Product Identifier: ORIBIOTIC® OINTMENT
DIN #: 02080478
MATERIAL SAFETY DATA SHEET SECTION 1 – PRODUCT IDENTIFICATION AND USE MANUFACTURER’S NAME:
BIMEDA-MTC ANIMAL HEALTH INC.
SUPPLIER’S NAME:
BIMEDA-MTC ANIMAL HEALTH INC.
STREET ADDRESS:
420 BEAVERDALE ROAD
STREET ADDRESS:
420 BEAVERDALE ROAD
CITY AND PROVINCE:
CAMBRIDGE, ONTARIO
CITY AND PROVINCE:
CAMBRIDGE, ONTARIO
POSTAL CODE:
N3C 2W4
POSTAL CODE:
N3C 2W4
TELEPHONE #
519-654-8000
TELEPHONE #
519-654-8000
EMERGENCY RESPONSE:
CHEMTREC
TELEPHONE #
1-800-424-9300
CHEMICAL NAME:
CHEMICAL FORMULA:
Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Ointment
Triamcinolone Acetonide C24H3206F Thiostrepton C72H85N19018S5 Neonycin Sulfate DC23H46N6013 Nystatin C46H83N018 PRODUCT USE:
PRODUCT CODE: 1ORI001P
1ORI002P
Topical use on dogs and cats only. Specific indications are listed on the product container label.
SECTION 2 – INGREDIENTS INGREDIENTS (per milliliter of product)
PEL/TLV (units)
CAS NUMBER
PRODUCT IDENTIFICATION NUMBER (PIN)
Nystatin 100,000 1400-61-9 No OSHA or ACGIH exposure limitations Neomycin Sulfate 2.5 mg 1405-10-3 established for the product Thiostrepton 2,500 Units 1393-48-21 mixture or its ingredients. Triamcinolone Acetonide 1.10 mg 76-25-5 Plastibase** Balance ** A plasticized hydrocarbon gel consisting of polyethylene and mineral oil.
SECTION 3 – PHYSICAL DATA PHYSICAL STATE:
ODOUR AND APPEARANCE:
ODOUR THRESHOLD (ppm):
Odour: Slight characteristic of Nystatin. Appearance: Yellow to amber coloured smooth homogeneous oily viscous liquid. VAPOUR PRESSURE (mm Hg):
VAPOUR DENSITY (Air = 1):
@ 25 deg C: Not determined
Not determined
BOILING POINT (DEG.C):
FREEZING POINT (DEG. C):
EVAPORATION RATE (Ether = 1): CRITICAL TEMPERATURE:
@ 760 mmHg: Not determined pH (100%):
SPECIFIC GRAVITY (H2O = 1):
SOLUBIITY IN WATER:
(25 deg C): 0.875-0.895
Ingredients in plastibase not considered to be soluble at 25 deg C
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COEFF: WATER/OIL DIST.:
Product Identifier: ORIBIOTIC® OINTMENT
DIN #: 02080478
SECTION 4 – FIRE AND EXPLOSION DATA FIRE & EXPLOSION HAZARDS: Thermal decomposition of the product mixture could result in a release of vapour containing small amounts of F-, SOx and NOx. Inhalation of such vapour is to be considered potentially serious and is therefore to be avoided. NFPA HAZARD CODE: HEALTH: 2 FLAMMABILITY: 0 REACTIVITY: 0 OTHER: -
NFPA rating assigned to this product by Bimeda-MTC Animal Health Inc. is based upon the estimated hazard potential of this material under fire conditions. FLAMMABLE: IF YES, UNDER WHICH CONDITIONS: MEANS OF EXTINCTION: Thermal decomposition of the product mixture will eventually occur upon exposure to
surrounding fire condition. Use appropriate medium, i.e. water fog, carbon dioxide, dry chemical, to extinguish the underlying cause of the fire. SPECIAL PROCEDURES: FLASHPOINT (Deg. C) AND METHOD:
Not determined TCC
UPPER FLAMMABLE LIMIT (% BY VOLUME):
LOWER FLAMMABLE LIMIT (% BY VOLUME):
Not determined
Not determined
AUTOIGNITION TEMPERATURE (DEG. C):
HAZARDOUS COMBUSTION PRODUCTS:
SENSITIVITY TO IMPACT:
SENSITIVITY TO STATIC DISCHARGE:
SECTION 5 – REACTIVITY DATA CHEMICAL STABILITY – (conditions to avoid): Stable under normal storage and handling conditions. INCOMPATIBILITY WITH OTHER SUBSTANCES (materials to avoid): Avoid strong chemical oxidizing and reducing agents. REACTIVITY, AND UNDER WHAT CONDITIONS? HAZARDOUS DECOMPOSITION PRODUCTS: Thermal decomposition of the product mixture could result in a release of vapour containing small amounts of f-, Sox and NOx. Inhalation of such vapour is to be considered potentially serious and is therefore to be avoided. HAZARDOUS POLYMERIZATION: Will not occur.
SECTION 6 – TOXICOLOGICAL PROPERTIES EFFECTS OF ACUTE EXPOSURE TO MATERIAL: EYE CONTACT: No effects from incidental exposure to persons handling the product mixture for its directed use are
known to exist. Avoid contact as a precaution. SKIN ABSORPTION: No effects from incidental exposure to persons handling the product mixture for its directed use are
known to exist. The product mixture contains the active ingredient Triamcinolone Acetonide, considered a potent glucocorticoid anti-inflammatory drug, which can be absorbed through the skin. The extent of absorption is determined by many factors, for example prolonged contact. Avoid routine contact as a precaution. Wear latex gloves during product mixture use and wash hands after use. SKIN CONTACT: No irritation effects from incidental exposure to persons handling the product mixture for its directed use are known to exist. Avoid routine contact as a precaution. Wear latex gloves during product mixture use and wash hands after use.
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Product Identifier: ORIBIOTIC® OINTMENT
DIN #: 02080478
INGESTION: No effects from incidental exposure to persons handling the product mixture under its directed use are
known to exist. Ingestion is not considered a likely route of exposure under its directed use. Wear latex gloves during product mixture use and wash hands after use to prevent accidental contact with subsequent consumption of food or drink. The product mixture contains the active ingredient Triamcinolone Acetonide, considered to be a potent glucocorticoid anti-inflammatory drug, which if ingested can be absorbed. INHALATION: No effects from incidental exposure to persons handling the product mixture for its directed use are known to exist. Under normal conditions of use the product mixture is not considered an inhalation hazard. EFFECTS OF OVEREXPOSURE: The product mixture contains an active ingredient, Triamcinolone Acetonide, considered a potent glucocorticoid anti-inflammatory drug. Adverse reactions to this active ingredient exist and are documented elsewhere. Refer to the product container label for additional information on this active ingredient and the product mixture. Reported toxicity effects by ingestion and irritation effects in the U.S. Dept. of Health and Human Services Registry of Toxic Effects of Chemical Substances for the product mixture’s ingredients include: Nystatin: LD50 (Mouse-Oral): 800mg/kg (No toxic effects noted) TDLo (Rat-oral 9 day preg): 100 mg/kg (fetal death) Neomycin Sulfate: Human, skin irritation: 6mg/3D-1 TDLo (woman-oral): 12600 mg/kg (7D) Behaviour effects, (Somnolence; Hallucinations, distorted perceptions; Anorexia) Triamcinolone Acetonide: LD50 (mouse-oral): 5000 mg/kg (No toxic effect noted) As with any reported toxicity information, the reference should be consulted for detailed review of the testing protocol and report of results. As a precaution avoid ingestion of the product mixture, inhalation of dried product mixture residue and prolonged skin contact. CARCINOGENIC EVALUATION*: 1) INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC):
Not listed 2)
NATIONAL TOXICOLOGY PROGRAM (NTP):
Not listed 3)
29 CFR PART 1910.1000 (OSHA):
Not listed 4)
AMERICAN CONFERENCE OF GOVERNMENT INDUSTRIAL HYGIENISTS (ACGIH):
∗
Not listed Evaluation includes product mixture as well as all ingredients greater than or equal to 0.1% by weight of the product mixture or ingredients considered as active in the product mixture.
SECTION 7 – PREVENTATIVE MEASURES FIRE FIGHTING PROTECTIVE EQUIPMENT / PROCEDURE: Where thermal decomposition of the product is likely, wear full protective clothing and a positive-pressure self contained breathing apparatus. Evacuate area of unprotected persons. VENTILATION: General ventilation is adequate when handling the product mixture for its directed use. RESPIRATORY PROTECTION (specify type): Not necessary under normal handling conditions where ventilation is provided. Should a spill occur, selection of appropriate respiratory protection for dried residual of the product mixture is recommended according to 29 CFR 1910.134 “Respiratory Protection”. SKIN PROTECTION: Use protective clothing to minimize the possibility of prolonged skin contact. Selection of specific items such as gloves (latex), apron or body clothing will depend upon the activity. Following handling of the product, wash potentially contacted skin areas with soap and warm water. Launder contaminated clothing prior to reuse. EYE PROTECTION: Use of safety glasses is recommended where incidental contact is likely to occur. Wearing of contact lenses is not recommended when handling this product mixture. ACTION TO BE TAKEN FOR SPILLS/RELEASES: Utilize dry methods, i.e. scraping, scooping for a product spillage. Wear appropriate personal protective equipment to minimize eye, skin and respiratory exposure especially to dried residue of the product mixture. Rinse area thoroughly of product residue with soap and warm water. DISPOSAL METHOD: Empty product or spilled product is to be disposed in accordance with all local regulations. These materials, intended for disposal, are not considered as hazardous.
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Product Identifier: ORIBIOTIC® OINTMENT
DIN #: 02080478
SECTION 8 – FIRST AID MEASURES Eyes: Skin: Ingestion:
Inhalation:
If eye contact occurs immediately flush with flowing water continuously for a minimum of 15 minutes. Consult with medical personnel in the event an irritation develops. If skin contact occurs wash exposed area with soap and water. Consult with medical personnel in the event an irritation develops. Seek medical attention immediately following an accidental ingestion of this product mixture. Provide symptomatic/supportive medical care based in part upon knowledge of the potential adverse reactions of the product mixture’s active ingredient, Triamcinolone Acetonide, as well as the other ingredients of the product mixture. Seek medical attention immediately should an adverse reaction occur following a suspected inhalation exposure associated with the product mixture. Inhalation exposure of the product mixture, a cream, is not considered likely under normal handling. Provide symptomatic/supportive medical care based in part upon knowledge of the potential adverse reactions of the product mixture’s ingredient, Triamcinolone Acetonide, as well as the other ingredients of the product mixture.
SECTION 9 – ADDITIONAL INFORMATION SPECIAL PRECAUTIONS TO BE TAKEN IN HANDLING AND STORAGE: Handle and store in the original labeled product container. Store in a cool, dry location.
SECTION 10 – PREPARATION DATA DATE: DATE UPDATED:
TELEPHONE NUMBER:
519-654-8000
August 2002, August 2007, June 2008, August 2009, August 2010
Information for this material safety data sheet was obtained from sources considered technically accurate and reliable. While every effort has been made to ensure full disclosure of product hazards, in some cases data is not available and is so stated. Since conditions of actual product use are beyond the control of the supplier, it is assumed that user of this material has been fully trained according to the mandatory requirements of WHMIS. No warranty, expressed or implied, is made and supplier will not be liable for any losses, injuries or consequential damages which may result from the use of or reliance on any information contained in this form. If user requires independent information on ingredients in this or any other material, we recommend contact supplier.
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