Gadoterate meglumine - USP reference standard SDS

SAFETY DATA SHEET

1. Identification

Product identifier Gadoterate Meglumine Other means of identification Catalog number 1287620 CAS number 92943-93-6 別名 Gadoteric acid * Gd-DOTA 化学物質名 1-Deoxy-1-(methylamino)-D-glucitol hydrogen [1,4,7,10-tetraazacyclododecane-1,4,7, 10-tetraacetato(4-)-κN1,κN4,κN7,κN10,κO1,κO4,κO7,κO10]gadolinate(1-) おすすめ use For analytical laboratory use only. おすすめ restrictions Not for use as a drug. Not for administration to humans or animals. メーカー/Importer/供給元/Distributor information メーカー Company name U. S. Pharmacopeia 住所 12601 Twinbrook Parkway Rockville MD 20852-1790 米国 Telephone Technical Services 301-816-8129 ウェブサイト 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 情報なし. Precautionary statement Prevention 情報なし. Response 情報なし. Storage 情報なし. Disposal 情報なし. Hazard(s) not otherwise None known. classified (HNOC) Supplemental information Pharmacologically active material.

3. 組成/information on ingredients

Substance 化学物質名 Common name and synonyms CAS number % Gadoterate Meglumine Gadoteric acid 92943-93-6 100 Gd-DOTA

Material name: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 1 / 6

Information provided in the SDS is not specific to the lot provided. Refer to the label and USP Certificate/Product Information Sheet for the assigned value of a particular lot.

4. First-aid measures

Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Wash off with soap and water. Get medical attention if irritation develops and persists. Eye contact Rinse with water. Get medical attention if irritation develops and persists. Ingestion Rinse mouth. Get medical attention if symptoms occur. Most important Pharmacologically active material. Occupational exposure may cause physiological effects. symptoms/effects, acute and delayed Indication of immediate Provide general supportive measures and 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 米国, 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 No unusual fire or explosion hazards noted. the chemical 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. General fire hazards No unusual fire or explosion hazards noted.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Wear appropriate personal protective equipment. Avoid protective equipment and inhalation of dust from the spilled material. Do not touch damaged containers or spilled material emergency procedures unless wearing appropriate protective clothing. Ensure adequate ventilation. 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. 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: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 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 Pharmacological effects may be seen with occupational exposure.

9. Physical and chemical properties

Appearance Appearance descriptions are general information and not specific to any USP lot. Physical state Solid. Form Powder. Color White. Odor 情報なし. Odor threshold 情報なし. pH 情報なし. Melting point/freezing point 情報なし. Initial boiling point and boiling 情報なし. range Flash point 情報なし. Evaporation rate 情報なし. Flammability (solid, gas) 情報なし. Upper/lower flammability or explosive limits Flammability limit - lower 情報なし. (%) Flammability limit - upper 情報なし. (%) Explosive limit - lower (%) 情報なし. Explosive limit - upper (%) 情報なし. Vapor pressure 情報なし. Vapor density 情報なし. Relative density 情報なし. Solubility(ies) Solubility (water) 情報なし. Auto-ignition temperature 情報なし. Decomposition temperature 情報なし. Viscosity 情報なし. Other information Density 1.18 g/cm3 分子式 C16H25GdN4O8 · C7H17NO5 分子量 753.86

Material name: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 3 / 6

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 Avoid temperatures exceeding the decomposition temperature. Contact with incompatible materials. Incompatible materials Strong oxidizing agents. Hazardous decomposition Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. NOx. Gadolinium. 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. Headache. Dizziness. physical, chemical and toxicological characteristics

Information on toxicological effects Acute toxicity Not known. 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. Mutagenicity Ames test Result: Negative. Chromosome aberration Result: Negative. Micronucleus assay Result: Negative. Species: Mouse Mutagenicity: In vivo gene mutation assay Result: Negative. 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. Reproductivity 0 - 10 mmol/L Reproductivity, No effects on embryo/fetal development. Maternal toxicity observed at highest dose. Species: Rat 0 - 7 mmol/L Reproductivity, No effects on embryo/fetal development. Maternal toxicity observed at highest dose. Species: Rabbit Specific target organ toxicity - Knowledge about health hazard is incomplete. single exposure

Material name: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 4 / 6

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.

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 substance. 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 Dispose of in accordance with local regulations. Empty containers or liners may retain some products product residues. This material and its container must 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. Empty containers should be taken to an approved waste handling site for recycling or disposal.

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.

Material name: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 5 / 6

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. 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 国・地域(s) or region Inventory name On inventory (yes/no)* オーストラリア オーストラリアn Inventory of Chemical Substances (AICS) No Canada Domestic Substances List (DSL) No Canada Non-Domestic Substances List (NDSL) No 中国 Inventory of Existing Chemical Substances in 中国 (IECSC) No Europe European Inventory of Existing Commercial Chemical No Substances (EINECS) Europe European List of Notified Chemical Substances (ELINCS) No 日本 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) Yes 米国 & 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 02-28-2023 改訂日 02-28-2023 Version # 02 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: Gadoterate Meglumine USP SDS US 1287620 Version #: 02 改訂日: 02-28-2023 Issue date: 02-28-2023 6 / 6