SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

SECTION 1. IDENTIFICATION
Product name:

Enalapril / Hydrochlorothiazide Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Combustible dust
Reproductive toxicity:

Category 1ASpecific target organ toxicity- repeated exposure:

Category 1 (Kidney, Parathyroid gland, Cardio-vascular system)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

If small particles are generated during further processing, handling or by other means, may form combustible dust concentrations in air.
H360D May damage the unborn child.
H372 Causes damage to organs (Kidney, Parathyroid gland,
Cardio-vascular system) through prolonged or repeated exposure.

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.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
1 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
CAS-No.
Hydrochlorothiazide
58-93-5
Starch
9005-25-8(S)-1-[N-[1-(Ethoxycarbonyl)-376095-16-4
phenylpropyl]-L-alanyl]-L-proline maleate
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 10 - < 20>= 10 - < 20>= 5 - < 10

SECTION 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: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.
If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
2 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Protection of first-aiders:

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

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

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Avoid generating dust; fine dust dispersed in air in sufficientconcentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides
Nitrogen oxides (NOx)
Chlorine compounds
Sulfur oxides
Metal oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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.

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

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal
protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Sweep up or vacuum up spillage and collect in suitablecontainer for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are
3 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

Materials to avoid:

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.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with 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 labeled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Explosives
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
inert or nuisance dust
50 Million particles per cubic footValue type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
15 mg/m³
4 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Value type (Form of exposure): TWA (total dust)
Basis: OSHA Z-3
5 mg/m³
Value type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
15 Million particles per cubic footValue type (Form of exposure): TWA (respirable fraction)
Basis: OSHA Z-3
Dust, nuisance dust and particulates

10 mg/m³
Value type (Form of exposure): PEL (Total dust)
Basis: CAL PEL
5 mg/m³
Value type (Form of exposure): PEL (respirable dust fraction)
Basis: CAL PEL

Components

CAS-No.

Hydrochlorothiazide

58-93-5

Starch

9005-25-8(S)-1-[N-[1-(Ethoxycarbonyl)-3phenylpropyl]-L-alanyl]-Lproline maleate

Value type
(Form ofexposure)
TWA

76095-16-4

TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA

Wipe limit
Engineering measures:

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

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

50 µg/m3 (OEB 3)

Internal

500 µg/100 cm²Internal

Internal
ACGIH
NIOSH RELAll engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Containment technologies suitable for controlling compounds
are required to control at source and to prevent migration of
the compound to uncontrolled areas (e.g., open-facecontainment devices).
Minimize open handling.

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
5 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks
Eye protection::

Skin and body protection:

Hygiene measures:

Consider double gloving.
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.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

No data available

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

Not applicable

Evaporation rate:

Not applicable
6 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

Not applicable

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition 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

SECTION 10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions:::

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

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

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

7 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

SECTION 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: 4,231 mg/kg
Method: Calculation method:

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

Components:
Hydrochlorothiazide:
Acute oral toxicity

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

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Acute oral toxicity: LD50 (Rat): 2,000 - 3,500 mg/kg
LDLo (Rat): 1,775 mg/kg
LD50 (Mouse): 2,000 - 3,500 mg/kg
LDLo (Mouse): 1,000 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Rat): 850 mg/kg
Application Route: Intravenous
LD50 (Mouse): 750 mg/kg
Application Route: Intravenous
LD50 (Dog): > 100 mg/kg
LDLo (Dog): 200 mg/kg
8 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Skin corrosion/irritation
Not classified based on available information.
Components:
Hydrochlorothiazide:
SpeciesResult::RabbitNo skin irritation(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Species: Rabbit
Result: No skin irritation
Serious eye damage/eye irritation
Not classified based on available information.
Components:
Hydrochlorothiazide:
SpeciesResult::RabbitMild eye irritation

Starch:SpeciesResult::RabbitNo eye irritation(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Species: Rabbit
Result: Severe irritation
Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Test Type: Maximization Test
Routes of exposure: Skin contact
9 / 19SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SpeciesResultSDS Number:
402641-00018::

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Guinea pig
Not a skin sensitizer.

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

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

:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro sister chromatid exchange assay in mammalian cells
Result: negative
Test Type: Alkaline elution assay
Result: negative

10 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

Genotoxicity in vivo

SDS Number:
402641-00018:

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative
Test Type: Mutagenicity (in vivo mammalian bone-marrowcytogenetic test, chromosomal analysis)
Species: Mouse
Application Route: Ingestion
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
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(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Species: Rat
Application Route: Ingestion
Exposure time
: 106 weeks
NOAEL: 90 mg/kg body weight
Result: negative
Species
Application RouteExposure time
NOAEL
Result
IARC

:
:
:
:
:

Mouse
Ingestion
94 weeks
90 - 180 mg/kg body weight
negative

Group 2B: Possibly carcinogenic to humans
Hydrochlorothiazide

58-93-5OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

No ingredient of this product present at levels greater than or equal to 0.1% is
11 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

identified as a known or anticipated carcinogen by NTP.
Reproductive toxicity
May damage the unborn child.
Components:
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 fetal 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.

(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Effects on fertility: Test Type: Fertility
Species: Rat, male and female
Application Route: Ingestion
Fertility: NOAEL: 90 mg/kg body weight
Result: No effects on fertility.
Effects on fetal development:

Species: Rat
Application Route: Ingestion
Developmental Toxicity: NOAEL: 200 mg/kg body weight
Result: No effects on fetal development.
Species: Rat
Application Route: Ingestion
Developmental Toxicity: LOAEL: 1,200 mg/kg body weight
Result: Fetotoxicity.
Species: Rat
Application Route: Ingestion
Developmental Toxicity: LOAEL: 30 mg/kg body weight
Result: Effects on postnatal development., Effects on
12 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

newborn., No teratogenic effects.
Species: Rabbit
Application Route: Ingestion
General Toxicity Maternal: LOAEL: 1 mg/kg body weight
Developmental Toxicity: LOAEL: 1 mg/kg body weight
Result: Fetotoxicity., Maternal toxicity observed., No
teratogenic effects.
Reproductive toxicity - Assessment:

Positive evidence of adverse effects on development fromhuman epidemiological studies.

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Kidney, Parathyroid gland, Cardio-vascular system) through prolonged or repeated exposure.
Components:
Hydrochlorothiazide:
Target Organs
Assessment::

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

(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Target Organs: Kidney, Cardio-vascular system
Assessment: Causes damage to organs through prolonged or repeatedexposure.
Repeated dose toxicity
Components:
Hydrochlorothiazide:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat, male and female
10 mg/kg
Oral
2y
Kidney, Parathyroid glandSpecies
NOAEL
Application RouteExposure time
Remarks:::::

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

Species

:
:
:
:
:

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

Application RouteExposure timeTarget Organs

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

Starch:Species
NOAEL
Application RouteExposure time
MethodSDS Number:
402641-00018

:
:
:
:
:

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

Rat>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Species: Dog
NOAEL: 15 mg/kg
LOAEL: 30 mg/kg
Application Route: Ingestion
Exposure time
: 1yTarget Organs: Kidney
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
90 mg/kgOral
1y
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time
Remarks:::::

Monkey30 mg/kg
Oral
1 Months
No significant adverse effects were reported

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

Symptoms: Eye irritation
Symptoms: Dizziness, Headache, Fatigue, Nausea, Abdominal pain, hypotension, dry mouth, electrolyte imbalance,eye pain(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Ingestion: Target Organs: Cardio-vascular system
Symptoms: hypotension, Cough, Dizziness, Headache,Blurred vision, Fatigue, Edema, Nausea, hyperkalemia, fainting, Weakness, skin rash
Remarks: May cause harm to the unborn child.
14 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Hydrochlorothiazide:
Toxicity to fish

Toxicity to daphnia and otheraquatic invertebrates:

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

EC50 (Daphnia magna (Water flea)): > 500 mg/l
Exposure time: 48 h(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Toxicity to fish
: LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 346 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to microorganisms:

EC50 (Natural microorganism): > 1,000 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Hydrochlorothiazide:
Stability in water:

Hydrolysis: 46.2 %(96 h)

Bioaccumulative potential
No data available
Mobility in soil
No data available
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.
15 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
Not regulated as a dangerous goodSpecial precautions for user
Not applicable
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.
SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Combustible dust
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
D-Glucose, 4-O-β-D-galactopyranosyl-, monohydrate
Hydrochlorothiazide
Starch(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-Lproline maleate
Sodium hydrogencarbonate

16 / 1964044-51-5
58-93-59005-25-8
76095-16-4
144-55-8

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

California Prop. 65
WARNING: This product can expose you to chemicals including Quartz, which is/are known to
the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
California Permissible Exposure Limits for Chemical Contaminants
Starch

9005-25-8

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

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information
NFPA 704:

HMIS® IV:
Flammability

HEALTH1
Health00Special hazard*

3

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
CAL PEL: California permissible exposure limits for chemical contaminants (Title 8, Article 107)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
OSHA Z-3: USA. Occupational Exposure Limits (OSHA) - Table Z-3 Mineral Dusts
ACGIH / TWA: 8-hour, time-weighted average
CAL PEL / PEL: Permissible exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
17 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

OSHA Z-1 / TWA
OSHA Z-3 / TWASDS Number:
402641-00018::

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016

8-hour time weighted average
8-hour time weighted average

AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.

18 / 19

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Enalapril / Hydrochlorothiazide Formulation
Version
7.1

Revision Date:
09/30/2023

SDS Number:
402641-00018

US / Z8

19 / 19

Date of last issue: 04/04/2023
Date of first issue: 01/07/2016