© 2026 Sinochem Nanjing Corporation,
All Right Reserved
Product Name: Methotrexate
Chemical Name: 4-Amino-10-methylfolic acid
Synonyms: Amethopterin, Mexate, Trexall
CAS Number: 59-05-2
Recommended Use: Antineoplastic, antimetabolite, treatment of certain cancers and autoimmune disorders
Manufacturer: Multiple generic manufacturers, see packaging
Emergency Phone Number: Refer to local Poison Control Center
Address: Refer to package insert
GHS Classification: Acute Toxicity (Oral, Dermal, Inhalation): Category 3, Serious Eye Damage/Irritation: Category 2A, Germ Cell Mutagenicity: Category 2, Carcinogenicity: Category 2, Reproductive Toxicity: Category 1A
Pictograms: Skull and Crossbones, Exclamation Mark, Health Hazard
Signal Word: Danger
Hazard Statements: Toxic if swallowed, inhaled or absorbed through skin; causes serious eye irritation; may cause genetic defects; may cause cancer; may damage fertility or unborn child
Precautionary Statements: Avoid all contact, do not breathe dust, wear appropriate protective clothing, use only in well-ventilated areas
Routes of Exposure: Ingestion, inhalation, skin contact, eye contact
Symptoms of Exposure: Nausea, vomiting, mucous membrane irritation, bone marrow suppression, liver toxicity, pulmonary symptoms, renal impairment, reproductive harm
Chemical Formula: C20H22N8O5
Methotrexate Content: ≥ 98% (by weight in active preparations)
Impurities: Trace related compounds
Inactive Ingredients: Variable depending on formulation (may include lactose, microcrystalline cellulose, starch, sodium hydroxide, water, mannitol)
Concentration in Solution/Tablet: Typically 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg per tablet or as per injectable vial labeling
Eye Contact: Rinse with plenty of water for at least 15 minutes, keep eyelids open, seek immediate medical attention
Skin Contact: Remove contaminated clothing, wash thoroughly with soap and water, seek medical attention if irritation persists
Inhalation: Move to fresh air immediately, provide artificial respiration if not breathing, obtain medical attention
Ingestion: Rinse mouth with water, do not induce vomiting, never give anything by mouth to an unconscious person, get medical help at once
Special Notes: Medical staff should avoid exposure to themselves while administering first aid
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: None known
Specific Hazards: Decomposes under fire conditions, emits toxic fumes (carbon oxides, nitrogen oxides)
Protective Equipment: Firefighters should use full protective equipment with self-contained breathing apparatus
Firefighting Procedures: Avoid runoff from fire control methods entering drains or watercourses, ventilate area after extinguishing
Personal Precautions: Wear respirator, chemical safety goggles, protective gloves, and coveralls
Environmental Precautions: Avoid release into the environment, prevent material from entering drains, surface water, or soil
Cleanup Methods: Absorb spills with damp disposable towel/cloth, place waste in appropriate container for proper disposal, clean contaminated surfaces with soap and water
Special Procedures: Decontaminate area after cleanup, dispose of all wastes as hazardous material
Handling: Use in chemical fume hood, minimize dust, avoid all exposure, wash hands thoroughly after handling, do not eat, drink, or smoke in work area
Storage: Keep container tightly closed, store in cool, dry, well-ventilated area, protect from light, keep away from incompatible substances (strong oxidizers, acids/bases)
Special Precautions: Store separately from food or feed; limit access to trained personnel
Shelf Life: Refer to product labeling
Occupational Exposure Limit: No OSHA PEL or ACGIH TLV established; minimize exposure by engineering and administrative controls
Engineering Controls: Use local exhaust ventilation, closed systems, biological safety cabinet for preparation
Eye Protection: Chemical safety goggles or face shield
Skin Protection: Use gloves (nitrile or latex), protective gown, and sleeve covers
Respiratory Protection: NIOSH-approved respirator if ventilation is not adequate
Hygiene Measures: No eating, drinking, or smoking; wash hands before breaks, after handling, and at end of shift
Appearance: Yellow to orange crystalline powder
Odor: Odorless
Solubility: Slightly soluble in water, more soluble in dilute alkali solutions
Melting Point: 195–200°C (decomposition above 200°C)
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Not volatile under normal conditions
pH: 8.5–10.5 (1% solution)
Relative Density: Approximately 1.4 g/cm³
Partition Coefficient (Log Pow): -1.85
Flash Point: Not applicable
Autoignition Temperature: Not available
Evaporation Rate: Not volatile
Chemical Stability: Stable under recommended storage conditions
Reactivity: No dangerous reactions under normal conditions
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition: Emits carbon monoxide, nitrogen oxides, and toxic fumes upon decomposition
Conditions to Avoid: Prolonged exposure to heat, light, or moisture
Acute Toxicity: Oral LD50 (rat): 135 mg/kg, oral LD50 (mouse): 6.7 mg/kg
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Symptoms: Nausea, vomiting, diarrhea, mucositis, bone marrow suppression, nephrotoxicity, hepatotoxicity, teratogenicity
Chronic Effects: Mutagenic, carcinogenic (IARC Group 2A), reproductive toxicity
Sensitization: May cause allergic reactions
Target Organs: Bone marrow, liver, kidneys, gastrointestinal tract, reproductive organs
Other Data: Occupational exposure linked to increased risk in healthcare personnel handling cytotoxic drugs
Toxicity to Aquatic Life: Harmful, long-lasting effects in aquatic organisms; chronic aquatic toxicity documented
Persistence and Degradability: Not readily biodegradable; persists in wastewater and surface water
Bioaccumulation Potential: Low potential for bioaccumulation
Mobility in Soil: Moderately mobile; possible groundwater contamination
Other Adverse Effects: Pharmaceuticals, including methotrexate, have been detected in municipal wastewaters and may harm fish and algae
Recommended Disposal: Treat as hazardous pharmaceutical waste
Method: Incineration preferred, in approved facility using pollution control devices
Container Disposal: Triple rinse, puncture, and dispose of by licensed hazardous waste handler
Do Not: Discharge to sewers, waterways, or general waste
National/Regional Regulations: Comply with local, state, and national regulations on pharmaceutical waste disposal
UN Number: UN 2811
Proper Shipping Name: Toxic Solid, Organic, N.O.S. (Methotrexate)
Hazard Class: 6.1 (Toxic substances)
Packing Group: II
Labels: Toxic
Special Transport Measures: Avoid release, contain securely, report spills immediately
Marine Pollutant: Methotrexate can cause long-term adverse effects in aquatic environments
OSHA Status: Regulated as hazardous drug
SARA Title III: Section 313: Not listed
RCRA Status: May be considered P-listed hazardous waste (P027)
TSCA Status: Listed
California Proposition 65: Methotrexate is recognized as a chemical known to cause birth defects or other reproductive harm
Other Regulations: Follow NIOSH/OSHA guidelines for safe handling of antineoplastic drugs in occupational settings
Workplace Controls: Compliance with USP Chapter <800> for hazardous drugs recommended
