HDR####
November 9, 2001
Page 1 of 7
Reno-60 MATERIAL SAFETY DATA SHEET
The author of this Material Safety Data Sheet (MSDS) is Bracco
Diagnostics Inc. This MSDS is generated and/or distributed by the
Bristol-Myers Squibb Company on behalf of Bracco Diagnostics Inc.
Please carefully review all of the information disclosed in this
MSDS prior to handling or using the product referenced below.
SECTION 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Bracco Diagnostics Inc.
P.O. Box 5225
Princeton, NJ 08543
Product Identification: Reno-60.
1. Chemical Name: For active (diatrizoate meglumine) D-Glucitol, 1-
deoxy-1-(methylamino)-3,5-diacetamido-2,4,6-triiodobenzoate
(salt).
2. Synonym: Diatrizoate meglumine injection USP 60%.
3. How Supplied: Ten 10 mL and twenty-five 50 mL single dose vials;
ten 100 mL and ten 150 mL single dose bottles; ten 150 mL single
dose bottles with ten solution administration sets.
4. Product Use: Iodinated radiopaque contrast agent.
5. Chemical Family: Not applicable (pharmacological mixture).
6. Molecular Formula: C11H9I3N2O4.C7H17NO5 (Diatrizoate meglumine)
7. CAS NUMBER: Diatrizoate meglumine (131-49-7).
EMERGENCY CONTACTS: (Health) 1-800-257-5181.
(U.S. Transportation)Chemtrec 1-800-424-9300.
(International Transportation)
Chemtrec 1-703-527-3887.
EMERGENCY OVERVIEW: Colorless to pale yellow sterile aqueous
solution. Non-combustible. See Health Effects
and Toxicology sections for additional
information.
SECTION 2: COMPOSITION/INFORMATION ON INGREDIENTS
COMPONENTS HAZARDOUS CONCENTRATION CAS EXPOSURE
(Y/N) %(w/v) NUMBER GUIDELINE
> 1%
Diatrizoate N 60 131-49-7 None
Meglumine
Water N >1 7732-18-5 None
Components present at < 1% or used for pH adjustment: edetate
disodium, sodium citrate.
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Reno-60 Material Safety Data Sheet (continued)
SECTION 3: HEALTH HAZARDS IDENTIFICATION
Effects of Overexposure
Routes of Entry:
1. Inhalation: Under normal conditions, this material is handled
in closed vials and exposure to this material by inhalation
is not expected to occur. However, in a situation where the
liquid would be aerosolized, there may be potential for
inhalation. The extent of systemic absorption of the material
after inhalation is not known.
2. Skin Contact: Exposure may occur via skin contact if gloves
and protective clothing are not worn. The extent of systemic
absorption of the material after skin contact is not known.
3. Ingestion: Ingestion of large quantities of this material in
an occupational setting would not be expected to occur.
Ingestion of trace amounts of the material might occur if the
material contacts hands and hands are not washed prior to
eating, drinking or smoking. Diatrizoate meglumine is very
poorly absorbed from the gastrointestinal tract.
Acute
1. Ingestion: Inadvertent ingestion of trace amounts of this
material would not be expected to result in symptoms.
Ingestion of large quantities of certain meglumine salts may
result in mild laxative effects, dehydration, electrolyte
disturbances, and occasionally hypersensitivity (allergic)
reactions.
2. Inhalation: Inhaling small doses of aerosolized material
would not be expected to result in symptoms, although a
hypersensitivity (allergic) reaction may (occasionally)
occur. Inhalation of large amounts of material may result in
inflammation and/or edema of the lungs.
3. Skin Contact:
a. Toxic: Contact with small quantities of material for
short periods is not expected to result in pharmacologic
or toxic effects.
b. Irritation: Material contains low concentrations of
components that are mild irritants or possible irritants.
It may have potential to cause mild irritation, however,
moderate or severe irritation is not expected.
c. Sensitization: This material may act as a sensitizer
(allergen) for those persons who are allergic to these
formulations, iodine, or other components in the
formulation.
4. Eye Contact: No information.
Chronic
Repeated and prolonged exposure to skin may cause skin
irritation. Reno-60 is not intended for chronic use and there is
no information on the possible adverse effects associated with
chronic exposure.
Exposure Guideline Summary: An exposure guideline has not been
established for diatrizoate meglumine.
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Page 3 of 7
Reno-60 Material Safety Data Sheet (continued)
Carcinogen Lists IARC: No. NTP: No. OSHA: No.
Target Organs: None known.
Medical Condition Aggravated by Exposure: Significant doses to
patients with multiple myeloma, pheochromocytoma or sickle cell
disease may aggravate conditions. Sensitivity to iodine.
SECTION 4: FIRST AID MEASURES
1. Ingestion: Get medical attention immediately. Vomiting may be
induced if a person is conscious and if ingestion has occurred
within the past three hours. Never induce vomiting in a person
who is unconscious or experiencing convulsions.
2. Inhalation: Remove exposed person to fresh air. If person is
not breathing, give artificial respiration. If breathing is
difficult administer oxygen. Get medical attention immediately.
3. Skin Contact: Remove contaminated clothing. Wash skin with
plenty of water for 5 minutes. Seek medical attention if
irritation (redness, itching or swelling) develops or persists.
4. Eye Contact: Hold eyelids apart and flush with plenty of water
for 5 minutes. Get medical attention if signs of irritation
develop.
5. Note to physicians: None.
SECTION 5: FIRE FIGHTING MEASURES
1. Flash Point: Not applicable.
2. Auto-ignition Temperature: Not available.
3. Flammability Limits:
a. LEL: Not applicable.
b. UEL: Not applicable.
4. Combustibility of Dusts: Not applicable, material exists as a
liquid.
5. Extinguishing Media: In case of fire, flood with water.
6. Fire-fighting Instructions: Firefighters should wear self-
contained breathing apparatus, flame and chemical resistant
clothing, boots and gloves. Evacuate personnel to an upwind
direction, remove unneeded material and cool container(s) with
water from a maximum distance.
7. Hazardous Combustion Products: carbon monoxide, carbon dioxide,
hydrogen iodide, iodine, nitrogen oxides.
8. Unusual Hazards: None.
SECTION 6: ACCIDENTAL RELEASE MEASURES
Spill/Clean-up: Lab coat, impermeable gloves (latex, latex/nitrile
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Page 4 of 7
Reno-60 Material Safety Data Sheet (continued)
or nitrile) and eye protection should be worn as a minimum
precaution. Absorb spill with inert material, e.g. sand,
vermiculite or other non-combustible absorbent materials, and place
into a closed container for reclamation or disposal. The spill
area should be ventilated and decontaminated after material has
been picked up.
SECTION 7: HANDLING AND STORAGE
1. Handling Precautions: Avoid splashing of liquid product.
Avoid skin and eye contact.
2. Container Requirements: 10 mL and 50 mL single dose vials; 100
mL and 150 mL single dose bottles; 150 mL single dose bottles
with solution administration sets.
3. Storage Conditions: Store at 20-25 degrees C (68-77 degrees
F). Protect from light.
SECTION 8: EXPOSURE CONTROLS & PERSONAL PROTECTION
1. Ventilation Requirements: None beyond good room ventilation.
2. Respiratory Protection: Not anticipated for normal clinical
environment. Non-routine exposure conditions may require NIOSH
approved respiratory protection appropriate for exposure
potential. Self-contained breathing apparatus should be
available for emergency use.
3. Eye Protection: Wear safety glasses (ANSI Z87.1).
4. Protective Gloves: Wear impervious gloves (latex, latex/nitrile,
or nitrile) if the potential exists for dermal contact.
5. Special Clothing: None.
6. Hygiene: Wash hands after handling product and before eating,
smoking, using lavatory and at the end of the day.
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
1. Appearance/Physical State/Color: Colorless to pale yellow
sterile aqueous solution.
2. Boiling Point: Not available.
3. Evaporation Rate: Not available.
4. Flash Point: Not applicable.
5. Freezing point/Melting Point: Not available.
6. Octanol/Water Partition Coefficient: Not available.
7. Odor (threshold): Practically odorless.
8. pH: 6.0-7.7.
9. Solubility in Water: Miscible.
10. Specific Gravity: 1.32.
11. Vapor Density: Not available.
12. Vapor Pressure: Not available.
13. Viscosity: 6.4 cps at 25 degrees Celsius.
$$$
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Reno-60 Material Safety Data Sheet (continued)
SECTION 10: STABILITY AND REACTIVITY
1. Stability: Filled containers are stable under normal conditions.
2. Incompatibilities: None known.
3. Conditions of Reactivity: No information.
4. Hazardous Decomposition Products: carbon monoxide, carbon
dioxide, hydrogen iodide, iodine, nitrogen oxides.
5. Hazardous Polymerization: None.
6. Explosion data relative to mechanical impact: No information.
7. Explosion data relative to static discharge: No information.
SECTION 11: TOXICOLOGICAL INFORMATION 鈥? for active ingredient,
diatrizoate meglumine.
1. RTECS # (U.S.): LZ4315000 (diatrizoate meglumine)
2. Diatrizoate meglumine:
Acute iv LD50 (rat)= 14,565 mg/kg
Acute iv LD50 (mouse)= 21,200 mg/kg
Acute ip LD50 (rat)= 44,504 mg/m=kg
Diatrizoate meglumine would be classified as essentially
nontoxic after acute intravenous injection.
3. LC50: Not applicable, exists as a liquid at room temperature.
4. Chronic
a. Carcinogenicity: No information.
b. Mutagenicity: No information.
c. Teratogenicity: When administered intravenously, diatrizoate
salts cross the placenta and are evenly distributed in fetal
tissues. No teratogenic effects attributable to diatrizoate
meglumine have been observed in teratology studies performed
in animals. There are, however, no adequate and well-
controlled studies in pregnant women.
d. Reproductive Effects: It is not known whether this product
can affect reproductive capacity. Diatrizoate meglumine is
excreted in breast milk following intravascular exposure.
e. Toxicological Synergistic Products: None known.
SECTION 12: ECOLOGICAL INFORMATION
1. Ecotoxicological Information: Not available.
2. Chemical Fate Information: Not available.
SECTION 13: DISPOSAL CONSIDERATIONS
Dispose in accordance with national, state, local or
applicable country regulations.
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Reno-60 Material Safety Data Sheet (continued)
SECTION 14: TRANSPORT INFORMATION
1. Domestic
a. Proper Shipping Name: Not classified.
b. Hazard Class, UN Number, Packing Group: Not classified.
c. Label Requirements: Not applicable.
d. Placard Requirements: Not applicable.
2. International
a. Proper Shipping Name: Not classified.
b. Hazard Class, UN Number, Packing Group: Not classified.
c. Label Requirements: Not applicable.
d. Placard Requirements: Not applicable.
SECTION 15: REGULATORY/STATUTORY INFORMATION (limited to health,
safety, environmental)
NOTE: Not meant to be all-inclusive.
1. U.S. Federal: None noted.
2. International: None noted.
3. EC Labeling: Not applicable.
SECTION 16: OTHER INFORMATION
November 9, 2001: New MSDS for Reno-60 was developed by Bracco
Diagnostics Inc and supercedes the previous version.
February 18, 1993: MSDS for Reno-60 developed by Bristol-Myers
Squibb.
Diagnostic agents are intended for use under direction of a
physician and only under the conditions of use described on the
label and the product鈥檚 package insert. As a general precaution,
personnel who handle these products should avoid contact
(ingestion, inhalation, skin and eye contact) with them.
This material safety data sheet is intended for use by personnel
who handle this material as part of their job responsibilities and
it does not address the diagnostic use of this material.
Information concerning the use of this diagnostic agent should be
obtained from the product package insert and other appropriate
references.
The information contained in this MSDS was obtained by Bracco
Diagnostics from sources believed to be accurate and reliable and
represents the best information currently on file and known by
Bracco. However, Bracco makes no representation, guaranty or
warranty, express or implied, with respect to any such information,
and specifically disclaims and assumes no liability
$$$
Page 7 of 7
Reno-60 Material Safety Data Sheet (continued)
resulting from the use, misuse or mishandling of either the product
or this MSDS.
$$$
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