MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
1. PRODUCT AND COMPANY IDENTIFICATION
Aquaflo鈩? Hydrogel Wound Dressing
Product Name
Wound Dressings
Use/Size
8884-476105, 8884-476139, 8884-476154
Product Numbers
Tyco Healthcare/ Kendall
Manufacturer/Supplier
15 Hampshire Street
Address
Mansfield, MA 02048
(508) 261-8000 (Monday 鈥? Friday 8:00 am to 5:00 pm)
Phone Number
(800) 424-9300
Chemtrec Number
January 30, 2004
Revision Date:
September 22, 1998
MSDS Date:
This MSDS has been compiled in accordance with - EC Directive 91/155/EC - OSHA's Hazcom Standard (29 CFR 1910.1200)
2. COMPOSITION/INFORMATION ON THE COMPONENTS
Component Name CAS#/Codes Concentration R Phrases Classification
Polyoxyethylene Glycol 25322-68-3 5.00 -20.00% R-None None
200-849-9
Propylene Glycol 57-55-6 5.00 -20.00% R-None None
200-338-0
Water 7732-18-5 20.00 -70.00% R-None None
231-791-2
Proprietary Urethane Polymer N.A. 10.00 -30.00% R-None None
No EC #
Polyoxyalkyleneamine 65605-36-9 0.20 -2.00% R-None None
3. HAZARD IDENTIFICATION
EU Main Hazards
Not classified as hazardous.
Routes of Entry
- Eye contact - Skin contact
Carcinogenic Status
Not considered carcinogenic by NTP, IARC, and OSHA.
Target Organs
- Eye - Skin
Health Effects - Eyes
Contact may cause very slight irritation.
Health Effects - Skin
This product is non-irritating to the skin and skin absorption is not associated with any health effects.
Does not cause irritation or sensitization.
Health Effects - Ingestion
No adverse effects are expected.
Health Effects - Inhalation
No adverse effects are expected during normal conditions of use.
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MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
4. FIRST AID MEASURES
Eyes
Immediately flood the eye with plenty of water for at least 15 minutes, holding the eye open. Obtain
medical attention if soreness or redness persists.
Skin
If skin irritation develops, or other symptoms occur, discontinue use. Seek medical attention if
symptoms persist.
Ingestion
Do not induce vomiting. Have victim drink 1-3 glasses of water to dilute stomach contents. Never
administer anything by mouth if a victim is losing consciousness, is unconscious or is convulsing.
Obtain medical attention immediately.
Inhalation
If there is difficulty in breathing, give oxygen. Seek medical attention if symptoms persist.
Advice to Physicians
Treat symptomatically.
5. FIRE FIGHTING MEASURES
Extinguishing Media
Use water spray, foam, dry chemical or carbon dioxide.
Unusual Fire and Explosion Hazards
This product may give rise to hazardous fumes in a fire.
Protective Equipment for Fire-Fighting
Wear full protective clothing and self-contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
This product, in final form, is a wound dressing, and is not expected to present a spill or release
hazard. No specific measures necessary.
7. HANDLING AND STORAGE
Keep container tightly closed when not in use. Storage area should be: - cool - dry - well ventilated
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Occupational Exposure Standards
Exposure limits are listed below, if they exist.
Polyoxyethylene Glycol
None assigned.
Propylene Glycol
None assigned.
Water
None assigned.
Proprietary Urethane Polymer
None assigned.
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MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Polyoxyalkyleneamine
None assigned.
Engineering Control Measures
No specific measures necessary.
Respiratory Protection
Respiratory protection not normally required.
Hand Protection
Skin protection not normally required.
Eye Protection
Chemical goggles or safety glasses with side shields
Body Protection
Normal work wear.
9. PHYSICAL AND CHEMICAL PROPERTIES
Gel
Physical State
Translucent
Color
Slight polyol
Odor
Slightly Alkaline
pH
No data.
Boiling Range/Point (掳C/F)
No data.
Flash Point (PMCC) (掳C/F)
No data.
Explosion Limits (%)
No data.
Vapor Pressure
No data.
Density
No data.
Solubility in Water
No data.
Vapor Density (Air = 1)
No data.
Viscosity (cSt)
10. STABILITY AND REACTIVITY
Stability
Stable under normal conditions.
Conditions to Avoid
- Heat - High temperatures - Pressure - Mechanical shock
Materials to Avoid
None known.
Hazardous Polymerization
Will not occur.
Hazardous Decomposition Products
- oxides of carbon - oxides of nitrogen
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MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
11. TOXICOLOGICAL INFORMATION
Acute Toxicity
Aquaflo鈩? Hydrogel Wound Dressing saline extract did not cause significant cytotoxicity.
Aquaflo鈩? Hydrogel Wound Dressing saline extract did not cause systemic toxicity by subcutaneous
and Intraperitoneal injections at 2, 24, 48 and 72 hours.
Aquaflo鈩? Hydrogel Wound Dressing did not cause erythema, edema or eschar formation from direct
IM injections at 24, 48 and 72 hours.
Aquaflo鈩? Hydrogel Wound Dressing did not cause dermal sensitization, edema or erythema at 24
and 72 hours.
Aquaflo鈩? Hydrogel Wound Dressing caused significant encapsulation when injected intramuscularly
into rodents. An inadvertent injection of this product does not pose a significant risk of harm based on
negative systemic toxicity and the encapsulation by a tissue barrier preventing release of non-soluble
components into the body.
There were no statistically different (95% confidence limit) product-related mortalities, clinical signs of
toxicity, loss in body weight or microscopic tissue pathology observed in groups of 10 mice of each
sex repeatedly injected with a saline extract of the product every day for 5 days over 4 weeks.
Chronic Toxicity/Carcinogenicity
This product is not expected to cause long-term adverse health effects.
Genotoxicity
Saline and DMSO extracts of Aquaflo鈩? Hydrogel Wound Dressing tested for genotoxicity using the
Ames Mutagenic Assay system was negative.
Reproductive/Developmental Toxicity
This product is not expected to cause reproductive or developmental health effects.
12. ECOLOGICAL INFORMATION
Mobility
No relevant studies identified.
Persistence/Degradability
The product is readily biodegradable.
Bio-accumulation
Product is not expected to bioaccumulate.
Ecotoxicity
No relevant studies identified.
13. DISPOSAL
Dispose of in accordance with all applicable local and national regulations.
14. TRANSPORT INFORMATION
Not Regulated
DOT CFR 172.101 Data
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MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
14. TRANSPORT INFORMATION
Not Regulated
UN Proper Shipping Name
None.
UN Class
None.
UN Number
None.
UN Packaging Group
Consult current IATA Regulations prior to shipping by air.
Classification for AIR
Transportation (IATA)
15. REGULATORY INFORMATION
EU Label Information
Classification and labelling have been performed according to EU directives 67/548/EEC and
99/45/EC including amendments.
EU Hazard Symbol and Indication of Danger
According to EC Commission Directive 67/548/EEC this product is not classified.
R phrases
None.
S phrases
None.
US REGULATIONS (Federal, State) and INTERNATIONAL CHEMICAL REGISTRATION LAWS
TSCA Listing
This product contains ingredients that are listed on or exempt from listing on the EPA Toxic Substance
Control Act Chemical Inventory.
EINECS Listing
All ingredients in this product are listed on the European Inventory of Existing Commercial Chemical
Substances (EINECS) or are exempt from listing.
DSL/NDSL (Canadian) Listing
This product contains ingredients which are not listed on the Domestic Substance List (DSL) or the
Non-Domestic Substance List (NDSL).
MA Right To Know Law
This product does not contain any chemicals listed on the Massachusetts Right To Know Substance
List.
PA Right To Know Law
This product does not contain any chemicals on the Pennsylvania Hazardous Substance List. 鈥?
Propylene glycol
NJ Right To Know Law
This product does not contain any chemicals on the New Jersey Workplace Hazardous Substance
List.
California Proposition 65
This product does not contain materials which the State of California has found to cause cancer, birth
defects or other reproductive harm.
SARA Title III Sect. 302 (EHS)
This product does not contain any chemicals subject to SARA Title III Section 302.
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MATERIAL SAFETY DATA SHEET
Aquaflo鈩? Hydrogel Wound Dressing
15. REGULATORY INFORMATION
SARA Title III Sect. 304
This product does not contain any chemicals subject to SARA Title III Section 304.
SARA Title III Sect. 311/312 Categorization
This product does not meet any of the SARA Title III Section 311/312 categorizations.
SARA Title III Sect. 313
This product does not contain a chemical that is listed in Section 313 at or above de minimis
concentrations.
16. OTHER INFORMATION
NFPA Ratings
NFPA Code for Flammability - 0
NFPA Code for Health - 0
NFPA Code for Reactivity - 0
NFPA Code for Special Hazards - 0
HMIS Ratings
HMIS Code for Flammability - 0
HMIS Code for Health - 0
HMIS Code for Reactivity - 0
HMIS Code for Personal Protection - See Section 8
Abbreviations
N/A: Denotes no applicable information found or available
CAS#: Chemical Abstracts Service Number
ACGIH: American Conference of Governmental Industrial Hygienists
OSHA: Occupational Safety and Health Administration
TLV: Threshold Limit Value
PEL: Permissible Exposure Limit
STEL: Short Term Exposure Limit
NTP: National Toxicology Program
IARC: International Agency for Research on Cancer
EU: European Union
R: Risk
S: Safety
LC50: Lethal Concentration 50%
LD50: Lethal Dose 50%
BOD: Biological Oxygen Demand
KoC: Soil Organic Carbon Partition Coefficient
EnviroNet LLC.
Prepared By:
The information and recommendations presented in this MSDS are based on sources believed to be
accurate; therefore, The Kendall Company assumes no liability for the accuracy or completeness of
this information. It is the user's responsibility to determine the suitability of the information for their
particular purposes.
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Revision Date: January 30, 2004
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