Oxytetracycline Safety Data Sheets

Acute toxicity - Category 4, Oral

Acute toxicity - Category 4, Dermal

Acute toxicity - Category 4, Inhalation

If inhaled

Following skin contact

Following eye contact

Following ingestion

SYMPTOMS: Symptoms of exposure to this compound may include nausea, anorexia, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region; edema, benign intracranial hypertension, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, hemolytic anemia, neutropenia, thrombocytopenia and eosinophilia. It can cause hypersensitivity reactions, such as rashes, urticaria, dermatitis, atrophic or hypertrophic glossitis, burning of the eyes, cheilosis, pruritus ani or vulvae, vaginitis and fever. Other symptoms of exposure to this type of compound include gastrointestinal disturbances with flatulence, drug fever, rise in blood urea and clinical deterioration in those with renal impairment. This class of compounds may also cause an overgrowth of resistant organisms (such as Candida species and other fungi) in the mouth and intestines, producing angular stomatitis, and rectal and vaginal irritation. It may also cause marked changes in the intestinal flora, resulting in multiplication of resistant organisms and deficiency of B vitamins. Staphylococcal enterocolitis may occur suddenly, often ending fatally. It may cause liver damage, especially in pregnancy. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits very toxic fumes of hydrogen chloride and nitrogen oxides. (NTP, 1992)

Flash point data for this chemical are not available. 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.

Oxytetracycline hydrochloride preparations should be stored at a temperature less that 40 deg C, preferably between 15-30 deg C; freezing of oxytetracycline injection should be avoided. Oxytetracycline hydrochloride capsules should be stored in tight, light-resistant containers. Oxytetracycline hydrochloride

Occupational Exposure limit values

Biological limit values

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

This chemical is hygroscopic. Water soluble. Undergoes slow hydrolysis in the presence of water. Concentrated aqueous solutions at neutral pH hydrolyze on standing.

Stable in air, but exposure to strong sunlight causes it to darken. oxytetracycline dihydrate

OXYTETRACYCLINE HYDROCHLORIDE is sensitive to light. It may be unstable at temperatures above 77° F. It darkens on exposure to sunlight or to moist air above 194° F. Concentrated aqueous solutions at neutral pH hydrolyze on standing. This chemical undergoes hydrolysis in the presence of water. It may be incompatible with alkalis. (NTP, 1992)

no data available

no data available

no data available

Acute toxicity

• Oral: LD50 Swiss mice oral 7200 mg/kg hydroxytetracycline monohydrochloride
• Inhalation: no data available
• Dermal: no data available

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 Lepomis macrochirus (Bluegill) >100 ppm/96 hr; static /formulated product/[USEPA, Office of Pesticide Programs; Pesticide Ecotoxicity Database (2000) on
• Toxicity to daphnia and other aquatic invertebrates: EC50 Daphnia magna (Water flea; intoxication, immobilization) >102 ppm/48 hr; static /formulated product/[USEPA, Office of Pesticide Programs; Pesticide Ecotoxicity Database (2000) on
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

AEROBIC: Oxytetracycline in a soil and manure sample underwent 0% degradation after 180 days(1). Fifty percent degradation of oxytetracycline took place in an aerobic sediment slurry after 43.8 days(1). Oxytetracycline in soil was degraded to 17 and 39% of the initial concentrations of 60 and 600 mg, respectively, after 35 days and to 3 and 29% of the initial concentrations of 120 and 1200 mg/kg, respectively, after 100 days during manometric respirometry tests(2).

An estimated BCF of 0.12 was calculated for oxytetracycline(SRC), using a log Kow of -0.90(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).

Koc values measured for oxytetracycline were 42,506 in Askov sandy loam soil (1.6% organic carbon), 93,317 in Flakkebjerg sandy loam soil (1.1% organic carbon), 27,792 in Borris loamy sand (1.5% organic carbon), and 47,881 in Lundgaard sandy soil (1.4% organic carbon)(1,2,3,4). The Koc of oxytetracycline measured in manure (49% organic carbon) was 195(4,5). According to a classification scheme(6), this range of Koc values suggests that oxytetracycline is expected to have moderate to no mobility in soil. Based on a measured pKa value of 9.5 (tertiary amine)(5), oxytetracycline is expected to exist primarily as a cation in the environment and cations generally have lower mobility in soil than their neutral counterparts(7).

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/