SAFETY DATA SHEET
1. Identification
Product identifier Gadobutrol
Other means of identification
Catalog number 1287449
CAS number 198637-52-4
Chemical name Gadolinium(III) [10-[(2RS,3SR)-1,3,4-trihydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-
1,4,7-triacetate] monohydrate
Recommended use For analytical laboratory use only.
Recommended restrictions Not for use as a drug. Not for administration to humans or animals.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
Company name U. S. Pharmacopeia
Address 12601 Twinbrook Parkway
Rockville
MD
20852-1790
United States
Telephone Customer Service 301-881-0666
Website www.usp.org
E-mail RSTECH@usp.org
Emergency phone number CHEMTREC within US & 1-800-424-9300
Canada
CHEMTREC outside US & +1 703-527-3887
Canada
2. Hazard(s) identification
Physical hazards Not classified.
Health hazards Not classified.
Environmental hazards Not classified.
OSHA defined hazards Not classified.
Label elements
Hazard symbol None.
Signal word None.
Hazard statement Not available.
Precautionary statement
Prevention Not available.
Response Not available.
Storage Not available.
Disposal Not available.
Hazard(s) not otherwise This product is supplied in a small quantity which does not constitute a combustible dust hazard.
classified (HNOC) The physical properties of this material indicate that in large quantities accumulated dust may be
hazardous.
Supplemental information Pharmacologically active material.
3. Composition/information on ingredients
Substance
Chemical name Common name and synonyms CAS number %
Gadobutrol 198637-52-4 100
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 1 / 6
4. First-aid measures
Inhalation Move to fresh air. Call a physician if symptoms develop or persist.
Skin contact Rinse skin with water/shower. Get medical attention if irritation develops and persists.
Eye contact Rinse with water. Get medical attention if irritation develops and persists.
Ingestion Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately.
Most important Pharmacologically active material. Occupational exposure may cause physiological effects.
symptoms/effects, acute and
delayed
Indication of immediate Treat symptomatically.
medical attention and special
treatment needed
General information Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from
an occupational health physician or other licensed health-care provider familiar with workplace
chemical exposures. In the United States, the national poison control center phone number is
1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give
oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must
receive immediate medical attention.
5. Fire-fighting measures
Suitable extinguishing media Water. Foam. Dry chemical or CO2. Use fire-extinguishing media appropriate for surrounding
materials.
Unsuitable extinguishing None known.
media
Specific hazards arising from Explosion hazard: Avoid generating dust; fine dust dispersed in air in sufficient concentrations and
the chemical in the presence of an ignition source is a potential dust explosion hazard.
Special protective equipment Wear suitable protective equipment.
and precautions for firefighters
Fire fighting Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area.
equipment/instructions Firefighters should use self-contained breathing equipment and protective clothing.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
6. Accidental release measures
Personal precautions, Keep unnecessary personnel away. Dust deposits should not be allowed to accumulate on
protective equipment and surfaces, as these may form an explosive mixture if they are released into the atmosphere in
emergency procedures sufficient concentration. Wear appropriate personal protective equipment. Avoid inhalation of dust
from the spilled material. Ensure adequate ventilation. Do not touch damaged containers or spilled
material unless wearing appropriate protective clothing. For personal protection, see section 8 of
the SDS.
Methods and materials for Avoid the generation of dusts during clean-up. Sweep up or vacuum up spillage and collect in
containment and cleaning up suitable container for disposal. Clean surface thoroughly to remove residual contamination. For
waste disposal, see section 13 of the SDS.
Environmental precautions Avoid discharge into drains, water courses or onto the ground.
7. Handling and storage
Precautions for safe handling As a general rule, when handling USP materials, avoid all contact and inhalation of dust, mists,
and/or vapors associated with the material. Clean equipment and work surfaces with suitable
detergent or solvent after use. After removing gloves, wash hands and other exposed skin
thoroughly. Avoid significant deposits of material, especially on horizontal surfaces, which may
become airborne and form combustible dust clouds and may contribute to secondary explosions.
Combustible dust clouds may be created where operations produce fine material (dust). Select
and use containment devices and personal protective equipment based on a risk assessment of
material potency and exposure potential.
Conditions for safe storage, Store in tight container. This material should be handled and stored per label instructions to ensure
including any incompatibilities product integrity.
8. Exposure controls/personal protection
Occupational exposure limits No exposure limits noted for ingredient(s).
Biological limit values No biological exposure limits noted for the ingredient(s).
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 2 / 6
Appropriate engineering For laboratory operations, use local exhaust ventilation or a ventilated enclosure for high energy
controls operations such as particle sizing. Control exposures to below the occupational exposure level (if
available). Select and use containment devices and personal protective equipment based on a risk
assessment of exposure potential. Cover all containers for solutions and slurries while being
transferred.
Individual protection measures, such as personal protective equipment
Eye/face protection Wear safety glasses with side shields, chemical splash goggles, or full face shield, if necessary.
Base the choice of protection on the job activity and potential for contact with eyes or face. An
emergency eye wash station should be available.
Skin protection
Hand protection Wear nitrile or other impervious gloves if skin contact is possible. When the material is dissolved
or suspended in an organic solvent, wear gloves that provide protection against the solvent.
Other Train employees in proper gowning and degowning practices. Wear lab coat. Base the choice of
skin protection on the job activity, potential for skin contact and solvents and reagents in use. Do
not wear protective garments in common areas (e.g., cafeterias) or out-of-doors.
Respiratory protection Respirators are generally not required for laboratory operations. Use a tight-fitting full-face
respirator with HEPA filters for spill cleanup. Choose respiratory protection appropriate to the task
and the level of existing engineering controls.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
General hygiene Handling practices in this SDS are recommendations for laboratory use of USP materials.
considerations
9. Physical and chemical properties
Appearance Appearance descriptions are general information and not specific to any USP lot.
Physical state Solid.
Form Crystalline powder.
Color White.
Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point > 572 °F (> 300 °C)
Initial boiling point and boiling Not available.
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 3 / 6
Other information
Dust explosion properties
Minimum ignition 30 - 100 mJ
energy (MIE) - dust
cloud
Molecular formula C18H31GdN4O9 · H20
Molecular weight 622.73 g/mol
10. Stability and reactivity
Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid Contact with incompatible materials.
Incompatible materials None known.
Hazardous decomposition NOx. Gadolinium. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.
products
11. Toxicological information
Information on likely routes of exposure
Inhalation Knowledge about health hazard is incomplete.
Skin contact Knowledge about health hazard is incomplete.
Eye contact Knowledge about health hazard is incomplete.
Ingestion Knowledge about health hazard is incomplete.
Symptoms related to the Gastrointestinal disturbances. Dizziness. Headache.
physical, chemical and
toxicological characteristics
Information on toxicological effects
Acute toxicity
Product Species Test Results
Gadobutrol (CAS 198637-52-4)
Oral
LD50 Rat > 12000 mg/kg
Skin corrosion/irritation Knowledge about health hazard is incomplete.
Serious eye damage/eye Knowledge about health hazard is incomplete.
irritation
Respiratory or skin sensitization
Respiratory sensitization Knowledge about health hazard is incomplete.
Skin sensitization Knowledge about health hazard is incomplete.
Germ cell mutagenicity Knowledge about mutagenicity is incomplete.
Carcinogenicity Knowledge about carcinogenicity is incomplete.
IARC Monographs. Overall Evaluation of Carcinogenicity
Not listed.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
US. National Toxicology Program (NTP) Report on Carcinogens
Not listed.
Reproductive toxicity Knowledge about health hazard is incomplete.
Specific target organ toxicity - Knowledge about health hazard is incomplete.
single exposure
Specific target organ toxicity - Knowledge about health hazard is incomplete.
repeated exposure
Aspiration hazard Based on available data, the classification criteria are not met.
Further information Pharmacologically active material. Occupational exposure may cause physiological effects.
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 4 / 6
12. Ecological information
Ecotoxicity The product is not classified as environmentally hazardous. However, this does not exclude the
possibility that large or frequent spills can have a harmful or damaging effect on the environment.
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential No data available.
Mobility in soil No data available.
Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.
13. Disposal considerations
Disposal instructions Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the
user of the product to determine, at the time of disposal, whether the product meets RCRA criteria
for hazardous waste.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused Empty containers or liners may retain some product residues. This material and its container must
products be disposed of in a safe manner (see: Disposal instructions).
Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied.
14. Transport information
DOT
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
Transport in bulk according to Not applicable.
Annex II of MARPOL 73/78 and
the IBC Code
General information It is the shipper's responsibility to determine the correct transport classification at the time of
shipment.
15. Regulatory information
US federal regulations This product is not known to be a "Hazardous Chemical" as defined by the OSHA Hazard
Communication Standard, 29 CFR 1910.1200.
Toxic Substances Control Act (TSCA)
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous No
chemical
SARA 313 (TRI reporting)
Not regulated.
Other federal regulations
Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 5 / 6
Safe Drinking Water Act Not regulated.
(SDWA)
US state regulations
California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material
is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. For
more information go to www.P65Warnings.ca.gov.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) No
Canada Domestic Substances List (DSL) No
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical No
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory No
Philippines Philippine Inventory of Chemicals and Chemical Substances No
(PICCS)
Taiwan Taiwan Chemical Substance Inventory (TCSI) No
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).
16. Other information, including date of preparation or last revision
Issue date 01-08-2020
Revision date 04-27-2023
Version # 05
Further information Refer to NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the
Manufacturing, Processing, and Handling of Combustible Particulate Solids, for safe handling.
Disclaimer USP materials are sold for analytical laboratory use only, and NOT for human consumption. The
information contained herein is applicable solely to the chemical substance when used for
analytical laboratory use and does not necessarily relate to any other use of the substance
described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP
materials are intended for use by persons having technical skill and at their own discretion and
risk. This information has been developed by USP staff from sources considered reliable but has
not been independently verified by the USP. Therefore, the USP Convention cannot guarantee the
accuracy of the information in these sources nor should the statements contained herein be
considered an official expression. NO REPRESENTATION OR WARRANTY, EXPRESS OR
IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE is made with respect to the information contained herein.
Material name: Gadobutrol USP SDS US
1287449 Version #: 05 Revision date: 04-27-2023 Issue date: 01-08-2020 6 / 6