SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Losartan / Hydrochlorothiazide Formulation

Supplier's company name, address and phone number
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

E-mail address:

EHSSTEWARD@organon.com

Emergency telephone number :+1-215-631-6999

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

2. HAZARDS IDENTIFICATIONGHS classification of chemical product
Serious eye damage/eye irri- : Category 1
tationSkin sensitisation:

Category 1

Reproductive toxicity:

Category 1BSpecific target organ toxicity repeated exposure:

Category 2 (Kidney, Parathyroid gland)Specific target organ toxicity repeated exposure (Oral):

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

Effects on or via lactation

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H317 May cause an allergic skin reaction.
1 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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 (Kidney, Parathyroid
gland) through prolonged or repeated exposure.
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.
Response:
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
Important symptoms and out- : Contact with dust can cause mechanical irritation or drying oflines of the emergency asthe skin.
sumed
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

Mixture2 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Components
Chemical name
Cellulose
Losartan
StarchCAS-No.
9004-34-6
124750-99-8
9005-25-8

Hydrochlorothiazide

58-93-5

Concentration (% w/w)>= 30 - < 40>= 20 - < 30>= 10 - < 20

ENCS No.

8-98>= 1 - < 10

4. FIRST AID MEASURES
General 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:

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, 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.
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.
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.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during fire-:

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

:

Avoid generating dust; fine dust dispersed in air in sufficient3 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

fighting

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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)
Chlorine compounds
Sulphur 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.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

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 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.

:

Static electricity may accumulate and ignite suspended dust
causing an explosion.

7. HANDLING AND STORAGE
Handling
Technical measures

4 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Local/Total ventilation:

Advice on safe handling:

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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.
Oxidizing agents
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.
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.
Keep in properly labelled 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
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

Value type
(Form ofexposure)
5 / 21

Control parameters / Reference
concentration /BasisSAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Cellulose
Losartan

9004-34-6
124750-99-8

TWA
TWA

StarchHydrochlorothiazide

9005-25-8
58-93-5TWA
TWA

Engineering measures:

Permissible concentration
10 mg/m3
100 µg/m3 (OEB
2)
10 mg/m3
100 µg/m3 (OEB
2)

ACGIH
Internal
ACGIH
Internal

Use feasible engineering controls to minimize exposure tocompound.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.

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
Eye protection:

Skin and body 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.
Work uniform or laboratory coat.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

powderColour:yellow

Odour:

odourlessOdour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
6 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Upper explosion limit / Upper flammability limit:

No data available

Lower explosion limit /Lower flammability limit:

No data available

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

Not applicableAuto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

Not applicable

Vapour pressure:

Not applicable

Density and / or relative density
Relative density:
Density

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

No data available:

No data available

Relative vapour density:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

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:

Heat, flames and sparks.

10. STABILITY AND REACTIVITY

7 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Incompatible materials
Hazardous decomposition
products::

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

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

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:

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

Hydrochlorothiazide:
Acute oral toxicity:

LD50 (Rat): > 2,750 mg/kg
LD50 (Mouse): > 2,830 mg/kg

Acute toxicity (other routes of :administration)

LD50 (Rat): 990 mg/kg
Application Route: Intravenous
8 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

LD50 (Mouse): 590 mg/kg
Application Route: Intravenous
Skin corrosion/irritation
Not classified based on available information.
Components:
Losartan:
SpeciesResult::RabbitMild skin irritation

Hydrochlorothiazide:
SpeciesResult::RabbitNo skin irritation

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

Starch:SpeciesResult::RabbitNo eye irritation

Hydrochlorothiazide:
SpeciesResult::RabbitMild 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
9 / 21SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

Starch:Test Type
Exposure routes
SpeciesResultSDS Number:
17071-00022

:
:
:
:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Maximisation 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 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

Hydrochlorothiazide:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
10 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: negative
Test Type: sister chromatid exchange assay
Test system: Chinese hamster ovary cells
Result: positive
Test Type: in vitro assay
Test system: mouse lymphoma cells
Result: positive
Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Chinese hamster
Cell type: Bone marrow
Result: negative
Test Type: in vivo assay
Species: Mouse
Cell type: Bone marrow
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.
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

11 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Hydrochlorothiazide:
Species
Application RouteExposure time
Result::::Mouse, female
Oral
2 Years
negative

Species
Application RouteExposure time
Result::::Mouse, maleOral
2 Years
equivocal

Species
Application RouteExposure time
Result::::Rat, male and female
Oral
2 Years
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
Test Type: Development
12 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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

Hydrochlorothiazide:
Effects on fertility:

Test Type: Fertility
Species: Rat, male and female
Application Route: oral (feed)
Fertility: NOAEL: 4 mg/kg body weight
Result: Effects on fertility
Test Type: Fertility
Species: Mouse, male and female
Application Route: oral (feed)
Fertility: NOAEL: 100 mg/kg body weight
Result: Effects on fertility

Effects on foetal development:

Test Type: Development
Species: Mouse
Application Route: Oral
Developmental Toxicity: NOAEL: 3,000 mg/kg body weight
Result: No teratogenic effects
Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: NOAEL: 1,000 mg/kg body weight
Result: No teratogenic effects

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs (Kidney, Parathyroid gland) through prolonged or 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.
13 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

Hydrochlorothiazide:
Target Organs
Assessment

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30::

Kidney, Parathyroid gland
Causes 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

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

Hydrochlorothiazide:
Species
LOAEL
Application RouteExposure time

:
:
:
:

Rat, male and female
10 mg/kg
Oral
2 yr

Repeated dose toxicity
Components:

14 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Target Organs:

Kidney, Parathyroid glandSpecies
NOAEL
Application RouteExposure time
Remarks:::::

Mouse, male and female
300 - 550 mg/kg
Oral
2 yr
No significant adverse effects were reported

Species

:
:
:
:
:

Dog
50 - 200 mg/kg
Oral
9 Months
Parathyroid gland

Application RouteExposure timeTarget Organs

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

Symptoms: Eye irritation

Ingestion:

Symptoms: hypotension, tachycardia

Hydrochlorothiazide:
Eye contact:

Symptoms: Eye irritation

Ingestion:

Symptoms: Dizziness, Headache, Fatigue, Nausea, Abdominal pain, hypotension, dry mouth, electrolyte imbalance,eye pain:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Cellulose:
Toxicity to fish

15 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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)
Hydrochlorothiazide:
Toxicity to fish

Toxicity to daphnia and otheraquatic invertebrates

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:

LC50 (Pimephales promelas (fathead minnow)): > 500 mg/l
Exposure time: 96 h:

EC50 (Daphnia magna (Water flea)): > 500 mg/l
Exposure time: 48 h

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Losartan:
Stability in water:

Hydrolysis: < 10 %(5 d)Hydrochlorothiazide:
Stability in water:

Hydrolysis: 46.2 %(96 h)

16 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Bioaccumulative potential
Components:
Losartan:
Partition coefficient: noctanol/water:log Pow: 1.2

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
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.

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable:Not applicable

14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number

17 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
17071-00022

:
:
:
:
:
:
:

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
18 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Not regulated as a dangerous good
Aviation Law
Not regulated as a dangerous goodMarine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determined

19 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

DSL:

not determined

IECSC

:

not determined:

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

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

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

yyyy/mm/dd

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 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
20 / 21

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
8.0

Revision Date:
2024/04/06

SDS Number:
17071-00022

Date of last issue: 2023/09/26
Date of first issue: 2014/09/30

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.
JP / EN

21 / 21