009180 liquid-polibar-plus-SDS.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

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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