1. IDENTIFICATION OF SUBSTANCE AND CONTACT INFORMATION
MSDS NAME: Florfenicol Powders
SYNONYM(S): AQUACOL VET Medicated Premix for Salmon
AQUAFLOR 50% Medicated Premix for Salmon
AQUAFLOR Type A Medicated Article
MSDS NUMBER: SP000956
2. HAZARDS IDENTIFICATION
May cause allergic reactions in susceptible individuals.
May cause effects to:
- gastrointestinal tract
- male reproductive system
May cause impaired fertility.
May cause developmental effects.
Toxic to aquatic organisms.
May cause long-term adverse effects in the aquatic environment
3. COMPOSITION AND INFORMATION ON INGREDIENTS
PRODUCT USE: Aquaculture product
CHEMICAL FORMULA: Mixture.
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4. FIRST AID MEASURES
INHALATION: Remove to fresh air. If any trouble breathing, get immediate medical attention. Administer artificialrespiration if breathing has ceased. If irritation or symptoms occur or persist, consult a physician.
SKIN CONTACT: In case of skin contact, while wearing protective gloves, carefully remove any contaminated clothing,including shoes, and wash skin thoroughly with soap and water. If irritation or symptoms occur or persist,consult a physician.
EYE CONTACT: In case of eye contact, immediately rinse eyes thoroughly with plenty of water. If wearing contact lenses,remove only after initial rinse, and continue rinsing eyes for at least 15 minutes. If irritation occurs orpersists, consult a physician.
INGESTION: Rinse mouth and drink a glass of water. Do not induce vomiting unless under the direction of a qualifiedmedical professional or Poison Control Center. If symptoms persist, consult a physician.
NOTE TO PHYSICIAN: This product contains florfenicol, a broad spectrum antibiotic which may cause allergic reactions insusceptible individuals.
5. FIRE FIGHTING MEASURES
Flash Point: Not determined (liquids) or not applicable (solids).OTHER EXPLOSION HAZARDS:
Under normal conditions of use, this material does not present a significant fire or explosion hazard. However, like most organic compounds, thismaterial may present a dust deflagration hazard if sufficient quantities are suspended in air.
This hazard may exist where sufficient quantities of finely divided material are (or may become) suspended in air during typical process operations. An assessment of each operation should be conducted andsuitable deflagration prevention and protection techniques employed.
The sensitivity of this material to ignition by electrostatic discharges has not been determined. In the absence of testing data, all conductive plant items and operations personnel handling this material should be suitably grounded.
SPECIAL FIRE FIGHTING PROCEDURES:
Wear full protective clothing and self-contained breathing apparatus (SCBA).
SUITABLE EXTINGUISHING MEDIA:
Carbon dioxide (CO2), extinguishing powder or water spray.
6. ACCIDENTAL RELEASE MEASURES
Avoid generation of dust during clean-up. Wear appropriate personal protective equipment as specified in Section 8. Keep personnel away from theclean-up area.
SPILL RESPONSE / CLEANUP:
All spills should be handled according to site requirements and based on precautions cited in the MSDS. In the case of liquids, use proper absorbent materials.
For laboratories and small-scale operations, incidental spills within a hood or enclosure should be cleaned by using a HEPA filtered vacuum orwet cleaning methods as appropriate. For large dry or liquid spills or those spills outside enclosure or hood, appropriate emergency response personnel should be notified.
In manufacturing and large-scale operations, HEPA vacuuming prior to wet mopping or cleaning is required.
This product is toxic to aquatic organisms. Do not allow product to reach ground water, water course, sewage or drainage systems.
7. HANDLING AND STORAGE
Keep containers adequately sealed during material transfer, transport, or when not in use.
Appropriate handling of this material is dependent on many factors, including physical form, duration and frequency of process or task, and effectiveness of engineering controls.
Site-specific risk assessments should be conducted to determine the feasibility and the appropriateness of all exposure control measures.
Store in a cool, dry, well ventilated area.
8. PHYSICAL AND CHEMICAL PROPERTIES
ODOR: Odor unknown
Water: Florfenicol: 1.32 mg/mL at pH7
Acetone: Florfenicol: Very soluble
9 STABILITY AND REACTIVITY
Stable under normal conditions.
INCOMPATIBLE MATERIALS / CONDITIONS TO AVOID:
Open flames and high temperatures.
HAZARDOUS DECOMPOSITION PRODUCTS / REACTIONS:
Carbon oxides (COx).
10. ECOLOGICAL INFORMATION
INGREDIENT ECOTOXICITY Florfenicol: 96-hr LC50 (bluegill): >830 mg/L
Florfenicol: 96-hr LC50 (trout): >780 mg/L
Florfenicol: 48-hr EC50 (daphnid): >330 mg/L
Florfenicol: Algae maximum cell density: MIC = 1.5 mg/L
Florfenicol: Algae maximum growth rate: MIC >2.9 mg/L
OTHER INGREDIENT ENVIRONMENTAL DATA: Florfenicol: log Pow (log octanol/water partition coefficient): 2.36Florfenicol is not readily biodegradable but there is evidence of inherent biodegradability.
11. DISPOSAL CONSIDERATIONS
Disposal must be in accordance with applicable federal,state/provincial, and/or local regulations. Incineration is the preferred method of disposal, when appropriate. Operations that involvethe crushing or shredding of waste materials or returned goods must be handled to meet the recommended exposure limit(s).
PACKAGING AND CONTAINERS:
Disposal must be in accordance with applicable federal, state/provincial, and/or local regulations.
SPECIAL ENVIRONMENTAL HANDLING PROCEDURES:
This product contains materials that are harmful to the environment. Donot allow product to reach ground water, water courses, sewage or drainage systems.
12. TRANSPORT INFORMATION
This material is not subject to the transportation regulations of DOT, ICAO, IMO, and the ADR.
13. TOXICOLOGICAL INFORMATION
ACUTE TOXICITY DATA
Florfenicol: Inhalation LC50 (4hr): >0.28 mg/L (rats)Rats exposed to florfenicol for 4 hours showed dry rales, anogenital staining, secretory discharge, soft stool, and decreased body weights.
These effects were seen immediately or up to one-week post exposure. Some effects did not resolve by study termination.
Florfenicol was not irritating to rabbit skin. Povidone did not produce primary dermal irritation in a human repeated insult patch test.
Florfenicol was slightly irritating to the eyes of rabbits. Povidone did not produce ocular irritation in rabbits.
Florfenicol: Oral LD50: >2000 mg/kg (rat, mouse).
Dogs (one animal/sex) were administered successive oral doses of florfenicol that ranged from 160 to 1280 mg/kg. No clinical effects occurred at doses as high as 640 mg/kg. At 640 mg/kg, the only female died from inhalation of vomitus. Vomiting or soft stool occurred at 640 to 1280 mg/kg.
Lactose: Oral LD50: > 10g/kg (rat)
Florfenicol was not a skin sensitizer in guinea pigs.
REPEAT DOSE TOXICITY DATA
SUBCHRONIC / CHRONIC TOXICITY:
Florfenicol was administered orally to dogs, rats, and mice at dosages as high as 100 to 400 mg/kg/day for up to 13 weeks.
Effects including decreased body weight, changes in liver weight or liver enzyme levels, changes in testicular weight, testicular atrophy, decreased white blood cell counts, and decreased hemoglobin levels were observed at high dosages. Cellular changes in the liver or lymph nodes of rats and mice, and histopathologic changes in the brain and spinal cord of dogs were also noted at these high dosages.
Although some effects were reversible after a 4-week withdrawal from treatment, testicular effects in rats persisted. Intramuscular injections of 45 mg/kg of florfenicol in swine produced diarrhea, injection site lesions, decreased body weight, decreased food and water consumption, changes in serum electrolytes and proteins, decreased red blood cell and white blood cell counts, decreased spleen weight, and decreased kidney weight.
In 52-week oral toxicity studies in dogs and rats, high dosages of florfenicol (12 and 48 mg/kg/day, respectively) increased liver weight and produced cellular changes in the gall bladder of dogs. In rats, florfenicol at the high dosage reduced body weight gain, reduced testicular weight, induced changes in hematologic and clinical chemistry parameters, and increased the incidence of testicular tubular atrophy.
In two-year chronic studies in mice and rats, florfenicol caused similar effects as those observed in other long-term studies including reduced body weight gain, reduced red blood cell count, reduced hemoglobin levels, and testicular effects such as small testes, tubular atrophy and aspermatogenesis in both the high dosage rats (48 mg/kg/day) and mice (200 mg/kg/day).
REPRODUCTIVE / DEVELOPMENTAL TOXICITY:
In a two-generation reproductive study, oral administration as high as 12 mg/kg/day of florfenicol reduced epididymal weights, decreased pup survival, and reduced lactation index in rats [NOAEL: 3 mg/kg/day].There was no evidence of teratogenicity in rats administered florfenicol at dosages of 4, 12 or 40 mg/kg/day.
Slight maternal toxicity, evidenced by decreased food and water consumption, was observed above 4 mg/kg/day. At 40 mg/kg/day, an increased incidence of delayed ossification and decreased fetal weight occurred. The NOAEL for maternal and fetal toxicity in rats was determined to be 4 mg florfenicol/kg/day.
Two teratogenicity studies were performed in mice. In the first study, the mice were administered florfenicol at dosages of 40, 120, or 400 mg/kg by gavage on days 6-15 of gestation. Florfenicol produced embryolethality at the 400 mg/kg/day dose level, which was evidenced by the high incidence of intrauterine deaths.
Significant decreases in mean fetal body weight, soft tissue defects, and retarded skeletal ossification were also observed at 400 mg/kg/day. Skeletal ossification was less pronounced, in a dose-related fashion, at the lower doses tested (40 and 120 mg/kg/day). A developmentalNOAEL could not be determined for these data [NOAEL for maternal: 120 mg/kg].
In the second teratogenicity study, florfenicol was retested at lower administered dosages of 1, 3, or 60 mg/kg/day. Maternal effects were limited to a slight increase in water consumption at the 60 mg/kg/day dose. There was no evidence of any adverse effects on the embryo/fetus at doses as high as 60 mg/kg/day in this study.
However, based upon the retarded skeletal ossification effects observed in the first study at 40 mg/kg/day the NOAEL for the two studies combined was determined to be between 3 and 40 mg/kg/day.
MUTAGENICITY / GENOTOXICITY:
Florfenicol was negative in a bacterial mutagenicity study (Ames), a mammalian mutagenicity study (mouse lymphoma), a bone marrow micronucleus assay, an in vitro chromosomal aberration assay in CHO cells, a cytogenetics assay in bone marrow, and an unscheduled DNA synthesis assay in rat hepatocytes.
Florfenicol was not carcinogenic in a 2-year study in rats administered dosages up to 48 mg/kg/day for 5 days a week or in mice at dosages up to 200 mg/kg/day for 5 days per week.
14. OTHER INFORMATION
DEPARTMENT ISSUING MSDS: Global Safety and Environmental AffairsOccupational and Environmental ToxicologySchering-Plough Corporation1095 Morris AvenueUnion, NJ 07083 USA
SCHERING-PLOUGH MSDS HELPLINE: (800) 770-8878 (US and Canada)(908) 629-3657 (Worldwide)
Monday to Friday, 9am to 5pm (US Eastern Time)
MSDS CREATION DATE: 12-Nov-1992
SUPERSEDES DATE: 02-Jun-2005