SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Etoricoxib Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: Avenida 16 de Septiembre No. 301
Xaltocan - Xochimilco Mexico 16090
Telephone: +52 55 57284444
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
Carcinogenicity (Inhalation):

Category 2

Reproductive toxicity:

Category 2

Specific target organ toxicity- repeated exposure (Oral):

Category 2 (Kidney, Liver, Gastrointestinal tract)

GHS label elements
Hazard pictograms:

Signal Word:

Warning

Hazard Statements:

H351 Suspected of causing cancer if inhaled.
H361d Suspected of damaging the unborn child.
H373 May cause damage to organs (Kidney, Liver, Gastrointestinal tract) 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.
P280 Wear protective gloves/ protective clothing/ eye protection/
face protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
1 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

P405 Store locked up.
Disposal:
P501 Dispose of contents/ 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.
May form explosive dust-air mixture during processing, handling or other means.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Cellulose
Etoricoxib
Titanium dioxide

CAS-No.
9004-34-6
202409-33-4
13463-67-7

Concentration (% w/w)>= 30 -< 50>= 20 -< 30>= 1 -< 5

SECTION 4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

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

Notes to physician:

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, 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.
Suspected of causing cancer if inhaled.
Suspected of damaging the unborn child.
May cause 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

2 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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)
Sulfur oxides
Chlorine compounds
Metal oxides
Oxides of phosphorus

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
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.

3 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

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.
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.
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.
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

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

CAS-No.

9004-34-6

Value type
(Form ofexposure)
VLE-PPT

Control parameters / Permissible
concentration
10 mg/m³

Cellulose

Etoricoxib

202409-33-4

TWA
TWA

Titanium dioxide

13463-67-7

VLE-PPT

10 mg/m³
400 ug/m3 (OEB
2)
10 mg/m³

Engineering measures

:

Basis

NOM-010STPS-2014
ACGIH
Internal
NOM-010STPS-2014

Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts,
dust collectors, vessels, and processing equipment) aredesigned in a manner to prevent the escape of dust into thework area (i.e., there is no leakage from the equipment).
4 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or
exposure assessment demonstrates exposures outside therecommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Choose gloves to protect hands against chemicals dependingon the concentration specific to place of work. Breakthroughtime is not determined for the product. Change gloves often!
For special applications, we recommend clarifying theresistance to chemicals of the aforementioned protective
gloves with the glove manufacturer. Wash hands before
breaks and at the end of workday.
Wear the following personal protective equipment:
Safety goggles
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

powderColor:

coloredOdor:

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

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

5 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative 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, 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 characteristics
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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
6 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

Product:
Acute oral toxicity

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014:

Acute toxicity estimate: > 5,000 mg/kg
Method: Calculation method

Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Etoricoxib:
Acute oral toxicity:

LD50 (Rat): 1,499 mg/kg

Components:

LD50 (Mouse): 1,499 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Rat): 238 mg/kg
Application Route: Intraperitoneal
LD50 (Mouse): 599 mg/kg
Application Route: Intraperitoneal

Titanium dioxide:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 6.82 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist
Assessment: The substance or mixture has no acute inhalation toxicity

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

Titanium dioxide:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.

7 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Components:
Etoricoxib:
SpeciesResult::RabbitMild eye irritation

Titanium dioxide:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Etoricoxib:
Test Type
Routes of exposure
Species
Assessment
Result:::::Local lymph node assay (LLNA)
Skin contact
Mouse
Did not cause sensitization on laboratory animals.
negative

Titanium dioxide:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

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

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Etoricoxib:
8 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

Genotoxicity in vitro

SDS Number:
26550-00025:

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Test Type: reverse mutation assay
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Test system: human lymphoblastoid cells
Result: negative
Test Type: Chromosomal aberration
Test system: Chinese hamster ovary cells
Result: negative
Test Type: Alkaline elution assay
Result: negative

Genotoxicity in vivo:

Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
Application Route: Oral
Result: negative
Test Type: Alkaline elution assay
Species: Rat
Application Route: Oral
Result: negative

Titanium dioxide:
Genotoxicity in vitro:

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

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Result: negative

Carcinogenicity
Suspected of causing cancer if inhaled.
Components:
Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Etoricoxib:
Species
Application RouteExposure time
Result::::Rat, male and female
oral (gavage)
2 Years
positive

Species
Application RouteExposure time:::

Mouse, male and female
oral (gavage)
2 Years
9 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Result:negative

Titanium dioxide:
Species
Application RouteExposure time
MethodResultRemarks

:
:
:
:
:
:

Rat
inhalation (dust/mist/fume)
2 Years
OECD Test Guideline 453
positive
The mechanism or mode of action may not be relevant in humans.

:

Limited evidence of carcinogenicity in inhalation studies withanimals.

Carcinogenicity - Assessment

Reproductive toxicity
Suspected of damaging the unborn child.
Components:
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

Etoricoxib:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat, female
Application Route: Oral
General Toxicity Parent: NOAEL: 10 mg/kg body weight
Result: positive
Test Type: Fertility/early embryonic development
Species: Rat, male
Application Route: Oral
Result: negative

Effects on fetal development:

Species: Rat
Application Route: Oral
Result: positive
Species: Rabbit
Application Route: Oral
Result: positive

Reproductive toxicity - Assessment:

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

10 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
May cause damage to organs (Kidney, Liver, Gastrointestinal tract) through prolonged or repeated exposure if swallowed.
Components:
Etoricoxib:
Routes of exposure
Target Organs
Assessment:::

Ingestion
Kidney, Liver, Gastrointestinal tract
May cause damage to organs through prolonged or repeatedexposure.

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

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

Etoricoxib:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
30 mg/kg
oral (gavage)
27 Weeks
Gastrointestinal tract, KidneySpecies
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
30 mg/kg
oral (gavage)
53 Weeks
Liver

Species
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
50 mg/kg
oral (gavage)
53 Weeks
Liver

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
200 mg/kg
oral (gavage)
14 Weeks
Gastrointestinal tract, Kidney

Titanium dioxide:
Species
NOAEL

:
:

Rat
24,000 mg/kg

Repeated dose toxicity
Components:

11 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Application RouteExposure time::

Ingestion
28 DaysSpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rat
10 mg/m³
inhalation (dust/mist/fume)
2yAspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Etoricoxib:
Ingestion:

Symptoms: upper respiratory tract infection, Headache, hypertension, Diarrhea, urinary tract infection, flu-like symptoms,
heartburn, Nausea, bronchitis, Dizziness, asthenia, Rash,
Back pain, Cough, Abdominal pain, pharyngitis, Edema

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

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

Etoricoxib:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 30 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 30 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202

Toxicity to algae/aquaticplants:

EC50 (Pseudokirchneriella subcapitata (green algae)): > 10
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

NOEC (Pimephales promelas (fathead minnow)): 7.93 mg/l
Exposure time: 32 d
Method: OECD Test Guideline 210

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)

NOEC (Daphnia magna (Water flea)): 0.75 mg/l
Exposure time: 21 d
Method: OECD Test Guideline 211

12 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

Toxicity to microorganisms

SDS Number:
26550-00025:

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

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

Titanium dioxide:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

EC50 (Skeletonema costatum (marine diatom)): > 10,000 mg/l
Exposure time: 72 h

Toxicity to microorganisms:

EC50: > 1,000 mg/l
Exposure time: 3 hMethod: OECD Test Guideline 209

Persistence and degradability
Components:
Cellulose:
Biodegradability:

Result: Readily biodegradable.

Etoricoxib:
Biodegradability:

Result: not rapidly degradable
Biodegradation: 0.2 %Exposure time: 28 d:log Pow: 2.3

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

13 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping name

:
:

Class
Packing group
LabelsEnvironmentally hazardous

:
:
:
:

IATA-DGR
UN/ID No.
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Etoricoxib)
9
III
9
yes

:
:
:
:

UN 3077
Environmentally hazardous substance, solid, n.o.s.
(Etoricoxib)
9III
Miscellaneous
956

:

956

:

yes

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
(Etoricoxib)
9III
9F-A, S-F
yes

Class
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
Environmentally hazardous

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
NOM-002-SCT
UN number
Proper shipping name::UN 3077
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID,
N.O.S.
14 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

Class
Packing group
LabelsSDS Number:
26550-00025:::

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014(Etoricoxib)
9III
9Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureFederal Law for the control of chemical precursors,: Not applicableessential chemical products and machinery for
producing capsules, tablets and pills.
The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

06.04.2024
dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NOM-010-STPS-2014: Mexico. Norm NOM-010-STPS-2014 on Chemicals Polluting
the Work Environment - Identification, Assessment and Control - Appendix 1 Occupational Exposure Limits
ACGIH / TWA: 8-hour, time-weighted average
NOM-010-STPS-2014 / VLE- : Time weighted average limit value
PPT
AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
15 / 16

SAFETY DATA SHEET
Etoricoxib Formulation
Version
6.2

Revision Date:
06.04.2024

SDS Number:
26550-00025

Date of last issue: 29.09.2023
Date of first issue: 29.10.2014

Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System

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/

The information is considered as correct, but not exhaustive, and will be used only as a guide,
which is based in the current knowledge of the substance or mixture, and is applicable to proper
safety precautions for the product.
MX / Z8

16 / 16