Lilly: Insulin, Human
Eli Lilly and Company
Material Safety Data Sheet
MSDS Index
Insulin, Human
Effective Date: 19-Apr-2000
Section 1 - Chemical Product and Company
Emergency Phone:
Manufacturer:
1-317-276-2000
Eli Lilly and Company
CHEMTREC:
Lilly Corporate Center
1-800-424-9300 (North America)
Indianapolis, IN 46285
1-703-527-3887 (International)
Common Name: Insulin, Human
Chemical Name: Insulin (human)
Synonym(s): Insulin; Biosynthetic Human Insulin; BHI; Cartridge; NPH; Lente; Ultralente; Berlinsulin H; 041001
Formulation
Tradename(s): Humulin; Human Insulin; Humulin Profilong; Humuline; Humulina; Umuline; Symbol; Pro-Humulin; Pro-
Huminsulin; Mix25; Lilly Human Insulin; Humutard; Humuline Profilongue; Humsulin; Huminsulin Profil; Bio-Insulin;
Huminsulin; Huminsulin Basal; Biosuline
Lilly Item Code(s): HI0010; HI0040; HI0080; HI0210; HI0211; HI0212; HI0217; HI0218; HI0219; HI0240; HI0241;
HI0242; HI0280; HI0310; HI0312; HI0314; HI0317; HI0318; HI0319; HI0340; HI0342; HI0380; HI0410; HI0412; HI0414;
HI0417; HI0418; HI0419; HI0440; HI0442; HI0480; HI0500; HI0610; HI0612; HI0617; HI0619; HI0640; HI0710; HI0714;
HI0717; HI0718; HI0719; HI0740; HI0810; HI0814; HI0817; HI0818; HI0819; HI0840; HI0910; HI0914; HI0917; HI0918;
HI0919; HI0940; HI1510; HI1514; HI1517; HI1518; HI1519; HI1540; HI1610; HI1614; HI1617; HI1618; HI1619; HI1640;
HP8120; HP8130; HP8150; HP8160; HP8170; HP8180; HP8190; HP8720; HP8730; HP8750; HP8760; HP8770; HP8780;
HP8790; MS8094; MS8095; MS8305; MS8306; VF0103; VF0104; VF0105; VF0106; VF0107; VF0108; VF0109; VF0110;
VF0111; VF0116; VF0117; VF0147; VF0149; VF0150; VF0179; VF0183; VF0228; VF0229; VL7613; VL7614; VL7615
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Zinc-Insulin Crystals Human 11061-68-0 0.1 - 0.4
Protamine Sulfate 9009-65-8 0 - 1.5
Glycerin 56-81-5 1.4 - 1.8
m-Cresol 108-39-4 0 - 0.22
http://ehs.lilly.com/msds/msds_insulin_human.html (1 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
Methylparaben 99-76-3 0 - 0.1
Phenol 108-95-2 0 - 0.28
Water for Injection 7732-18-5 95
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater) not listed above.
Exposure Guidelines:
Insulin crystals - LEG 120 micrograms/m3 TWA (respirable) for 12 hours, 600 micrograms/m3 TWA (respirable) for 15
minutes STEG.
Protamine sulfate - No known occupational exposure limits established.
Glycerin (mist) - PEL 5 mg/m3 TWA (respirable) and 15 mg/m3 TWA (total). TLV 10 mg/m3 TWA.
UK - Exposure Standard 10 mg/m3 TWA.
Ireland - Occupational Exposure Limit 10 mg/m3 TWA.
France - Occupational Exposure Limit 10 mg/m3 (VME) TWA.
Section 3 - Hazards Identification
Appearance: Clear solution to white milky suspension
Physical State: Liquid
Odor: Odorless
Emergency Overview
Emergency Overview Effective Date: 26-Aug-1998
Lilly Laboratory Labeling Codes:
Health 0 Fire 0 Reactivity 0
Primary Physical and Health Hazards: Not Considered a Health Hazard.
Caution Statement: Insulin, Human is not considered to be a health hazard.
Routes of Entry: Inhalation and skin contact.
Potential Signs and Symptoms of Occupational Exposure: None reported.
Medical Conditions Aggravated by Exposure: Hypersensitivity to insulin.
Carcinogenicity: Zinc-insulin crystals human - Not listed by IARC, NTP, ACGIH, or OSHA. One-year subcutaneous
http://ehs.lilly.com/msds/msds_insulin_human.html (2 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
injection studies with insulin, lispro demonstrated no evidence of carcinogenicity in rats.
Protamine sulfate - No carcinogenicity data found. Not listed by IARC, NTP, ACGIH, or OSHA.
Glycerin - No carcinogenicity data found. Not listed by IARC, NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Flush eyes with plenty of water. Get medical attention.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with plenty of soap and
water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not breathing, provide
artificial respiration assistance (mouth-to-mouth) and call a physician immediately.
Ingestion: Call a physician or poison control center. No first aid procedures are normally required.
Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
Unusual Fire and Explosion Hazards: None known.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Prevent further migration into the environment. Use absorbent/adsorbent material to solidify liquids. Sweep up or
vacuum. Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for specific handling
precautions).
Section 7 - Handling and Storage
Storage Conditions: Refrigerator: 2 to 8 C (36 to 46 F).
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Under normal use and handling conditions, no protective equipment is required. The following is recommended for a
http://ehs.lilly.com/msds/msds_insulin_human.html (3 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
production setting:
Respiratory Protection: Use an approved respirator.
Eye Protection: Safety glasses.
Ventilation: Laboratory fume hood or local exhaust ventilation.
Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin contact. If handled in a
ventilated enclosure, as in a laboratory setting, respirator and goggles or face shield may not be required. Safety glasses are
always required.
Section 9 - Physical and Chemical Properties
Boiling Point: >100 C (212 F)
Melting Point: No applicable information found
Specific Gravity: 1.004-1.007
pH: 7.0-7.8
Evaporation Rate: No applicable information found
Water Solubility: Slightly soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid, etc.).
Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Animal Toxicity Data Single Exposure
No data are available for Insulin, Human. Toxicity data for insulin, lispro crystals are presented.
Oral: No applicable information found.
Skin: No applicable information found.
Inhalation: No applicable information found.
http://ehs.lilly.com/msds/msds_insulin_human.html (4 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
Intravenous: Insulin, lispro crystals - Rat, 10 units/kg, no deaths or toxicity.
Dog, 0.1 units/kg, no deaths, decreased blood glucose values.
Subcutaneous: Insulin, lispro crystals - Rat, 10 units/kg, no deaths or toxicity.
Dog, 2 units/kg, no deaths or toxicity.
Skin Contact: No applicable information found.
Eye Contact: No applicable information found.
Animal Toxicity Data Repeat Exposure
Toxicity data for Insulin, Human, insulin, insulin, lispro crystals, and protamine sulfate are presented as indicated.
Target Organ Effects: Insulin - Hormonal effects (decreased blood sugar).
Reproduction: Insulin - Mixed results reported in animal studies. Effects were attributed to hypoglycemia. Insulin itself is
not considered a reproduction hazard.
Protamine sulfate - No effects identified in limited animal studies.
Sensitization: Insulin, lispro crystals - Rhesus monkeys, extremely weak immunogenic potential.
Mutagenicity: Insulin, Human - Not mutagenic in bacterial or mammalian cells.
Section 12 - Ecological Information
No applicable ecological information found.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws and regulations. This
material contains m-cresol and may be regulated under 40 CFR 261.24 when disposed in bulk quantities or in a production
setting. The finished product, e.g., vials, would not be regulated under 40 CFR 261 for disposal under normal use and
handling conditions.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
http://ehs.lilly.com/msds/msds_insulin_human.html (5 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Eli Lilly and Company usage. This section is not a
complete analysis or reference to all applicable regulatory information. Please consider all applicable laws and regulations
for your country/state.
U.S. Regulations:
Zinc-insulin crystals human
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
Protamine sulfate and glycerin
TSCA - Yes
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EC Classification and Risk and Safety Phrases:
Not assigned an overall EC classification.
Section 16 - Other Information
MSDS Sections Revised: Section 1.
As of the date of issuance, we are providing available information relevant to the handling of this material in the
workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS MATERIAL
SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY WARRANTY OF ANY KIND (INCLUDING
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse
incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with
appropriately trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which may
accompany the finished product.
For additional information contact:
Eli Lilly and Company
Environmental Science and Hazard Communication
317-277-4259
For additional copies contact:
Eli Lilly and Company
1-800-LILLY-Rx (1-800-545-5979)
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
http://ehs.lilly.com/msds/msds_insulin_human.html (6 of 7) [07/12/2002 4:02:42 PM]
Lilly: Insulin, Human
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
http://ehs.lilly.com/msds/msds_insulin_human.html (7 of 7) [07/12/2002 4:02:42 PM]
|