| Product name | methotrexate |
|---|
| Product number | - |
|---|---|
| Other names | R 9985 |
| Identified uses | For industry use only. |
|---|---|
| Uses advised against | no data available |
| Company | MOLBASE (Shanghai) Biotechnology Co., Ltd. |
|---|---|
| Address | Floor 4 & 5, Building 12, No. 1001 North Qinzhou Road, Xuhui District, Shanghai, China |
| Telephone | +86(21)64956998 |
| Fax | +86(21)54365166 |
| Emergency phone number | +86-400-6021-666 |
|---|---|
| Service hours | Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours). |
Acute toxicity - Oral, Category 3
Skin irritation, Category 2
Eye irritation, Category 2
Reproductive toxicity, Category 1B
2.2 GHS label elements, including precautionary statements| Pictogram(s) |   |
|---|---|
| Signal word | Danger |
| Hazard statement(s) | H301 Toxic if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H360 May damage fertility or the unborn child |
| Precautionary statement(s) | |
| Prevention | 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. P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. |
| Response | P301+P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor/… P321 Specific treatment (see ... on this label). P330 Rinse mouth. P302+P352 IF ON SKIN: Wash with plenty of water/... P332+P313 If skin irritation occurs: Get medical advice/attention. 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. P337+P313 If eye irritation persists: Get medical advice/attention. P308+P313 IF exposed or concerned: Get medical advice/ attention. |
| Storage | P405 Store locked up. |
| Disposal | P501 Dispose of contents/container to ... |
none
3.Composition/information on ingredients 3.1 Substances| Chemical name | Common names and synonyms | CAS number | EC number | Concentration |
|---|---|---|---|---|
| methotrexate | methotrexate | 59-05-2 | none | 100% |
Consult a physician. Show this safety data sheet to the doctor in attendance.
If inhaledIf breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
In case of skin contactWash off with soap and plenty of water. Consult a physician.
In case of eye contactRinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
If swallowedNever give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.
4.2 Most important symptoms/effects, acute and delayedSYMPTOMS: 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.
4.3 Indication of immediate medical attention and special treatment needed, if necessaryLeucovorin 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.
5.Fire-fighting measures 5.1 Extinguishing media Suitable extinguishing mediaFires involving this material can be controlled using a dry chemical, carbon dioxide or Halon extinguisher. A water spray may also be used.
5.2 Specific hazards arising from the chemicalFlash point data for this chemical are not available; however, it is probably combustible.
5.3 Special protective actions for fire-fightersWear self-contained breathing apparatus for firefighting if necessary.
6.Accidental release measures 6.1 Personal precautions, protective equipment and emergency proceduresUse personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.
6.2 Environmental precautionsPrevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.
6.3 Methods and materials for containment and cleaning upPick up and arrange disposal. Sweep up and shovel. Keep in suitable, closed containers for disposal.
7.Handling and storage 7.1 Precautions for safe handlingAvoid contact with skin and eyes. Avoid formation of dust and aerosols. Avoid exposure - obtain special instructions before use.Provide appropriate exhaust ventilation at places where dust is formed. For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilitiesMethotrexate sodium tablets should be protected from light and stored in well-closed containers at 15-30°C. Methotrexate sodium injection and powder for injection should be protected from light and stored at 15-30°C. /Methotrexate sodium/
8.Exposure controls/personal protection 8.1 Control parameters Occupational Exposure limit valuesno data available
Biological limit valuesno data available
8.2 Appropriate engineering controlsHandle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.
8.3 Individual protection measures, such as personal protective equipment (PPE) Eye/face protectionSafety glasses with side-shields conforming to EN166. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protectionWear impervious clothing. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique(without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. 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.
Respiratory protectionWear dust mask when handling large quantities.
Thermal hazardsno data available
9.Physical and chemical properties| Physical state | yellow crystalline powder |
|---|---|
| Colour | Orange-brown, crystalline powder |
| Odour | no data available |
| Melting point/ freezing point | 3°C(lit.) |
| Boiling point or initial boiling point and boiling range | 170°C(lit.) |
| Flammability | no data available |
| Lower and upper explosion limit / flammability limit | no data available |
| Flash point | 43°C(lit.) |
| Auto-ignition temperature | no data available |
| Decomposition temperature | no data available |
| pH | no data available |
| Kinematic viscosity | no data available |
| Solubility | In water:Insoluble. |
| Partition coefficient n-octanol/water (log value) | no data available |
| Vapour pressure | 2.1X10-19 mm Hg at 25°C /Estimated/ |
| Density and/or relative density | 1.536 g/cm3 |
| Relative vapour density | no data available |
| Particle characteristics | no data available |
no data available
10.2 Chemical stabilityStable under recommended storage conditions.
10.3 Possibility of hazardous reactionsMETHOTREXATE decomposes in very acidic or alkaline conditions. This chemical is incompatible with strong oxidizing agents and strong acids.
10.4 Conditions to avoidno data available
10.5 Incompatible materialsno data available
10.6 Hazardous decomposition productsWhen heated to decomposition it emits toxic fumes including /nitrogen oxides/.
11.Toxicological information Acute toxicity- Oral: LD50 Rat oral 180 +/- 45 mg/kg body weight
- Inhalation: no data available
- Dermal: no data available
no data available
Serious eye damage/irritationno data available
Respiratory or skin sensitizationno data available
Germ cell mutagenicityno data available
CarcinogenicityClassification 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/
Reproductive toxicityno data available
STOT-single exposureno data available
STOT-repeated exposureno data available
Aspiration hazardno data available
12.Ecological information 12.1 Toxicity- Toxicity to fish: no data available
- Toxicity to daphnia and other aquatic invertebrates: no data available
- Toxicity to algae: no data available
- Toxicity to microorganisms: no data available
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).
12.3 Bioaccumulative potentialAn 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).
12.4 Mobility in soilThe 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).
12.5 Other adverse effectsno data available
13.Disposal considerations 13.1 Disposal methods ProductThe 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.
Contaminated packagingContainers 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.
14.Transport information 14.1 UN Number| ADR/RID: UN2811 | IMDG: UN2811 | IATA: UN2811 |
| ADR/RID: TOXIC SOLID, ORGANIC, N.O.S. |
| IMDG: TOXIC SOLID, ORGANIC, N.O.S. |
| IATA: TOXIC SOLID, ORGANIC, N.O.S. |
| ADR/RID: 6.1 | IMDG: 6.1 | IATA: 6.1 |
| ADR/RID: III | IMDG: III | IATA: III |
| ADR/RID: no | IMDG: no | IATA: no |
no data available
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Codeno data available
15.Regulatory information 15.1 Safety, health and environmental regulations specific for the product in question| Chemical name | Common names and synonyms | CAS number | EC number |
|---|---|---|---|
| methotrexate | methotrexate | 59-05-2 | none |
| European Inventory of Existing Commercial Chemical Substances (EINECS) | Listed. | ||
| EC Inventory | Listed. | ||
| United States Toxic Substances Control Act (TSCA) Inventory | Listed. | ||
| China Catalog of Hazardous chemicals 2015 | Not Listed. | ||
| New Zealand Inventory of Chemicals (NZIoC) | Listed. | ||
| Philippines Inventory of Chemicals and Chemical Substances (PICCS) | Not Listed. | ||
| Vietnam National Chemical Inventory | Listed. | ||
| Chinese Chemical Inventory of Existing Chemical Substances (China IECSC) | Not Listed. | ||
| Creation Date | Aug 12, 2017 |
|---|---|
| Revision Date | Aug 12, 2017 |
- CAS: Chemical Abstracts Service
- ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
- RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
- IMDG: International Maritime Dangerous Goods
- IATA: International Air Transportation Association
- TWA: Time Weighted Average
- STEL: Short term exposure limit
- LC50: Lethal Concentration 50%
- LD50: Lethal Dose 50%
- EC50: Effective Concentration 50%
- IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
- HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
- IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
- eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
- CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
- ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
- ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
- Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
- ECHA - European Chemicals Agency, website: https://echa.europa.eu/
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