5-Aminosalicylic acid Safety Data Sheets

Skin irritation, Category 2

Skin sensitization, Category 1

Eye irritation, Category 2

Specific target organ toxicity – single exposure, Category 3

If inhaled

Following skin contact

Following eye contact

Following ingestion

SYMPTOMS: Symptoms of exposure to this compound include acute intolerance syndrome characterized by cramping, acute abdominal pain and discomfort, and bloody diarrhea. It may also cause headache, rash, gas (flatulence), nausea, flu, tiredness, weakness, malaise, fatigue, cold, sore throat, leg pain, joint pain, dizziness, bloating, back pain, hemorrhoids, itching, rectal pain, constipation, hair loss, peripheral edema, urinary burning, rectal soreness and burning, asthenia and insomnia. Other symptoms include fever, gastrointestinal problems, anorexia, epigastric pain, skin eruptions of various types, agranulocytosis, leukopenia, eosinophilia, lymphocytosis, atypical mononucleosis syndrome, thrombocytopenia and acute hemolytic anemia. Symptoms of exposure to a related compound include pruritus, erythematous macular or bullous eruptions, acidosis, hypokalemia, crystalluria, vomiting, hepatic necrosis, leukocytosis, laryngeal edema, methemoglobinemia and thyroid suppression. Other symptoms include allergic reactions, gastrointestinal irritation and prolonged prothrombin times. ACUTE/CHRONIC HAZARDS: This compound may be harmful by inhalation, ingestion or skin absorption. It may cause irritation. When heated to decomposition it emits toxic fumes of carbon monoxide, carbon dioxide and nitrogen oxides. (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.

Commercially available oral mesalamine delayed-release tablets should be stored at a controlled room temperature of 20-25 deg C, while the commercially available oral extended-release capsules should be stored at 25 deg C but may be exposed to temperatures ranging from 15-30 deg C.

Occupational Exposure limit values

Biological limit values

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

Sensitive to moisture. Water insoluble.

Mesalamine is unstable in the presence of water and light, since oxidation and, to a lesser extent, light-catalyzed degradation of the drug occur.

5-AMINOSALICYLIC ACID is incompatible with acids, acid chlorides, acid anhydrides, chloroformates and strong oxidizers. (NTP, 1992)

no data available

no data available

no data available

Acute toxicity

• Oral: LD50 - rat (male/female) - 2 800 mg/kg bw.
• Inhalation: no data available
• Dermal: LD50 - rabbit - > 5 000 mg/kg bw.

Skin corrosion/irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure

STOT-repeated exposure

Aspiration hazard

• Toxicity to fish: LC50 - 155 mg/L - 96 h.
• Toxicity to daphnia and other aquatic invertebrates: LC50 - Daphnia sp. - 12 mg/L - 48 h.
• Toxicity to algae: EC50 - 66 mg/L - 96 h.
• Toxicity to microorganisms: IGC50 - Tetrahymena pyriformis - 64.34 mg/L - 48 h.

ANAEROBIC: Mesalamine, present at 250 mg/L, produced 95.6% methane following a lag phase of 65 days using 2-nitrophenol-adapted sludge in batch assays conducted in 120 ml glass serum flasks and is considered completely biodegradable under anaerobic conditions(1). Mesalamine was completely degraded by a mesophilic sludge in 30 days (mesophilic granular sludge from a full-scale UASB reactor treating chemical industry wastewater of Shell Nederland Chemie at Moerdijk, The Netherlands, VSS concn - 25.5 g/L; specific aceticlastic activity - 0.3 COD/L/g VSS, 30 deg C) following a 20-day lag period(2). It was also completely degraded using a mesophilic floccular sludge from a lab-scale UASB reactor treating cattle manure wastewater - VSS concn 20.5 g/L; specific aceticlastic activity - 0.05 to 0.06 g COD/L/g VSS, so deg C; however, specific incubation and acclimation details were not provided(2). Degradation using a thermophilic sludge was 100% in 48 days following a 34 day lag period - full-scale CSTR reactor digesting primary and secondary sludges at Kur'yanovskaya municipal aeration station, Moscow, Russia - VSS concn 20.5 g/L; specific aceticlastic activity 0.1 g COD/L g VSS, 55 deg C(2).

An estimated BCF of 3 was calculated in fish for mesalamine(SRC), using an estimated log Kow of 0.98(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).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of mesalamine can be estimated to be 10(SRC). According to a classification scheme(2), this estimated Koc value suggests that mesalamine is expected to have very high mobility in soil. A predicted Kd value of 1.37 calculated for sludge samples in the UK, suggests that adsorption to sludge is low(3). Estimated pKa values of 2.09, 5.26 and 13.64(4) indicate that this compound will dissociate to the zwitterion form in the environment(SRC).

no data available

Product

Contaminated packaging

no data available

no data available

Information on revision

Abbreviations and acronyms

• 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%

References

• 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/