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

Acute toxicity - Oral, Category 3

Acute toxicity - Dermal, Category 3

2.2 GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H301+H311 Toxic if swallowed or in contact with skin
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.
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/... P312 Call a POISON CENTER/doctor/…if you feel unwell. P361+P364 Take off immediately all contaminated clothing and wash it before reuse.
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 compound may include drowsiness, ataxia, skin rash, dysarthria, nausea, diplopia, anxiety, depression, constipation, changes in salivation, blurred vision, urinary retention, incontinence, tremor, headache, confusion, slurred speech, vertigo, changes in libido and jaundice. Other symptoms of exposure include fatigue, dizziness, respiratory depression, nystagmus, incoordination of the upper extremities, cardiac arrest, hyporeflexia, muscular weakness, agitation, insomnia, grand mal seizures, organic brain syndrome, paradoxical excitement, delirium, coma, hallucinations, vomiting, lethargy and respiratory failure or arrest. It can cause tinnitus, excitability, rage reaction, phlebitis and lactic acidosis. It can also cause central nervous depression, brown discoloration of the lenses, lightheadedness, amnesia, mental depression, blood disorders, dysphoria, slight wheezing, cyanosis, increased respiratory rate, abnormal blood gases, convulsions, increase in chromosomal aberrations, aplastic anemia, leukopenia, leukocytosis, encephalopathy, bilateral gynecomastia, allergic conjunctivitis, angle closure glaucoma, reduction of cardiac output and stroke volume, increase in heart rate and peripheral resistance, cholestasis, disorganization of thought, depressed pupillary response, inhibited performance recall, improved recall of information, reduced reaction time, apprehension, vascular disease, bronchopneumonia, bullous and vesicular skin eruptions, eccrine sweat gland and sweat duct necrosis, skin pallor and death. Exposure can cause decreased blood pressure, increase in hostility and irritability, and vivid or disturbing dreams. Exposure can also lead to hypotension, increased muscle spasticity, sleep disturbances, stimulation, neutropenia, hypoactivity, syncope, bradycardia, urticaria, cardiovascular collapse and hiccups. Damage to the eyes, central nervous system and pulmonary tract may occur. It may also cause dryness of the mouth, aggressive behavior, blood dyscrasias and hepatic dysfunction. If exposure occurs during pregnancy, it may cause lethargy and hypotonia in the offspring. The neonate may also experience apneic attacks. Symptoms may include hypertonia, hyperreflexis, difficulty in sucking, hypothermia and midline cleft deformities of the lip and palate. Depressed central nervous system function may also occur in the neonate. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits very toxic fumes of chlorine and nitrogen oxides.

4.3 Indication of immediate medical attention and special treatment needed, if necessary

Emergency and supportive measures; 1. Protect the airway and assist ventilation if necessary. 2. Treat coma, hypotension, and hypothermia if they occur. Hypotension usually respond promptly to supine position and intravenous fluids /Benzodiazepines/.

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials. ... As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

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

Wear approved respiratory protection, chemically compatible gloves, and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site.

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

Store in tight container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity.

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 under recommended storage conditions.

10.3 Possibility of hazardous reactions

no data available

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

A significant interaction exists between diazepam and infusion fluid containers constructed of pvc plastics, due to absorption of diazepam into the pvc matrix.

10.6 Hazardous decomposition products

When heated to decomp it emits very toxic fumes of hydrogen chloride and NO(x)

11.Toxicological information

Acute toxicity

• Oral: LD50 Rat oral 710 mg/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

Evaluation: There is evidence suggesting a lack of carcinogenicity of diazepam to the breast and inadequate evidence for carcinogenicity at other sites in humans. There is inadequate evidence in experimental animals for the carcinogenicity of diazepam. Overall Evaluation: Diazepam is not classifiable as to its carcinogenicity in humans (Group 3).

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: no data available
• Toxicity to daphnia and other aquatic invertebrates: EC50; Species: Daphnia magna (Water flea, <24 hr neonate); Conditions: freshwater, static, 21°C, pH 7.6; Concentration: 0.015 mM for 24 hr; Effect: increased intoxication, immobilization
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2 Persistence and degradability

AEROBIC: 14C-Labeled diazepam exhibited a biodegradation half-life of greater than 365 days when incubated using water/sediment sample from the Wickerbach creek in Floersheim, Germany; less than 2% mineralization and 60% sorption to sediment was observed, indicating high persistence(1). The removal rate of diazepam in 3 of 6 Italian sewage treatment plants (Naples, Latina, and Cuneo) sampled in 2004 was generally less than 40%; one plant (Varese Lago) reported 64% removal rate; two plants (Varese Olona and Cagliari) reported 0% removal(2).

12.3 Bioaccumulative potential

An estimated BCF of 33 was calculated in fish for diazepam(SRC), using log Kow of 2.82(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is moderate(SRC).

12.4 Mobility in soil

Using river sediments from the Burgan and Dausenau Rivers in Germany, the log Koc of diazepam was shown to be 2.4 (Kd 1.9) and 2.8 (Kd 24.8), respectively(1), corresponding to respective Koc values of 251 and 630(SRC). A Koc of 192 (Kd 3.0) was reported using sediment sample from the Wickerbach creek in Floersheim, Germany(2). According to a classification scheme(3), these Koc values suggest that diazepam is expected to have moderate to low mobility in soil. Mobility studies using a clayey silt soil and a silty sand soil typical of German agricultural soils indicated a Kd range of 4 to 20(4).

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.