Gadobutrol Monohydrate SDS

Version 1.1 Revision Date: 18.11.2025

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006, as amended

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier

Trade name : Gadobutrol Monohydrate Product code : G0503 CAS RN : 198637-52-4

1.2 Relevant identified uses of the substance or mixture and uses advised against Use of the Substance/Mixture : Use as laboratory reagent

1.3 Details of the supplier of the safety data sheet Company : TCI EUROPE N.V. Address : Boereveldseweg 6 - Haven 1063, B-2070 Zwijndrecht, Belgium Telephone : +32 (0)3 735 07 00 Telefax : +32 (0)3 735 07 01 E-mail address of person respon- : sales-eu@tcichemicals.com sible for the SDS

1.4 Emergency telephone number Emergency telephone number : +44 844 892 0111

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Not a hazardous substance or mixture.

2.2 Label elements

Labelling (REGULATION (EC) No 1272/2008) No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required.

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. Ecological information: The substance/mixture does not contain components considered to have endocrine disrupt- ing properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commis- sion Regulation (EU) 2018/605 at levels of 0.1% or higher. Toxicological information: The substance/mixture does not contain components considered to have endocrine dis- rupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Com- mission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients

3.1 Substances Substance name : Gadobutrol Monohydrate CAS RN : 198637-52-4

Components Remarks : No hazardous ingredients

SECTION 4: First aid measures

4.1 Description of first aid measures

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G0503: Gadobutrol Monohydrate Version 1.1 Revision Date: 18.11.2025

If inhaled : Remove person to fresh air and keep comfortable for breathing. Get medical advice/ attention if you feel unwell.

In case of skin contact : Take off all contaminated clothing immediately. If on skin, rinse well with water. If skin irritation or rash occurs: Get medical advice/ attention.

In case of eye contact : Rinse with plenty of water. If easy to do, remove contact lens, if worn. If eye irritation persists: Get medical advice/ attention.

If swallowed : Get medical advice/ attention. Rinse mouth.

4.2 Most important symptoms and effects, both acute and delayed None known.

4.3 Indication of any immediate medical attention and special treatment needed None known.

SECTION 5: Firefighting measures

5.1 Extinguishing media Suitable extinguishing media : Dry powder, Foam, Water spray, Carbon dioxide (CO2)

5.2 Special hazards arising from the substance or mixture Specific hazards during fire- : No information available. fighting

5.3 Advice for firefighters Special protective equipment for : Use personal protective equipment. firefighters Specific extinguishing methods : Use extinguishing measures that are appropriate to local circum- stances and the surrounding environment. Immediately evacuate personnel to safe areas. Remove undamaged containers from fire area if it is safe to do so.

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures Personal precautions : Wear suitable protective equipment. Keep people away from and upwind of spill/leak. Entry to non-involved personnel should be con- trolled around the leakage area by roping off, etc.

6.2 Environmental precautions Environmental precautions : Prevent product from entering drains.

6.3 Methods and material for containment and cleaning up Methods for cleaning up : Pick up and arrange disposal without creating dust.

6.4 Reference to other sections See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage

7.1 Precautions for safe handling Technical measures : Prevent dispersion of dust.

Local/Total ventilation : Ensure adequate ventilation. Use a local exhaust ventilation.

Advice on safe handling : Avoid contact with skin, eyes and clothing. Wear personal protective equipment. Wash hands and face thoroughly after handling.

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7.2 Conditions for safe storage, including any incompatibilities Requirements for storage areas : Keep container tightly closed. Store in a refrigerator. Protect from and containers moisture. Keep under inert gas.

Storage class (TRGS 510) : 11

7.3 Specific end use(s) Specific use(s) : No information available.

SECTION 8: Exposure controls/personal protection

8.1 Control parameters Contains no substances with occupational exposure limit values.

8.2 Exposure controls

Engineering measures Install a closed system or local exhaust. Also install safety shower and eye bath.

Personal protective equipment Eye/face protection : Safety glasses, Face-shield Hand protection : Protective gloves Skin and body protection : Protective suit

Respiratory protection : Dust mask

*Use personal protective equipment(PPE) approved under appropriate government standards and follow local and national regulations.

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties Physical state : Solid form Colour : white Odour : No data available Odour Threshold : No data available

Melting point/freezing point : No data available Boiling point/boiling range : No data available Flammability : No data available Upper explosion limit/Upper : No data available flammability limit Lower explosion limit/Lower : No data available flammability limit Flash point : No data available Auto-ignition point : No data available Decomposition temperature : No data available pH : No data available Viscosity Viscosity, dynamic : No data available Viscosity, kinematic : No data available Solubility(ies) Water solubility : very soluble Solubility in other solvents : Solvent: Ethanol insoluble

Partition coefficient: n- : -5,4 octanol/water (log value) Vapour pressure : No data available Relative density : No data available Relative vapour density : No data available Particle characteristics : No data available

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9.2 Other information

Molecular weight : 622,74 g/mol

SECTION 10: Stability and reactivity

10.1 Reactivity No data available

10.2 Chemical stability Stable under normal conditions.

10.3 Possibility of hazardous reactions Hazardous reactions : None under normal processing.

10.4 Conditions to avoid Conditions to avoid : Heat, Exposure to moisture

10.5 Incompatible materials Materials to avoid : Oxidizing agents,

10.6 Hazardous decomposition products

Carbon monoxide, Carbon dioxide (CO2), Nitrogen oxides (NOx)

SECTION 11: Toxicological information

11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008 Acute toxicity : No information available. Skin corrosion/irritation : No information available. Serious eye damage/eye irrita- : No information available. tion Respiratory or skin sensitisa- : No information available. tion Germ cell mutagenicity : No information available. Carcinogenicity : No information available. Reproductive toxicity : No information available. STOT - single exposure : No information available. STOT - repeated exposure : No information available. Repeated dose toxicity : No information available. Aspiration hazard : No information available.

11.2 Information on other hazards

Endocrine disrupting properties

Product: Assessment : The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Com- mission Regulation (EU) 2018/605 at levels of 0.1% or higher.

SECTION 12: Ecological information

12.1 Toxicity No data available

12.2 Persistence and degradability No data available

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12.3 Bioaccumulative potential No data available

12.4 Mobility in soil No data available

12.5 Results of PBT and vPvB assessment

Product: Assessment : This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

12.6 Endocrine disrupting properties

Product: Assessment : The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Com- mission Regulation (EU) 2018/605 at levels of 0.1% or higher.

12.7 Other adverse effects

No data available

SECTION 13: Disposal considerations

13.1 Waste treatment methods Product : Disposal in accordance with local and national regulations. Entrust disposal to a licensed waste disposal company.

Contaminated packaging : Disposal in accordance with local and national regulations. Before disposal of used container, remove contents completely.

SECTION 14: Transport information

14.1 UN number or ID number

ADR : Not regulated as a dangerous good

IMDG : Not regulated as a dangerous good

IATA : Not regulated as a dangerous good

14.2 UN proper shipping name

ADR : Not regulated as a dangerous good

IMDG : Not regulated as a dangerous good

IATA : Not regulated as a dangerous good

14.3 Transport hazard class(es)

ADR : Not regulated as a dangerous good

IMDG : Not regulated as a dangerous good

IATA : Not regulated as a dangerous good

14.4 Packing group

ADR : Not regulated as a dangerous good

IMDG : Not regulated as a dangerous good

IATA (Cargo) : Not regulated as a dangerous good

IATA (Passenger) : Not regulated as a dangerous good

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14.5 Environmental hazards Not regulated as a dangerous good

14.6 Special precautions for user Remarks : Not classified as dangerous in the meaning of transport regulations.

14.7 Maritime transport in bulk according to IMO instruments Not applicable for product as supplied.

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture REACH - Restrictions on the manufacture, placing on the mar- : Not applicable ket and use of certain dangerous substances, mixtures and articles (Annex XVII)

REACH - Candidate List of Substances of Very High Concern : Not applicable for Authorisation (Article 59).

Regulation (EC) on substances that deplete the ozone layer : Not applicable

Regulation (EC) No 850/2004 on persistent organic pollutants : Not applicable

Regulation (EU) No 649/2012 of the European Parliament and : Not applicable the Council concerning the export and import of dangerous chemicals

REACH - List of substances subject to authorisation (Annex : Not applicable XIV)

Water hazard class (Germany) : WGK 3 highly hazardous to water Classification according to AwSV, Annex 1 (5.2)

The components of this product are reported in the following inventories: CH BAGREG : Not in compliance with the inventory

TSCA : Substance(s) not listed on TSCA inventory

AICS : Not in compliance with the inventory

DSL : This product contains the following components that are not on the Canadian DSL nor NDSL.

Gadobutrol Monohydrate

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

NZIoC : Not in compliance with the inventory

15.2 Chemical safety assessment A Chemical Safety Assessment is not required for this substance.

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SECTION 16: Other information

Full text of other abbreviations

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by Road; AIIC - Australian Inventory of In- dustrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Tox- icant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA - European Chemicals Agency; EC-Number - European Community number; ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships carry- ing Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Danger- ous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - Inter- national Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - In- ternational Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observa- ble Effect Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co- operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioac- cumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regu- lations concerning the International Carriage of Dangerous Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; SVHC - Substance of Very High Concern; TCSI - Taiwan Chemical Sub- stance Inventory; TECI - Thailand Existing Chemicals Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA - Toxic Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very Bioac- cumulative

Further information

This SDS was prepared sincerely based on the information obtained, however, any warranty shall not be given re- garding the data contained and the assessment of hazards and toxicity. Prior to use, please investigate not only the hazards and toxicity information but also the laws and regulations of the organization, area and country where the products are to be used, which shall be given the first priority. The products are supposed to be used promptly after purchase in consideration of safety. Some new information or amendments may be added afterwards. If the products are to be used far behind the expected time of use or you have any questions, please feel free to contact us. The stated cautions are for normal handling only. In case of special handling operations, sufficient care should be taken, in addition to the safety measures suitable for the given situation. All chemical products should be treated with the recognition of "having unknown hazards and toxicity", which differ greatly depending on the conditions and handling when in use and/or the conditions and duration of storage. The products must be handled only by those who are familiar with specialized knowledge and have experience or under the guidance of those specialists throughout use from opening to storage and disposal. Safe usage conditions shall be set up on each user's own responsibility.

DE / 6N

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