SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

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

Olmesartan 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.
30 Hudson Street, 33nd floor
07302 Jersey City, New Jersey, U.S.A
Telephone:+1-551-430-6000

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)
Reproductive toxicity, Category 1A
H360D: May damage the unborn child.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms:

Signal word:

DangerHazard statements:

H360D May damage the unborn child.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017
Response:
P308 + P313
attention.

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

IF exposed or concerned: Get medical advice/

Storage:
P405 Store locked up.
Hazardous components which must be listed on the label:
Olmesartan
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.
Dust contact with the eyes can lead to mechanical irritation.
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

CAS-No.
EC-No.
Index-No.
Registration number
144689-63-4

Olmesartan

Classification

Concentration(% w/w)

Acute Tox. 4; H302
Eye Irrit. 2; H319
Repr. 1A; H360D>= 1 - < 10

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.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of eye contact:

If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.

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 damage the unborn child.
Contact with dust can cause mechanical irritation or drying of
the skin.
Dust contact with the eyes can lead to mechanical irritation.
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:

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.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

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.
Local authorities should be advised if significant spillages
cannot be contained.

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.
Do not get on skin or clothing.
Do not breathe dust.
Do not swallow.
Avoid contact with eyes.
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.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Hygiene measures:

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
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. 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
Components
Cellulose

Olmesartan

CAS-No.

Value type (Form Control parametersBasisof exposure)9004-34-6
OEL-RL
10 mg/m3
ZA OEL
Further information: Occupational Exposure Limits - Restricted Limits For
Hazardous Chemical Agents
144689-63TWA
30 µg/m3 (OEB 3)
Internal
4
Wipe limit
300 µg/100 cm²Internal

8.2 Exposure controls
Engineering measures
All engineering controls should be implemented by facility design and operated in accordancewith GMP principles to protect 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-face containment devices).
Minimize open handling.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

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

Remarks
Skin and body protection::

Respiratory protection:

Consider double gloving.
Work uniform or laboratory coat.
Additional body garments should be used based upon the task
being performed (e.g., sleevelets, apron, gauntlets, disposable
suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Particulates type (P)Filter type:

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: powderColour: No data available
Odour: No data available
Odour Threshold: No data available
pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range
Flash point:

No data available:

Not applicable

Evaporation rate:

No data available

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:

No data available

Relative vapour density:

No data available

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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Relative density:

No data available

Density:

No data available::

No data available
No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

9.2 Other information
Flammability (liquids):

No data available

Molecular weight:

No data available

Particle size:

No data available

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

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
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.

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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

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 (Rat): > 2.000 mg/kg

Components:
Olmesartan:
Acute oral toxicity

LD50 (Mouse): > 2.000 mg/kg
LD50 (Dog): > 1.500 mg/kg
Acute inhalation toxicity:

Remarks: No data available

Acute dermal toxicity:

Remarks: No data available

Skin corrosion/irritation
Not classified based on available information.
Components:
Olmesartan:
Remarks:

No data available

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Olmesartan:
Species
MethodResult:::RabbitDraize Test
Moderate eye irritation

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Components:
Olmesartan:
Exposure routes
Remarks::

Skin contact
No data available

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

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Mutagenicity (in vitro mammalian cytogenetic test)
Result: negative
Test Type: Chromosome aberration test in vitro
Test system: Chinese hamster lung cells
Result: positive
Test Type: Mouse Lymphoma
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Cell type: Bone marrow
Application Route: Oral
Result: negative

Germ cell mutagenicity- Assessment:

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

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

:
:
:
:

Rat
Oral
2 Years
negative

Species
Application RouteExposure time
Result

:
:
:
:

Mouse
Oral
6 Months
negative

Reproductive toxicity
May damage the unborn child.

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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Components:
Olmesartan:
Effects on fertility

Effects on foetal development:

Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 1.000 mg/kg body weight
Result: No effects on fertility:

Test Type: Development
Species: Rat
Application Route: Oral
Dose: 1000 milligram per kilogram
Result: No teratogenic effects
Test Type: Development
Species: Rabbit
Application Route: Oral
Dose: 1 milligram per kilogram
Result: No teratogenic effects
Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: LOAEL: >= 1,6 mg/kg body weight
Symptoms: Malformations were observed., Reduced bodyweightResult: Effects on postnatal development

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
Not classified based on available information.
Repeated dose toxicity
Components:
Olmesartan:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
2.000 mg/kg
Oral
24 Months
No significant adverse effects were reported

Aspiration toxicity
Not classified based on available information.

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SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

Experience with human exposure
Components:
Olmesartan:
Eye contact
Ingestion::

Symptoms: Eye irritation
Symptoms: hypotension
Remarks: May cause harm to the unborn child.
Based on Human Evidence

SECTION 12: Ecological information
12.1 Toxicity
No data available
12.2 Persistence and degradability
No data available
12.3 Bioaccumulative potential
No data available
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.

:

The substance/mixture does not contain components considered to have endocrine disrupting properties according to
REACH Article 57(f) or Commission Delegated regulation(EU) 2017/2100 or Commission Regulation (EU) 2018/605 at
levels of 0.1% or higher.

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

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

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

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
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
H319
H360D

:
:
:

Harmful if swallowed.
Causes serious eye irritation.
May damage the unborn child.

Full text of other abbreviations
Acute Tox.
: Acute toxicity
Eye Irrit.
: Eye irritation
Repr.
: Reproductive toxicity
ZA OEL: South Africa. The Regulations for Hazardous Chemical
Agents, Occupational Exposure LimitsZA OEL / OEL-RL: Occupational Exposure Limit Restricted limit - 8- hour exposure or equivalent (12 hour shifts)
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 popula13 / 14

SAFETY DATA SHEET

Olmesartan Formulation
Version
3.1

Revision Date:
30.09.2023

SDS Number:
717990-00017

Date of last issue: 04.04.2023
Date of first issue: 01.06.2016

tion; 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
Sheet

:

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

Classification of the mixture:

Classification procedure:

Repr. 1A

Calculation method

H360D

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.
ZA / EN

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