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

Skin sensitization, Category 1

Carcinogenicity, 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 H317 May cause an allergic skin reaction H351 Suspected of causing cancer 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. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P272 Contaminated work clothing should not be allowed out of the workplace. 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/... P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before reuse. P308+P313 IF exposed or concerned: Get medical advice/ attention.
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 class of compounds via ingestion include sedation, nystagmus, ataxia, irritability and hyperexcitability in children, exfoliative dermatitis and hypoprothrombinemia in the neonate. Other symptoms via ingestion include confusion and restlessness in the elderly or in the presence of pain; respiratory depression, occasional allergic reactions, particularly affecting the skin; maculopapular skin rash, fixed-drug eruptions purpura, photosensitivity, erythema multiforme (the Stevens-Johnson syndrome), toxic epidermal necrolysis, hypothermia with associated pyrexia during recovery; hepatitis, cholestasis, nephritis, hepatic dysfunction and shoulder-hand syndrome. Ingestion may cause agitation in the elderly, hemorrhage in the neonate, morbilliform or scarlatiniform rash, megaloblastic anemia and osteomalacia. Ingestion can also cause sleepiness, unsteadiness, mental confusion, slow and shallow respiration, flaccid muscles, hypotension, cyanosis, hyperthermia, absent reflexes and coma. The duration of coma is dependent on the dose. Cerebral edema contributes to the persistence of coma. If coma persists, moist rales are heard in the lower lung fields, indicating pulmonary edema. Atelectasis or aspiration pneumonia with signs of lung consolidation and fever can also occur. Carbon dioxide retention under these conditions can cause acidosis. Death may occur from pneumonia, pulmonary edema or refractory hypotension. Other symptoms of exposure may include drowsiness, headache, irregular respiration and central nervous system effects Inhalation of the dust may cause irritation of the upper respiratory tract. Hypnosis and excitement have been reported. Other reported symptoms include delirium and deep unconsciousness. It can cause poor judgment and hangover. Chronic symptoms include effects on neurological and pyschic functions, disorientation, skin rash, ataxia, dizziness, depression an foliate deficiency. Chronic exposure may also result in drowsiness, emotional lability, irritability, neglect of personal appearance and other behavior disturbances. Other symptoms of chronic exposure are nystagmus, tremor, mild changes in mental condition such as loss of memory, inability to concentrate, giddiness, depression and dullness of mental perception, and precipitation of acute porphyria. Overdosage may cause hemorrhagic and erythematous bullae, respiratory depression, cardiovascular depression, hypotension and shock leading to renal failure; prolonged coma and death due t respiratory or circulatory failure. Absent bowel sounds are a sign of severe poisoning and their return sometimes indicates further absorption of any remaining compound in the gastrointestinal tract with resultant relapse. Dangerous central nervous system effects occur in children at 10 mg/kg. It causes respiratory depression in the neonate and diminished milk flow in the nursing mother. Eye effects through ingestion include slow eye reaction to light, mydriasis, miosis, bilateral ptosis, rapid fluttering of the eyelids, disturbance of eye movement, weakness of convergence, weakness of vertical gaze and of individual extraocular muscles and transient loss of vision following coma. There has been one case of spontaneous abortion. Exposure to this compound may also cause somnolence, motor activity changes, pulmonary changes, allergic dermatitis, fever, developmental abnormalities of the central nervous system, body wall, musculoskeletal, respiratory, gastrointestinal and urogenital systems. It may also cause jaundice. This compound may increase the metabolism of other drugs. Pyschic or physical dependence may occur with continued use. Abrupt withdrawal may result in severe abstinence syndrome which includes grand mal seizures and delirium. ACUTE/CHRONIC HAZARDS: This compound is highly toxic by ingestion. It is also toxic if absorbed through the skin. It is harmful by inhalation and may cause irritation by skin or eye contact. When heated to decomposition it emits toxic fumes of nitrogen oxides.

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

Treatment of overdosage is mainly supportive including maintenance of an adequate airway and assisted respiration and oxygen administration if needed. Resuscitative measures should be initiated promptly. Standard treatment for shock should be administered if necessary. Management of hypotension may include administration of iv fluids, elevation of the lower extremities, and/or use of vasopressor or inotropic agents. For seizures, iv diazepam and phenytoin may be used; in case of refractory seizures, general anesthesia and paralysis induced by a neuromuscular blocking agent may be necessary. Activated charcoal is an effective barbiturate adsorbant when administered within 30 minutes following ingestion of the drugs. ... Gastric aspiration is not recommended unless there is evidence that the drug has been ingested recently (within 4 hours); care should be taken to prevent pulmonary aspiration of gastric contents. Multiple-dose, nasogastric administration of activated charcoal has been used effectively to treat phenobarbital overdose; activated charcoal enhances elimination of the drug and shortens the duration of coma. The patient's vital signs, fluid intake, blood gases, and serum electrolytes should be monitored closely. Analeptic drugs should not be administered because they may produce paroxysmal cerebral activity which may result in generalized seizures. In addition, it has been demonstrated that analeptics are incapable of stimulating respiration and exerting an arousal effect in patients with severe barbiturate poisoning and profound CNS depression. If renal function is normal, forced diuresis may be of benefit. In addition, alkalinization of the urine increases renal excretion of phenobarbital, aprobarbital, and mephobarbital which is metabolized to phenobarbital. Peritoneal dialysis or hemodialysis may be useful in severe barbiturate intoxication and/or if the patient is anuric or in shock. /Barbiturates General Statement/

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.

5.2 Specific hazards arising from the chemical

This chemical is 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

Wipe up spillage or collect spillage using a high- efficiency vacuum cleaner. Avoid breathing dust. Wash spill site. Place spillage and all contaminated cleanup materials in a thick plastic hazardous waste disposal bag or leakproof container and label it CAUTION: HAZARDOUS CHEMICAL WASTE.

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

Aqueous solutions of "phenobarbital" sodium are not generally stable. The drug is more stable in polyethylene glycol or propylene glycol.

10.3 Possibility of hazardous reactions

PHENOBARBITAL is also sensitive to prolonged exposure to light. Incompatible with strong oxidizing agents. Forms a complex of reduced solubility with macrogol 4000. Able to form metal derivatives .

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

Solutions of "phenobarbital" sodium should not be added to acidic solutions because precipitation of "phenobarbital" may occur. Solutions for injection should not be used if they contain a precipitate.

10.6 Hazardous decomposition products

When heated to decomposition it emits toxic fumes of /nitrogen oxides/.

11.Toxicological information

Acute toxicity

• Oral: LD50 rat oral 162 +/- 14 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 inadequate evidence in humans for the carcinogenicity of phenobarbital. There is sufficient evidence in experimental animals for the carcinogenicity of phenobarbital. Overall evaluation: Phenobarbital is possibly carcinogenic to humans (Group 2B).

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; Species: Pimephales promelas (Fathead minnow, age 30 days, mean length 16.5 mm, mena weight 0.067 g); Conditions: flow through, 24.9°C, pH 7.8, hardness 45.1 mg/L CaCO3, alkalinity 108 mg/L CaCO3, dissolved oxygen 6.8 mg/L; Concentration: 484 mg/L for 96 hr (95% confidence limit: 446-526 mg/L) /99+% purity
• Toxicity to daphnia and other aquatic invertebrates: LC50; Species: Daphnia magna (Water flea); Concentration: 1,460 mg/L for 24 hr /Conditions of bioassay not specified
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2 Persistence and degradability

AEROBIC: Phenobarbital, present at 100 mg/L, reached 0% of its theoretical BOD in 4 weeks using an activated sludge inoculum at 30 mg/L in the Japanese MITI test(1).

12.3 Bioaccumulative potential

An estimated BCF of 4 was calculated in fish for phenobarbital(SRC), using a log Kow of 1.47(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 phenobarbital is estimated as 59(SRC), using a log Kow of 1.47(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that phenobarbital is expected to have high mobility in soil. The pKa of phenobarbital is 7.3(4), indicating that this compound will exist partially in the anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(5).

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.