1.Identification

1.1 GHS Product identifier

1.2 Other means of identification

1.3 Recommended use of the chemical and restrictions on use

1.4 Supplier's details

1.5 Emergency phone number

2.Hazard identification

2.1 Classification of the substance or mixture

Germ cell mutagenicity, Category 2

Carcinogenicity, Category 1B

Specific target organ toxicity – repeated exposure, Category 2

2.2 GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H341 Suspected of causing genetic defects H350 May cause cancer H373 May cause damage to organs through prolonged or repeated exposure
Precautionary statement(s)
Prevention	P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/protective clothing/eye protection/face protection. P260 Do not breathe dust/fume/gas/mist/vapours/spray.
Response	P308+P313 IF exposed or concerned: Get medical advice/ attention. P314 Get medical advice/attention if you feel unwell.
Storage	P405 Store locked up.
Disposal	P501 Dispose of contents/container to ...

2.3 Other hazards which do not result in classification

none

3.Composition/information on ingredients

3.1 Substances

4.First-aid measures

4.1 Description of necessary first-aid measures

General advice

Consult a physician. Show this safety data sheet to the doctor in attendance.

If inhaled

If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

In case of skin contact

Wash off with soap and plenty of water. Consult a physician.

In case of eye contact

Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.

If swallowed

Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

4.2 Most important symptoms/effects, acute and delayed

SYMPTOMS: Symptoms of exposure to this chemical may include nerve or sheath structural changes, eye changes, tremors, fever, jaundice and other liver changes. It may cause convulsive seizures, numbness, nausea, vomiting, abdominal discomfort, diarrhea, sharp, unpleasant metallic taste, erythematous rash, pruritus, dizziness, syncope, ataxia, thrombophlebitis after intravenous infusion, darkened urine, anorexia, epigastric distress, constipation, glossitis, stomatitis, reversible thrombocytopenia and vertigo. Flattening of the T-wave may be seen in electrocardiographic tracings. It may also cause incoordination, irritability, depression, weakness, insomnia, nasal congestion dysuria, cystitus, polyuria, incontinence, a sense of pelvic pressure, dyspareunia, decrease of libido, proctitis and fleeting joint pains sometimes resembling serum sickness. It may cause skin rash and drowsiness. Other symptoms of exposure include malaise, transient rashes, gastrointestinal disturbances and peripheral neuropathy. It may cause coated tongue, dry mouth, urethral discomfort, temporary leukopenia, increase in chromosome aberrations, candidal vaginitis, lethargy and sore furred tongue. In conjunction with alcohol it may provoke a disulfuram-like reaction. Pregnant women expose to this compound have given birth to premature, stillborn infants. One infant has died of white asphyxia. It may cause epigastric distress, abdominal cramping, numbness or paresthesia of an extremity, urticaria, flushing, dryness of vagina or vulva, abdominal distress, headache (if ingested with alcohol), confusional and psychotic states, blood dyscrasias, temporary neutropenia which reverses after therapy, and low concentrations of lipids in plasma. ACUTE/CHRONIC HAZARDS: This compound is harmful by ingestion, inhalation or skin absorption. It may cause irritation. 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 necessary

Maintain an open airway and assist ventilation if necessary. Treat coma, seizures, hypotension, anaphylaxis, and hemolysis if they occur. Replace fluid losses resulting from gastroenteritis with intravenous crystalloids. ... Administer activated charcoal. Gastric emptying is not necessary if activated charcoal can be given promptly. Most antibiotics are excreted unchanged in the urine, so maintenance of adequate urine flow is important. The role of forced diuresis is unclear. Hemodialysis is not usually indicated, except perhaps in patients with renal dysfunction and a high level of toxic agent. /Antibacterial Agents/

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher.

5.2 Specific hazards arising from the chemical

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

5.3 Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

6.Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Use 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 precautions

Prevent 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 up

PRECAUTIONS FOR "CARCINOGENS": A high-efficiency particulate arrestor (HEPA) or charcoal filters can be used to minimize amt of carcinogen in exhausted air ventilated safety cabinets, lab hoods, glove boxes or animal rooms ... Filter housing that is designed so that used filters can be transferred into plastic bag without contaminating maintenance staff is avail commercially. Filters should be placed in plastic bags immediately after removal ... The plastic bag should be sealed immediately ... The sealed bag should be labelled properly ... Waste liquids ... should be placed or collected in proper containers for disposal. The lid should be secured & the bottles properly labelled. Once filled, bottles should be placed in plastic bag, so that outer surface ... is not contaminated ... The plastic bag should also be sealed & labelled. ... Broken glassware ... should be decontaminated by solvent extraction, by chemical destruction, or in specially designed incinerators. /Chemical Carcinogens/

7.Handling and storage

7.1 Precautions for safe handling

Avoid 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 incompatibilities

PRECAUTIONS FOR "CARCINOGENS": Storage site should be as close as practical to lab in which carcinogens are to be used, so that only small quantities required for ... expt need to be carried. Carcinogens should be kept in only one section of cupboard, an explosion-proof refrigerator or freezer (depending on chemicophysical properties ...) that bears appropriate label. An inventory ... should be kept, showing quantity of carcinogen & date it was acquired ... Facilities for dispensing ... should be contiguous to storage area. /Chemical Carcinogens/

8.Exposure controls/personal protection

8.1 Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2 Appropriate engineering controls

Handle 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 protection

Safety 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 protection

Wear 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 protection

Wear dust mask when handling large quantities.

Thermal hazards

no data available

9.Physical and chemical properties

10.Stability and reactivity

10.1 Reactivity

no data available

10.2 Chemical stability

Stable in air but darkens on exposure to light.

10.3 Possibility of hazardous reactions

METRONIDAZOLE darkens on exposure to light. This chemical is incompatible with strong oxidizing agents. .

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

Because reconstituted metronidazole hydrochloride solution has a low pH, the solution may interact with aluminum resulting in a reddish-brown discoloration of the solution. Therefore, aluminum hub needles should not be used to reconstitute the drug or to transfer the reconstituted solution to the diluting fluid. Metronidazole hydrochloride that has been reconstituted, diluted, and neutralized and metronidazole injection do not interact with aluminum when administered over the time period specified by the manufacturers; however, some discoloration of these solutions may occur when they are in contact with aluminum for periods of 6 hours or longer.

10.6 Hazardous decomposition products

no data available

11.Toxicological information

Acute toxicity

• Oral: LD50 Albino Rat oral > 5 g/kg
• Inhalation: no data available
• Dermal: no data available

Skin corrosion/irritation

no data available

Serious eye damage/irritation

no data available

Respiratory or skin sensitization

no data available

Germ cell mutagenicity

no data available

Carcinogenicity

Metronidazole: reasonably anticipated to be a human carcinogen.

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

12.Ecological information

12.1 Toxicity

• Toxicity to fish: LC50 Lepomis macrochirus (Bluegill sunfish, weight 0.1g) >100 ppm/96 hr; static /99.4% AI formulated product
• Toxicity to daphnia and other aquatic invertebrates: EC50 Daphnia magna (Water flea, age <24 hr; intoxication, immobilization) >1000 ppm/48 hr; static /99% AI formulated product
• Toxicity to algae: EC50 Pseudokirchneriella subcapitata (Green algae; decreased population growth) 40.4 mg/L/72 hr (95% confidence limit: 2.17-750 mg/L); static
• Toxicity to microorganisms: no data available

12.2 Persistence and degradability

AEROBIC: The biodegradation half-lives in sandy soil-manure slurry were 9.7 to 14.7 days and in clay soil-manure slurry were 13.1 to 26.9 days(1). Metronidazole was found to be non-degradable in sewage treatment conditions(2). Metronidazole did not degrade in closed bottle tests at concentrations of 5.95 ug/L and 5.95 mg/L(3).

12.3 Bioaccumulative potential

An estimated BCF of 3 was calculated for metronidazole(SRC), using a log Kow of -0.02(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).

12.4 Mobility in soil

The Koc of metronidazole is estimated as 23(SRC), using a log Kow of -0.02(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that metronidazole is expected to have very high mobility in soil.

12.5 Other adverse effects

no data available

13.Disposal considerations

13.1 Disposal methods

Product

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.

Contaminated packaging

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.

14.Transport information

14.1 UN Number

14.2 UN Proper Shipping Name

14.3 Transport hazard class(es)

14.4 Packing group, if applicable

14.5 Environmental hazards

14.6 Special precautions for user

no data available

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

no data available

15.Regulatory information

15.1 Safety, health and environmental regulations specific for the product in question

16.Other information

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/

Disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product.