Hebei Kangtai Pharmaceutical Co., Ltd.

MATERIAL SAFETY DATA SHEET

according to Directive 67/548/EC and Regulation 1907/2006/EC as amended(Regulaiton(EC) No 1272/2008)

1. IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND OF THE COMPANY/UNDERTAKING

Tenofovir Alafenamide Fumarate Cangzhou Enke Pharma-tech Co., Ltd
40# Shuiyuesi Street ,Cangzhou City ,Hebei Province ,China
Tel: 0086(0)317 5105699 Fax: 0086(0)317-5106596
www.enkepharma.com

2. HAZARDS IDENTIFICATION
Emergency overview: Not available
Potential Health Effects: The toxicological properties of this material have not been investigated. Use appropriate procedures to
prevent opportunities for direct contact with the skin or eyes and to prevent inhalation.

3. COMPOSITION/INFORMATION ON INGREDIENTS
Tenofovir Alafenamide Fumarate 2(C21H29N6O5P).C4H4O4 1069.02
CAS:1392275-56-7 EC No: Information not available. EC Index number: none
Symbol: Information not available.
H phrases: Information not available.

4. FIRST AID MEASURES

General advice: Consult a physician. Show this safety data sheet to the doctor in attendance.
Inhalation: If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
Skin contact: Wash off with soap and plenty of water. Consult a physician.
Eyes contact: Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Ingestion: Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.
In case of reactions described in hazards identification or other severe, immediate or persisting symptoms seek medical advice and
call the nearest poison centre. Show the label and this safety data sheet.

5. FIRE FIGHTING MEASURES0

Suitable extinguishing Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
media:
Special protective Wear self contained breathing apparatus for fire fighting if necessary.
equipment for
fire-fighters

6. ACCIDENTAL RELEASE MEASURES

Personal precautions: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure
adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust.
Environmental Do not let product enter drains.
precautions:
Methods and materials f Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed
or containment and clea containers for disposal.
ning up:

7. HANDLING AND STORAGE

Precautions for safe Avoid contact with skin and eyes. Avoid breathing dust, vapor, mist or gas.
handling: Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive
fire protection.
Conditions for safe Store in room temperature, Nitrogen filled protection &Avoid moisture.
storage:

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Respiratory protention: For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level
protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use
respirators and components tested and approved under appropriate government standards such as NIOSH
(US) or CEN (EU).
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without
Hand protection:
touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves

Address: Cangzhou economic development zone Jiuhe east road No.21

Tel: 0086(0)317 5105699 Fax: 0086(0)317-5106596
 Hebei Kangtai Pharmaceutical Co., Ltd.
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.
Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and
Eye protection:
approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
impervious clothing, The type of protective equipment must be selected according to the concentration
Skin protection: and amount of the dangerous substance at the specific workplace.
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at
Hygiene measures: the end of workday.

9. PHYSICAL AND CHEMICALS PROPERTIES

Appearance: White to off-white powder.
Density: NA
Boiling point: NA
Melting point: NA
Flash point: NA
Refractive index:NA

10. STABILITY AND REACTIVITY

Chemical stability:
Conditions to avoid:
Materials to avoid:
Dangerous decomposition
products:
Stable under recommended storage conditions.
Heat. Ignition. Humid
Information not available.
Hazardous decomposition products formed under fire conditions. - Carbon monoxide, carbon
dioxide, and hydrogen chloride.

11. TOXICOLOGICAL INFORMATION

Acute toxicity:
Skin corrosion/irritation:
Serious eye damage/eye
irritation:
Respiratory or skin
sensitization:
Germ cell mutagenicity:
Carcinogenicity:
Reproductive toxicity:
Specific target organ
toxicity- single exposure:
Specific target organ
toxicity- repeated
exposure:
Aspiration hazard:
Potential health effects
Inhalation:
Ingestion:
Skin:
Eyes:
Signs and symptoms of exposure:
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
Additional information:
Information not available.
Information not available.
Information not available.
Information not available.
Information not available.
No component of this product present at levels greater than or equal to 0.1% is identified as
probable, possible or confirmed human carcinogen by IARC.
Information not available.
Information not available.
Information not available.
Information not available.
Information not available.
May be harmful if inhaled. Causes respiratory tract irritation.
May be harmful if swallowed.
May be harmful if absorbed through skin. Causes skin irritation.
Causes serious eye irritation.
Information not available.

12. ECOLOGICAL INFORMATION

Ecotoxicity:
LC50 (fish-96h): Information not available.
EC50 (daphnies-48h): Information not available.
IC50 (algae-72h): Information not available.

Biodegradation: Information not available.

Bioaccumulation and mobility:

Log Pow: Information not available.
BCF: Information not available.

Address: Cangzhou economic development zone Jiuhe east road No.21

Tel: 0086(0)317 5105699 Fax: 0086(0)317-5106596
 Hebei Kangtai Pharmaceutical Co., Ltd.

13. DISPOSAL CONSIDERATIONS

Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed
professional waste disposal service to dispose of this material. Dissolve or mix the material with a
Product: combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber.
Contaminated packaging: Dispose of as unused product.

14. TRANSPORT INFORMATION

Transport regulation Not regulated as a hazardous materials.

IATA/ICAO (air) Not classified
ADR/RID (road/railway) Not classified
IMDG (sea) Not classified
Marine pollutant: Not classified
General information: handle gently to prevent the package material from damaging and shaping during transportation. Keep
containers tightly closed in dry, cool and well-ventilated place. Be away from light.

15. REGULATORY INFORMATION

This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.

16. OTHER INFORMATION

Label Statements: Caution! This material may form explosive dust-air mixtures minimize dust generation and accumulation. This
information contained herein is based on current knowledge and experience, no responsibility is accepted that the information is
sufficient or correct in all cases. Users should consider these data only as a supplement to other information gathered by them and
must make independent determinations of suitability and completeness of information from all sources to assure proper use and
disposal of these materials and the safety and health of employees and customers and the protection of the environment.

Address: Cangzhou economic development zone Jiuhe east road No.21

Tel: 0086(0)317 5105699 Fax: 0086(0)317-5106596