hazardous Components:

7727-43-7 Barium sulphate 58.0% w/w Information on components:

7727-43-7 Barium sulphate 58.0% w/w

Description of first aid measures After inhalation: Supply fresh air; consult doctor in case of complaints.

After skin contact:

Immediately wash with water and soap and rinse thoroughly.

If skin irritation continues, consult a doctor.

After eye contact:

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

After swallowing: Do not induce vomiting; immediately call for medical help.

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.

Extinguishing media Suitable extinguishing agents:

Use extinguishing measures appropriate to local circumstances and the environment.

CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

Special hazards arising from the substance or mixture No further relevant information available.

Advice for firefighters Protective equipment:

Firefighters should wear adequate personal protective equipment with protection of respiratory tract (selfcontained breathing apparatus) (SCBA).

In addition, firefighters should wear flame and chemicals resistant clothing, boots and gloves.

Additional information Move containers from fire area if safe to do so. Cool closed containers exposed to fire with water spray. Do not allow run off from fire fighting to enter drains or water courses. Dike for water control.

Evacuate personell to an upwind direction. Remove uneeded material.

Personal precautions, protective equipment and emergency procedures Wear protective equipment. Keep unprotected persons away.

Remove persons from danger area.

3 Composition/information on ingredients

4 First-aid measures

5 Fire-fighting measures

6 Accidental release measures

REACTIVITY 0

FIRE

HEALTH 0

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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.

Methods and material for containment and cleaning up:

Dispose of the collected material according to regulations.

Ventilate area of release.

Stop spill or leak at source if safely possible.

Contain and absorb spilled liquid with non-combustible, inert absorbent material (e.g. sand), then place absorbent material into a container for later disposal (see Section 13).

Notify the appropriate authorities as required.

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.

Precautions for safe handling Ensure good ventilation/exhaustion at the workplace.

Avoid contact with the eyes and skin.

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

Conditions for safe storage, including any incompatibilities Requirements to be met by storerooms and receptacles:

Store in a cool, dry place in tightly closed receptacles.

Information about storage in one common storage facility: Not required.

Further information about storage conditions:

Storage area should be clearly identified, clear of obstruction and accessible only to trained and authorized personnel.

Protect against physical damage.

Specific end use(s) No further relevant information available.

Control parameters Components with limit values that require monitoring at the workplace:

7727-43-7 Barium sulphate CAD AB OEL (Canada) CAD BC OEL (Canada)

CAD MB OEL (Canada) CAD ON OEL (Canada) OEL (QUE) (Canada)

ACGIH (USA)

ACGIH 2014 TLV (USA)

CAL/OSHA PEL (USA)

NIOSH/GUIDE - REL (USA)

OSHA PEL₁ (USA)

Long-term value: 10 mg/m³ Long-term value: 3* ; 10** mg/m³ *: Respirable Fraction; **: Total Dust Long-term value: 10 mg/m³ Long-term value: 10 mg/m³ Long-term value: 5* ; 10** mg/m³ *: Respirable Fraction; **: Total Dust Long-term value: 10 mg/m³ Long-term value: 5 mg/m³ Total Dust, no asbestos and <1% crystalline silica Long-term value: 5* ; 10** mg/m³ *:Respirable Fraction; **:Total Dust Long-term value: 5* ; 10** mg/m³ *: Respirable Fraction; **: Total Dust Long-term value: 5* ; 15** mg/m³ *: Respirable Fraction; **:Total Dust

7 Handling and storage

8 Exposure controls/personal protection

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Additional information: The lists that were valid during the creation 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.

Wash hands before breaks and at the end of work.

Do not eat, drink, smoke or sniff while working.

Breathing equipment:

In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure use respiratory protective device that is independent of circulating air.

Protection of hands:

Protective gloves

The glove material must be impermeable and resistant to the product/ the substance/ the preparation.

Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/ the chemical mixture.

Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation Material of gloves The selection of the suitable gloves does not only depend on the material, but also on further marks of quality and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the application.

Penetration time of glove material The exact break through time has to be found out by the manufacturer of the protective gloves and has to be observed.

Eye protection: Goggles recommended during refilling.

Body protection: Protective work clothing

Information on basic physical and chemical properties General Information Appearance:

Form: Suspension Color: White

Odor: Sweet Odour Odor threshold: Not determined.

pH-value: Not determined.

Melting point/Melting range: Not determined.

Boiling point/Boiling range: Not determined.

Flash point: Not determined.

Flammability (solid, gaseous): Not determined.

Ignition temperature: Not determined.

9 Physical and chemical properties

Page 5/9 acc. to OSHA HCS

Decomposition temperature: Not determined.

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

Flammability Limits:

Lower: Not Determined.

Upper: Not Determined.

Explosion limits:

Lower: Not determined.

Upper: Not determined.

Oxidizing properties Not determined.

Vapor pressure: Not determined.

Density: Not determined.

Relative density Not determined.

Vapor density Not determined.

Evaporation rate Not determined.

Solubility in / Miscibility with

Water: Not determined.

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

Viscosity:

Dynamic: 950-1675 cPs Kinematic: Not determined.

Solids content: 80.0 %

Other information No further relevant information available.

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: Reactive metals.

Hazardous decomposition products:

Sulfur oxides (SOx) Barium Oxide (BaO) Other unidentified organic compounds.

Information on toxicological effects Acute toxicity:

LD/LC50 values that are relevant for classification:

7727-43-7 Barium sulphate Oral LD50 > 20000 mg/kg (Rat) (External SDS) 9000-01-5 Gum arabic Oral LD50 > 16000 mg/kg (Rat) (RTEC)

10 Stability and reactivity

11 Toxicological information

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50-70-4 D-glucitol Oral LD50 15900 mg/kg (Rat) 11138-66-2 Xanthan gum Oral LD50 > 5000 mg/kg (Rat) 9000-07-1 Carrageenan Oral Dermal Inhalative

LD50

LD50

LC50/4h

> 5000 mg/kg (Rat) > 2000 mg/kg (Rabbit) > 0.93 mg/L (Rat) (Maximum attainable concentration - zero mortality)

590-00-1 Potassium sorbate Oral Dermal

LD50

LD50

>2000 mg/kg (unknown) >2000 mg/kg (unknown)

532-32-1 Sodium Benzoate Oral LD50 3140 mg/kg (Rat) (Exernal SDS) 7447-40-7 potassium chloride Oral LD50 2600 mg/kg (Rat) 57-55-6 propane-1,2-diol Oral Dermal

LD50

LD50

19400 - 36000 mg/kg (Rat) (Literature) 20800 mg/kg (Rabbit) (Literature)

77-92-9 Citric Acid, Anhydrous Oral LD50 5040 mg/kg (Mouse)

3000 mg/kg (Rat) (RTEC) 9005-65-6 Polysorbate 80 Oral LD50 42200 mg/kg (Rat) (External SDS) 6132-04-3 Trisodium citrate dihydrate Oral LD50

LD50 iv

LD50 ip

> 8000 mg/kg (Rat) (IUCLID - Anhydrous substance) 170 mg/kg (Mouse) 449 mg/kg (Rabbit) 1364 mg/Kg (Mouse) 1548 mg/Kg (Rat)

Primary irritant effect:

on the skin: No irritant effect.

on the eye: No irritating effect.

Sensitization: No sensitizing effects known.

Additional toxicological information:

The product is not subject to classification according to internally approved calculation methods for preparations.

When used and handled according to specifications, the product does not have any harmful effects to our experience and the information provided to us.

Carcinogenic categories IARC (International Agency for Research on Cancer) 9000-07-1 Carrageenan 3 6155-57-3 Saccharin Sodium dihydrate Yes: Carc. 3 NTP (National Toxicology Program) 63231-67-4 Silica gel K 6155-57-3 Saccharin Sodium dihydrate YES

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Version 5Printing date 01/20/2021 Reviewed on 01/20/2021

Toxicity Aquatic toxicity:

7727-43-7 Barium sulphate EC50/48h 32 mg/L (Daphnia Magna) 11138-66-2 Xanthan gum LC50/96h LC50/48h LC50/96h

490 mg/L (Rainbow Trout) 980 mg/L (Daphnia Magna) > 50000 ppm (Mysid Shrimp) (Suspended Particulate (2 lb./bbl of Xanthan Gum))

532-32-1 Sodium Benzoate

LC50

EC0

IC50/72h EC50/48h

460 mg/L (Leuciscus Idus) (ECOTOX Database) 1000 mg/L (Bacteria) (Exernal SDS) > 10 mg/L (Algae) (Exernal SDS) > 100 mg/L (Daphnia) (Exernal SDS)

57-55-6 propane-1,2-diol LC50/96h IC50/96h EC50/3h EC50/48h

51600 mg/L (Onchorhyncus Mykiss) (External SDS) 19000 mg/L (Pseudokirchneriella Subcapitata) (External SDS) > 1000 mg/L (Activated Sludge) (Literature) 34400 mg/L (Daphnia Magna) (Literature)

77-92-9 Citric Acid, Anhydrous LC50/96h

LC50

IC5/7d EC5/72h IC5/8d EC5/16h EC50/72h

440 - 760 mg/L (Leuciscus Idus) (IUCLID) 440-706 mg/L (Fish) 640 mg/L (Scenedesmus Quadricauda) (Literature)(Max. Permissible Toxic Concentration) 485 mg/L (Echinodontium Sulcatum) (Literature) 80 mg/L (Microcystis Aeruginosa) (Literature)(Max. Permissible Toxic Concentration) > 10000 mg/L (Pseudomonas Putida) (Literature)(Max. Permissible Toxic Concentration)

ca. 120 mg/L (Daphnia Magna) (IUCLID)

9005-65-6 Polysorbate 80 LC50/96h

EC0

471 mg/L (Onchorhyncus Mykiss) (External SDS) > 10000 mg/L (Pseudomonas Putida) (External SDS)

6132-04-3 Trisodium citrate dihydrate LC50/96h IC50/96h EC50/8h EC50/48h

> 18000 - 32000 mg/L (Poecilia Reticulata) (IUCLID - Anhydrous substance) > 18000 - 32000 mg/L (Chlorella Vulgaris) (IUCLID - Anhydrous substance) > 1800 - 3200 mg/L (Pseudomonas Fluorescens) (IUCLID - Anhydrous substance) 5600 - 10000 mg/L (Daphnia Magna) (IUCLID - Anhydrous substance)

Persistence and degradability No further relevant information available.

Bioaccumulative potential No further relevant information available.

Mobility in soil No further relevant information available.

Additional ecological information Use according to the good working practice. Avoid transfer into the environment.

General notes: Generally not hazardous for water

Results of PBT and vPvB assessment PBT: Not applicable.

vPvB: Not applicable.

Other adverse effects No further relevant information available.

12 Ecological information

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Waste treatment methods The information presented only applies to the material as supplied. The identification based on characteristic(s) or listing may not apply if the material has been used or otherwise contaminated. It is the responsibility of the waste generator to determine the toxicity and physical properties of the material generated to determine the proper waste identification and disposal methods in compliance with applicable regulations. Disposal should be in accordance with applicable regional, national and local laws and regulations.

Recommendation: Reutilise if possible or contact a waste processors for recycling or safe disposal.

Waste disposal key:

If this product, as supplied, becomes a waste in the United States, it may meet the criteria of a hazardous waste as defined under RCRA, Title 40 CFR 261. It is the responsibility of the waste generator to determine the proper waste identification and disposal method. For disposal of unused or waste material, check with local, state and federal environmental agencies.

Uncleaned packagings:

Recommendation:

Disposal must be made according to official regulations.

Packagings that cannot be cleansed are to be disposed of in the same manner as the product.

UN-Number DOT Void

TDG, ADN, IMDG, IATA Void

UN proper shipping name DOT, TDG, ADN, IMDG, IATA Void

Transport hazard class(es)

DOT, TDG, ADN, IMDG, IATA

Class Void

Packing group DOT, TDG, IMDG, IATA Void

Environmental hazards:

Marine pollutant: No

Special precautions for user Not applicable.

Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

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

13 Disposal considerations

14 Transport information

15 Regulatory information

None of the ingredients is listed.

Section 355 (extremely hazardous substances):

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Section 313 (Specific toxic chemical listings):

None of the ingredients is listed.

Canadian Ingredient Disclosure list (limit 0.1%) None of the ingredients is listed.

Canadian Ingredient Disclosure list (limit 1%) None of the ingredients is listed.

GHS label elements Not applicable.

Hazard pictograms Not applicable.

Signal word Not applicable.

Hazard statements Not applicable.

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship.

Date of preparation / last revision: 01/20/2021 Abbreviations and acronyms:

ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) IMDG: International Maritime Code for Dangerous Goods DOT: US Department of Transportation IATA: International Air Transport Association EINECS: European Inventory of Existing Commercial Chemical Substances ELINCS: European List of Notified Chemical Substances CAS: Chemical Abstracts Service (division of the American Chemical Society) NFPA: National Fire Protection Association (USA) HMIS: Hazardous Materials Identification System (USA) WHMIS: Workplace Hazardous Materials Information System (Canada) LC50: Lethal concentration, 50 percent LD50: Lethal dose, 50 percent

16 Other information

SAFETY DATA SHEET

Creation Date 22-February-2010 Revision Date 22-July-2019 Revision Number 5

1. Identification Product Name Protocol™ 10% Neutral Buffered Formalin

Cat No. : 2300528, 2300532, 2300545, 2300546, 23005500, 23011120, 23032059, 23032060, 23245684, 23245685, 23253998, 23305510, 23316154, 23316155, 23426796, 23426797, 23427098, 51601BMT

Synonyms No information available

Recommended Use In vitro diagnostic.

Uses advised against Food, drug, pesticide or biocidal product use

Details of the supplier of the safety data sheet

2. Hazard(s) identification Classification

WHMIS 2015 Classification Classified as hazardous under the Hazardous Products Regulations (SOR/2015-17)

Label Elements

Signal Word Danger

Hazard Statements Causes skin irritation May cause an allergic skin reaction

Company Fisher Diagnostics A Division of Fisher Scientific Company, LLC A Part of Thermo Fisher Scientific, Inc.

8365 Valley Pike Middletown, VA 22645-1905 Tel: (800) 528-0494

Manufacturer Fisher Scientific One Reagent Lane Fair Lawn, NJ 07410 Tel: (201) 796-7100

Emergency Telephone Number Chemtrec US: (800) 424-9300 Chemtrec EU: 001 (202) 483-7616

Skin Corrosion/irritation Category 2 Serious Eye Damage/Eye Irritation Category 1 Skin Sensitization Category 1 Carcinogenicity Category 1A Specific target organ toxicity (single exposure) Category 1 Target Organs - Central nervous system (CNS).

Specific target organ toxicity - (repeated exposure) Category 2 Target Organs - Kidney, Liver, spleen, Blood.

Page 1 / 8

ITEM# 012335

Protocol™ 10% Neutral Buffered Formalin Revision Date 22-July-2019

Causes serious eye damage May cause drowsiness and dizziness May cause cancer Causes damage to organs May cause damage to organs through prolonged or repeated exposure

Precautionary Statements Prevention Do not breathe dust/fumes/gas/mist/vapours/spray Wash face, hands and any exposed skin thoroughly after handling Obtain special instructions before use Do not handle until all safety precautions have been read and understood Do not eat, drink or smoke when using this product Use only outdoors or in a well-ventilated area Contaminated work clothing should not be allowed out of the workplace Wear protective gloves/protective clothing/eye protection/face protection Response IF ON SKIN: Wash with plenty of soap and water IF INHALED: Remove person to fresh air and keep comfortable for breathing IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing If exposed or concerned: Call a POISON CENTER/ doctor Immediately call a POISON CENTER/doctor Take off contaminated clothing Storage Store locked up Store in a well-ventilated place. Keep container tightly closed Disposal Dispose of contents/container to an approved waste disposal plant

3. Composition/Information on Ingredients

Component CAS-No Weight % Water 7732-18-5 > 90

Formaldehyde 50-00-0 3.5 - 4.0 Methyl alcohol 67-56-1 1.0 - 2.0

Sodium phosphate, monobasic 7558-80-7 < 1.0 Sodium phosphate dibasic 7558-79-4 < 1.0

4. First-aid measures

Eye Contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Get medical attention.

Skin Contact Wash off immediately with plenty of water for at least 15 minutes. Obtain medical attention.

Inhalation Move to fresh air. If breathing is difficult, give oxygen. Get medical attention immediately if symptoms occur.

Ingestion Do not induce vomiting. Obtain medical attention.

Page 2 / 8

Most important symptoms/effects Causes eye burns. May cause allergic skin reaction. Symptoms of allergic reaction may include rash, itching, swelling, trouble breathing, tingling of the hands and feet, dizziness, lightheadedness, chest pain, muscle pain or flushing

Notes to Physician Treat symptomatically

5. Fire-fighting measures Suitable Extinguishing Media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Unsuitable Extinguishing Media No information available

Flash Point > 93.3 °C / 199.9 °F

Method - No information available

Autoignition Temperature No information available Explosion Limits

Upper No data available Lower No data available Sensitivity to Mechanical Impact No information available Sensitivity to Static Discharge No information available

Specific Hazards Arising from the Chemical Thermal decomposition can lead to release of irritating gases and vapors. Keep product and empty container away from heat and sources of ignition.

Hazardous Combustion Products Thermal decomposition can lead to release of irritating gases and vapors Protective Equipment and Precautions for Firefighters As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear.

NFPA

6. Accidental release measures Personal Precautions Use personal protective equipment. Ensure adequate ventilation. Remove all sources of ignition. Avoid contact with skin, eyes and clothing.

Environmental Precautions Should not be released into the environment. See Section 12 for additional ecological information.

Methods for Containment and Clean Up

Remove all sources of ignition. Soak up with inert absorbent material. Keep in suitable, closed containers for disposal.

7. Handling and storage Handling Use only under a chemical fume hood. Wear personal protective equipment. Keep away from open flames, hot surfaces and sources of ignition. Do not breathe vapors or spray mist. Do not get in eyes, on skin, or on clothing.

Storage Keep containers tightly closed in a dry, cool and well-ventilated place. Keep away from heat and sources of ignition.

8. Exposure controls / personal protection Exposure Guidelines

Component Alberta British Columbia

Ontario TWAEV Quebec ACGIH TLV OSHA PEL NIOSH IDLH

Health

Flammability

Instability

Page 3 / 8

Physical hazards N/A

Formaldehyde Ceiling: 1 ppm Ceiling: 1.3 mg/m3

TWA: 0.75 ppm TWA: 0.9 mg/m3

TWA: 0.3 ppm Ceiling: 1 ppm

STEL: 1 ppm CEV: 1.5 ppm

Ceiling: 2 ppm Ceiling: 3 mg/m3

TWA: 0.1 ppm STEL: 0.3 ppm

(Vacated) TWA:

3 ppm

(Vacated) STEL:

10 ppm

(Vacated) Ceiling: 5 ppm TWA: 0.75 ppm STEL: 2 ppm

IDLH: 20 ppm TWA: 0.016 ppm Ceiling: 0.1 ppm

Methyl alcohol TWA: 200 ppm

TWA: 262

mg/m3

STEL: 250 ppm

STEL: 328

mg/m3

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

TWA: 200 ppm

TWA: 262

mg/m3

STEL: 250 ppm

STEL: 328

mg/m3

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

(Vacated) TWA:

200 ppm

(Vacated) TWA:

260 mg/m3

(Vacated) STEL:

250 ppm

(Vacated) STEL:

325 mg/m3

Skin TWA: 200 ppm

TWA: 260

mg/m3

IDLH: 6000 ppm TWA: 200 ppm

TWA: 260

mg/m3

STEL: 250 ppm

STEL: 325

mg/m3

Legend

ACGIH - American Conference of Governmental Industrial Hygienists

OSHA - Occupational Safety and Health Administration

NIOSH IDLH: The National Institute for Occupational Safety and Health Immediately Dangerous to Life or Health

Engineering Measures Use only under a chemical fume hood. Ensure adequate ventilation, especially in confined areas. Ensure that eyewash stations and safety showers are close to the workstation location.

Wherever possible, engineering control measures such as the isolation or enclosure of the process, the introduction of process or equipment changes to minimise release or contact, and the use of properly designed ventilation systems, should be adopted to control hazardous materials at source

Personal protective equipment

Eye Protection Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard

EN166.

Hand Protection Wear appropriate protective gloves and clothing to prevent skin exposure.

Inspect gloves before use. observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. (Refer to manufacturer/supplier for information) gloves are suitable for the task: Chemical compatability, Dexterity, Operational conditions, User susceptibility, e.g. sensitisation effects, also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion. gloves with care avoiding skin contamination.

Respiratory Protection When workers are facing concentrations above the exposure limit they must use appropriate certified respirators. Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced.

To protect the wearer, respiratory protective equipment must be the correct fit and be used and maintained properly

When RPE is used a face piece Fit Test should be conducted

Environmental exposure controls No information available.

Hygiene Measures Handle in accordance with good industrial hygiene and safety practice. Keep away from food, drink and animal feeding stuffs. Do not eat, drink or smoke when using this product. Remove and wash contaminated clothing before re-use. Wash hands before

Glove material Breakthrough time Glove thickness Glove comments Nitrile rubber See manufacturers recommendations

- Splash protection only

Page 4 / 8 breaks and at the end of workday.

9. Physical and chemical properties Physical State Liquid Appearance Colorless Odor Characteristic formaldehyde Odor Threshold No information available pH 6.9 - 7.1 Melting Point/Range No data available Boiling Point/Range 102 °C / 215.6 °F Flash Point > 93.3 °C / 199.9 °F Evaporation Rate No information available Flammability (solid,gas) No information available Flammability or explosive limits

Upper No data available Lower No data available

Vapor Pressure No information available Vapor Density No information available Specific Gravity 1.0 Solubility No information available Partition coefficient; n-octanol/water No data available Autoignition Temperature No information available Decomposition Temperature No information available Viscosity No information available

10. Stability and reactivity

Reactive Hazard None known, based on information available

Stability Stable under normal conditions.

Conditions to Avoid Incompatible products. Heat, flames and sparks.

Incompatible Materials Strong oxidizing agents

Hazardous Decomposition Products Thermal decomposition can lead to release of irritating gases and vapors

Hazardous Polymerization Hazardous polymerization does not occur.

Hazardous Reactions None under normal processing.

11. Toxicological information Acute Toxicity

Product Information No acute toxicity information is available for this product Oral LD50 Based on ATE data, the classification criteria are not met. ATE > 2000 mg/kg.

Dermal LD50 Based on ATE data, the classification criteria are not met. ATE > 2000 mg/kg.

Vapor LC50 Based on ATE data, the classification criteria are not met. ATE > 20 mg/l.

Component Information

Component LD50 Oral LD50 Dermal LC50 Inhalation Water - Not listed Not listed

Formaldehyde 500 mg/kg (Rat) LD50 = 270 mg/kg (Rabbit) 0.578 mg/L (Rat) 4 h

Methyl alcohol Calc. ATE 60 mg/kg LD50 > 1187 – 2769 mg/kg ( Rat )

Calc. ATE 60 mg/kg LD50 = 17100 mg/kg ( Rabbit )

Calc. ATE 0.6 mg/L (vapours) or

0.5 mg/L (mists)

LC50 = 128.2 mg/L ( Rat ) 4 h Sodium phosphate, monobasic LD50 = 8290 mg/kg ( Rat ) LD50 > 7940 mg/kg ( Rabbit ) Not listed

Sodium phosphate dibasic LD50 = 17 g/kg ( Rat ) Not listed Not listed

Page 5 / 8

Toxicologically Synergistic Products

No information available

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Irritation Risk of serious damage to eyes Irritating to respiratory system and skin

Sensitization May cause sensitization by skin contact

Carcinogenicity The table below indicates whether each agency has listed any ingredient as a carcinogen.

Component CAS-No IARC NTP ACGIH OSHA Mexico Water 7732-18-5 Not listed Not listed Not listed Not listed Not listed

Formaldehyde 50-00-0 Group 1 Known A1 X A2 Methyl alcohol 67-56-1 Not listed Not listed Not listed Not listed Not listed

Sodium phosphate, monobasic

7558-80-7 Not listed Not listed Not listed Not listed Not listed

Sodium phosphate dibasic

7558-79-4 Not listed Not listed Not listed Not listed Not listed

IARC: (International Agency for Research on Cancer) IARC: (International Agency for Research on Cancer) Group 1 - Carcinogenic to Humans Group 2A - Probably Carcinogenic to Humans Group 2B - Possibly Carcinogenic to Humans

NTP: (National Toxicity Program) NTP: (National Toxicity Program) Known - Known Carcinogen Reasonably Anticipated - Reasonably Anticipated to be a Human Carcinogen

ACGIH: (American Conference of Governmental Industrial Hygienists)

A1 - Known Human Carcinogen A2 - Suspected Human Carcinogen A3 - Animal Carcinogen ACGIH: (American Conference of Governmental Industrial Hygienists)

Mutagenic Effects Mutagenic effects have occurred in humans.

Reproductive Effects Experiments have shown reproductive toxicity effects on laboratory animals.

Developmental Effects Developmental effects have occurred in experimental animals. Component substance is listed on California Proposition 65 as a developmental hazard.

Teratogenicity Teratogenic effects have occurred in experimental animals.

STOT - single exposure Central nervous system (CNS) STOT - repeated exposure Kidney Liver spleen Blood

Aspiration hazard No information available

Symptoms / effects,both acute and delayed

Symptoms of allergic reaction may include rash, itching, swelling, trouble breathing, tingling of the hands and feet, dizziness, lightheadedness, chest pain, muscle pain or flushing

Endocrine Disruptor Information No information available

Other Adverse Effects See actual entry in RTECS for complete information.

12. Ecological information Ecotoxicity

Component Freshwater Algae Freshwater Fish Microtox Water Flea Formaldehyde Not listed Leuciscus idus: LC50 = 15 mg/L 96h Not listed EC50 = 20 mg/L 96h

EC50 = 2 mg/L 48h Methyl alcohol Not listed Pimephales promelas: LC50

> 10000 mg/L 96h EC50 = 39000 mg/L 25 min EC50 = 40000 mg/L 15 min EC50 = 43000 mg/L 5 min

EC50 > 10000 mg/L 24h

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Persistence and Degradability No information available

Bioaccumulation/ Accumulation No information available.

Mobility .

Component log Pow Formaldehyde -0.35 Methyl alcohol -0.74

13. Disposal considerations Waste Disposal Methods Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. Chemical waste generators must also consult local, regional, and national hazardous waste regulations to ensure complete and accurate classification.

Component RCRA - U Series Wastes RCRA - P Series Wastes Formaldehyde - 50-00-0 U122 - Methyl alcohol - 67-56-1 U154 -

14. Transport information DOT Not regulated TDG Not regulated IATA Not regulated IMDG/IMO Not regulated

15. Regulatory information

International Inventories

Component DSL NDSL TSCA EINECS ELINCS NLP PICCS ENCS AICS IECSC KECL Water X - X 231-791-2 - X - X X KE-3540

Formaldehyde X - X 200-001-8 - X X X X KE-1707

Methyl alcohol X - X 200-659-6 - X X X X KE-2319

Sodium phosphate, monobasic X - X 231-449-2 - X X X X KE-3157

Sodium phosphate dibasic X - X 231-448-7 - X X X X KE-1234

Canada

SDS in compliance with provisions of information as set out in Canadian Standard - Part 4, Schedule 1 and 2 of the Hazardous Products Regulations (HPR) and meets the requirements of the HPR (Paragraph 13(1)(a) of the Hazardous Products Act (HPA)).

Component Canada - National Pollutant Release Inventory (NPRI)

Canadian Environmental Protection Agency (CEPA)

- List of Toxic Substances

Canada's Chemicals Management Plan (CEPA)

Formaldehyde Part 1, Group A Substance Part 5, Individual Substances Part 4

Substance

Schedule I

Methyl alcohol Part 1, Group A Substance Part 5, Individual Substances Part 4

Substance

16. Other information Prepared By Regulatory Affairs

Thermo Fisher Scientific Email: EMSDS.RA@thermofisher.com

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Creation Date 22-February-2010 Revision Date 22-July-2019 Print Date 22-July-2019 Revision Summary This document has been updated to comply with the requirements of WHMIS 2015 to align with the Globally Harmonised System (GHS) for the Classification and Labelling of Chemicals.

Disclaimer The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text

End of SDS

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MATERIAL SAFETY DATA SHEETMATERIAL SAFETY DATA SHEETMATERIAL SAFETY DATA SHEETMATERIAL SAFETY DATA SHEET

1. Product and Company Identification1. Product and Company Identification1. Product and Company Identification1. Product and Company Identification Material nameMaterial nameMaterial nameMaterial name IOTHALAMIC ACIDIOTHALAMIC ACIDIOTHALAMIC ACIDIOTHALAMIC ACID Version #Version #Version #Version # 02 Issue dateIssue dateIssue dateIssue date 12-05-2014 Revision dateRevision dateRevision dateRevision date 12-05-2014 Supersedes dateSupersedes dateSupersedes dateSupersedes date 12-05-2014

CAS #CAS #CAS #CAS # 2276-90-6

Product useProduct useProduct useProduct use Diagnostic imaging agent.

Synonym(s)Synonym(s)Synonym(s)Synonym(s) 5-Acetamido-2,4,6-triiodo-N-methylisophthalamic acid * Benzoic acid, 3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbony l]-

Mallinckrodt 675 McDonnell Blvd.

Hazelwood, MO 63042

Manufacturer informationManufacturer informationManufacturer informationManufacturer information

Customer Service 888-744-1414 24 Hour Emergency 314-654-1600 Chemtrec 800-424-9300

Item codeItem codeItem codeItem code 1083, 1183

2. Hazards Identification2. Hazards Identification2. Hazards Identification2. Hazards Identification Emergency overviewEmergency overviewEmergency overviewEmergency overview WARNING

Flammable Solid.

Combustible. Exposure to powder or dusts may be irritating to eyes, nose and throat. Avoid prolonged contact with eyes, skin and clothing. Health injuries are not known or expected under normal use.

Handle in accordance with good industrial hygiene and safety practice.

OSHA regulatory statusOSHA regulatory statusOSHA regulatory statusOSHA regulatory status NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. This substance is not classified as dangerous according to Directive 67/548/EEC. This product is considered not hazardous under 29 CFR 1910.1200 (Hazard Communication).

Potential health effectsPotential health effectsPotential health effectsPotential health effects Routes of exposureRoutes of exposureRoutes of exposureRoutes of exposure Inhalation. Ingestion. Skin contact. Eye contact.

EyesEyesEyesEyes Dust in the eyes will cause irritation. Health injuries are not known or expected under normal use.

SkinSkinSkinSkin Dust or powder may irritate the skin.

InhalationInhalationInhalationInhalation Inhalation of dusts may cause respiratory irritation. Dust may irritate respiratory system. Inhalation of dusts of this product may result in shortness of breath, limitation of chest expansion, dry cough, and a lessened capacity for work. Dust may irritate throat and respiratory system and cause coughing.

IngestionIngestionIngestionIngestion Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea. May cause irritation.

Do not ingest. Health injuries are not known or expected under normal use. Large quantities: Acute ingestion may result in mild gastrointestinal distress.

Chronic effectsChronic effectsChronic effectsChronic effects None known.

Signs and symptomsSigns and symptomsSigns and symptomsSigns and symptoms Dust or powder may irritate eye tissue. Inhalation of dusts may cause respiratory irritation.

Coughing. Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea.

Potential environmental effectsPotential environmental effectsPotential environmental effectsPotential environmental effects Ecological injuries are not known or expected under normal use.

Material name: IOTHALAMIC ACID MSDS ID: LACAD Version #: 02 Revision date: 12-05-2014

MSDS US

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Item# 012890

ComponentsComponentsComponentsComponents CAS #CAS #CAS #CAS # PercentPercentPercentPercent

3. Composition / Information on Ingredients3. Composition / Information on Ingredients3. Composition / Information on Ingredients3. Composition / Information on Ingredients

2276-90-6 90 - 100IOTHALAMIC ACID

4. First Aid Measures4. First Aid Measures4. First Aid Measures4. First Aid Measures First aid proceduresFirst aid proceduresFirst aid proceduresFirst aid procedures

Eye contactEye contactEye contactEye contact Immediately flush eyes with plenty of water for at least 15 minutes. If a contact lens is present, DO NOT delay irrigation or attempt to remove the lens. Get medical attention if irritation develops and persists.

Skin contactSkin contactSkin contactSkin contact Flush skin thoroughly with water. Get medical attention if irritation develops and persists. Rinse skin with water/shower.

InhalationInhalationInhalationInhalation If dust from the material is inhaled, remove the affected person immediately to fresh air. If breathing is difficult, give oxygen. If breathing stops, provide artificial respiration. Call a physician if symptoms develop or persist.

IngestionIngestionIngestionIngestion Get medical attention if any discomfort continues. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Do not induce vomiting without advice from poison control center.

Never give anything by mouth to a victim who is unconscious or is having convulsions. Rinse mouth. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs. IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. If ingestion of a large amount does occur, call a poison control center immediately.

Notes to physicianNotes to physicianNotes to physicianNotes to physician Not applicable.

General adviceGeneral adviceGeneral adviceGeneral advice Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves. If you feel unwell, seek medical advice (show the label where possible). Call a POISON CENTER or doctor/physician if you feel unwell.

5. Fire Fighting Measures5. Fire Fighting Measures5. Fire Fighting Measures5. Fire Fighting Measures Flammable propertiesFlammable propertiesFlammable propertiesFlammable properties Combustible by OSHA criteria. NFPA Rating Fire = 2. Materials that must be moderately heated or exposed to relative high ambient temperatures before ignition can occur. Dust may form explosive mixture with air. Heat may cause the containers to explode. Runoff to sewer may cause fire or explosion hazard. The product is not flammable. None known. As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source. Not flammable by OSHA criteria. No unusual fire or explosion hazards noted.

Extinguishing mediaExtinguishing mediaExtinguishing mediaExtinguishing media Suitable extinguishingSuitable extinguishingSuitable extinguishingSuitable extinguishing mediamediamediamedia

Water. Foam. Dry chemical powder. Alcohol foam. Carbon dioxide (CO2). Use any media suitable for the surrounding fires.

Unsuitable extinguishingUnsuitable extinguishingUnsuitable extinguishingUnsuitable extinguishing mediamediamediamedia

Do not use a solid water stream as it may scatter and spread fire.

Protection of firefightersProtection of firefightersProtection of firefightersProtection of firefighters Specific hazards arisingSpecific hazards arisingSpecific hazards arisingSpecific hazards arising from the chemicalfrom the chemicalfrom the chemicalfrom the chemical

None known.

Protective equipment andProtective equipment andProtective equipment andProtective equipment and precautions for firefightersprecautions for firefightersprecautions for firefightersprecautions for firefighters

Firefighters must use standard protective equipment including flame retardant coat, helmet with face shield, gloves, rubber boots, and in enclosed spaces, SCBA. Structural firefighters protective clothing will only provide limited protection. As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear.

Fire fightingFire fightingFire fightingFire fighting equipment/instructionsequipment/instructionsequipment/instructionsequipment/instructions

In case of fire and/or explosion do not breathe fumes. As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear. If tank, rail car or tank truck is involved in a fire, ISOLATE for 800 meters (1/2 mile) in all directions;

also consider initial evacuation for 800 meters (1/2 mile) in all directions. ALWAYS stay away from tanks engulfed in flame. Withdraw immediately in case of rising sound from venting safety device or any discoloration of tanks due to fire. In the event of fire, cool tanks with water spray. Move containers from fire area if you can do so without risk. For massive fire in cargo area, use unmanned hose holder or monitor nozzles, if possible. If not, withdraw and let fire burn out. Not applicable. Wear full protective clothing, including helmet, self-contained positive pressure or pressure demand breathing apparatus, protective clothing and face mask. Cool containers exposed to flames with water until well after the fire is out.

Material name: IOTHALAMIC ACID MSDS ID: LACAD Version #: 02 Revision date: 12-05-2014

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Specific methodsSpecific methodsSpecific methodsSpecific methods In the event of fire and/or explosion do not breathe fumes. Self-contained breathing apparatus and full protective clothing must be worn in case of fire. Move container from fire area if it can be done without risk. Cool containers exposed to flames with water until well after the fire is out. Use standard firefighting procedures and consider the hazards of other involved materials.

General fire hazardsGeneral fire hazardsGeneral fire hazardsGeneral fire hazards No unusual fire or explosion hazards noted. The product is not flammable.

6. Accidental Release Measures6. Accidental Release Measures6. Accidental Release Measures6. Accidental Release Measures Personal precautionsPersonal precautionsPersonal precautionsPersonal precautions Keep unnecessary personnel away. Keep out of low areas. Wear appropriate protective equipment and clothing during clean-up. Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. Keep upwind. Ventilate closed spaces before entering them. Avoid inhalation of dust from the spilled material. Ensure adequate ventilation.

Environmental precautionsEnvironmental precautionsEnvironmental precautionsEnvironmental precautions Prevent further leakage or spillage if safe to do so. Avoid discharge into drains, water courses or onto the ground. No special environmental precautions required.

Methods for containmentMethods for containmentMethods for containmentMethods for containment ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area). Stop the flow of material, if this is without risk. If sweeping of a contaminated area is necessary use a dust suppressant agent which does not react with the product.

Methods for cleaning upMethods for cleaning upMethods for cleaning upMethods for cleaning up Ventilate the contaminated area. The product is immiscible with water and will spread on the water surface. Stop the flow of material, if this is without risk. Dike far ahead of spill for later disposal.

Cover with plastic sheet to prevent spreading. Small Dry Spills: With clean shovel place material into clean, dry container and cover loosely; move containers from spill area. Collect dust using a vacuum cleaner equipped with HEPA filter. Avoid dust formation. Following product recovery, flush area with water. For waste disposal, see section 13 of the MSDS. Use only non-sparking tools.

Other informationOther informationOther informationOther information Clean up in accordance with all applicable regulations.

7. Handling and Storage7. Handling and Storage7. Handling and Storage7. Handling and Storage HandlingHandlingHandlingHandling DO NOT handle, store or open near an open flame, sources of heat or sources of ignition. Protect material from direct sunlight. Avoid dust formation. Guard against dust accumulation of this material. Provide appropriate exhaust ventilation at places where dust is formed. All equipment used when handling the product must be grounded. Do not breathe dust from this material. Do not ingest. Avoid contact with skin and eyes. Do not use in areas without adequate ventilation. Use personal protective equipment as required. When using, do not eat, drink or smoke. Wash thoroughly after handling. Handle and open container with care. Practice good housekeeping.

Avoid release to the environment. Avoid breathing dust. Avoid contact with eyes. Keep formation of airborne dusts to a minimum. In case of insufficient ventilation, wear suitable respiratory equipment.

StorageStorageStorageStorage The pressure in sealed containers can increase under the influence of heat. Keep away from heat and sources of ignition. This material can accumulate static charge which may cause spark and become an ignition source. Prevent electrostatic charge build-up by using common bonding and grounding techniques. Keep container tightly closed. Store in a well-ventilated place. Avoid dust formation. Guard against dust accumulation of this material. Use care in handling/storage. Store in accordance with local/regional/national/international regulation. Store in a cool, dry place.

8. Exposure Controls / Personal Protection8. Exposure Controls / Personal Protection8. Exposure Controls / Personal Protection8. Exposure Controls / Personal Protection Occupational exposure limitsOccupational exposure limitsOccupational exposure limitsOccupational exposure limits No exposure limits noted for ingredient(s).

Biological limit valuesBiological limit valuesBiological limit valuesBiological limit values No biological exposure limits noted for the ingredient(s).

Exposure guidelinesExposure guidelinesExposure guidelinesExposure guidelines No exposure standards allocated.

Engineering controlsEngineering controlsEngineering controlsEngineering controls Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level.

Ventilation should be sufficient to effectively remove and prevent buildup of any dusts or fumes that may be generated during handling or thermal processing. Ensure adequate ventilation, especially in confined areas.

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Personal protective equipmentPersonal protective equipmentPersonal protective equipmentPersonal protective equipment Eye / face protectionEye / face protectionEye / face protectionEye / face protection Use tight fitting goggles if dust is generated. Safety glasses. Provide eyewash station and safety shower. Safety glasses with side-shields.

Skin protectionSkin protectionSkin protectionSkin protection Chemical resistant gloves. Wear appropriate chemical resistant clothing.

Respiratory protectionRespiratory protectionRespiratory protectionRespiratory protection Use a positive-pressure air-supplied respirator if there is any potential for an uncontrolled release, exposure levels are not known, or any other circumstances where air-purifying respirators may not provide adequate protection. Wear respirator with dust filter. Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits.

Particulate air-purifying respirator approved for dust or oil mist is recommended.

General hygieneGeneral hygieneGeneral hygieneGeneral hygiene considerationsconsiderationsconsiderationsconsiderations

When using do not smoke. Do not breathe dust. Avoid contact with eyes. Handle in accordance with good industrial hygiene and safety practice. Avoid breathing dust.

9. Physical & Chemical Properties9. Physical & Chemical Properties9. Physical & Chemical Properties9. Physical & Chemical Properties AppearanceAppearanceAppearanceAppearance Powder.

Physical statePhysical statePhysical statePhysical state Solid.

FormFormFormForm Powder.

ColorColorColorColor White

OdorOdorOdorOdor Odorless.

Odor thresholdOdor thresholdOdor thresholdOdor threshold Not available.

pHpHpHpH Not available.

Vapor pressureVapor pressureVapor pressureVapor pressure Not available.

Vapor densityVapor densityVapor densityVapor density Not available.

Boiling pointBoiling pointBoiling pointBoiling point Not available.

Melting point/Freezing pointMelting point/Freezing pointMelting point/Freezing pointMelting point/Freezing point 545 °F (285 °C)

Solubility…