Section 1: Identification Product name .. Etoricoxib Formulation Manufacturer or supplier's details Company : Organon & Co.
: 30 Hudson Street, 33nd floor Jersey City, New Jersey, U.S.A  07302
： +1-551-430-6000 Emergency telephone number   :    +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: Hazard identification GHS Classification Carcinogenicity (Inhalation) : Category 2 Reproductive toxicity : Category 2 Specific target organ toxicity -    : repeated exposure (Oral) Category 2 (Kidney, Liver, Gastrointestinal tract) Hazardous to the aquatic environment - chronic hazard .. Category 2 GHS label elements Hazard pictograms Signal word : Hazard statements : H351 Suspected of causing cancer if inhaled. H361d Suspected of damaging the unborn child. H373 May cause damage to organs (Kidney, Liver, Gastroin- testinal tract) through prolonged or repeated exposure if swal- lowed. H411 Toxic to aquatic life with long lasting effects.
Precautionary statements :
Disposal: P501 Dispose of contents/ container to an approved waste disposal plant. Other hazards which do not result in classification 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 : Mixture Components

Section 4: First-aid measures

Section 8: Exposure controls/personal protection
SAFETY DATA SHEET
Particle size No data available : Section 10: Stability and reactivity
Section 11: Toxicological information Exposure routes
Acute toxicity Not classified based on available information. Product: Acute oral toxicity Acute toxicity estimate: > 2,000 mg/kg . Method: Calculation method
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 inhala- tion toxicity Skin corrosion/irritation Not classified based on available information. Components: Etoricoxib: Species : Result : Rabbit No skin irritation Titanium dioxide:
. Result : No skin irritation Serious eye damage/eye irritation Not classified based on available information. Components: Etoricoxib: Species Result Rabbit : Mild eye irritation : Titanium dioxide: Species
:
: Respiratory or skin sensitisation Skin sensitisation Not classified based on available information. Respiratory sensitisation Not classified based on available information. Components: Etoricoxib: Test Type Exposure routes Local lymph node assay (LLNA) : Skin contact :
Chronic toxicity Germ cell mutagenicity Not classified based on available information.
ORGANON
Test Type: Alkaline elution assay Species: Rat Application Route: Oral Result: negative
Test Type: Bacterial reverse mutation assay (AMES) Carcinogenicity Suspected of causing cancer if inhaled. Components: Cellulose:
Reproductive toxicity Suspected of damaging the unborn child.
Not classified based on available information. STOT - repeated exposure May cause damage to organs (Kidney, Liver, Gastrointestinal tract) through prolonged or repeat- ed exposure if swallowed. Components:
Repeated dose toxicity Components: Cellulose: Species NOAEL Application Route Exposure time Etoricoxib: Species LOAEL Application Route Exposure time Target Organs Species NOAEL Application Route Exposure time Target Organs
Titanium dioxide: Species NOAEL Application Route Exposure time
Aspiration toxicity Not classified based on available information.
Gastrointestinal tract, Kidney
:
Experience with human exposure Components:
Section 12: Ecological information
ORGANON
Persistence and degradability Components: Cellulose: Biodegradability : Result: Readily biodegradable.
Bioaccumulative potential Components: Etoricoxib: Partition coefficient: n- octanol/water : log Pow: 2.3 Mobility in soil No data available Other adverse effects No data available Section 13: Disposal considerations
ORGANON
Section 14: Transport information International Regulations UNRTDG UN number Proper shipping name Class Packing group Labels Environmentally hazardous IATA-DGR UN/ID No. Proper shipping name
: UN 3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, : N.O.S. (Etoricoxib) : 9 :  9 . yes .. UN 3077 : Environmentally hazardous substance, solid, n.o.s. .. (Etoricoxib) 9 .. III : Miscellaneous : 956 :
: Environmentally hazardous
IMDG-Code UN number Proper shipping name : UN 3077 :    ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Etoricoxib) . 9 = .. .. 9 F-A, S-F .. yes ..
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. National Regulations NZS 5433 UN number Proper shipping name : UN 3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, ..
Special 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, and var- iations in regional or country regulations. Section 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mix- ture HSNO Approval Number not allocated Tolerable Exposure Limits (TEL) Not applicable Environmental Exposure Limits (EEL) Not applicable The components of this product are reported in the following inventories: AICS :    not determined DSL :
IECSC

Section 16: Other information

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport by Land 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 for Standardisation; 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 Sys- tem; 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 con- centration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemi- cal Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Or- ganisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Con- centration 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) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Leve!; NOELR - No Observable Effect Loading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Develop- ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu- lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc- es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua- tion, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tem- perature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Trans- portation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Sub- stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recom- mendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumu- lative; WHMIS - Workplace Hazardous Materials Information System The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor- mation 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 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 mate- rial 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 their intended manner of handling, use, processing and storage, including an assessment of the ap- propriateness of the SDS material in the user's end product, if applicable. NZ / EN