SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:

Losartan / Hydrochlorothiazide Formulation

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

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

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Serious eye damage, Category 1
Skin sensitisation, Category 1
Reproductive toxicity, Category 1B
Effects on or via lactation
Specific target organ toxicity - repeatedexposure, Category 2

H318: Causes serious eye damage.
H317: May cause an allergic skin reaction.
H360D: May damage the unborn child.
H362: May cause harm to breast-fed children.
H373: May cause damage to organs through prolonged or repeated exposure.

2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)

1 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Hazard pictograms:

Signal word:

DangerHazard statements

:

H317
H318
H360D
H362
H373

Precautionary statements:

Prevention:
P201
Obtain special instructions before use.
P260
Do not breathe dust.
P263
Avoid contact during pregnancy and while nursing.
P280
Wear protective gloves/ protective clothing/ eyeprotection/ face protection.

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 repeated exposure.

Response:
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiouslywith water for several minutes. Remove contactlenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Hazardous components which must be listed on the label:
Losartan
Hydrochlorothiazide
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
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
3.2 Mixtures
Components
Chemical name

Losartan

CAS-No.
EC-No.
Index-No.
Registration number
124750-99-8

2 / 22

Classification

Concentration(% w/w)

Acute Tox. 4; H302
Eye Dam. 1; H318
Skin Sens. 1; H317>= 20 - < 30

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Hydrochlorothiazide

58-93-5
200-403-3

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021
Repr. 1B; H360D
Lact.H362
STOT RE 2; H373
(Blood, Cardiovascular system,
Stomach, Kidney)
STOT RE 1; H372
(Kidney, Parathyroid gland)

Substances with a workplace exposure limit :Cellulose
9004-34-6
232-674-9
Starch
9005-25-8
232-679-6>= 1 - < 10>= 30 - < 50>= 10 - < 20

For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of 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.
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).

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.

4.2 Most important symptoms and effects, both acute and delayed
Risks: May cause an allergic skin reaction.
3 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 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

5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides
Chlorine compounds
Nitrogen oxides (NOx)
Chlorine compounds
Sulphur oxides:

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

:

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.

4 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 6: Accidental release measures
6.1 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).
6.2 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.
If spillage enters rivers or watercourses, inform the Environment Agency (emergency telephone number 0800 807060).

6.3 Methods and material 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
certain local or national requirements.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:

Local/Total ventilation:

Advice on safe handling:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Avoid contact during pregnancy and while nursing.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure as5 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Hygiene measures:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

sessment
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. Contaminatedwork clothing should not be allowed out of the workplace.
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.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store locked up. Keepareas and containers
tightly closed. Store in accordance with the particular national
regulations.
Advice on common storage

7.3 Specific end use(s)Specific use(s):Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

:

No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
dust of any kind
10 mg/m3
Value type (Form of exposure): TWA (Inhalable)
Basis: GB EH40
4 mg/m3
Value type (Form of exposure): TWA (Respirable fraction)
Basis: GB EH40
Components

CAS-No.

Cellulose

9004-34-6

Value type (Formof exposure)
TWA (inhalable
6 / 22Control parameters

Basis

10 mg/m3

GB EH40SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

Losartan
StarchHydrochlorothiazide

SDS Number:
9371243-00007

124750-998
9005-25-8

58-93-5

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

dust)
TWA (Respirable
dust)
STEL (inhalable
dust)
TWA
TWA (inhalable
dust)
TWA (Respirable
dust)
TWA

4 mg/m3

GB EH40

20 mg/m3

GB EH40

100 µg/m3 (OEB 2)Internal

10 mg/m3

GB EH40

4 mg/m3

GB EH40

100 µg/m3 (OEB 2)Internal

8.2 Exposure controls
Engineering measures
Use feasible engineering controls to minimize exposure to compound.
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect products, workers, and the environment.
Personal protective equipment
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Hand protection
Material: Chemical-resistant gloves
Skin and body protection
Respiratory protection

Filter type::

Work uniform or laboratory coat.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to BS EN 143
Particulates type (P):SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: yellowOdour: odourless
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
7 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Flash point:

Not applicable

Evaporation rate:

Not applicable

Flammability (solid, gas):

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

Upper explosion limit / Upper
flammability limit:

No data available

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::

No data available
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.

9.2 Other information
Flammability (liquids):

No data available:

No data available

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperatureParticle size

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
8 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Hazardous reactions:

May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.

10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

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

LD50 (Mouse): 1,257 - 1,590 mg/kg

Components:
Losartan:Acute oral toxicity

LDLo (Rat): 200 mg/kg
LDLo (Mouse): 400 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

Cellulose:
9 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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

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

Hydrochlorothiazide:
SpeciesResult::RabbitNo skin irritation

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

Hydrochlorothiazide:
SpeciesResult::RabbitMild eye irritation

Starch:SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitisation
Skin sensitisation
May cause an allergic skin reaction.

10 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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.
Components:
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

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
11 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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
Cellulose:
Genotoxicity in vitro:

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

:

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

Starch:Genotoxicity in vitro:

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

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

:
:
:
:
:

Mouse
Oral
92 weeks
200 mg/kg body weight
negative

Species
Application RouteExposure time
Dose

:
:
:
:

Rat
Oral
105 weeks
270 mg/kg body weight
12 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Result:negative

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

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

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

Effects on foetal development:

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
13 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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

Cellulose:
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

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
May cause damage to organs through prolonged or repeated exposure.

14 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

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.

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

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

Repeated dose toxicity
Components:

15 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SpeciesSDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Application RouteExposure timeTarget Organs

:
:
:
:
:

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

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

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
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

16 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 12: Ecological information
12.1 Toxicity
Components:
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
Cellulose:
Toxicity to fish

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

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

12.2 Persistence and degradability
Components:
Losartan:

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SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

Stability in water:

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

Hydrolysis: 46.2 %(96 h)

Cellulose:
Biodegradability:

Result: Readily biodegradable.

:

log Pow: 1.2

12.3 Bioaccumulative potential
Components:
Losartan:
Partition coefficient: noctanol/water
12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Contaminated packaging:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
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.

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SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 14: Transport information
14.1 UN number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.

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SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17): Not applicable
UK REACH Candidate list of substances of very high: Not applicableconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained : Not applicable
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Not applicable
Other regulations:
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to new and expectant mothers at work contained in Regulation 16 to 18) and of thePregnant Workers Directive 92/85/EEC.
Take note of The Management of Health and Safety at Work Regulations 1999 (requirements
relating to protection of young people at work contained in Regulation 19) and of Directive
94/33/EC on the protection of young people at work.
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of H-Statements
H302
H317
H318
H360D

:
:
:
:

Harmful if swallowed.
May cause an allergic skin reaction.
Causes serious eye damage.
May damage the unborn child.
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SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

H362
H372

:
:

H373

:

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

May cause harm to breast-fed children.
Causes damage to organs through prolonged or repeatedexposure.
May cause damage to organs through prolonged or repeatedexposure if swallowed.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Eye Dam.
: Serious eye damage
Lact.
: Effects on or via lactation
Repr.
: Reproductive toxicity
Skin Sens.
: Skin sensitisation
STOT RE: Specific target organ toxicity - repeated exposure
GB EH40: UK. EH40 WEL - Workplace Exposure Limits
GB EH40 / TWA: Long-term exposure limit (8-hour TWA reference period)
GB EH40 / STEL
: Short-term exposure limit (15-minute reference period)
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; 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; 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 and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; 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
Further information
Sources of key data used tocompile the Safety Data:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agen21 / 22

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Losartan / Hydrochlorothiazide Formulation
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9371243-00007

Sheet

Date of last issue: 26.09.2023
Date of first issue: 27.08.2021

cy, http://echa.europa.eu/

Classification of the mixture:

Classification procedure:

Eye Dam. 1

H318

Calculation method

Skin Sens. 1

H317

Calculation method

Repr. 1B

H360D

Calculation method

Lact.

H362

Calculation method

STOT RE 2

H373

Calculation method

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.
GB / EN

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