SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Section 1: Identification
Product identifier:

Olmesartan Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
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:

Section 2: Hazard identification
Classification of the substance or mixture
Reproductive toxicity: Category 1A
GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.

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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
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.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Olmesartan
Cellulose

CAS-No.
144689-63-4
9004-34-6

Concentration (% w/w)>= 1 -< 10>= 1 -< 10Section 4: First-aid measures
Description of necessary 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.
If inhaled: If inhaled, remove to fresh air.
Get medical attention.
In case of skin contact: In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of eye contact: If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed: If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Most important symptoms and effects, both acute and delayed
Risks: May damage the unborn child.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
Protection of first-aiders: First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

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

Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, 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

Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances 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.
Section 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
Environmental precautions
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 containment and cleaning up
Methods for 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).
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

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.
Section 7: Handling and storage
Precautions for safe handlingTechnical measures:

Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
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.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents
4 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Olmesartan

144689-63-4

Cellulose

9004-34-6

Appropriate engineering
control measures:

Value type
(Form ofexposure)
TWA
Wipe limit
PEL (long
term)
TWA

Control parameters / Permissible
concentration
30 µg/m3 (OEB 3)
300 µg/100 cm²
10 mg/m3

Basis

10 mg/m3

ACGIH

Internal
Internal
SG OELAll engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-face containment devices).
Minimize open handling.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Skin protection: Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
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:

Consider double gloving.

Section 9: Physical and chemical properties

5 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Appearance:

powderColour:No data available

Odour

:

No data available

Odour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

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

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(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

6 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle characteristics
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.

Section 10: Stability and reactivity

Section 11: Toxicological information
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method:

LD50 (Rat): > 2,000 mg/kg

Components:
Olmesartan:
Acute oral toxicity

LD50 (Mouse): > 2,000 mg/kg
LD50 (Dog): > 1,500 mg/kg
Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Cellulose:
7 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

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

No data available

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Olmesartan:
SpeciesResult
Method:::RabbitModerate eye irritation
Draize Test

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Olmesartan:
Exposure routes
Remarks::

Skin contact
No data available

Germ cell mutagenicity
Not classified based on available information.
Components:
Olmesartan:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Mutagenicity (in vitro mammalian cytogenetic test)
Result: negative
8 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Test Type: Chromosome aberration test in vitro
Test system: Chinese hamster lung cells
Result: positive
Test Type: Mouse Lymphoma
Result: negative
Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Germ cell mutagenicity Assessment:

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

:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Cellulose:
Genotoxicity in vitro

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

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
Olmesartan:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Oral
2 Years
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
6 Months
negative

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative
9 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Reproductive toxicity
May damage the unborn child.
Components:
Olmesartan:
Effects on fertility

Effects on foetal development:

Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 1,000 mg/kg body weight
Result: No effects on fertility:

Test Type: Development
Species: Rat
Application Route: Oral
Dose: 1000 milligram per kilogram
Result: No teratogenic effects
Test Type: Development
Species: Rabbit
Application Route: Oral
Dose: 1 milligram per kilogram
Result: No teratogenic effects
Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: >= 1.6 mg/kg body weight
Symptoms: Malformations were observed., Reduced bodyweightResult: Effects on postnatal development

Reproductive toxicity - Assessment
Cellulose:
Effects on fertility

Effects on foetal development:

Positive evidence of adverse effects on development fromhuman epidemiological studies.

:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
10 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Repeated dose toxicity
Components:
Olmesartan:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
2,000 mg/kg
Oral
24 Months
No significant adverse effects were reported

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Olmesartan:
Eye contact
Ingestion::

Symptoms: Eye irritation
Symptoms: hypotension
Remarks: May cause harm to the unborn child.
Based on Human Evidence

Section 12: Ecological information
Toxicity
Components:
Cellulose:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Bioaccumulative potential
No data available
11 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Mobility in soil
No data available
Other adverse effects
No data available
Section 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.

Section 14: Transport information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to IMO instruments
Not applicable for product as supplied.

12 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

Special precautions for user
Not applicable
Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

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

Section 16: Other information

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
SG OEL: Singapore. Workplace Safety and Health (General Provisions)
Regulations - First Schedule Permissible Exposure Limits of
Toxic Substances.
ACGIH / TWA
SG OEL / PEL (long term)::

8-hour, time-weighted average
Permissible Exposure Level (PEL) Long Term

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
13 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.0

Revision Date:
06.04.2024

SDS Number:
717988-00017

Date of last issue: 30.09.2023
Date of first issue: 01.06.2016

x% response; 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; 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 - 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 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.
SG / EN

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