SAFETY DATA SHEET

1. IdentificationProduct identifier

Other means of identification Chemical name

Company name Address

1-800-535-5053

TelephoneWebsiteE-mailEmergency phone number

2. Hazard(s) identificationPhysical hazards

Category 3Health hazardsCategory 4Category 2Category 2ACategory 2

Diclofenac Sodium

Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino]-, monosodium salt Not for use as a drug.

Triova Pharmaceuticals, LLC 115 W 3rd Street Suite 720Tulsa, OK 74103539 777 0720www.triovarx.comquality@triovarx.com INFOTRAC within US & Canada

Not classified.Acute toxicity, oralAcute toxicity, dermalSkin corrosion/irritationSerious eye damage/eye irritation Reproductive toxicity

Category 1 (cardiovascular system,gastrointestinal tract, liver)

Specific target organ toxicity, repeatedexposureNot classified.OSHA hazard(s)

Label elements

Signal word Danger

Hazard statement Toxic if swallowed. Harmful in contact with skin. Causes skin irritation. Causes serious eyeirritation. Suspected of damaging fertility or the unborn child. Causes damage to organs(cardiovascular system, gastrointestinal tract, liver) through prolonged or repeated exposure.

Precautionary statementPrevention Obtain special instructions before use. Do not handle until all safety precautions have been read

and understood. Wash thoroughly after handling. Wear protective gloves/protective clothing/eyeprotection/face protection.

Response Rinse mouth. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. If onskin: Wash with plenty of water/soap. If skin irritation occurs: Get medical advice/attention. Takeoff contaminated clothing and wash before reuse. If in eyes: Rinse cautiously with water forseveral minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eyeirritation persists: Get medical advice/attention. If exposed or concerned: Get medicaladvice/attention.

Storage Store locked up.Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.

Not classified.Hazard(s) not otherwiseclassified (HNOC)

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3. Composition/information on ingredientsSubstanceHazardous components

CAS number %Chemical name Common name and synonyms

15307-79-6Diclofenac Sodium 100

4. First-aid measuresInhalationSkin contact

Eye contact

Ingestion

Most importantsymptoms/effects, acute anddelayedIndication of immediatemedical attention and specialtreatment needed

General information

5. Fire-fighting measuresSuitable extinguishing media

Unsuitable extinguishingmediaSpecific hazards arising fromthe chemicalSpecial protective equipmentand precautions for firefightersFire-fightingequipment/instructionsSpecific methods

Move to fresh air. Call a physician if symptoms develop or persist.Wash off with soap and plenty of water. For minor skin contact, avoid spreading material on unaffected skin. Call a POISON CENTER or doctor/physician if you feel unwell. If skin irritation occurs: Get medical advice/attention.Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists.Call a physician or poison control center immediately. Rinse mouth. Do not induce vomiting without advice from poison control center. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs. Do not use mouth-to-mouth method if victim ingested the substance.Irritant effects. Liver damage. Jaundice. Gastrointestinal disturbances. Central nervous system effects

Treatment of nonsteroidal anti-inflammatory drug (NSAID) overdose should be symptomatic and supportive and may include the following: Induce vomiting (DO NOT use syrup of ipecac) or perform gastric lavage. Administer activated charcoal as a slurry. For gastrointestinal hemorrhage, monitor stool guaiac and administer antacids or sucralfate. For mild/moderate allergic reactions, administer antihistamines with or without inhaled beta agonists, corticosteroids, or epinephrine. For severe allergic reactions, administer oxygen, antihistamines, epinephrine, or corticosteroids. Nephritis or nephrotic syndrome, thrombocytopenia, or hemolytic anemia may respond to glucocorticoid administration. For severe acidosis, administer sodium bicarbonate. Administer as required: plasma volume expanders for severe hypotension; diazepam or other benzodiazepine for convulsions; vitamin K1 for hypoprothrombinemia; and/or dopamine plus dobutamine intravenously to prevent or reverse early indications of renal failure. Forced diuresis, alkalinization or urine, and hemoperfusion may not be useful. Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider familiar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention.

Use fire-extinguishing media appropriate for surrounding materials. Water. Foam. Dry chemical or CO2.None known.

No unusual fire or explosion hazards noted.

Wear suitable protective equipment.

Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.Use standard firefighting procedures and consider the hazards of other involved materials.

6. Accidental release measuresPersonal precautions,protective equipment andemergency proceduresMethods and materials forcontainment and cleaning up

7. Handling and storagePrecautions for safe handling

Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment.

Sweep up or vacuum up spillage and collect in suitable container for disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surface thoroughly to remove residual contamination.

As a general rule, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly.

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Conditions for safe storage,including any incompatibilities

Store in tight container as defined in the USP-NF. This material should be handled and stored perlabel instructions to ensure product integrity.

8. Exposure controls/personal protectionExposure limit values

Industrial Use

ValueMaterial TypeTWA 0.5 mg/m3Diclofenac Sodium (CAS

15307-79-6)Biological limit values No biological exposure limits noted for the ingredient(s).Appropriate engineeringcontrols

Airborne exposure should be controlled primarily by engineering controls such as general dilutionventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generallypreferred to general exhaust because it can control the contaminant at its source, preventingdispersion into the work area. An industrial hygiene survey involving air monitoring may be usedto determine the effectiveness of engineering controls. Effectiveness of engineering controlsintended for use with highly potent materials should be assessed by use of nontoxic surrogatematerials. Local exhaust ventilation such as a laboratory fume hood or other vented enclosure isrecommended, particularly for grinding, crushing, weighing, or other dust-generating procedures.

Individual protection measures, such as personal protective equipmentEye/face protection Safety glasses with sideshields are recommended. Face shields or goggles may be required if

splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearingthe ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area.

Skin protectionHand protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protective

against the solvent being used. Use handling practices that minimize direct hand contact.Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatexgloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy.

Other For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significantquantities are handled, work clothing may be necessary to prevent take-home contamination.

Respiratory protection Where respirators are deemed necessary to reduce or control occupational exposures, useNIOSH-approved respiratory protection and have an effective respirator program in place(applicable U.S. regulation OSHA 29 CFR 1910.134).

Thermal hazards Not available.General hygieneconsiderations

Handle in accordance with good industrial hygiene and safety practice.

9. Physical and chemical propertiesAppearance Off-white to faint yellow crystalline powder.

Physical state Solid.Form Powder.

Odor Odorless.Odor threshold Not available.

pH Not available.

Melting point/freezing point 541.4 - 545 °F (283 - 285 °C)

Initial boiling point and boilingrange

Not available.

Flash point Not available.

Evaporation rate Not available.Flammability (solid, gas) Not applicable.Upper/lower flammability or explosive limits

Flammability limit - lower(%)

Not available.

Flammability limit - upper(%)

Not available.

Explosive limit - lower (%) Not available.

Explosive limit - upper (%) Not available.

Vapor pressure < 0.0000001 kPa at 25 °C

Vapor density Not available.

Relative density Not available.

Solubility in water Sparingly soluble.

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Partition coefficient(n-octanol/water)

0.7

Auto-ignition temperature Not available.

Decomposition temperature Not available.

Viscosity Not available.

Other informationChemical family Phenylacetic acid derivative.

Dust explosion propertiesMinimum ignitionenergy (MIE) - dustcloud

> 1000 mJ

Molecular formula C14H11Cl2NO2.Na

Molecular weight 318.13

pH in aqueous solution 7 - 8.5 (1% solution)

Solubility (other) Soluble in ethanol; practically insoluble in chloroform and in ether; freely soluble in methanol.

Specific gravity 0.3 - 0.7

10. Stability and reactivityReactivity No reactivity hazards known.Chemical stability Stable at normal conditions.Possibility of hazardousreactions

No dangerous reaction known under conditions of normal use.

Conditions to avoid None known.Incompatible materials Strong oxidizing agents.Hazardous decompositionproducts

NOx, Cl-, NaOx. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.

11. Toxicological informationInformation on likely routes of exposure

Ingestion Toxic if swallowed.

Inhalation Due to lack of data the classification is not possible.

Skin contact Harmful in contact with skin.

Eye contact Causes serious eye irritation.

Symptoms related to thephysical, chemical, andtoxicological characteristics

Irritant effects. Swelling of extremities. Yellow eyes and/or skin. Lethargy. Right upper quadranttenderness.For nonsteroidal anti-inflammatory drugs (NSAIDs): Nausea. Vomiting. Diarrhea. Constipation.Heartburn. Stomach pain. Black or tarry stools. Bleeding or bruising. Swelling. Sores, ulcers, orwhite spots on lips or mouth. Sweating. Bluish-colored skin. Insomnia. Mood, mental or behavioralchanges. Confusion. Dizziness. Drowsiness. Headache. Itching. Weight gain. Vision, speech, orwalking problems. Ringing in ears. Trouble breathing. Tremors.

Delayed and immediate effectsof exposure

Fluid retention. Liver damage.For nonsteroidal anti-inflammatory drugs (NSAIDs): Gastrointestinal ulceration or bleeding.Hypertension. Kidney impairment. Blood disorders. Cardiovascular thrombotic events. Stroke.Central nervous system effects. Coma.

Cross sensitivity Persons sensitive to aspirin or any of the nonsteroidal anti-inflammatory agents may be sensitiveto this material also.

Medical conditions aggravatedby exposure

Porphyria. Systemic lupus erythematosus.For nonsteroidal anti-inflammatory drugs (NSAIDs): Asthma. Aspirin allergy. Active alcoholism.Anemia. Impaired kidney or liver function. Cardiovascular disorders. Bleeding disorders. Pepticulcer or gastrointestinal bleeding. Hypertension. Stomatitis.

Acute toxicity Toxic if swallowed. Harmful in contact with skin.

Test ResultsProduct SpeciesDiclofenac Sodium (CAS 15307-79-6)

LD50 RabbitDermalAcute

2000 mg/kg

LD50 MouseOral

125 mg/kg

95 mg/kg

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Test ResultsProduct SpeciesRat 53 mg/kg

Skin corrosion/irritation Causes skin irritation.Serious eye damage/eyeirritation

Causes serious eye irritation.

Respiratory sensitization Due to lack of data the classification is not possible.Skin sensitization Due to lack of data the classification is not possible.

A formulation containing this material showed no evidence of skin sensitization when tested inhumans.There have been reports of allergic reactions and contact dermatitis following therapeuticexposure to this material.

Germ cell mutagenicity Based on available data, the classification criteria are not met.Mutagenicity

Ames testResult: Negative.Chromosome aberration test in Chinese hamstersResult: Negative.Dominant lethal test in miceResult: Negative.In vivo sister chromatid exchangeResult: No change in sister chromatid exchange rate inlymphocytes from humans dosed with this material for 14days.Male germinal epithelial chromosome test in miceResult: Negative.Mouse lymphoma testResult: Negative.Nucleus anomaly test in Chinese hamstersResult: Negative.

Carcinogenicity Based on available data, the classification criteria are not met.This material is not considered to be a carcinogen by IARC, NTP, or OSHA.

0.25 - 2 mg/kg Carcinogenicity study, administered orally tofemale rats.Result: Increased incidence of benign mammary tumors.Test Duration: 2 years0.3 mg/kg/day Carcinogenicity study, administered orally tomale mice.Result: No evidence of oncogenic potential.Test Duration: 2 years1 mg/kg/day Carcinogenicity study, administered orally tofemale mice.Result: No evidence of oncogenic potential.Test Duration: 2 years2 mg/kg/day Carcinogenicity study, administered orally.Result: No evidence of carcinogenic potential.Species: RatTest Duration: 2 years

Reproductive toxicity Suspected of damaging fertility or the unborn child.Therapeutic use of nonsteroidal anti-inflammatory agents (NSAIDs) during the second half ofpregnancy is associated with adverse effects in the fetus such as premature closure of the ductusarteriosus, which may lead to persistent pulmonary hypertension in the newborn. Animal studieshave shown that NSAIDs administered during late pregnancy can cause prolonged gestation,difficult labor, delayed birth, and decreased pup survival rates.

Reproductivity10 mg/kg/day Reproductivity and development studyResult: Maternally toxic; fetotoxic; not teratogenic.Species: Rat10 mg/kg/day Reproductivity and development study,administered orally.Result: Maternally toxic; fetotoxic; not teratogenic.Species: Rabbit20 mg/kg/day Reproductivity and development studyResult: Maternally toxic; fetotoxic; not teratogenic.Species: Mouse4 mg/kg/day Reproductivity and development studyResult: No impairment of fertility.Species: Rat

Specific target organ toxicity -single exposure

Based on available data, the classification criteria are not met.

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Specific target organ toxicity -repeated exposure

Causes damage to organs (cardiovascular system, gastrointestinal tract, liver) through prolongedor repeated exposure.

Aspiration hazard Based on available data, the classification criteria are not met.

12. Ecological informationEcotoxicity

Product Test ResultsSpeciesDiclofenac Sodium (CAS 15307-79-6)

AcuteEC50Crustacea 56 mg/l, 24 hoursDaphnia magna

EC50Fish 130.6 mg/l, 96 hoursOncorhynchus mykiss

LC50 214 mg/l, 96 hoursDanio rerio

Persistence and degradability The product is potentially degradable.Bioaccumulative potential Not available.Mobility in soil Not available.Other adverse effects Not available.

13. Disposal considerationsDisposal instructions Dispose of contents/container in accordance with local/regional/national/international regulations.

Under RCRA, it is the responsibility of the user of the product to determine, at the time ofdisposal, whether the product meets RCRA criteria for hazardous waste.

Local disposal regulations Not available.Hazardous waste code Not available.Waste from residues / unusedproducts

Dispose of in accordance with local regulations. Empty containers or liners may retain someproduct residues. This material and its container must be disposed of in a safe manner (see:Disposal instructions).

Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.Since emptied containers may retain product residue, follow label warnings even after container isemptied.

14. Transport informationDOT

UN2811UN numberToxic, solid, organic, n.o.s. (Diclofenac Sodium) UN proper shipping name6.1Transport hazard class(es)Not available.Subsidiary class(es)IIIPacking group

IATAUN2811UN numberToxic, solid, organic, n.o.s. (Diclofenac Sodium) UN proper shipping name6.1Transport hazard class(es)-Subsidiary class(es)IIIPackaging group

Transport in bulk according toAnnex II of MARPOL 73/78 andthe IBC Code

No information available.

DOT; IATA

15. Regulatory informationUS federal regulations CERCLA/SARA Hazardous Substances - Not applicable.

One or more components are not listed on TSCA.

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Superfund Amendments and Reauthorization Act of 1986 (SARA)Hazard categories Immediate Hazard - Yes

Delayed Hazard - NoFire Hazard - NoPressure Hazard - NoReactivity Hazard - No

SARA 302 Extremelyhazardous substance

No

SARA 311/312 Hazardouschemical

No

Other federal regulationsSafe Drinking Water Act(SDWA)

Not regulated.

Food and DrugAdministration (FDA)

Not regulated.

US state regulations California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This materialis not known to contain any chemicals currently listed as carcinogens or reproductive toxins.

International InventoriesCountry(s) or region Inventory name On inventory (yes/no)*

YesAustralia Australian Inventory of Chemical Substances (AICS)YesCanada Domestic Substances List (DSL)NoCanada Non-Domestic Substances List (NDSL)NoChina Inventory of Existing Chemical Substances in China (IECSC)

YesEurope European Inventory of Existing Commercial ChemicalSubstances (EINECS)

NoEurope European List of Notified Chemical Substances (ELINCS)NoJapan Inventory of Existing and New Chemical Substances (ENCS)

YesKorea Existing Chemicals List (ECL)YesNew Zealand New Zealand InventoryYesPhilippines Philippine Inventory of Chemicals and Chemical Substances

(PICCS)NoUnited States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory

*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)

16. Other information, including date of preparation or last revisionIssue dateRevision dateVersion #Further informationDisclaimer

01/01/201701/01/201700Not available.This SDS is intended to provide a summary of our knowledge and guidance regarding the use of this material. The information contained here has been compiled from sources considered to be dependable and is accurate to the best of Triova Pharmaceuticals knowledge. However, the information is provided without any representation or warranty, expressed or implied regarding its accuracy or correctness. Triova Pharmaceuticals cannot assume responsibility for adverse events which may occur in the use and/or misuse of this product and expressly disclaims liability for loss, damage and/or expense arising out of or in any way connected with the handling, storage, use and/or disposal of this product.

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