SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

SECTION 1. IDENTIFICATION
Product name:Carbidopa / Levodopa 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
Acute toxicity (Oral):

Category 4

Reproductive toxicity:

Category 2

Specific target organ toxicity- repeated exposure (Oral):

Category 1 (Central nervous 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.
H302 Harmful if swallowed.
H361d Suspected of damaging the unborn child.
H372 Causes damage to organs (Central nervous system)
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.
1 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P301 + P312 + P330 IF SWALLOWED: Call a doctor if you feelunwell. Rinse mouth.
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.
Levodopa
59-92-7
Carbidopa
38821-49-7
Cellulose
9004-34-6
Starch
9005-25-8
Magnesium stearate557-04-0
Actual concentration is withheld as a trade secretConcentration (% w/w)>= 70 - < 90>= 10 - < 20>= 1 - < 5>= 1 - < 5>= 1 - < 5

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:

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.
2 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Harmful if swallowed.
Suspected of damaging the unborn child.
Causes damage to organs through prolonged or repeatedexposure if swallowed.
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
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
3 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

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 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.
Use only with adequate ventilation.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
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.
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 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

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.

Levodopa

59-92-7

Value type
(Form ofexposure)
TWA

Carbidopa

38821-49-7

TWA

Cellulose

9004-34-6

TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA
TWA (Respirable)
TWA (total)
TWA (total
dust)
TWA (respirable fraction)
TWA (Inhalable particulate matter)
TWA (Respirable particulate matter)

Starch

9005-25-8

Magnesium stearate

Engineering measures

557-04-0:

Control parameters / Permissible
concentration
500 µg/m3 (OEB
2)
2,000 µg/m3(OEB 1)10 mg/m³
5 mg/m³

Basis

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

10 mg/m³
5 mg/m³

ACGIH
NIOSH REL

10 mg/m³
15 mg/m³

NIOSH REL
OSHA Z-1

5 mg/m³

OSHA Z-1

10 mg/m³

ACGIH

3 mg/m³

ACGIH

Internal
Internal
ACGIH
NIOSH REL

Use feasible engineering controls to minimize exposure tocompound.
5 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

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: 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
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
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 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

:

odorless

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

6 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Flash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

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

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, dynamic:

No data available

Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

No data available

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

Not classified as a reactivity hazard.
Stable under normal conditions.
May form explosive dust-air mixture during processing,7 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

tions

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

handling or other means.
Can react with strong oxidizing agents.

Conditions to avoid:

Incompatible materials
Hazardous decomposition
products::

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

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Harmful if swallowed.
Product:
Acute oral toxicity:

Acute toxicity estimate: 1,952 mg/kg
Method: Calculation method:

LD50 (Rat): 1,780 mg/kg

Components:
Levodopa:
Acute oral toxicity

LD50 (Mouse): 2,363 mg/kg
Carbidopa:
Acute oral toxicity:

LD50 (Rat): 4,810 mg/kg
LD50 (Mouse): 1,750 mg/kg

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

Starch:Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

8 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Magnesium stearate:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg
Method: OECD Test Guideline 423
Assessment: The substance or mixture has no acute oral toxicity
Remarks: Based on data from similar materials

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Remarks: Based on data from similar materials

Skin corrosion/irritation
Not classified based on available information.
Components:
Carbidopa:
SpeciesResult::RabbitNo skin irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo skin irritation
Based on data from similar materials

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Carbidopa:
SpeciesResult::RabbitMild eye irritation

Starch:SpeciesResult::RabbitNo eye irritation

Magnesium stearate:
SpeciesResultRemarks:::

RabbitNo eye irritation
Based on data from similar materials

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.

9 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Components:
Levodopa:
SpeciesResult::Guinea pig
Not a skin sensitizer.

Carbidopa:
Remarks:

No data available

Starch:Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative

Magnesium stearate:
Test Type
Routes of exposure
Species
MethodResultRemarks

:
:
:
:
:
:

Maximization Test
Skin contact
Guinea pig
OECD Test Guideline 406
negative
Based on data from similar materials

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

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Test system: mouse lymphoma cells
Result: equivocal
Test Type: Micronucleus test
Test system: Chinese hamster lung cells
Result: positive
Test Type: sister chromatid exchange assay
Test system: Chinese hamster lung cells
Result: positive

Carbidopa:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: positive
Test Type: In vitro mammalian cell gene mutation test
Result: positive
10 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Application Route: Oral
Result: negative

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

Starch:Genotoxicity in vitro:

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

Magnesium stearate:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Remarks: Based on data from similar materials
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative
Remarks: Based on data from similar materials
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials

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

:
:
:
:

Rat
Oral
2 Years
negative

Carbidopa:
Species
Application Route

:
:

Rat
Oral
11 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

Exposure timeSDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Result:::96 weeks
135 mg/kg body weight
negative

Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

IARC

No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.

OSHA

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% isidentified as a known or anticipated carcinogen by NTP.

Reproductive toxicity
Suspected of damaging the unborn child.
Components:
Levodopa:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 100 mg/kg body weight
Result: Animal testing did not show any effects on fertility.

Effects on fetal development:

Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: LOAEL: 125 mg/kg body weight
Symptoms: Skeletal malformations., Visceral malformations.
Result: positive
Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Test Type: Development
Species: Mouse
Application Route: Oral
Developmental Toxicity: LOAEL: 500 mg/kg body weight
Symptoms: Effects on fetal development.
Result: positive

Reproductive toxicity - Assessment:

Some evidence of adverse effects on development, based onanimal experiments.

12 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Carbidopa:
Effects on fertility:

Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 120 mg/kg body weight
Symptoms: Reduced body weight
Result: Animal testing did not show any effects on fertility.

Effects on fetal development:

Test Type: Development
Species: Mouse
Application Route: Oral
Developmental Toxicity: NOAEL: 120 mg/kg body weight
Result: No teratogenic effects.
Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 120 mg/kg body weight
Result: No teratogenic effects.

Cellulose:
Effects on fertility:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative

Effects on fetal development:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative

Magnesium stearate:
Effects on fertility:

Test Type: Combined repeated dose toxicity study with thereproduction/developmental toxicity screening test
Species: Rat
Application Route: Ingestion
Method: OECD Test Guideline 422
Result: negative
Remarks: Based on data from similar materials

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative
Remarks: Based on data from similar materials

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Central nervous system) through prolonged or repeated exposure if
swallowed.
13 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Components:
Levodopa:
Routes of exposure
Target Organs
Assessment

:
:
:

Oral
Central nervous system
Causes damage to organs through prolonged or repeatedexposure.

Levodopa:
Species
LOAEL
Application RouteExposure timeTarget Organs
Symptoms

:
:
:
:
:
:

Rat
100 mg/kg
Oral
106 WeeksCentral nervous system
Salivation

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Monkey100 mg/kg
Oral
22 Weeks
Central nervous system

Carbidopa:
Species
LOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
25 mg/kg
Oral
96 Weeks
No significant adverse effects were reported

Species
NOAEL
Application RouteExposure time
Remarks:::::

Monkey135 mg/kg
Oral
1y
No significant adverse effects were reported

Species
NOAEL
LOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:
:

Dog
5 mg/kg
15 mg/kg
Oral
238 d
Diarrhea, Vomiting, Tremors

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Repeated dose toxicity
Components:

14 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

Magnesium stearate:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
> 100 mg/kg
Ingestion
90 DaysBased on data from similar materials

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Levodopa:
Ingestion:

Symptoms: Nausea, central nervous system effects, Drowsiness

Carbidopa:
Ingestion:

Symptoms: involuntary movement

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Levodopa:
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 16 mg/l
Exposure time: 48 h

Carbidopa:
Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 35.3 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Cellulose:
Toxicity to fish:

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

Magnesium stearate:
Toxicity to fish:

LC50 (Leuciscus idus (Golden orfe)): > 100 mg/l
15 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

Exposure time: 48 h
Method: DIN 38412
Remarks: Based on data from similar materials
Toxicity to daphnia and otheraquatic invertebrates:

EL50 (Daphnia magna (Water flea)): > 1 mg/l
Exposure time: 47 h
Test substance: Water Accommodated Fraction
Method: Directive 67/548/EEC, Annex V, C.2.
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.

Toxicity to algae/aquaticplants:EL50 (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials
No toxicity at the limit of solubility.
NOELR (Pseudokirchneriella subcapitata (green algae)): > 1
mg/l
Exposure time: 72 h
Test substance: Water Accommodated Fraction
Method: OECD Test Guideline 201
Remarks: Based on data from similar materials

Toxicity to microorganisms:

EC10 (Pseudomonas putida): > 100 mg/l
Exposure time: 16 h
Test substance: Water Accommodated Fraction
Remarks: Based on data from similar materials

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Magnesium stearate:
Biodegradability:

Result: Not biodegradable
Remarks: Based on data from similar materials

Levodopa:
Partition coefficient: noctanol/water:log Pow: -2.39

Magnesium stearate:
Partition coefficient: noctanol/water:log Pow: > 4

Bioaccumulative potential
Components:

16 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

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.

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
Acute toxicity (any route of exposure)
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)17 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SARA 313

SDS Number:
50125-00022:

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

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
Levodopa
Carbidopa
Hydroxypropyl cellulose
Cellulose
Starch59-92-7
38821-49-7
9004-64-2
9004-34-6
9005-25-8

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, andLevodopa, which is/are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
California Permissible Exposure Limits for Chemical Contaminants
Cellulose
StarchMagnesium stearate

9004-34-6
9005-25-8
557-04-0

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

18 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015
HMIS® IV:

Flammability

HEALTH1
Health10Special 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
OSHA Z-1 / TWA: 8-hour time weighted average
OSHA Z-3 / TWA: 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 Pre19 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Carbidopa / Levodopa Formulation
Version
9.1

Revision Date:
09/30/2023

SDS Number:
50125-00022

Date of last issue: 04/04/2023
Date of first issue: 01/23/2015

vention 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.
US / Z8

20 / 20