SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Losartan / Hydrochlorothiazide Formulation

Manufacturer or supplier's details
Company: Organon & Co.
Address:JL Raya Pandaan KM. 48
Pandaan, Jawa Timur - Indonesia

Telephone:+1-551-430-6000

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

E-mail address

EHSSTEWARD@organon.com:

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

2. HAZARDS IDENTIFICATIONGHS Classification
Serious eye damage/eye irritation:

Category 1

Skin 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 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
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/ 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
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name

CAS-No.
2 / 19Concentration (% w/w)

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Cellulose
Losartan
StarchHydrochlorothiazide

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

9004-34-6
124750-99-8
9005-25-8
58-93-5>= 30 -< 60>= 10 -< 30>= 10 -< 30>= 1 -< 10

4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek 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.
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 firefighting::

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.
Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
3 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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:

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.

Special protective equipment :for firefighters

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.

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.

7. HANDLING AND STORAGE

4 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Conditions for safe storage:

Materials to avoid:

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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.
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

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

CAS-No.

Control parameBasisters / Permissible
concentration
9004-34-6
10 mg/m3
ID OEL
10 mg/m3
ACGIH124750-99-8
100 µg/m3 (OEBInternal
2)9005-25-8NAB
10 mg/m3
ID OEL
Further information: Not classified as carcinogenic to humans. Not
enough data to classify these materials as carcinogenic to humans or animals
TWA
10 mg/m3
ACGIH
58-93-5
TWA
100 µg/m3 (OEBInternal
2)

Cellulose
Losartan
StarchHydrochlorothiazide

Engineering measures:

Value type
(Form ofexposure)
NAB
TWA
TWA

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 rec5 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

Filter type
Hand protection
Material:

ommended guidelines, use respiratory protection.
Particulates type:Chemical-resistant gloves

Eye protection:

Skin and body protection
Hygiene measures::

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.
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.

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColour:yellow

Odour:

odourlessOdour Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

Not applicable

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

6 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

Not applicable

Relative vapour density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Auto-ignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

Not applicable

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

No data available

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

Heat, flames and sparks.
Avoid dust formation.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact
7 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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
LD50 (Mouse): 590 mg/kg
Application Route: Intravenous

Skin corrosion/irritation
Not classified based on available information.
Components:
Losartan:
SpeciesResult::RabbitMild skin irritation
8 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

Hydrochlorothiazide:
SpeciesResultSDS Number:
17065-00022::

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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

Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.

9 / 19SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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
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
10 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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

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

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

Species:Rat, male and female
11 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

Application RouteExposure time
ResultSDS Number:
17065-00022:::

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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
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:
12 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

Effects on fertility

SDS Number:
17065-00022:

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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.

Hydrochlorothiazide:
Target Organs
Assessment::

Kidney, Parathyroid gland
Causes damage to organs through prolonged or repeatedexposure.

Repeated dose toxicity
Components:
Cellulose:
13 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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 timeTarget Organs

:
:
:
:
:

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

Application RouteExposure time

14 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

Target Organs

SDS Number:
17065-00022:

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

Parathyroid gland

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
Ingestion::

Symptoms: Eye irritation
Symptoms: hypotension, tachycardia

Hydrochlorothiazide:
Eye contact
Ingestion::

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

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

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

12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:

15 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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):log Pow: 1.2

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

16 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

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.

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

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

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Special precautions for user
Not applicable

17 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or mixture
Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered: Not applicable
Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Substances
Hazardous substances approved for use: Not applicable
Prohibited substances:

Not applicable

Restricted substances:

Not applicable

Regulation of the Ministry of Trade No. 7 of 2022 on Distribution and Control of Hazardous
Materials
Type of hazardous materials subject to distribution and : Not applicable
control, Annex I
Type of hazardous materials subject to distribution and :control, Annex II

Not applicable

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

not determined

IECSC

:

not determined

Revision Date:

2023/09/26

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/

Date format:

yyyy/mm/dd

16. OTHER INFORMATION

Full text of other abbreviations
18 / 19

SAFETY DATA SHEET

Losartan / Hydrochlorothiazide Formulation
Version
5.1

Revision Date:
2023/09/26

SDS Number:
17065-00022

Date of last issue: 2023/03/20
Date of first issue: 2014/09/30

ACGIH
ID OEL::USA. ACGIH Threshold Limit Values (TLV)
Indonesia. Occupational Exposure Limits

ACGIH / TWA
ID OEL / NAB::

8-hour, time-weighted averageLong term exposure limit

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
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.
ID / EN

19 / 19