Superiority:

SAFETY DATA SHEETS

According to the UN GHS revision 10

Version: 1.0

Creation Date: July 15, 2019

Revision Date: July 15, 2019

SECTION 1: Identification

1.1GHS Product identifier

Product name	N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide)

1.2Other means of identification

Product number	-
Other names	VELCADE;Radiciol;MG-341 PS-341

1.3Recommended use of the chemical and restrictions on use

Identified uses	Industrial and scientific research use.
Uses advised against	no data available

 

SECTION 2: Hazard identification

 

2.1Classification of the substance or mixture

Acute toxicity - Category 1, Oral

Skin irritation, Category 2

Eye irritation, Category 2

Reproductive toxicity, Category 2

Specific target organ toxicity – repeated exposure, Category 1

Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 2

2.2GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H300 Fatal if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H361 Suspected of damaging fertility or the unborn child H372 Causes damage to organs through prolonged or repeated exposure H411 Toxic to aquatic life with long lasting effects
Precautionary statement(s)
Prevention	P264 Wash ... thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/... P203 Obtain, read and follow all safety instructions before use. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P273 Avoid release to the environment.
Response	P301+P316 IF SWALLOWED: Get emergency medical help immediately. P321 Specific treatment (see ... on this label). P330 Rinse mouth. P302+P352 IF ON SKIN: Wash with plenty of water/... P332+P317 If skin irritation occurs: Get medical help. P362+P364 Take off contaminated clothing and wash it before reuse. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P318 IF exposed or concerned, get medical advice. P319 Get medical help if you feel unwell. P391 Collect spillage.
Storage	P405 Store locked up.
Disposal	P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.

2.3Other hazards which do not result in classification

no data available

SECTION 3: Composition/information on ingredients

3.1Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide)	N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide)	179324-69-7	605-854-3	100%

SECTION 4: First-aid measures

4.1Description of necessary first-aid measures

If inhaled

Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.

Following skin contact

Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.

Following eye contact

Rinse with pure water for at least 15 minutes. Consult a doctor.

Following ingestion

Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.

4.2Most important symptoms/effects, acute and delayed

no data available

4.3Indication of immediate medical attention and special treatment needed, if necessary

no data available

SECTION 5: Fire-fighting measures

5.1Suitable extinguishing media

Use dry chemical, carbon dioxide or alcohol-resistant foam.

5.2Specific hazards arising from the chemical

no data available

5.3Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

SECTION 6: Accidental release measures

6.1Personal precautions, protective equipment and emergency procedures

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

6.2Environmental precautions

Prevent further spillage or leakage if it is safe to do so. Do not let the chemical enter drains. Discharge into the environment must be avoided.

6.3Methods and materials for containment and cleaning up

Collect and arrange disposal. Keep the chemical in suitable and closed containers for disposal. Remove all sources of ignition. Use spark-proof tools and explosion-proof equipment. Adhered or collected material should be promptly disposed of, in accordance with appropriate laws and regulations.

SECTION 7: Handling and storage

7.1Precautions for safe handling

Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

7.2Conditions for safe storage, including any incompatibilities

Store the container tightly closed in a dry, cool and well-ventilated place. Store apart from foodstuff containers or incompatible materials.

SECTION 8: Exposure controls/personal protection

8.1Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2Appropriate engineering controls

Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

8.3Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).

Skin protection

Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

Respiratory protection

If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.

Thermal hazards

no data available

SECTION 9: Physical and chemical properties and safety characteristics

Physical state	yellow solid
Colour	no data available
Odour	no data available
Melting point/freezing point	122-124°C
Boiling point or initial boiling point and boiling range	no data available
Flammability	no data available
Lower and upper explosion limit/flammability limit	no data available
Flash point	no data available
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	no data available
Partition coefficient n-octanol/water	no data available
Vapour pressure	no data available
Density and/or relative density	1.214
Relative vapour density	no data available
Particle characteristics	no data available

SECTION 10: Stability and reactivity

10.1Reactivity

no data available

10.2Chemical stability

no data available

10.3Possibility of hazardous reactions

no data available

10.4Conditions to avoid

no data available

10.5Incompatible materials

no data available

10.6Hazardous decomposition products

no data available

SECTION 11: Toxicological information

Acute toxicity

• Oral: no data available
• Inhalation: no data available
• Dermal: no data available

Skin corrosion/irritation

no data available

Serious eye damage/irritation

no data available

Respiratory or skin sensitization

no data available

Germ cell mutagenicity

no data available

Carcinogenicity

no data available

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

SECTION 12: Ecological information

12.1Toxicity

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2Persistence and degradability

no data available

12.3Bioaccumulative potential

no data available

12.4Mobility in soil

no data available

12.5Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1Disposal methods

Product

The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.

Contaminated packaging

Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.

SECTION 14: Transport information

14.1UN Number

ADR/RID: UN3261 (For reference only, please check.)

IMDG: UN3261 (For reference only, please check.)

IATA: UN3261 (For reference only, please check.)

14.2UN Proper Shipping Name

ADR/RID: CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (For reference only, please check.)

IMDG: CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (For reference only, please check.)

IATA: CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (For reference only, please check.)

14.3Transport hazard class(es)

ADR/RID: 8 (For reference only, please check.)

IMDG: 8 (For reference only, please check.)

IATA: 8 (For reference only, please check.)

14.4Packing group, if applicable

ADR/RID: I (For reference only, please check.)

IMDG: I (For reference only, please check.)

IATA: I (For reference only, please check.)

14.5Environmental hazards

ADR/RID: Yes

IMDG: Yes

IATA: Yes

14.6Special precautions for user

no data available

14.7Transport in bulk according to IMO instruments

no data available

SECTION 15: Regulatory information

15.1Safety, health and environmental regulations specific for the product in question

Chemical name	Common names and synonyms	CAS number	EC number
N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide)	N,N',N''-((2S,2'S,2''S)-(((1R,1'R,1''R)-(1,3,5,2,4,6-trioxatriborinane-2,4,6-triyl)tris(3-methylbutane-1,1-diyl))tris(azanediyl))tris(1-oxo-3-phenylpropane-2,1-diyl))tris(pyrazine-2-carboxamide)	179324-69-7	605-854-3
European Inventory of Existing Commercial Chemical Substances (EINECS)			Not Listed.
EC Inventory			Not Listed.
United States Toxic Substances Control Act (TSCA) Inventory			Not Listed.
China Catalog of Hazardous chemicals 2015			Not Listed.
New Zealand Inventory of Chemicals (NZIoC)			Not Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS)			Not Listed.
Vietnam National Chemical Inventory			Not Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Not Listed.
Korea Existing Chemicals List (KECL)			Not Listed.

SECTION 16: Other information

Information on revision

Creation Date	July 15, 2019
Revision Date	July 15, 2019

Abbreviations and acronyms

• CAS: Chemical Abstracts Service
• ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
• RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
• IMDG: International Maritime Dangerous Goods
• IATA: International Air Transportation Association
• TWA: Time Weighted Average
• STEL: Short term exposure limit
• LC50: Lethal Concentration 50%
• LD50: Lethal Dose 50%
• EC50: Effective Concentration 50%

 

The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid.

 

The molecular weight is 384.24. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5.

 

 

	179324-69-7
	White to off-white powder
	C19H25BN4O4
	384.24
	99%
	50-100 kg/year

 

 

Sold under the brand name Velcade among others, Bortezomib is an anti-cancer medication used for treating multiple myeloma and mantle cell lymphoma. This includes multiple myeloma in those who have and have not previously received treatment.

 

 

 

As a generic medication on the World Health Organization's List of Essential Medicines, Bortezomib was approved for medical use in the United States in 2003 and in the European Union in 2004.

 

 

Bortezomib for Injection is indicated for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

 

 

lymphoma who have received at least 1 prior therapy.

 

 

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling cascades within the cell. This disruption of normal homeostatic mechanisms can lead to cell death. Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types in vitro. Bortezomib causes a delay in tumor growth in vivo in nonclinical tumor models, including multiple myeloma.

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