SAFETY DATA SHEET

SAFETY DATA SHEET

1. Identification

Product identifier

RIMADYL (Carprofen) Chewable Tablets (reduced size tablets)

Other means of identification Synonyms

Recommended use Recommended restrictions

Rimadyl Veterinary product used as non-steroidal, anti-inflammatory drug (nsaid) Not for human use

Manufacturer/Importer/Supplier/Distributor information

Company Name (US)

Zoetis Inc.

10 Sylvan Way

Parsippany, New Jersey 07054 (USA)

Rocky Mountain Poison & Drug Safety Product Support/Technical Services Emergency telephone numbers

1-866-531-8896 1-888-963-8471 CHEMTREC (24 hours): 1-800-424-9300 International CHEMTREC (24 hours): +1-703-527-3887

Company Name (EU)

Zoetis Belgium S.A.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Telephone

+32 10 808080

Emergency telephone number Contact E-Mail

International CHEMTREC (24 hours): +1-703-527-3887 VMIPSrecords@

2. Hazard(s) identification

Physical hazards

Not classified.

Health hazards Environmental hazards

Reproductive toxicity (the unborn child)

Specific target organ toxicity, repeated exposure Not classified.

OSHA defined hazards

Not classified.

Category 2 Category 2 (digestive system)

Label elements

Signal word Hazard statement Precautionary statement

Prevention

Response

Storage Disposal

Warning Suspected of damaging the unborn child. May cause damage to organs (digestive system) through prolonged or repeated exposure.

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapors/spray. Wear protective gloves/protective clothing/eye protection/face protection. If exposed or concerned: Get medical advice/attention. Take off contaminated clothing and wash it before reuse. Store locked up. Dispose of contents/container in accordance with local/regional/national/international regulations.

Material name: RIMADYL (Carprofen) Chewable Tablets (reduced size tablets) Version #: 03 Revision date: 12-04-2023 Issue date: 10-02-2013

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Hazard(s) not otherwise classified (HNOC)

Supplemental information

None known. None.

3. Composition/information on ingredients

Mixtures

Chemical name

Common name and synonyms

CAS number

%

Carprofen

53716-49-7

5

Magnesium stearate

557-04-0

*

Starch

9005-25-8

*

Sucrose

57-50-1

*

Composition comments

*Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret. In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture has been withheld as a trade secret.

4. First-aid measures

Inhalation Skin contact Eye contact

Ingestion

Most important symptoms/effects, acute and delayed

Indication of immediate medical attention and special treatment needed General information

Move to fresh air. Call a physician if symptoms develop or persist. Wash off with soap and water. Get medical attention if irritation develops and persists. Do not rub eyes. Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. Rinse mouth. Call a physician or poison control center immediately. Only induce vomiting at the instruction of medical personnel. Never give anything by mouth to an unconscious person. Not an eye irritant. Not a skin irritant (based on animal data). There have been anecdotal reports that workers handling this material have experienced skin irritation and/or sensitivity reactions. Prolonged exposure may cause chronic effects. Repeat-dose studies in animals have shown a potential to cause adverse effects on developing fetus, gastrointestinal system. Provide general supportive measures and treat symptomatically. Symptoms may be delayed.

Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves. Show this safety data sheet to the doctor in attendance. IF exposed or concerned: Get medical advice/attention.

5. Fire-fighting measures

Suitable extinguishing media

Unsuitable extinguishing media

Specific hazards arising from the chemical

Special protective equipment and precautions for firefighters

Fire fighting equipment/instructions

Specific methods

General fire hazards

Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2). Do not use water jet as an extinguisher, as this will spread the fire.

During fire, gases hazardous to health may be formed.

Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

Use water spray to cool unopened containers.

Use standard firefighting procedures and consider the hazards of other involved materials. No unusual fire or explosion hazards noted.

6. Accidental release measures

Personal precautions, protective equipment and emergency procedures

Methods and materials for containment and cleaning up

Keep unnecessary personnel away. Wear appropriate protective equipment and clothing during clean-up. Ensure adequate ventilation. Local authorities should be advised if significant spillages cannot be contained. For personal protection, see section 8 of the SDS.

Avoid release to the environment. Ensure adequate ventilation.

Large Spills: Stop the flow of material, if this is without risk. Shovel the material into waste container. Clean surface thoroughly to remove residual contamination.

Small Spills: Sweep up or vacuum up spillage and collect in suitable container for disposal. Clean surface thoroughly to remove residual contamination.

Environmental precautions

Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS. Avoid discharge into drains, water courses or onto the ground.

Material name: RIMADYL (Carprofen) Chewable Tablets (reduced size tablets) Version #: 03 Revision date: 12-04-2023 Issue date: 10-02-2013

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7. Handling and storage

Precautions for safe handling

Conditions for safe storage, including any incompatibilities

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Avoid contact with eyes, skin, and clothing. Avoid prolonged exposure. When using do not eat or drink. Wear appropriate personal protective equipment. Avoid release to the environment. Do not empty into drains. Observe good industrial hygiene practices.

Store locked up. Store in original tightly closed container. Keep away from food, drink and animal feedingstuffs. Store as directed by product packaging. Store away from incompatible materials (see Section 10 of the SDS).

8. Exposure controls/personal protection

Occupational exposure limits

The following constituents are the only constituents of the product which have a PEL, TLV or other recommended exposure limit. At this time, the other constituents have no known exposure limits.

Zoetis Components

Type

Value

Carprofen (CAS 53716-49-7)

TWA

1000 ?g/m3

US. OSHA Table Z-1 Permissible Exposure Limits (PEL) for Air Contaminants (29 CFR 1910.1000)

Components

Type

Value

Form

Starch (CAS 9005-25-8)

PEL

5 mg/m3

15 mg/m3

Sucrose (CAS 57-50-1)

PEL

5 mg/m3

15 mg/m3

US. OSHA Table Z-3 Permissible Exposure Limits (PEL) for Mineral Dusts (29 CFR 1910.1000)

Components

Type

Value

Respirable fraction. Total dust. Respirable fraction. Total dust.

Form

Starch (CAS 9005-25-8) Sucrose (CAS 57-50-1)

TWA TWA

5 mg/m3 15 mg/m3 50 mppcf 15 mppcf 5 mg/m3 15 mg/m3 50 mppcf 15 mppcf

Respirable fraction. Total dust. Total dust. Respirable fraction. Respirable fraction. Total dust. Total dust. Respirable fraction.

US. ACGIH Threshold Limit Values (TLV)

Components

Type

Magnesium stearate (CAS 557-04-0)

TWA

Starch (CAS 9005-25-8) Sucrose (CAS 57-50-1)

TWA TWA

Value 3 mg/m3

10 mg/m3 10 mg/m3 10 mg/m3

Form Respirable fraction. Inhalable fraction.

US. NIOSH: Pocket Guide to Chemical Hazards Recommended Exposure Limits (REL)

Components

Type

Value

Form

Starch (CAS 9005-25-8) Sucrose (CAS 57-50-1)

TWA TWA

5 mg/m3 10 mg/m3 5 mg/m3 10 mg/m3

Respirable. Total Respirable. Total

Biological limit values Control banding approach Appropriate engineering controls

No biological exposure limits noted for the ingredient(s).

Not available.

Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. General ventilation normally adequate.

Material name: RIMADYL (Carprofen) Chewable Tablets (reduced size tablets) Version #: 03 Revision date: 12-04-2023 Issue date: 10-02-2013

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Individual protection measures, such as personal protective equipment

Eye/face protection

If contact is likely, safety glasses with side shields are recommended.

Skin protection Hand protection

Wear appropriate chemical resistant gloves. Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations.

Other Respiratory protection

Thermal hazards

Wear appropriate chemical resistant clothing. Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations.

No personal respiratory protective equipment normally required. In case of insufficient ventilation, wear suitable respiratory equipment. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.

Not applicable.

General hygiene considerations

Observe any medical surveillance requirements. Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.

9. Physical and chemical properties

Appearance Physical state Form Color

Odor

Tablet Solid. Solid. Light brown. Not available.

Odor threshold

Not available.

pH

Not available.

Melting point/freezing point

285.8 ?F (141 ?C) estimated

Initial boiling point and boiling Not available. range

Flash point

Not available.

Evaporation rate Flammability (solid, gas)

Not available. Not available.

Upper/lower flammability or explosive limits Explosive limit - lower (%) Not available.

Explosive limit - upper (%) Not available.

Vapor pressure

Not available.

Vapor density

Not available.

Relative density

Not available.

Solubility(ies) Solubility (water)

Not available.

Partition coefficient (n-octanol/water)

Not available.

Auto-ignition temperature

Not available.

Decomposition temperature Not available.

Viscosity

Not available.

Other information Explosive properties Oxidizing properties

Not explosive. Not oxidizing.

10. Stability and reactivity

Reactivity

The product is stable and non-reactive under normal conditions of use, storage and transport.

Chemical stability

Material is stable under normal conditions.

Possibility of hazardous reactions

Conditions to avoid

No dangerous reaction known under conditions of normal use. Contact with incompatible materials.

Incompatible materials

Strong oxidizing agents.

Material name: RIMADYL (Carprofen) Chewable Tablets (reduced size tablets) Version #: 03 Revision date: 12-04-2023 Issue date: 10-02-2013

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Hazardous decomposition products

Toxic fumes of carbon monoxide, carbon dioxide, oxides of nitrogen, hydrogen chloride and other chlorine-containing compounds may be emitted.

11. Toxicological information

Information on likely routes of exposure

Inhalation

Prolonged inhalation may be harmful.

Skin contact Carprofen

No adverse effects due to skin contact are expected.

Species: Rabbit Severity: Non-irritating

Eye contact Carprofen

Direct contact with eyes may cause temporary irritation.

Species: Rabbit Severity: Non-irritating

Ingestion

May be harmful if swallowed.

Symptoms related to the physical, chemical and toxicological characteristics

Direct contact with eyes may cause temporary irritation.

Information on toxicological effects

Acute toxicity

May be harmful if swallowed.

Components Carprofen (CAS 53716-49-7)

Acute Intraperitoneal LD50

Species Rat

Test Results 140 - 110 mg/kg (M/F)

Oral LD50

Mouse

282 mg/kg

Rat

149 mg/kg

Subcutaneous

LD50

Rat

230 - 190 mg/kg (M/F)

Chronic

Oral

NOAEL

Dog

Rat

Subchronic

Oral

NOAEL

Dog

Rat

Magnesium stearate (CAS 557-04-0)

Acute

Inhalation

LC50

Rat

25 mg/kg/day, 2 years (Not carcinogenic; No effects at maximum dose) 10 mg/kg/day, 2 years (Not carcinogenic, Gastrointestinal system effects)

5 mg/kg/day, 13 weeks (Target organs: None identified) 5 mg/kg/day, 13 weeks (Target organs: Gastrointestinal System)

> 2000 mg/m3

Oral

LD50

Rat

> 2000 mg/kg

Sucrose (CAS 57-50-1)

Acute

Oral

LD50

Rat

29700 mg/kg

Skin corrosion/irritation

Prolonged skin contact may cause temporary irritation.

Material name: RIMADYL (Carprofen) Chewable Tablets (reduced size tablets) Version #: 03 Revision date: 12-04-2023 Issue date: 10-02-2013

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