Superiority:

SAFETY DATA SHEETS

According to the UN GHS revision 10

Version: 1.0

Creation Date: July 15, 2019

Revision Date: July 15, 2019

SECTION 1: Identification

1.1GHS Product identifier

Product name	Nifedipine

1.2Other means of identification

Product number	-
Other names	dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate;Adalat CC;1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Dimethyl Ester

1.3Recommended use of the chemical and restrictions on use

Identified uses	Industrial and scientific research use.
Uses advised against	no data available

SECTION 2: Hazard identification

2.1Classification of the substance or mixture

Acute toxicity - Category 4, Oral

2.2GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Warning
Hazard statement(s)	H302 Harmful if swallowed
Precautionary statement(s)
Prevention	P264 Wash ... thoroughly after handling. P270 Do not eat, drink or smoke when using this product.
Response	P301+P317 IF SWALLOWED: Get medical help. P330 Rinse mouth.
Storage	none
Disposal	P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.

2.3Other hazards which do not result in classification

no data available

SECTION 3: Composition/information on ingredients

3.1Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
Nifedipine	Nifedipine	21829-25-4	244-598-3	100%

SECTION 4: First-aid measures

4.1Description of necessary first-aid measures

If inhaled

Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.

Following skin contact

Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.

Following eye contact

Rinse with pure water for at least 15 minutes. Consult a doctor.

Following ingestion

Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.

4.2Most important symptoms/effects, acute and delayed

SYMPTOMS: Symptoms of exposure to this compound via ingestion include diabetes mellitus, hallucinations, distorted perceptions, cardiac effects, nausea, vomiting, changes in regional blood flow, dermatitis, anaphylaxis and decreased blood pressure. Other symptoms via ingestion include headache, dizziness, flushing, hypotension, tachycardia, fatigue and edema. It also causes dilation of coronary arteries and arterioles, reduced oxygen requirements, decreased platelet aggregation, weakness, heartburn, muscle cramps, tremor, nervousness, mood changes, palpitation, dyspnea, wheezing, cough, nasal congestion, sore throat, chest congestion, diarrhea, constipation flatulence, muscle inflammation, joint stiffness, shakiness, blurred vision, difficulties in balance, jitteriness, sleep disturbances, pruritus, urticaria, fever, sweating, chills, sexual difficulties and syncopal episodes. It can cause bradycardia, lethargy and anginal pain. It can also cause improved contractility and segmental ventricular function, increased heart rate and cardiac output, and increased peripheral blood flow due to arterial dilation (with no change in venous tone). It can cause negative inotropy, excessive vasodilation, depression of the sinus nodal rate, A-V nodal conduction disturbances, digital dysesthesia, sedation and aggravation of myocardial ischemia. Somnolence may occur. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits toxic fumes of nitrogen oxides. (NTP, 1992)

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

Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.

SECTION 5: Fire-fighting measures

5.1Suitable extinguishing media

Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. A water spray may also be used. (NTP, 1992)

5.2Specific hazards arising from the chemical

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

5.3Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

SECTION 6: Accidental release measures

6.1Personal precautions, protective equipment and emergency procedures

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.

6.2Environmental precautions

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.

6.3Methods and materials for containment and cleaning up

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.

SECTION 7: Handling and storage

7.1Precautions for safe handling

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.

7.2Conditions for safe storage, including any incompatibilities

Nifedipine liquid-filled capsules should be protected from light and moisture and stored in tight, light-resistant containers at a temperature of 15-25 deg C, and extended-release tablets of the drug should be protected from light and moisture and stored in tight, light-resistant containers at a temperature less than 30 deg C.

SECTION 8: Exposure controls/personal protection

8.1Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2Appropriate engineering controls

Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

8.3Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).

Skin protection

Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. 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

If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.

Thermal hazards

no data available

SECTION 9: Physical and chemical properties and safety characteristics

Physical state	PHYSICAL DESCRIPTION: Odorless yellow crystals or powder. Tasteless. (NTP, 1992)
Colour	Yellow crystals
Odour	no data available
Melting point/freezing point	-77°C(lit.)
Boiling point or initial boiling point and boiling range	173°C(lit.)
Flammability	no data available
Lower and upper explosion limit/flammability limit	no data available
Flash point	53°C(lit.)
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	less than 1 mg/mL at 67.1° F (NTP, 1992)
Partition coefficient n-octanol/water	no data available
Vapour pressure	2.68E-08mmHg at 25°C
Density and/or relative density	1.271g/cm3
Relative vapour density	no data available
Particle characteristics	no data available

SECTION 10: Stability and reactivity

10.1Reactivity

Aqueous solutions are very sensitive to light. (NTP, 1992). Insoluble in water.

10.2Chemical stability

no data available

10.3Possibility of hazardous reactions

NIFEDIPINE is sensitive to light.

10.4Conditions to avoid

no data available

10.5Incompatible materials

no data available

10.6Hazardous decomposition products

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

SECTION 11: Toxicological information

Acute toxicity

• Oral: LD50 Rat oral 1022 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

no data available

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

SECTION 12: Ecological information

12.1Toxicity

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2Persistence and degradability

no data available

12.3Bioaccumulative potential

An estimated BCF of 13 was calculated for Nifedipine(SRC), using a log Kow of 2.20(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).

12.4Mobility in soil

The Koc of Nifedipine is estimated as 370(SRC), using a log Kow of 2.20(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that Nifedipine is expected to have moderate mobility in soil.

12.5Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1Disposal 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.

SECTION 14: Transport information

14.1UN Number

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.2UN Proper Shipping Name

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.3Transport hazard class(es)

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.4Packing group, if applicable

ADR/RID: Not dangerous goods. (For reference only, please check.)

IMDG: Not dangerous goods. (For reference only, please check.)

IATA: Not dangerous goods. (For reference only, please check.)

14.5Environmental hazards

ADR/RID: No

IMDG: No

IATA: No

14.6Special precautions for user

no data available

14.7Transport in bulk according to IMO instruments

no data available

SECTION 15: Regulatory information

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

Chemical name	Common names and synonyms	CAS number	EC number
Nifedipine	Nifedipine	21829-25-4	244-598-3
European Inventory of Existing Commercial Chemical Substances (EINECS)			Listed.
EC Inventory			Listed.
United States Toxic Substances Control Act (TSCA) Inventory			Not Listed.
China Catalog of Hazardous chemicals 2015			Not Listed.
New Zealand Inventory of Chemicals (NZIoC)			Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS)			Not Listed.
Vietnam National Chemical Inventory			Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Not Listed.
Korea Existing Chemicals List (KECL)			Listed.

SECTION 16: Other information

Information on revision

Creation Date	July 15, 2019
Revision Date	July 15, 2019

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