Methotrexate

Acute toxicity - Category 3, Oral

Skin irritation, Category 2

Eye irritation, Category 2

Reproductive toxicity, Category 1B

H225 Highly Flammable liquid and vapour

H301 Toxic if swalloed

H315 Causes skin irritation

H319 Causes serious eye irritation

H340 May cause genetic defects

H360 May damage fertility or the unborn child

H370 Causes damage to organs

P201 Obtain special instructions before use.

P210 Keep away from heat/sparks/open flames/hot surfaces. — No smoking.

P260 Do not breathe dust/fume/gas/mist/vapours/spray.

P280 Wear protective gloves/protective clothing/eye protection/face protection.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continuerinsing.

P405 Store locked up.

P403+P233 Store in a well-ventilated place. Keep container tightly closed.

P264 Wash ... thoroughly after handling.

P270 Do not eat, drink or smoke when using this product.

P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...

P203 Obtain, read and follow all safety instructions before use.

P301+P316 IF SWALLOWED: Get emergency medical help immediately.

P321 Specific treatment (see ... on this label).

P330 Rinse mouth.

P302+P352 IF ON SKIN: Wash with plenty of water/...

P332+P317 If skin irritation occurs: Get medical help.

P362+P364 Take off contaminated clothing and wash it before reuse.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P318 IF exposed or concerned, get medical advice.

P405 Store locked up.

P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.

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Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.

Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.

Rinse with pure water for at least 15 minutes. Consult a doctor.

Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.

SYMPTOMS: Symptoms of exposure to this compound include renal damage, leukopenia, headache, drowsiness, blurred vision, aphasia and hemiparesis. In addition, it causes developmental abnormalities of the craniofacial area and the musculoskeletal system, carcinogenic effects, leukemia, lymphoma effects including Hodgkin's disease, thrombocytopenia, bone marrow changes, other blood changes, cerebral spinal fluid effects, eye effects, blood pressure lowering, cough, dyspnea, fibrosis (pneumoconiosis), cyanosis, gastrointestinal effects, fatty liver degeneration and other liver changes, hepatitis, impaired liver function tests, skin tumors, fever, effects on inflammation or mediation of inflammation. Other symptoms include hemorrhagic enteritis, dermatitis, interstitial pneumonitis, neurotoxicity, nephrotoxicity, defective oogenesis o spermatogenesis, teratogenesis, hepatic dysfunction, progressive weight loss, depression, swelling and cytoplasmic vacuolization of the mucosal cells of the intestinal epithelium, desquamation of epithelial cells, extrusion of plasma into the lumen of the bowel, leukocytic infiltration of the submucosa, disturbance in the maturation of erythrocytes, rapid pathological alteration in myelopoiesis, diminution in content of lymphoid cells in lymphatic tissue and interference with embryogenesis. Interference with cellular reproduction, embryotoxicity, abortion, fetal defects, fertility impairment, menstrual dysfunction, hematopoiesis suppression, acute and chronic hepatotoxicity, nonspecific pneumonitis, chemical arachnoiditis manifested by headache, back pain and nuchal rigidity, paresis manifested by paraplegia, leukoencephalopathy manifested by confusion, irritability, somnolence, ataxia, dementia and convulsions, ulcerative stomatitis, nausea, alopecia, ecchymosis, telangiectasia, acne, furunculosis, vomiting, diarrhea, gastrointestinal ulceration and bleeding, azotemia, cystitis, hematuria, vaginal discharge, arthralgia, myalgia, metabolic changes, precipitating diabetes, osteoporotic effects, abdominal distress, malaise, undue fatigue, chills, dizziness, reduce resistance to infection, erythematous rash, pruritus, urticaria, gingivitis, photosensitivity, pigmentary changes, pharyngitis, anorexia, hematemesis, melena, transient oligospermia and sudden death may also result. In children it can cause pulmonary tract damage by ingestion, and blood dyscrasia intravenously. It may also cause lung changes, uro-genital toxicity and conjunctivitis. It may also cause septicemia and bleeding from various sites, mucositis, cerebral and cerebellar calcification, bone pain, fractures, aseptic necrosis of the head of the femur and shortness of breath. Granulocytopenia, hypoplasia of all elements of bone marrow and anemia may also occur. It may cause congenital malformation in the fetus and alter genetic material. Ulceration of the mouth, megaloblastic anemia, hypogammaglobulinemia, kidney damage, pulmonary reactions, progressive intellectual impairment, coma and pyrexia may also occur. ACUTE/CHRONIC HAZARDS: This compound can cause eye irritation. It may be absorbed through the skin and may be fatal if inhaled, swallowed or absorbed through the skin. It is readily absorbed through the gastrointestinal tract. When heated to decomposition it emits toxic fumes of carbon monoxide, carbon dioxide and nitrogen oxides. (NTP, 1992)

Leucovorin is indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Leucovorin administration should begin as promptly as possible. As the time interval between methotrexate administration and leucovorin initiation increases, the effectiveness of leucovorin in counteracting toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.

Fires involving this material can be controlled using a dry chemical, carbon dioxide or Halon extinguisher. A water spray may also be used. (NTP, 1992)

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

Wear self-contained breathing apparatus for firefighting if necessary.

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

Prevent further spillage or leakage if it is safe to do so. Do not let the chemical enter drains. Discharge into the environment must be avoided.

Collect and arrange disposal. Keep the chemical in suitable and closed containers for disposal. Remove all sources of ignition. Use spark-proof tools and explosion-proof equipment. Adhered or collected material should be promptly disposed of, in accordance with appropriate laws and regulations.

Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

Methotrexate sodium tablets should be protected from light and stored in well-closed containers at 15-30 deg C. Methotrexate sodium injection and powder for injection should be protected from light and stored at 15-30 deg C. Methotrexate sodium

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Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).

Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.

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This chemical is sensitive to hydrolysis, oxidation and light. Insoluble in water.

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METHOTREXATE decomposes in very acidic or alkaline conditions. This chemical is incompatible with strong oxidizing agents and strong acids. (NTP, 1992)

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When heated to decomposition it emits toxic fumes including /nitrogen oxides/.

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Classification of carcinogenicity: 1) evidence in humans: Inadequate data; 2) evidence in animals: Inadequate data. Overall summary evaluation of carcinogenic risk to humans is Group 3: The agent is not classifiable as to its carcinogenicity to humans. From table

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AEROBIC: An OECD confirmatory test was carried out in a laboratory-scale treatment plant, using a sludge inoculum from the municipal sewage plant in Bochum-Olbachtal, Germany(1). The test was run for 10 days, flow rate of 1 L/hr, and a retention time of 3 hrs. Methotrexate, at concentrations of 10 and 20 mg/L, at both concns, the compound reached a rate of 95% biodegradation after approximately 8 days, with a maximum rate of 98% biodegradation measured at 10 days; however, the biodegradation process resulted in the formation of 7-hydroxymethotrexate which is toxic and persistent(1). When presented as a mixture including cyclophosphamide (150 mg/L), cytarabine (12.5 mg/L), and 5-fluorouracil (5.0 mg/L), methotrexate (4.0 mg/L) exhibited a similar biodegradation rate(1).

An estimated BCF of 3.2 was calculated for methotrexate(SRC), using a log Kow of -1.85(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC), provided the compound is not altered physically or chemically once released into the environment(SRP).

The Koc of methotrexate is estimated as 1(SRC), using a log Kow of -1.85(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that methotrexate is expected to have very high mobility in soil. The pKa of the carboxylic acid moiety of methotrexate is 4.70(4), indicating that this compound will primarily exist in anion form in the environment and anions generally do not adsorb more strongly to organic carbon and clay than their neutral counterparts(5). However, aromatic amines are expected to bind strongly to humus or organic matter in soils due to the high reactivity of the aromatic amino group(6,7), suggesting that mobility may be much lower in some soils(SRC).

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The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.

Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.

ADR/RID: UN2811 (For reference only, please check.)

IMDG: UN2811 (For reference only, please check.)

IATA: UN2811 (For reference only, please check.)

ADR/RID: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)

IMDG: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)

IATA: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)

ADR/RID: 6.1 (For reference only, please check.)

IMDG: 6.1 (For reference only, please check.)

IATA: 6.1 (For reference only, please check.)

ADR/RID: I (For reference only, please check.)

IMDG: I (For reference only, please check.)

IATA: I (For reference only, please check.)

ADR/RID: No

IMDG: No

IATA: No

no data available

no data available