SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

SECTION 1. IDENTIFICATION
Product name:Infliximab Formulation - (OGN)

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
GHS label elements
Signal Word:

Warning

Hazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.

Other hazards
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Sucrose57-50-1
Infliximab
170277-31-3
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 70 - < 90>= 10 - < 20

SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders
Notes to physician:::

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.
Wash with water and soap.
Get medical attention if symptoms occur.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
Wear self-contained breathing apparatus for firefighting if
necessary.
Use personal protective equipment.

SECTION 6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Follow safe handling advice (see section 7) and personal
protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials for:

Sweep up or vacuum up spillage and collect in suitable2 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

containment and cleaning up

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

container for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are
released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation
Advice on safe handling::

Conditions for safe storage:

Materials to avoid:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not breathe dust.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
15 Million particles per cubic foot3 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL

Components

CAS-No.

Sucrose57-50-1

Infliximab
Engineering measures

170277-31-3:

Value type
(Form ofexposure)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA

Control parameters / Permissible
concentration
10 mg/m³
5 mg/m³

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

150 µg/m³

Internal

ACGIH
NIOSH REL

Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,
dust collectors, vessels, and processing equipment) aredesigned in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

For prolonged or repeated contact use protective gloves.
Wash hands before breaks and at the end of workday.
Wear the following personal protective equipment:
Safety goggles
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

Skin and body protection
Hygiene measures

SDS Number:
9875895-00006::

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Skin should be washed after contact.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Amorphous powder

Color

:

white

Odor

:

No data available

Odor Threshold:

No data available

pH

:

7.2

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

May form explosive dust-air mixture during processing,handling or other means.

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

1 g/cm³

Solubility(ies)
Water solubility:

No data available:

No data available:

No data available

Partition coefficient: noctanol/water
Autoignition temperature

5 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing,handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Components:
Infliximab:
Remarks:

No data available

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Infliximab:
Remarks:

No data available

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Components:
Sucrose:Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative

Infliximab:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: Chromosomal aberration
Test system: human lymphoblastoid cells
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Method: OECD Test Guideline 474
Result: negative

Germ cell mutagenicity Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

Carcinogenicity
Not classified based on available information.
IARC
No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.
OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as a known or anticipated carcinogen by NTP.

7 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Reproductive toxicity
Not classified based on available information.
Components:
Infliximab:
Effects on fertility:

Test Type: Fertility
Species: Mouse
Application Route: Intravenous injection
Fertility: NOAEL: 40 mg/kg body weight
Remarks: Based on data from similar materials

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Mouse, female
Application Route: Intravenous injection
Duration of Single Treatment: 6 - 12 dGeneral Toxicity Maternal: NOAEL: 40 mg/kg body weight
Teratogenicity: NOAEL F1: 40 mg/kg body weight
Developmental Toxicity: NOAEL F1: 40
Embryo-fetal toxicity.: NOAEL: 40 mg/kg body weight
Remarks: Based on data from similar materials

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Infliximab:Species
NOAEL
Application RouteExposure time
Number of exposures

:
:
:
:
:

Mouse
40 mg/kg
Intravenous
6 Monthsdaily

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Infliximab:
Inhalation:

Symptoms: Nausea, Vomiting, Abdominal pain, Diarrhea,
Fatigue, Headache, Back pain

8 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Infliximab:
Ecotoxicology Assessment
Acute aquatic toxicity:

No data available

Chronic aquatic toxicity

No data available:

Persistence and degradability
No data available
Bioaccumulative potential
Components:
Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

Mobility in soil
No data available
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
9 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

Domestic regulation
49 CFR
Not regulated as a dangerous goodSpecial precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
SucroseInfliximab

57-50-1
170277-31-3

California Permissible Exposure Limits for Chemical Contaminants
Sucrose57-50-1

The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

10 / 12SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021
HMIS® IV:

Flammability

HEALTH1
Health00Special hazard/

0

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 8-hour time weighted average
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Pre11 / 12

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
09/30/2023

SDS Number:
9875895-00006

Date of last issue: 04/04/2023
Date of first issue: 10/19/2021

vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

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