General Information
Version
2.1
Revision date
2017-04-11
Product name
Spinraza
Product Synonyms
Nusinersen, IONIS-SMNRx, Dry Oligo, Modified oligonucleotide ("Oligo")
Chemical name
2"-O-methoxyethyl modified phosphorothioate oligonucleotide
CAS No.
1258984-36-9
1.2.1 Relevant identified uses
Active pharmaceutical ingredient ("API") designed to treat Spinal Muscular of the substance or Atrophy mixture and uses
Emergency telephone
1-(800) 424-9300
Icons in SDS
Company Information
company name
Ionis Pharmaceuticals
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@ionisph.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
1999/45/EC Classification of the substance or mixture
2.2 Label elements
CLP/GHS hazard None required
Signal word
None required SECTION 2 - HAZARDS IDENTIFICATION …continued CLP/GHS hazard None required US Hazard overview Note Caution Substance not yet fully tested This substance does not meet criteria for classification according to directive 67/
Hazard statements
CLP/GHS None required
2.3 Other hazards
Oligonucleotides are molecules composed of approximately 16 to 20 covalently linked naturally-occurring nucleotides on a phosphodiester or phosphorothioate backbone. Based on their intended diagnostic or therapeutic use, engineered oligonucleotides vary in nucleotide sequence to match and bind with a specific target genetic sequence. In clinical trials, modified oligonucleotides were generally well-tolerated. Although non-specific binding of oligonucleotides to other RNA sequences may occur, the drug candidates are designed to avoid this interaction. No genotoxic, reproductive (males or females) and/or developmental effects are expected, based on epidemiological and non-clinical data. The hazardous properties of oligonucleotides have not been fully investigated and the potential health hazards associated with exposure/handling are unknown, but these compounds are generally not irritating and are not absorbed directly through skin or oral exposure routes. While chemical modification of oligonucleotides increases their stability in the body via parenteral routes, the likelihood of systemic effects following accidental ingestion or inhalation in a workplace setting is low, due to their rapid breakdown in the digestive tract and low bioavailability via inhalation.
2.1 Classification of the substance or mixture
substance or mixture Regulation (EC) Substance not yet fully tested. 1272/2008 [GHS] Directive 67/548/EEC Substance not yet fully tested
