Safety Data Sheet
1. PRODUCT AND COMPANY IDENTIFICATION
Product Name: Kaltostat® Wound Dressing
Synonyms/Generic KALTOSTAT® Calcium Sodium Alginate Wound Dressing
Names:
Product Use: For Exuding Wounds
The use of KALTOSTAT® and KALTOSTAT® Fortex™ wound dressings is
not recommended for infants less than 12 months of age.
Manufacturer: ConvaTec Limited
200 Headquarters Park Drive
Skillman, NJ 08558.
Customer Helpline Customer Interaction Center: 800-422-8811 or 908-904-2432
8:30 AM – 8:00 PM EST Monday – Thursday
8:30 AM – 6:00 PM EST Friday
10:00 AM – 2:00 PM EST Saturday
In Case Of Emergency 24 Hours 7 Days a Week
Call: U.S.: CHEMTREC 1-800-424-9300
Outside U.S.: CHEMTREC 703-527-3887
2. HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW: A fiber dressing for wounds. Not considered hazardous.
Product Classification under OSHA Hazard Communication rule. Not hazardous
Potential Health Hazards:
(For liquid absorbed onto non-hazardous pads.)
Skin: No affects.
Eyes: No affects (and not an anticipated route of exposure).
Inhalation: No affects (and not an anticipated route of exposure).
Ingestion: Not an anticipated route of exposure
Delayed Effects: None anticipated.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient Name CAS Number Weight %
No hazardous ingredients listed --- ---
Trace impurities and additional material names not listed above may appear in Section 15 of this SDS. These
materials may be listed for local "Right-To-Know" compliance and for other reasons.
4. FIRST AID MEASURES
Skin: Not normally required. Product is used on the skin.
Eyes: Flush eyes thoroughly with running water. Get medical attention if irritation
develops.
Inhalation: Not normally required.
Ingestion: Not normally required.
SDS: Kaltostat® Wound Dressing Current Issue Date: September 26, 2011 Page 1 of 4
SDS – Kaltostat® Wound Dressing
Advice to Physician: Treat symptomatically.
5. FIRE FIGHTING MEASURES
Flammable Properties
Flash Point (and method) Solid material. Not applicable.
Autoignition Temperature: Not determined
Upper Flame Limit (volume % in air): Not applicable
Lower Flame Limit (volume % in air): Not applicable
Flame Propagation Rate (solids): Not determined
Extinguishing Media: If ignited by a fire, use water, water fog, CO2 or dry chemical
Unusual Fire And Explosion Hazards: None
Special Fire Fighting Wear self contained breathing apparatus.
Precautions/Instructions:
6. ACCIDENTAL RELEASE MEASURES
In Case Of Spill or (See Section 8 for recommended personal protective equipment.)
Other Release: Pick up wound dressings and discard
Spills and releases may have to be reported to Federal and/or local authorities. See Section 15
regarding reporting requirements.
7. HANDLING AND STORAGE
Normal Handling: Wash hands after handling.
Storage Store in a cool, dry place suitable for medical supplies.
Recommendations:
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Engineering Controls: Not required
Personal Protective Equipment
Skin Protection: Not required.
Protection: Not required.
Respiratory Protection: Not required.
Additional Not normally required.
Recommendations:
Exposure Guidelines
Ingredient ACGIH TLV OHSA PEL NIOSH REL
None --- --- ---
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SDS – Kaltostat® Wound Dressing
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: A dressing.
Physical State: Solid
Specific Gravity (water = 1.0): Not determined
Solubility In Water (weight %): Not determined
pH: Not applicable
Boiling Point: Not determined
Freezing Point: Not determined
Viscosity Not determined
Vapour Pressure: Not determined
Vapour Density (air = 1.0): Not determined
Evaporation Rate: Not determined Compared To:
% Volatiles: Not applicable
Flash Point: Not applicable
10. STABILITY AND REACTIVITY
Normally Stable: Stable
Incompatibilities: Strong oxidizing agents may cause smoldering or a fire.
Hazardous Decomposition Products: Carbon monoxide and carbon dioxide are primary hazardous
thermal decomposition products.
Hazardous Polymerization: Will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity: Solid dressing material not likely to cause toxic effects.
Eye Irritation: Not expected.
Skin Irritation: None. Product is used on skin.
Chronic data: None anticipated. This material has not been identified as a carcinogen by NTP, IARC, or
OSHA.
12. ECOLOGICAL INFORMATION
Product has not been tested as a mixture. Do not discharge to waterways.
13. DISPOSAL CONSIDERATIONS
The information offered in Section 13 is for the product as shipped. Use and/or alterations to the product such
as mixing with other materials may significantly change the characteristics of the material and alter the proper
disposal method.
Disposal Not a RCRA hazardous waste. May be disposed of as waste medical supplies.
Considerations:
14. TRANSPORT INFORMATION
Shipping Name: Not regulated
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SDS – Kaltostat® Wound Dressing
ADR Hazard Class Not regulated
Canadian TDG Hazard Class: Not regulated
IATA Hazard Class (air): Not regulated
IMDG Hazard Class (sea): Not regulated
US DOT Hazard Class: Not regulated
15. REGULATORY INFORMATION
TSCA & DSL STATUS
TSCA Inventory Status: This is a medical supply manufactured from TSCA listed materials.
Other TSCA Issues: None
DSL Status (Canada) This is a medical supply manufactured from materials on the Canadian
Domestic Substances List.
SARA TITLE III/CERCLA
Reportable Quantities (RQs) and/or Threshold Planning Quantities (TPQs) exist for the following
ingredients.
Ingredient Name SARA/CERCLA RQ (lb) SARA EHS TPQ (lb)
No ingredients listed in this section.
Spills or releases resulting in the loss of any ingredient at or above its RQ requires immediate notification
to the National Response Center [(800) 424-8802] and to your Local Emergency Planning Committee.
SECTION 311 HAZARD CLASS: None
SARA 313 TOXIC CHEMICALS:
The following ingredients are SARA 313 "Toxic Chemicals". CAS numbers and weight percents are found
in Section 3. These chemicals may be subject to annual ‘chemical release’ reporting.
Ingredient Name Comment
No ingredients listed in this section
STATE RIGHT-TO-KNOW
In addition to the ingredients found in Section 2, the following are listed for state right-to-know purposes.
Ingredient Name Weight % Comment
No ingredients listed in this section.
OTHER REGULATORY INFORMATION:
Additional Regulatory None
Information:
WHMIS Classification (Canada): Not a controlled product as shipped.
This product has been classified in accordance with hazard criteria of the
Controlled Products Regulations and the MSDS contains all the
information required by the Controlled Products Regulations.
16. OTHER INFORMATION
Current Issue Date: September 26, 2011
Previous Issue Date: None
Changes from previous Issue Date: New SDS
Other Product Information: None
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