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1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
IVX Animal Health, inc. th 3915 South 48 Street Terrace PO Box 8039 St. Joseph, MO 64503 Date Approved: August 17, 2007 Date Last Revision:
Telephone Number: 816-364-3777 Emergency Number: 1-888-838-2872
Griseofulvin Powder, Microsize
Griseofulvin Powder (Microsize) 15-gram packets (2.5 grams of griseofulvin, microsize), cartons of 12. Chemical Name: Spiro[benzofuran-2(3H),1'-cyclohexene]-3,4'-dione, 7-chloro-2',4,6-trimethoxy-6'-methyl-, (1'S-trans)Intended Use: Oral administration to horses – Not for use in horses intended for food. The Powder may be given on a small amount of feed or in a drench. Usual dose is one half to one packet daily – 15 grams (2.5g active ingredient)
2. COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient Griseofulvin Inert Materials See Section 8 for exposure limits.
CAS Number 126-07-8
According to 29 CFR 1910.1200, no other toxic ingredients are present at > 1% and no carcinogens are present at > 0.1%.
3. HAZARDS IDENTIFICATION
Emergency Overview: Cancer suspect agent, reproductive hazard, possible hypersensitization. The health hazards associated with this mixture have not been thoroughly investigated. The signs and symptoms of exposure listed below are based upon potential health effects from the active pharmaceutical ingredient contained in this formula unless otherwise noted. Routes of Exposure Eyes: Possible mild to moderate irritant. Skin: Possible mild to moderate irritant. Prolonged contact may cause skin rashes, hives, or itching and an increased sensitivity of skin to sunlight.
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Ingestion: Clinical Route; Possible mild to moderate gastrointestinal irritant. Ingestion may cause vomiting, diarrhea, headache, soreness or irritation of mouth and tongue, taste disturbances, fever, stomach pain, trouble sleeping, unusual tiredness, and dizziness. Inhalation: Possible mild to moderate upper respiratory irritation Signs and Symptoms of Over Exposure: Adverse effects may include confusion, skin rashes, hives, or itching; nausea, vomiting, diarrhea, headache, soreness or irritation of mouth and tongue, increased sensitivity of skin to sunlight, blurred vision, taste disturbances, fever, stomach pain, trouble sleeping, unusual tiredness, and dizziness. Effects from high doses or prolonged use may include fever, hallucinations, yellow eyes or skin, and numbness, tingling, pain, or weakness in hands or feet. Griseofulvin may enhance the effects of alcohol. Possible allergic reaction to material if inhaled, ingested, or in contact with skin. Carcinogenicity: Griseofulvin has been classified by the International Agency for the Research on Cancer (IARC) as possibly carcinogenic to humans - Group 2B. Refer to Section 11, Toxicological Information. NTP: OSHA: Not Listed Not Listed IARC: ACGIH: Yes Not Listed
Teratogenicity/Reproductive Effects: Some reproductive effects have been observed in humans. Potential adverse effects from exposure may occur in males and females during reproduction and in the developing fetus. Refer to Section 11, Toxicological Information. Medical Conditions Aggravated By Exposure: Hypersensitivity to material, porphyria, liver function impairment, and lupus erythematosus. Persons sensitive to penicillin or penicillamine may be sensitive to this material. Cross-sensitivity has not been clinically substantiated.
4. FIRST AID MEASURES
Eyes: Remove from source of exposure. Flush with copious amounts of water for a minimum of 15 minutes. If irritation persists or signs of toxicity occur, seek medical attention. Skin: Remove from source of exposure. Remove contaminated clothing and flush with copious amounts of water for a minimum of 15 minutes. If irritation persists or signs of toxicity occur, seek medical attention. Ingestion: Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Inhalation: Remove from source of exposure. If person is not breathing, give artificial respiration. If breathing is difficult, give oxygen. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Persons developing hypersensitivity (anaphylactic) reactions should receive immediate medical attention.
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Note to Physicians: Significant overdoses should be handled with gut emptying, charcoal and cathartic administration unless contraindicated. Contact a poison control center for more information.
5. FIRE FIGHTING MEASURES
Flashpoint: N/D Flashpoint Method: N/D Fire and explosion hazards: This material is assumed to be combustible. As with all dry powders, it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Extinguishing media: Use dry chemical, carbon dioxide, water spray or foam, as appropriate for surrounding fire and materials. Hazardous combustion products: May produce carbon dioxide, carbon monoxide, chlorinated compounds and other toxic thermal decomposition products. Fire fighting instructions: Because fire may produce toxic thermal decomposition products, wear selfcontained breathing apparatus and protective clothing. Do not release runoff from fire control methods to sewers or waterways.
6. ACCIDENTAL RELEASE MEASURES
Spills: Wear approved respiratory protection, chemical protective gloves, and clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Wash spill site. Place spillage and all contaminated cleanup materials in a thick plastic waste disposal bag or leak proof container and dispose of as pharmaceutical waste. Keep spills and runoff from entering drains or any surface water. Contact the appropriate authorities as required by Federal, State, and Local regulations.
7. HANDLING AND STORAGE
Handling: Avoid inhalation and contact with eyes, skin or clothing. Use only with appropriate personal protective equipment, safe work practices and good hygiene practices. Wash thoroughly after handling and before eating, drinking, smoking, and/or applying cosmetics. Storage: Store at controlled room temperature: 36°- 86°F (2°-30°C). Microsize powders should be stored in well-closed containers.
8. EXPOSURE CONTROL/ PERSONAL PROTECTION
Exposure Limits: Ingredient Griseofulvin Inert Materials – Treat as PNOR OSHA PEL Not Established 5mg/M3 - Respirable dust ACGIH TLV Not Established 3mg/M3 - Respirable dust Other None Identified None Identified
Eye/Skin Protection: Avoid contact with eyes and skin. Wear eye protection and appropriate gloves while handling.
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Respiratory Protection: Avoid inhalation, use a NIOSH-approved supplied air or air purifying respirator with HEPA/N100 filter cartridges, if it is determined to be necessary by an industrial hygiene survey involving air monitoring. Respiratory use must comply with OSHA’s Respiratory Protection Standard, 29 CFR 1910.134.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: White to off-white powder, odorless Vapor Pressure: N/D Vapor Density: N/D Specific Gravity: N/D Solubility: Slightly soluble in water, soluble in ethanol, methanol, and ethyl acetate and practically insoluble in petroleum ether. Boiling Point: N/D pH: N/D
10. STABILITY AND REACTIVITY
Stability: Stable. Conditions to Avoid: None known Incompatibility: Strong oxidizing agents Hazardous Polymerization: No Hazardous Decomposition Products: Upon heating, may produce toxic emissions including chlorine compounds.
11. TOXICOLOGICAL INFORMATION
Unless otherwise noted the following pertains to the active pharmaceutical ingredient. Oral Toxicity: LD50 = >10,000 mg/kg (oral, rat) LD50 = > 50,000 mg/kg (oral, mouse) Acute Effects: Adverse effects may include confusion, skin rashes, hives, or itching, nausea, vomiting, diarrhea, headache, soreness or irritation of mouth and tongue, increased sensitivity of skin to sunlight, blurred vision, taste disturbances, fever, stomach pain, trouble sleeping, unusual tiredness, and dizziness. Effects of Repeated Doses: Effects from high doses or prolonged use may include fever, hallucinations, yellow eyes or skin, and numbness, tingling, pain, or weakness in hands or feet. Griseofulvin may enhance the effects of alcohol.
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Reproductive and Developmental Effects: In humans, Griseofulvin use during pregnancy has been associated with conjoined twins, abortion, cleft palate, and heart failure. Because Griseofulvin may interfere with chromosomal distribution during cell division, males are advised to wait six months after completing therapy before fathering a child. Studies in pregnant rats given 0.5 - 1.5 grams/kg orally for 10 days showed a moderate to high incidence of skeletal defects and a reduced survival rate in the pups. Sensitization: Possible allergic reaction to material if inhaled, ingested, or in contact with skin. Persons sensitive to penicillin or penicillamine may be sensitive to this material also; however, cross-sensitivity has not been clinically substantiated. Mutagenicity: Griseofulvin was negative for mutagenicity in the Ames Salmonella typhimurium test, with and without metabolic activation. Griseofulvin induced sister chromatid exchange in bone-marrow cells and chromosomal aberration in spermatocytes, but it did not cause micronucleus formation or chromosomal aberrations in bone-marrow cells of mice. It induced aneuploidy in vivo and in vitro and micronucleus formation in cells in vitro. Griseofulvin did not induce recombination or mutation in fungi, but it induced DNA damage and somatic mutation or mitotic recombination in insects. Griseofulvin was not mutagenic and did not induce DNA damage in bacteria. Carcinogenicity: Griseofulvin has been shown to cause hepatomas in several strains of mice when chronically administered orally and when given subcutaneously in small doses. Griseofulvin has also been shown to cause thyroid and liver tumors, mostly adenomas but also some carcinomas, in both male and female rats when administered orally. National Toxicology Program: Not listed I.A.R.C. Monographs: Listed as a Group 2B - Possibly carcinogenic to humans OSHA: Not listed
12. ECOLOGICAL INFORMATION
13. DISPOSAL CONSIDERATIONS
This product should be disposed of as pharmaceutical waste in accordance with all Federal, State, and Local regulations.
14. TRANSPORTATION INFORMATION
Proper Shipping Name: All packaging and transportation must meet the applicable Federal, State, and Local regulations.
15. REGULATORY INFORMATION
The following regulations apply to storage and/or handling. It is the responsibility of the end user to determine the applicability of these regulations at their specific location. This product is regulated under the Food, Drug, and Cosmetic Act. TSCA Status: FDA-regulated material is exempt from TSCA. EPCRA Section 313 (SARA Title III): Not listed EPCRA 302: Not listed CERCLA: Not listed
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RCRA: Not a RCRA hazardous waste DOT: Not applicable California Proposition 65: Carcinogenic International Regulatory Information: EINECS#: 204-767-4 Hazard code: T (Toxic) Risk phrases: R45: May cause cancer. R46: May cause heritable genetic damage, R61: May cause harm to the unborn child Safety phrases: S22: Do not breathe dust, S36/37/39: Wear suitable protective clothing, gloves and eye/face protection.
16. OTHER INFORMATION
N/A = Not Applicable N/D = Not Determined
~ = Approximately Equal To
DISCLAIMER OF EXPRESSED AND IMPLIED WARRANTIES Although reasonable care has been taken in the preparation of this document, we extend no warranties and make no representations as to the accuracy or completeness of the information contained therein, and assume no responsibility regarding the suitability of this information for the user's intended purposes or for the consequences of its use. Each individual should make a determination as to the suitability of the information for his or her particular purpose(s).