SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

SECTION 1. IDENTIFICATION
Product name:

Losartan Formulation

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
Acute toxicity (Oral):

Category 4

Serious eye damage:

Category 1

Skin sensitization:

Category 1

Reproductive toxicity:

Category 1B:

Category 2 (Blood, Cardio-vascular system, Stomach, Kidney)

Effects on or via lactation
Specific target organ toxicity- repeated exposure (Oral)
GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H302 Harmful if swallowed.
H317 May cause an allergic skin reaction.
H318 Causes serious eye damage.
H360D May damage the unborn child.
H362 May cause harm to breast-fed children.
1 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

H373 May cause damage to organs (Blood, Cardio-vascularsystem, Stomach, Kidney) through prolonged or repeated exposure if swallowed.
Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust.
P263 Avoid contact during pregnancy and while nursing.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P272 Contaminated work clothing must not be allowed out of
the workplace.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P301 + P312 + P330 IF SWALLOWED: Call a doctor if you feelunwell. Rinse mouth.
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously withwater for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISONCENTER.
P308 + P313 IF exposed or concerned: Get medical attention.
P333 + P313 If skin irritation or rash occurs: Get medical attention.
P363 Wash contaminated clothing before reuse.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.

Other hazards
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.
Cellulose
9004-34-6
Losartan
124750-99-8
Starch
9005-25-8
Actual concentration is withheld as a trade secret
SECTION 4. FIRST AID MEASURES
2 / 18

Concentration (% w/w)>= 30 - < 50>= 30 - < 50>= 10 - < 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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:

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.
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 contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention immediately.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Harmful if swallowed.
May cause an allergic skin reaction.
Causes serious eye damage.
May damage the unborn child.
May cause harm to breast-fed children.
May cause damage to organs through prolonged or repeatedexposure if swallowed.
Contact with dust can cause mechanical irritation or drying of
the skin.
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).
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
Chlorine compounds
Nitrogen oxides (NOx)Specific extinguishing methods:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
3 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

Special protective equipment
for fire-fighters

SDS Number:
19367-00022:

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

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

Use personal protective equipment.
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 forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer 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:

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.
Avoid contact during pregnancy and while nursing.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
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.
4 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Conditions for safe storage:

Materials to avoid:

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

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 footValue 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.

Cellulose

9004-34-6

5 / 18

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

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

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

ACGIH
NIOSH REL

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Losartan

124750-99-8

Starch

9005-25-8

Engineering measures:

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014
TWA (respirable fraction)
TWA
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)

5 mg/m³

OSHA Z-1

100 µg/m3 (OEB
2)
10 mg/m³
5 mg/m³

Internal

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

ACGIH
NIOSH REL

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).
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

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:

Skin and body protection:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
Wear the following personal protective equipment:
Chemical resistant goggles must be worn.
If splashes are likely to occur, wear:
Face-shield
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
6 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

Hygiene measures

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
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.
Contaminated work clothing should not be allowed out of theworkplace.
Wash contaminated clothing before re-use.

:

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

White to light yellow

Odor

:

No data available

Odor 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:

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

Partition coefficient: n-:

No data available
7 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

octanol/water
Autoignition temperature:

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

Minimum ignition energy:> 300 mJ

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
Harmful if swallowed.
Product:
Acute oral toxicity:

Acute toxicity estimate: 1,502 mg/kg
Method: Calculation method

Components:
Cellulose:
8 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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

Losartan:Acute oral toxicity:

LD50 (Mouse): 1,257 - 1,590 mg/kg
LDLo (Rat): 200 mg/kg
LDLo (Mouse): 400 mg/kg

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

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

Skin corrosion/irritation
Not classified based on available information.
Components:
Losartan:
SpeciesResult::RabbitMild skin irritation

Serious eye damage/eye irritation
Causes serious eye damage.
Components:
Losartan:
SpeciesResult::RabbitSevere irritation

Starch:SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
May cause an allergic skin reaction.
Respiratory sensitization
Not classified based on available information.

9 / 18SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Components:
Losartan:
Test Type
Routes of exposure
Species
Assessment
Result:::::Maximization Test
Skin contact
Guinea pig
Probability or evidence of skin sensitization in humans
positive

Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

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

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

Losartan:
Genotoxicity in vitro:

Test Type: in vitro test
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: Chinese hamster ovary cells
Result: negative
Test Type: Alkaline elution assay
Result: negative
Test Type: Chromosomal aberration
Result: negative

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Result: negative

Starch:10 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

Genotoxicity in vitro

SDS Number:
19367-00022:

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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

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

:
:
:
:

Rat
Ingestion
72 weeks
negative

Losartan:
Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Mouse
Oral
92 weeks
200 mg/kg body weight
negative

Species
Application RouteExposure time
Dose
Result

:
:
:
:
:

Rat
Oral
105 weeks
270 mg/kg body weight
negative

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.

Reproductive toxicity
May damage the unborn child.
May cause harm to breast-fed children.
Components:
Cellulose:
Effects on fertility:

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

Effects on fetal development:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative
11 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Losartan:
Effects on fertility:

Test Type: Fertility
Species: Rat, female
Application Route: Oral
Fertility: LOAEL: 200 mg/kg body weight
Result: female reproductive effects
Remarks: Maternal toxicity observed.

Effects on fetal development:

Test Type: Development
Species: Rabbit
Application Route: Oral
General Toxicity Maternal: NOAEL: 10 mg/kg body weight
Developmental Toxicity: NOAEL F1: 20 mg/kg body weight
Result: Embryotoxic effects and adverse effects on theoffspring were detected only at high maternally toxic doses,
No teratogenic effects.
Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Result: Fetotoxicity., No teratogenic effects.

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on development, based onanimal experiments.
Studies indicating a hazard to babies during the lactation
periodSTOT-single exposure
Not classified based on available information.
STOT-repeated exposure
May cause damage to organs (Blood, Cardio-vascular system, Stomach, Kidney) through prolonged or repeated exposure if swallowed.
Components:
Losartan:
Routes of exposure
Target Organs
Assessment:::

Ingestion
Blood, Cardio-vascular system, Stomach, Kidney
May cause damage to organs through prolonged or repeatedexposure.

:
:
:
:

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

Repeated dose toxicity
Components:
Cellulose:
Species
NOAEL
Application RouteExposure time

12 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Losartan:
Species
LOAEL
Application RouteExposure time
Number of exposures
Target Organs

:
:
:
:
:
:

Rat
15 mg/kg
Oral
309 d
daily
Blood, Kidney, Cardio-vascular system, StomachSpecies
NOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:

Dog
5 mg/kgOral
1 Months
Salivation, Vomiting

Species
LOAEL
Application RouteExposure time
Number of exposures
Symptoms

:
:
:
:
:
:

Dog
25 mg/kgOral
53 Weeks
daily
Salivation, Vomiting

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Aspiration toxicity
Not classified based on available information.
Components:
Losartan:
No aspiration toxicity classification
Experience with human exposure
Components:
Losartan:
Eye contact
Ingestion::

Symptoms: Eye irritation
Symptoms: hypotension, tachycardia

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
13 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

Toxicity to fish:

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

Losartan:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 929 mg/l
Exposure time: 96 h
Method: FDA 4.11

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 331 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:NOEC (Microcystis aeruginosa (blue-green algae)): 949 mg/l
Exposure time: 10 d
Method: FDA 4.01
NOEC (Selenastrum capricornutum (green algae)): 143 mg/l
Exposure time: 10 d
Method: FDA 4.01

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Pimephales promelas (fathead minnow)): 10 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210
NOEC (Daphnia magna (Water flea)): 100 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Losartan:
Stability in water:

Hydrolysis: < 10 %(5 d):log Pow: 1.2

Bioaccumulative potential
Components:
Losartan:
Partition coefficient: noctanol/water
Mobility in soil
No data available
Other adverse effects
No data available
14 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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.
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
Acute toxicity (any route of exposure)Respiratory or skin sensitization
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)
Serious eye damage or eye irritation

15 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

SARA 313:

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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
Cellulose
Losartan
D-Glucose, 4-O-β-D-galactopyranosyl-, monohydrate
Starch

9004-34-6
124750-99-8
64044-51-5
9005-25-8

California Permissible Exposure Limits for Chemical Contaminants
Cellulose
Starch

9004-34-6
9005-25-8

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
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health30Special hazard*

4

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)
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

NIOSH REL
OSHA Z-1::

OSHA Z-3:

ACGIH / TWACAL PEL / PELNIOSH REL / TWA:::

OSHA Z-1 / TWA
OSHA Z-3 / TWA::

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

USA. NIOSH Recommended Exposure Limits
USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
8-hour, time-weighted average
Permissible exposure limit
Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
8-hour time weighted average
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 Prevention 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:

09/26/2023

17 / 18

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Losartan Formulation
Version
9.1

Revision Date:
09/26/2023

SDS Number:
19367-00022

Date of last issue: 03/20/2023
Date of first issue: 10/07/2014

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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