General Information
Revision date
2010-08-08
Product name
Belinostat - For Injection (IV)
Product Synonyms
N-hydroxy-3-(phenylsulphamoylphenyl) acrylamide, PXD101
Chemical name
Mixture that contains an HDAC inhibitor of the hydroxamate class
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical product / Formulated pharmaceutical product packaged in final form for patient use. Formulation is being investigated for the
Emergency telephone
157 Technology Drive
Icons in SDS
Company Information
company name
Spectrum Pharmaceuticals, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
msds@spectrumpharm.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H341, H373
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
1272/2008 Appearance Yellow cake in clear glass vials
Signal word
Warning Hazard overview Substance not yet fully tested. Under investigation as a treatment for cancer. May cause damage to the gastrointestinal tract, blood and the lymphoid/hematopoietic system, based on animal data. May form combustible dust concentrations in air during processing. Very sensitive to electrostatic ignition. Known clinical effects Treatment with belinostat has been generally well-tolerated. The most frequent treatment emergent adverse effects have been nausea, vomiting, fatigue, and diarrhea. In clinical studies with belinostat, the most frequent serious adverse events among the first 346 patients have been infections (11), hypersensitivity (4), nausea (3) and thrombocytopenia (3). Hemorrhage has also been reported in trials with belinostat. Warning - Substance not yet fully tested.
2.1 Classification of the substance or mixture
Mutagenic - Category 2. Target organ systemic toxicity (repeat exposure) - Category 2. SECTION 2 - HAZARDS IDENTIFICATION …continued
Hazard statements
H341 - Suspected of causing genetic defects. H373 - May cause damage to gastrointestinal tract, blood and the lymphoid/hematopoietic system through prolonged or repeated exposure. precautions have been read and understood. P260 - Do not breathe mist/vapors/ spray. P281 - Use personal protective equipment as required. P308 + P313 - If exposed or concerned: get medical advice/attention. P314 - Get medical advice/ attention if you feel unwell. P405 - Store locked up. P501 - Dispose of contents/ container to location in accordance with local/regional/national/international regulations. EU indicator of danger Xn - Harmful. Substance not yet fully tested.
Precautionary statements
P201 - Obtain special instructions before use. P202 - Do not handle until all safety
EU Classification
R48/20/22, R68 Note This product/mixture is classified as hazardous according to directive 1999/45/EC, Regulation EC No 1272/2008 (EU CLP) and applicable US regulations. See Section 16 for full text of EU and GHS classifications. The GHS classifications are based on Regulation (EC) 1272/2008.
