General Information
Revision date
2015-03-19
Product name
Hexalen
Product Synonyms
Altretamine
Chemical name
Mixture - contains a triazine derivative
CAS No.
645-05-6
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ of the substance or mixture packaged in final form for patient use; indicated in the palliative treatment mixture and uses of persistent or recurrent ovarian cancer
Icons in SDS
Company Information
company name
Eisai, Inc. (HQ)
e-mail address of the competent person responsible for the Safety Data Sheet
eisai_ehs@eisai.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H302, H341, H360FD, H373
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk drug product. SECTION 2 - HAZARDS IDENTIFICATION …continued Regulation (EC) 1272/ Acute Toxicity (Oral) Category 4. Germ Cell Mutagenicity - Category 2. 2008 [GHS] Reproductive Toxicity - Category 1B. Specific Target Organ Toxicity (repeated exposure) - Category 2. Directive 67/548/EEC T: R22; R48/22; R60 (Repr. Cat. 2); R61 (Repr. Cat. 2); R68 or 1999/45/EC
Signal word
Danger Caution SECTION 2 - HAZARDS IDENTIFICATION …continued US Hazard overview Contains altretamine. Harmful if swallowed. May cause damage to hematopoietic and gastrointestinal systems, liver, and kidneys. Possible reproductive and developmental hazard - may cause adverse reproductive and developmental effects (based on animal data and mechanism of action). Note This mixture is classified as dangerous/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.
CLP CLASSIFICATION
H302 - Harmful if swallowed. H341 - Suspected of causing genetic defects.
Hazard statements
H360FD - May damage fertility. May damage the unborn child. H373 - May cause damage to hematopoietic and gastrointestinal systems, liver, and kidneys. CLP/GHS P201 - Obtain special instructions before use. P202 - Do not handle until all safety
Precautionary statements
precautions have been read and understood. P260 - Do not breathe dust. P264 Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P281 - Use personal protective equipment as required. P301+P312 IF SWALLOWED Call a Poison Center or doctor/physician if you feel unwell. P308 + P313 - If exposed or concerned: get medical advice/attention. P330 - Rinse mouth. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. EU symbol/indication of danger T- Toxic. Risk (R) Phrase(s) R22 - Harmful if swallowed. R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed. R60 - May impair fertility. R61 - May cause harm to the unborn child. R68 - Possible risk of irreversible effects.
2.3 Other hazards
Hexalen capsules contain altretamine, an active pharmaceutical ingredient used as an anticancer agent. Its exact mechanism of action is unknown, but evidence suggests that it may be a DNA alkylating agent. Moderate bone marrow depression has been reported. Common adverse events include nausea and vomiting. Prolonged or high-dose use may be associated with neurotoxicity.
