General Information
Revision date
2018-11-30
Product name
None identified
Product Synonyms
Humanized antibody (anti-folate receptor & (FRO®)) conjugated to N2"-deacetyl- N2"-(4-mercapto-4-methyl-1-oxopropyl)-maytansine (DM4) via a disulfide linker; huM9346A anti-FOLR1 - DM4
Chemical name
Mixture - contains humanized antibody linked to a maytansine/maytansinoid or benzoansamacrolide derivative
1.2.1 Relevant identified uses
= Bulk formulated pharmaceutical mixture for research and development purposes of the substance or only; under investigation to treat cancer mixture and uses
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
ImmunoGen, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
info@immunogen.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H341, H351, H361fd
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
(EC) No 1272/2008 Classification of the substance or mixture Globally Harmonized System [GHS] Germ Cell Mutagenicity - Category 2. Carcinogenic - Category 2. Reproductive Toxicity - Category 2 Other/Supplemental Mixture not yet fully tested ImmunoGen - IMGN853 (DM4 Antibody-Drug Conjugate (ADC)) (Solution, in vials) Revision date: 30 November 2018, Version: 1.2.0 Page 1 of 11 HAZARDS IDENTIFICATION .. continued
Signal word
Warning
Hazard statements
H341 - Suspected of causing genetic defects. H351 - Suspected of causing cancer. H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child. precautions have been read and understood. P281 - Use personal protective equipment as required. P308 + P313 - IF exposed or concerned: get medical advice/ attention. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.
Precautionary statements
P201 - Obtain special instructions before use. P202 - Do not handle until all safety
2.3 Other hazards
IMGN8353 is an antibody-drug conjugate (ADC) consisting of a humanized antibody (M9346A) linked via a degradable disulfide linker (sulfo-SPDB) to DM4, a highly potent derivative of maytansine (i.e., a maytansinoid). Maytansinoids are members of a series of ansa-macrolide compounds that inhibit the assembly of microtubules during cell replication, interfering with the process and leading to programmed cell death (apoptosis). The target receptor of M9346A is FR& (,a GPI-linked protein showing limited normal tissue expression, but over-expression on the surfaces of solid tumors, particularly ovarian, endometrial, non-small cell lung, and renal cell cancers. The most common serious adverse effect noted in early clinical trials with IMGN853 was bone marrow suppression (characterized primarily by neutropenia and thrombocytopenia). Other frequent effects included fatigue, fever/chills, gastrointestinal (GI) disturbances, muscle weakness, hyperglycemia, and increased liver enzymes. Injection site reactions and peripheral sensory neuropathy were also noted. Although it is expected to have reduced toxicity in comparison to its DM4 payload, the extent of payload release if IMGN853 is accidentally inhaled or ingested is not known. Note This mixture is classified as hazardous under GHS as implemented by Regulation
2.1 Classification of the substance or mixture
substance or mixture Globally Harmonized Germ Cell Mutagenicity - Category 2. Carcinogenic - Category 2. Reproductive System [GHS] Toxicity - Category 2. Other/Supplemental Mixture not yet fully tested ImmunoGen - IMGN853 (DM4 Antibody-Drug Conjugate (ADC)) (Solution, in vials) Revision date: 30 November 2018, Version: 1.2.0 Page 1 of 11 SECTION 2 - HAZARDS IDENTIFICATION .. continued
