SAFETY DATA SHEET

According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
1. IDENTIFICATION OF SUBSTANCE/MIXTURE AND COMPANY/UNDERTAKING
A
PRODUCT INFORMATION
sadasProduct Name : Human Insulin – Bulk (rDNA origin)
Intended Use : Used in manufacture of pharmaceutical product

DETAILS OF MANUFACTURER/ SUPPLIER

Company : Biocon Biologics Limited
20th KM, Hosur Road
Electronic City
Bangalore 560 100, Karnataka, India
Telephone : 91 80 2808 2808
Emergency Telephone : 91 80 2808 2663
Contact E-mail : Biocon-SDS@biocon.com

2. HAZARD IDENTIFICATION

CLASSIFICATION OF THE SUBSTANCE OR MIXTURE

GHS Classification
No classification and labelling according to GHS

LABEL ELEMENTS
Pictograms : N/A

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
Signal Word : N/A
A
Hazard Statements
sadasN/A
Precautionary Statements
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing

OTHER HAZARDS
No data available
Note: This document has been prepared in accordance with standards for workplace safety, which
requires inclusion of all known hazards of the product or its ingredients regardless of the potential
risk. The precautionary statements and warning included may not apply in all cases. Your needs
may vary depending upon the potential for exposure in your workplace.

3. COMPOSITION / INFORMATION ON INGREDIENTS

HAZARDOUS COMPONENTS

EU EINECS /
Ingredient Name CAS No. R- Phrases Concentration
ELINCS List
Human Insulin - Bulk --- --- --- ---
(rDNA origin)

For any EHS Regulations/Legislations specific to this mixture, please see Section 15

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
4. FIRST AID MEASURES
A
sadas
General Advice Have the product container, label or Safety Data Sheet with
you when calling the Biocon Emergency Number, a poison
control center or physician, or going for treatment
Inhalation If inhaled, remove to fresh air; if breathing is difficult, give
oxygen; if breathing stops, give artificial respiration. Call a
physician if symptoms develop or persist.
Skin Contact Flush with copious amounts of water; remove contaminated
clothing and shoes; call a physician. Get medical attention if
any irritation develops and persists.
Eye Contact Check for and remove contact lenses and flush with copious
amounts of water; assure adequate flushing by separating
the eyelids with fingers; call a physician
Ingestion If symptoms persist, wash out mouth with copious
amounts of water; call a physician

Symptoms and Effects of Exposure

For information on potential signs and symptoms of exposure see Section 2 – Hazards
Identification and/or Section 11 – Toxicological Information

5. FIRE-FIGHTING MEASURES
Suitable Extinguishing Media Adapt extinguishing media to surrounding fire conditions
Fire/Explosion Hazards No information available
Further Information Wear self-contained breathing apparatus and protective
clothing to prevent contact with skin and eyes.

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
6. ACCIDENTAL RELEASE MEASURES
A
Personal Precautions Ensure adequate ventilation. Avoid inhalation of vapors.
sadas Wear self-contained breathing apparatus, rubber boots
and heavy rubber gloves
Environmental Precautions Take steps to avoid release into environment
Methods for Containment/Cleaning Absorb spillage with suitable absorbent material. Mop
area with soap and water. Ventilate area and wash spill
site after material pick up is complete.
Additional Advice Transfer to a chemical waste container for disposal in
accordance with local regulations

7. HANDLING AND STORAGE

Precautions for Safe Handling Avoid inhalation and contact with skin and eyes. Normal
measures for preventive fire protection
Storage Area and Containers Store as per directed on the container/packaging

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

OCCUPATIONAL EXPOSURE LIMITS

Type of Exposure
Components Exposure Limits Source of OEL data
Limit
Human Insulin- Bulk
--- --- ---
(rDNA origin)

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
Occupational Exposure Band (OEB) : ---

APERSONAL PROTECTIVE EQUIPMENT

Respiratory Protection NIOSH/MSHA-approved respirator protecting mask
sadas (Filter P2 and above)
Hand Protection Chemical-resistant rubber gloves
Eye Protection Chemical safety goggles.
Skin and Body Protection Choose body protection in relation to its type, to the
concentration and amount of dangerous substances,
and to the specific work-place.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State : Solid
Colour and Appearance : A white or almost white
Odour : No data
Molecular Formula : No data
PH : No data
Solvent Solubility : No data
Water Solubility : Insoluble
Boiling Point : No data

FLAMMABILITY

Auto ignition Temperature (ºC) : No data

Flash Point (Liquid) (ºC) : No data

Flammability (Solids) : No data

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Human Insulin – Bulk (rDNA origin)
Revision Date: 11/08/2021
SDS Number: BLKINS0010
Dasd
Upper Explosive Limits (% by vol.)
ALower Explosive Limits (% by vol.)
sadas
10. STABILITY AND REACTIVITY
Conditions to Avoid
Hazardous Decomposition Products
Incompatible Materials
Possibility of Hazardous Reactions
11. TOXICOLOGICAL INFORMATION
INFORMATION ON TOXICOLOGICAL EFFECTS
Acute Toxicity
Irritation/ Sensitization
Reproduction &
Developmental Toxicity
Genetic Toxicity
Carcinogenicity
Germ Cell Mutagenicity
Carcinogen Status
Other Toxicity Information
Version No: 4.0 Print Date: 11/08/2021
: No data
: No data
Protect from light and heat
No data available
Avoid storing with strong oxidizing agents, acids, bases
No data available
Based on available data, the classification criteria are not met
May cause skin and eye irritation.
Based on available data, the classification criteria are not met.
Based on available data, the classification criteria are not met.
Based on available data, the classification criteria are not met.
Based on available data, the classification criteria are not met.
Based on available data, the classification criteria are not met.
If absorbed through the mucous membranes such as respiratory tract or
mouth, may exert a systemic hypoglycemic effect.
RTECS #: --; Only select Registry of Toxic Effects of Chemical Substances
(RTECS) data is presented here. See actual entry in RTECS for complete
information
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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
A 12. ECOLOGICAL INFORMATION
sadas
Environmental Overview Avoid release into the environment
Toxicity No appreciable eco-toxic potential is to be expected
Persistence and Degradability No data is available
Bio-accumulative potential No data is available
Mobility in Soil No data is available

13. DISPOSAL CONSIDERATIONS

Product Disposal Incinerate in an approved facility. Do not allow wash

Contaminated Packaging Disposal
Waste Treatment Methods
water from cleaning or process equipment to enter
drains
Material and packaging should be disposed of in
accordance with Federal, State and local environmental
control regulations.
Contact a licensed professional waste disposal service to
dispose of this material.

14. TRANSPORT INFORMATION

Marine Pollutant – No
LAND TRANSPORT (ADR-RID)
NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
SEA TRANSPORT (IMDG)
NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS

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SAFETY DATA SHEET
According to UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Human Insulin – Bulk (rDNA origin)

Revision Date: 11/08/2021 Version No: 4.0 Print Date: 11/08/2021
SDS Number: BLKINS0010

Dasd
AIR TRANSPORT (ICAO-IATA)
NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS
A
15. REGULATORY INFORMATION
sadas
EU EINECS / ELINCS List : No data available
EHS Regulations/Legislations specific to mixture : No data available
Other Information : No data available
According to present data no classification and labeling is required according to Directives
67/548/EEC or 1999/45/EC.

16. OTHER INFORMATION

Revision Details: Version 3.0 to 4.0 – Section 1,3 and 16 updated

Note: This SDS confirms to GHS, Classification, Labelling and Packaging (CLP) Regulation 1272/2008/EC
(CLP) and 1907/2006/EC (REACH) regulations.

Biocon Biologics Limited believes that the above information is believed to be correct and while it is
provided in good faith, it is without warranty of any kind, expressed or implied. If data for hazard is not
included in this document there is no known information at that time. Actual conditions of use are beyond
the seller's control. User is responsible to evaluate all available information when using product for any
particular use and to comply with all Federal, State, Provincial and Local laws and regulations.

For use only by trained personnel. The burden of safe use of this material rests entirely with the user. BBL
disclaims all liability for any damage resulting from use of this material. The information relates only to
the specific material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text. This version replaces all previous versions

Revision Date : 11/08/2021

Prepared by : Biocon Biologics Environment Health and Safety Department
*** END OF SAFETY DATA SHEET***

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