SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

Section 1: Identification
Product identifier:

Losartan 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
Acute toxicity (Oral): Category 4
Serious eye damage/eye irritation:

Category 1

Skin sensitisation:

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, including precautionary statements
Hazard pictograms:

Signal word:

DangerHazard statements:

H302 Harmful if swallowed.
H317 May cause an allergic skin reaction.
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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

H318 Causes serious eye damage.
H360D May damage the unborn child.
H362 May cause harm to breast-fed children.
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 should not be allowed out of
the workplace.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P301 + P312 + P330 IF SWALLOWED: Call a POISONCENTER/ doctor if you feel unwell. Rinse mouth.
P302 + P352 IF ON SKIN: Wash with plenty of 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/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention.
P362 + P364 Take off contaminated clothing and wash it before
reuse.
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
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

CAS-No.
2 / 17

Concentration (% w/w)

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Cellulose
Losartan
StarchDate of last issue: 26.09.2023
Date of first issue: 07.10.2014

9004-34-6
124750-99-8
9005-25-8>= 30 -< 50>= 30 -< 50>= 10 -< 20

Section 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: 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: If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Most important symptoms and effects, both acute and delayed
Risks: 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.
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).
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:

Water spray
Alcohol-resistant foam
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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

Unsuitable extinguishingmedia

SDS Number:
19366-00023:

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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
Chlorine compounds
Nitrogen oxides (NOx)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).
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
4 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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.
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.
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.
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.
Contaminated work clothing should not be allowed out of theworkplace.
Wash contaminated clothing before re-use.

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

5 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Components

CAS-No.

Cellulose

9004-34-6

Losartan

124750-99-8

Starch

9005-25-8

Appropriate engineering
control measures:

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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

Control parameters / Permissible
concentration
10 mg/m3

Basis

10 mg/m3
100 µg/m3 (OEB
2)
10 mg/m3

ACGIH
Internal

10 mg/m3

ACGIH

SG OELSG OEL

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 thework area (i.e., there is no leakage from the equipment).
If sufficient ventilation is unavailable, use with local exhaust
ventilation.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear the following personal protective equipment:
Chemical resistant goggles must be worn.
If splashes are likely to occur, wear:
Face-shield
Skin protection: Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).
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:

Choose gloves to protect hands against chemicals dependingon the concentration and quantity of the hazardous substance and specific to place of work. Breakthrough time is notdetermined for the product. Change gloves often! For special
applications, we recommend clarifying the resistance tochemicals of the aforementioned protective gloves with theglove manufacturer. Wash hands before breaks and at theend of workday.

Section 9: Physical and chemical properties
Appearance:

powder

6 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

Colour:White to light yellow

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:

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

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

1 g/cm³

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

Oxidizing properties:

The substance or mixture is not classified as oxidizing.
7 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

Molecular weight:

No data available

Minimum ignition energy:> 300 mJ

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
Harmful if swallowed.
Product:
Acute oral toxicity:

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

Cellulose:
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

Components:

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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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 sensitisation
Skin sensitisation
May cause an allergic skin reaction.
Respiratory sensitisation
Not classified based on available information.
Components:
Losartan:
Test Type
Exposure routes
Species
Assessment
Result:::::Maximisation Test
Skin contact
Guinea pig
Probability or evidence of skin sensitisation in humans
positive

Starch:Test Type:Maximisation Test
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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

Exposure routes
SpeciesResultSDS Number:
19366-00023:::

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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 assay
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:Genotoxicity in vitro:

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

Carcinogenicity
Not classified based on available information.
Components:
Cellulose:
Species:Rat
10 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

Application RouteExposure time
Result:::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

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

Effects on foetal development

Losartan:
Effects on fertility

Effects on foetal development:

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:

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

:

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 the offspring were detected only at high maternally toxic doses, No
teratogenic effects
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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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 period

STOT - 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:
Exposure routes
Target Organs
Assessment:::

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

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

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

Repeated dose toxicity
Components:

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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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
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

Losartan:
Toxicity to fish:

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

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

Toxicity to daphnia and otheraquatic invertebrates

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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

Toxicity to algae/aquaticplantsSDS Number:
19366-00023:

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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
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.

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SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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.
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)
15 / 17:

Not applicableSAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

Regulations
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
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
16 / 17

SAFETY DATA SHEET

Losartan Formulation
Version
5.0

Revision Date:
06.04.2024

SDS Number:
19366-00023

Date of last issue: 26.09.2023
Date of first issue: 07.10.2014

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.
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