MATERIAL SAFETY DATA SHEET
Thermazene Cream
1. PRODUCT AND COMPANY IDENTIFICATION
Thermazene Cream
Product Name
Burn Cream / 50-1000 gm
Use/Size
8884-473000, 8884-473400, 8884-473800, 8884-472609, 8884-
Product Numbers
473888
Tyco Healthcare/ Kendall
Manufacturer/Supplier
15 Hampshire Street
Address
Mansfield, MA 02048
(508) 261-8000 (Monday ?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
Water 7732-18-5 > 75.00% R-None None
231-791-2
Stearyl Alcohol 112-92-5 15.00 -25.00% R-None None
204-017-6
Petroleum Jelly 8009-03-8 10.00 -20.00% R-None None
232-373-2
Polyethylene glycol monostearate 9004-99-3 5.00 -10.00% R-None None
No EC #
Propylene Glycol 57-55-6 5.00 -10.00% R-None None
200-338-0
Isopropyl Myristate 110-27-0 5.00 -10.00% R-None None
203-751-4
Silver Sulfadiazine 22199-08-2 1.00 -3.00% R-None None
244-834-5
3. HAZARD IDENTIFICATION
EU Main Hazards
Not classified as hazardous.
Routes of Entry
- Eye contact - Ingestion - Skin contact
Carcinogenic Status
Not considered carcinogenic by NTP, IARC, and OSHA.
Target Organs
- Eye - Skin - Kidney - Central Nervous System
Health Effects - Eyes
Contact may cause conjunctival irritation and transient corneal damage.
Health Effects - Skin
This product is non-irritating to the skin and skin absorption is not associated with any health effects.
Repeated or prolonged contact may produce defatting of the skin leading to irritation and dermatitis.
Page 1 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
3. HAZARD IDENTIFICATION
Health Effects - Ingestion
A large dose may have the following effects: nausea - vomiting - diarrhea - gastrointestinal irritation
- kidney damage - central nervous system depression
Health Effects - Inhalation
No adverse effects are expected during normal conditions of use.
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
Wash skin thoroughly with soap and water. Obtain medical attention if blistering occurs or redness
persists.
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
Not Flammable. Select extinguishing agent appropriate to other materials involved.
Unusual Fire and Explosion Hazards
None known.
Protective Equipment for Fire-Fighting
Wear full protective clothing and self-contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
This product may be collected by carefully scooping into a pan, paper towel or other absorbent
material. Transfer into suitable containers for recovery or disposal. No specific measures necessary.
7. HANDLING AND STORAGE
Keep container tightly closed when not in use. Storage area should be: - cool - dry - well ventilated
- away from incompatible materials
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Occupational Exposure Standards
Exposure limits are listed below, if they exist.
Stearyl Alcohol
None assigned.
Page 2 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Petroleum Jelly
None assigned.
Polyethylene glycol monostearate
(as Stearates) ACGIH: TLV 10mg/m3 8h TWA.
A4 - not classifiable as a human carcinogen.
Propylene Glycol
None assigned.
Isopropyl Myristate
None assigned.
Silver Sulfadiazine
(as silver, metal) ACGIH: TLV 0.1mg/m3 8h TWA.
UK EH40: OES 0.1mg/m3 8h TWA.
(as Silver, Soluble) ACGIH: TLV 0.01mg/m3 8h TWA.
Engineering Control Measures
No specific measures necessary. Good general room ventilation is expected to be adequate to control
airborne levels.
Respiratory Protection
Respiratory protection not normally required.
Hand Protection
Skin protection not normally required.
Eye Protection
Eye protection not normally required. However, care should be taken to avoid accidental exposure.
Body Protection
Normal work wear.
9. PHYSICAL AND CHEMICAL PROPERTIES
Cream
Physical State
White
Color
Fragrant
Odor
No data.
pH
No data.
Specific Gravity
No data.
Boiling Range/Point (癈/F)
No data.
Melting Point (癈/F)
No data.
Flash Point (PMCC) (癈/F)
No data.
Explosion Limits (%)
No data.
Vapor Pressure
No data.
Density
Insoluble
Solubility in Water
No data.
Vapor Density (Air = 1)
No data.
Viscosity (cSt)
Page 3 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
10. STABILITY AND REACTIVITY
Stability
Stable under normal conditions.
Conditions to Avoid
- Heat - High temperatures
Materials to Avoid
- Strong oxidizing agents
Hazardous Polymerization
Will not occur.
Hazardous Decomposition Products
- acrid smoke and irritating fumes - oxides of carbon - silver oxide - oxides of sulfur
11. TOXICOLOGICAL INFORMATION
Acute Toxicity
All components have a low order of acute toxicity. All components have oral LD50s (rat) greater than
10000mg/kg. In dermal toxicity studies, this product was not found to be a primary skin irritant when
applied to rabbit skin for 24 or 48 hours.
Propylene Glycol: Oral LD50 (rat) 30 g/kg.
Isopropyl Myristate: Dermal LD50 (rabbit) 5 g/kg.
Chronic Toxicity/Carcinogenicity
Stearyl Alcohol: When implanted in mice (1000 mg/kg) caused an increased incidence of tumors in
the kidney, ureter and bladder.
Genotoxicity
Propylene Glycol: DNA inhibition (mouse-subcutaneous); cytogenetic analysis (mouse-
subcutaneous; hamster-fibroblast).
Silver Sulfadiazine: DNA damage, unscheduled DNA synthesis and DNA inhibition (microorganisms).
Reproductive/Developmental Toxicity
Propylene Glycol: Intraperitoneal injections (100 mg/kg) to mice during pregnancy resulted in an
increase in post-implantation mortality and fetotoxicity.
Silver Sulfadiazine: Subcutaneous administration to rats prior to pregnancy (11 gm/kg) resulted in an
increase in pre- and post-implantation mortality and decreased litter size. When given
subcutaneously to rats (11 gm/kg) and rabbits (26-65 gm/kg) during pregnancy, caused
developmental abnormalities of the musculoskeletal system and decreased viability of newborns.
12. ECOLOGICAL INFORMATION
Mobility
(Isopropyl Myristate)
If released to soil, isopropyl myristate is expected to have no mobility based upon an estimated Koc of
15,000.
(Stearyl Alcohol)
If released to soil, 1-octadecanol is not expected to be mobile due to strong soil adsorption.
Persistence/Degradability
(Isopropyl Myristate)
Isopropyl myristate is expected to rapidly biodegrade in aerobic soils as suggested by the rapid
biodegradation of structurally similar long-chain fatty acid esters. If released into water, isopropyl
myristate is expected to adsorb to suspended solids and sediment in the water column based upon
Page 4 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
10. STABILITY AND REACTIVITY
the estimated Koc. Isopropyl myristate is expected to rapidly biodegrade in aerobic waters as
suggested by the rapid biodegradation of structurally similar long-chain fatty acid esters.
(Propylene Glycol)
Photodegrades rapidly if released to the atmosphere. Will biodegrade rapidly if released to water or
soil. Leaching in the soil will occur (Log Kow = -0.92), however, biodegradation is rapid enough to
diminish the importance of leaching. Volitilization, adsorption to sediment and bioconcentration
(BCF<1) are not expected to be significant.
Bio-accumulation
(Isopropyl Myristate)
An estimated BCF of 1200 suggests the potential for bioconcentration in aquatic organisms is very
high.
(Stearyl Alcohol)
An estimated BCF value of 28,800 suggests that 1-octadecanol will bioconcentrate in aquatic
organisms.
Ecotoxicity
(Propylene Glycol)
Tests on the following species gave a 96h LC50 of 10000mg/litre: - guppies
13. DISPOSAL
Dispose of in accordance with all applicable local and national regulations.
14. TRANSPORT INFORMATION
Not Regulated
DOT CFR 172.101 Data
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.
Page 5 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
15. REGULATORY INFORMATION
US REGULATIONS (Federal, State) and INTERNATIONAL CHEMICAL REGISTRATION LAWS
TSCA Listing
This product contains an ingredient(s) that is exempt from listing on the EPA Toxic Substance Control
Act Chemical Inventory. - Silver Sulfadiazine (22199-08-2)
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
The following ingredient(s) have not been verified for inclusion on the Canadian Domestic Substance
List (DSL) or the Non-Domestic Substance List (NDSL): - Silver Sulfadiazine (22199-08-2)
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 contains the following chemicals found on the Pennsylvania Hazardous Substance List:
- Propylene Glycol
NJ Right To Know Law
This product does not contain any chemicals on the New Jersey Workplace Hazardous Substance
List. - Silver Sulfadiazine (as silver compound)
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.
SARA Title III Sect. 304
RQ 1000 lbs. (as silver 7440-22-4)
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 contains a chemical that is listed in Section 313 at or above de minimis concentrations.
The following listed chemicals are present: - Silver Sulfadiazine (as silver) 7440-22-4
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
Page 6 of 7
Revision Date: January 30, 2004
MATERIAL SAFETY DATA SHEET
Thermazene Cream
16. OTHER INFORMATION
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.
Page 7 of 7
Revision Date: January 30, 2004
|