SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:Infliximab Formulation - (OGN)

Manufacturer or supplier's details
Company: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

Emergency telephone number :+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

2. HAZARDS IDENTIFICATION
Manufacture, Storage and Import of Hazardous Chemicals Rules 1989
Classification
Not classified as hazardous according to criteria laid down in Part I of Schedule-1.
GHS Classification
Not a hazardous substance or mixture.
GHS label elements
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
Other hazards which do not result in classification
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name

CAS-No.

SucroseInfliximab

57-50-1
170277-31-3
1 / 10Concentration (%w/w)>= 70 - < 90>= 10 - < 20

SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

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 medicaladvice.

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed
Protection of first-aiders
Notes to physician: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 ofthe skin.
Dust contact with the eyes can lead to mechanical irritation.
No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

::

5. FIREFIGHTING 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 firefighters:

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.

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).

2 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version2.1Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

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 forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitable 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 and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

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 labelled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents

7. HANDLING AND STORAGE

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Components with workplace control parameters
Components

CAS-No.

SucroseInfliximab

57-50-1
170277-31-3

3 / 10

Value type
(Form ofexposure)
TWATWA

Control parameters / Permissible
concentration
10 mg/m3
150 µg/m3

Basis

ACGIHInternal

SAFETY DATA SHEETaccording to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

Engineering measures

SDS Number:
9875905-00006:

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

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) are designed in a manner to prevent the escape of dust into the work
area (i.e., there is no leakage from the equipment).

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body 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
Skin should be washed after contact.

Hygiene measures:

If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the workingplace.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

Amorphous powder

Colour:whiteOdour:

No data available

Odour 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
4 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

1 g/cm³Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

No data available

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

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.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :Inhalation
5 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

exposure

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

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

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

No data available

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
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

6 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

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

Effects on foetal development:

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

Test Type: Embryo-foetal 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-foetal 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.

7 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

Experience with human exposure
Components:
Infliximab:
Inhalation:

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

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: < 1Mobility in soil
No data available
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:Contaminated packaging:

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

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
8 / 10SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version
2.1

Revision Date:
30.09.2023

SDS Number:
9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

30.09.2023

Further information
Sources of key data used tocompile the Safety DataSheet:

Internal technical data, data from raw material SDSs, OECDeChem Portal search results and European Chemicals Agency, http://echa.europa.eu/Date format:

dd.mm.yyyy

16. OTHER INFORMATION

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH / TWA:

8-hour, time-weighted average

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated withx% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA- International Air Transport Association; IBC - International Code for the Construction andEquipment 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 - InternationalMaritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Or9 / 10

SAFETY DATA SHEET
according to the Globally Harmonized System

Infliximab Formulation - (OGN)
Version2.1

Revision Date:
30.09.2023

SDS Number:9875905-00006

Date of last issue: 04.04.2023
Date of first issue: 19.10.2021

ganisation 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 (MedianLethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of 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; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
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 forsafe handling, use, processing, storage, transportation, disposal and release and shall 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 specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
IN / EN

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