MATERIAL SAFETY DATA SHEET

Issued Date: 01/08/2011

Reference code: RENALSOL-A
Ver: 00
SECTION 1.-PRODUCT AND COMPANY IDENTIFICATION

Product name: Haemodialysis (HD) Liquid Acid Concentrate, BP

RENAL-SOL ® A Series
Medical device: Class IIb (Malaysia: Class C)
GMDN code: 40100
Synonym code: 35849, 33626

Manufacturer: Renal Laboratories Sdn. Bhd. (394956-H)

PT42, Lengkuk Teknologi 4, Persiaran Teknologi 4,
Techpark@Enstek, 71760 Negeri Sembilan, Malaysia.

Emergency Telephone Numbers: MEDI-CHEM SYSTEMS SDN. BHD. (146451-T)

Tel: +603-6188 8811

SECTION 2.- COMPOSITION/INFORMATION ON INGREDIENTS

Component CAS # Approx. W/V. %
Sodium Chloride, BP 7647-14-5 16 – 22
Potassium Chloride, BP 7447-40-7 0 - 0.5
Calcium Chloride, BP 10043-52-4 0 - 0.5
Magnesium Chloride, BP 7786-30-3 0.1
Glacial Acetic Acid, BP 64-19-7 0-7
Highly Purified Water, BP 7732-18-5 75 - 80

SECTION 3.- HAZARD IDENTIFICATION

Appearance: Clear, colourless solution

Physical State: Liquid
Odor: Vinegar
Hazards of Product: Corrosive

Potential Health Effects

Inhalation: Effects from inhalation may cause mild irritation to the upper respiratory tract.
Symptoms may include sneezing, sore throat or runny nose.
Ingestion: Swallowing may cause burns of mouth, throat, and stomach.
Symptoms may include bleeding, vomiting, or diarrhea.
Skin Contact: Contact with skin can cause irritation.
Eye Contact: Causes irritation of eyes.

SECTION 4.- FIRST AID MEASURES

EYES AND SKIN: Immediately flush with water for at least 15 minutes, lifting the upper
and lower eyelids intermittently. If burn or irritation has occurred, seek
medical attention or a medical doctor or ophthalmologist
immediately. If clothing contaminated, remove clothing, wash skin
and wash clothing and/or shoes before reusing. See a medical doctor.

INGESTION: If swallowed, rinse mouth with water and drink large amounts of water.
Do not attempt to induce vomiting. Never give anything by mouth to
an unconscious person. See a medical doctor.

INHALATION: If inhaled, move to fresh air. If breathing discomfort occurs and persists,
see a medical doctor.
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SECTION 5.- FIRE FIGHTING MEASURES

Flash Point: N/A

Flammable Limits: N/A
Extinguishing Media: N/A
Unusual Fire and Explosion Hazards: Does not support combustion

EXTINGUISHING MEDIA: use water to keep fire exposed containers cool.

FIRE FIGHTING PROCEDURES:

Use flooding quantities of water ONLY. Use water spray to keep fire exposed containers
cool. Fight fire from protected location or maximum distance. Use proper personal
protective equipment.

SECTION 6.- ACCIDENTAL RELEASE MEASURES

RELEASE NOTES:
• Put on eye protection, protective gloves, boots, clothing and a respirator if air
contamination is above the permitted levels.
• Contain the spill.
• If allowed by federal, state or local regulatory authority, flush spill to the sewer.
• If mops, towels, paper towel or similar material is used, insure that these items are
thoroughly rinsed with copious amounts of water.
• Do not reuse the liquid material. Stop or control leak using protective clothing.
• Control run off and isolate discharged material for proper disposal.

SECTION 7.- HANDLING AND STORAGE:

GENERAL HANDLING:
• Avoid contamination; impurities accelerate decomposition of the product.
• Store in a dry area under 30ºC.
• For quality purposes avoid temperatures above 30ºC.
• Do not reuse or topping the solution from others.
• Do not store unused product in original closed container.
• Never return product to original storage area or container.
• Keep container closed when not in use.
• Do not break the seal if not in use.
• Always read the user manual before use.

VENTILATION: Handle in well-ventilated area.

SECTION 8.-EXPOSURE CONTROL AND PERSONAL PROTECTION

TECHNICAL CONTROLS: Proper ventilation

PERSONAL PROTECTIVE EQUIPMENT

EYES AND FACE: ANSI approved safety glasses / goggles/facial protection.

A face shield should be worn when splashes are likely.

PROTECTIVE CLOTHING: A protective apron should be worn when splashes are likely.
Rubber boots should be used for spill response.

GLOVES: Protective gloves should be worn.

RESPIRATOR: If air contamination is above the permitted levels, use a NIOSH

approved respirator.
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SECTION 9.-PHYSICAL AND CHEMICAL PROPERTIES

Physical State : Liquid

Appearance : Clear, colourless solution
pH (as a concentrate) : 1.5 – 3.5
Solubility in Water (By weight) : Complete
Odor : Vinegar like
Specific Gravity (H2O = 1) : 1.2
Vapor Density (air = 1) : 1.0

SECTION 10. - STABILITY AND REACTIVITY

Stability status : Stable under recommended storage conditions (<30 ºC)

Conditions to Avoid : None Known
Incompatible Materials : Bases and corrosive to metals
Hazardous Polymerization : Not applicable
Hazardous Decomposition : Not applicable

SECTION 11. - TOXICOLOGICAL DATA

Hemodialysis Acid Concentrate as a product was tested and determined not to be toxic to
humans.

IRRITABILITY:
Eyes: irritating Skin: irritating Inhalation: irritating

SECTION 12.- ECOLOGICAL INFORMATION

Environmental Fate: No information found

Environmental Toxicity: No information found

SECTION 13.- DISPOSAL CONSIDERATIONS

Dispose of this product in accordance with all applicable Federal, State and Local
Regulations.

SECTION 14.- TRANSPORT INFORMATION

This product is not defined as a hazardous material in accordance with the Department of
Transportation.

SECTION 15.- REGULATORY INFORMATION

Hemodialysis Acid Concentrate must registered as a medical device with Medical Device
Control Division, MOH Malaysia as class C product. International registration for CE marking,
Council Directive 93/42/EEC Annex I, according to Annexe IX Section III rules 3, class IIb.

SECTION 16. - OTHER INFORMATION

NFPA classification: Health: 2 Flammability: 0 Reactivity: 0 Specific Hazard: Corrosive

HMIS Ratings: Health: 2 Flammability: 0 Reactivity: 0 PPE: B

End of MSDS.

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