5663043pdf.pdf

Loading ...
Global Do...
News & Politics
 
  
Schering-Plough Animal Health Corporation 
556 Morris Avenue 
Summit, NJ  07901
  
MATERIAL SAFETY DATA SHEET 
  
Schering-Plough urges each user or recipient of this MSDS to read the entire data sheet to become aware of the hazards associated with this material.
  
 
SECTION 1.  IDENTIFICATION OF SUBSTANCE AND CONTACT INFORMATION
  
MSDS NAME:
Gentamicin Sulfate Topical Sprays (with Betamethasone Valerate)
  
SYNONYM(S):
Garagen Topical Spray 
Gentocin Topical Spray 
Topagen Spray
  
MSDS NUMBER:
SP000071
  
EMERGENCY NUMBER(S):
Schering-Plough Security Control Center  (908) 820-6921 (24 hours) 
Transportation Emergencies -  CHEMTREC: 
(800) 424-9300 (Inside Continental USA)   
(703) 527-3887 (Outside Continental USA) 
Rocky Mountain Poison Center (For Human Exposure): 
(303) 595-4869 
Animal Health Technical Services: 
For Animal Adverse Events: Small Animals and Horses: (800) 224-5318  
For Animal Adverse Events: Livestock: (800) 211-3573   
For Animal Adverse Events: Poultry: (800) 219-9286
  
INFORMATION:
Animal Health Technical Services:  
For Small Animals and Horses: (800) 224-5318  
For Livestock: (800) 211-3573  
For Poultry: (800) 219-9286 
  
SCHERING-PLOUGH MSDS HELPLINE:
(800) 770-8878 (US and Canada) 
(908) 629-3657 (Worldwide) 
Monday to Friday, 9am to 5pm (US Eastern Time) 
  
 
SECTION 2.  HAZARDS IDENTIFICATION
 
 
  
EMERGENCY OVERVIEW 
 
Solution
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
 
 
Odor unknown
MSDS NUMBER: SP000071
Latest Revision Date: 18-Nov-2005
 
Clear, Colorless to light yellow
Page 1 of 8 
Published Date:  18-Nov-2005
 
Irritating to eyes.
May cause dermal sensitization.
May be irritating to respiratory system.
May be absorbed through the skin.
May be a reproductive toxicant.
May cause developmental effects.
 
POTENTIAL HEALTH EFFECTS:
 
The toxicological properties of the mixture(s) have not been fully characterized in humans or animals.  However, there are data to describe the 
toxicological properties of the individual ingredients.  The following summary is based upon available information about the individual ingredients of the 
mixture(s), or of the expected properties of the mixture(s). Only information about the ingredients that are expected to contribute significantly to the 
potential health hazard profile of the formulation(s) is presented.
 
Gentamicin sulfate, an active ingredient, is an aminoglycoside antibiotic that acts by inhibiting normal protein synthesis in susceptible bacteria.   
Gentamicin sulfate may be irritating to the eyes and skin.  It may cause damage to the nervous system and kidneys.  Balance and hearing problems may 
occur as well as numbness and convulsions.  Gentamicin sulfate may produce severe reactions in persons allergic or sensitized to aminoglycoside 
antibiotics.  Exposure to gentamicin sulfate by individuals already using potent diuretics should be avoided.   
Aminoglycosides, the class to which gentamicin sulfate belongs,  are associated with significant nephrotoxicity (kidney damage) and neurotoxicity 
(nervous system damage), the latter manifested by ototoxicity (ear damage), numbness, and convulsions.  Aminoglycosides can cause fetal harm since 
they can cross the placenta.  Animal reproduction studies did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate.  It is 
not known; however, whether fetal harm or effects on the reproductive capacity can be caused by exposure to gentamicin sulfate by pregnant women.   
Betamethasone is an anti-inflammatory corticosteroid used in the treatment of various disease states.  As a class, corticosteroids are known to cause 
systemic effects such as reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, increased blood sugar, sugar in the urine, impairment 
of glucose tolerance, and changes in general metabolism, bone metabolism, white blood cell counts, and some blood serum chemistry levels. The 
clinical relevance of these changes in healthy adults is unknown. Cushing's syndrome may occur from excessive exposure to corticosteroids.  Use of 
aerosolized corticosteroid inhalers has caused nasal irritation or burning, occasional sneezing, runny or bloody nose.  Rare instances of nasal ulceration, 
septum perforation and increased intraocular pressure have been reported following prolonged use of or overexposure to aerosolized corticosteroids. 
Prolonged use of systemic steroids is also known to be associated with the formation of cataracts and glaucoma. Corticosteroids may mask some signs 
of infection, and opportunistic infections may appear during their use due to effects on immune system.  Persons with pre-existing skin conditions 
including dermatitis and acne, a history of asthma, or those taking or those with a history of taking systemic steroids are more susceptible to allergic 
reactions from exposure to steroids.  Serious health effects including death have occured in asthmatic patients during transfer from systemic 
corticosteroid to topical corticosteroid clinical use. 
Reported occupational effects include allergic skin reactions such as dermatitis and rash. 
The most common side effects in studies with betamethasone-containing topical preparations were local, including erythema, steroid-induced rosacea 
(redness, acne-like reaction on face), mild burning, itching, skin dryness and irritation. Betamethasone has been shown to decrease collagen synthesis 
in human skin following treatment with topical cream.  Adverse reactions reported following injection of betamethasone include effects on fluid and 
electrolytes, musculoskeletal, gastrointestinal, dermatologic, neurological, endocrine, opthalmic and metabolic parameters. 
Corticosteroids are teratogenic in laboratory animals and may be considered teratogenic in non-human primates as well.  Widespread clinical use of 
corticosteroids has resulted in very few reports of teratogenic activity in humans. There is no evidence of impaired fertility in humans treated with 
corticosteroids although hypo-adrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. 
 
Isopropanol is an irritant of the eyes and mucous membranes.  Acute exposure to isopropanol by ingestion or inhalation may cause redness of the skin, 
headache, dizziness, hallucinations, distorted perception, labored breathing, nausea, and vomiting. Exposure to very high concentrations of isopropanol 
has been reported to cause central nervous system (CNS) depression, brain or nerve damage, respiratory depression, absence of reflexes, low blood 
pressure, slow or fast heart rates, low body temperature, bleeding and inflammation of the stomach, decreased urination, failure to form urine,  kidney 
and liver damage, and coma.  Chronic exposure may also cause irritation, sensitization, corrosion, thinning, inflammation, drying and cracking of the 
skin. Corneal epithelium changes may occur with prolonged vapor contact.  
Propylene glycol is considered to be relatively non-toxic.  It is a mild irritant to the eyes and has been reported to irritate the skin.  It may cause skin 
sensitization resulting in allergic contact dermatitis in susceptible individuals.  Inhalation exposure to saturated and supersaturated atmospheres of 
propylene glycol for prolonged periods of time produced no adverse effects.  Propylene glycol may cause nervous system depression, acidosis, stupor, 
and seizures after chronic ingestion.
 
  
 
MSDS NUMBER: SP000071
 
Causes effects to:
- skin
- endocrine system
May cause effects to:
- central nervous system
- gastrointestinal tract
- immune system
- liver
- kidney
- brain
- reproductive system
- fetus
Latest Revision Date: 18-Nov-2005
Page 2 of 8 
Published Date:  18-Nov-2005
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
LISTED CARCINOGENS
CHEMICAL NAME
CAS NUMBER
OSHA
IARC
NTP
ACGIH
Isopropyl Alcohol
67-63-0
Not 
classifiable.
Group A4     
Not 
classifiable as 
a human 
carcinogen.
 
Isopropyl alcohol is classified by IARC as a Group 3 carcinogen (unclassifiable as to carcinogenicity in humans).
  
SECTION 3.  COMPOSITION AND INFORMATION ON INGREDIENTS
  
PRODUCT USE:
Veterinary product
 
CHEMICAL FORMULA:
Mixture.
 
The formulation for this product is proprietary information.  Only hazardous ingredients in concentrations of 1% or greater and/or carcinogenic ingredients 
in concentrations of 0.1% or greater are listed in the Chemical Composition table.  Active ingredients in any concentration are listed.  For additional 
information about carcinogenic ingredients see Section 3.
 
  
CHEMICAL COMPOSITION
CHEMICAL NAME
CAS NUMBER
PERCENT
Gentamicin Sulfate
1405-41-0
0.057
Betamethasone Valerate
2152-44-5
0.036
Propylene Glycol
57-55-6
10-20
Isopropyl Alcohol
67-63-0
10-20
 
  
ADDITIONAL INFORMATION: 
This MSDS is written to provide health and safety information for individuals who will be handling the final 
product formulation during research, manufacturing, and distribution.  For health and safety information for 
individual ingredients used during manufacturing, refer to the appropriate MSDS for each ingredient.  Refer 
to the package insert or product label for handling guidance for the consumer.  
  
SECTION 4. FIRST AID MEASURES
  
INHALATION:
Remove to fresh air.  If any trouble breathing, get immediate medical attention.  Administer artificial 
respiration 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 or 
persists, consult a physician.
  
INGESTION:
Rinse mouth and drink a glass of water.  Do not induce vomiting unless under the direction of a qualified 
medical professional or Poison Control Center.  If symptoms persist, consult a physician.
  
NOTE TO PHYSICIAN:
Gentamicin sulfate is a aminoglycoside antibiotic.  Allergic reactions may occur in susceptible individuals.  
Exposure to gentamicin sulfate by individuals already using potent diuretics should be avoided.   This 
product contains betamethasone valerate, a steroid hormone.  This product is indicated for the relief and 
treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.  
Persons with a prior history of asthma, treatment with systemic steroids, or pre-existing skin conditions, 
such as acne and dermatitis, may be more susceptible to the adverse effects of steroid exposure.  Serious 
health effects including death have occured in asthmatic patients during transfer from systemic 
corticosteroid to topical corticosteroid clinical use.
  
SECTION 5. FIRE FIGHTING MEASURES
  
FLAMMABILITY DATA: 
 
 
Flash Point: 
93.3 deg C ( 200 deg F )
  
  
  
SPECIAL FIRE FIGHTING PROCEDURES:
Wear full protective clothing and self-contained breathing apparatus (SCBA).
  
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 3 of 8 
Published Date:  18-Nov-2005
SUITABLE EXTINGUISHING MEDIA:
Water. Carbon dioxide (CO2). Dry chemical.
  
See Section 9 for Physical and Chemical Properties. 
 
SECTION 6. ACCIDENTAL RELEASE MEASURES
  
PERSONAL PRECAUTIONS:
Keep personnel away from the clean-up area. Wear appropriate personal protective equipment as specified in Section 8.
 
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 or 
wet 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.
 
 
See Sections 9 and 10 for additional physical, chemical, and hazard information.  
 
SECTION 7. HANDLING AND STORAGE
  
HANDLING:
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.  See Section 8 (Exposure Controls) for additional guidance.
 
STORAGE:
Store in a cool, dry, well ventilated area. Store between 2 and 30 deg C (36 and 86 deg F).
 
SPECIAL PRECAUTIONS:
Store spray bottles upright
 
 
See Section 8 for exposure controls and additional safe handling information.  
 
SECTION 8. EXPOSURE CONTROLS AND PERSONAL PROTECTION
  
The following guidance applies to the handling of the active ingredient(s) in this formulation.
 
S-P OCCUPATIONAL EXPOSURE GUIDELINE (OEG):
Schering-Plough Corporation has established an Occupational Exposure Guideline of 5 mcg/m3 (8-hr TWA) for betamethasone (base).
 
EXPOSURE CONTROLS:
The health hazard risks of handling this material are 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.  Exposure controls for normal operating or routine procedures follow a tiered strategy.  Engineering controls are the 
preferred means of long-term or permanent exposure control.  If engineering controls are not feasible, appropriate use of personal protective equipment 
(PPE) may be considered as alternative control measures.  However, PPE should not be used as a method of permanent or long-term exposure control.  
Exposure controls for non-routine operations must be evaluated and addressed as part of the site-specific risk assessment.
 
 
RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT (PPE): 
  
 
Respiratory Protection:
Respiratory protective equipment (RPE) may be required for certain laboratory and large-scale 
manufacturing tasks if potential airborne breathing zone concentrations of substances exceed the relevant 
exposure limit(s).  Workplace risk assessment should be completed before specifying and implementing 
RPE usage.  Potential exposure points and pathways, task duration and frequency, potential employee 
contact with the substance, and the ability of the substance to be rendered airborne during specific tasks 
should be evaluated.  Initial and ongoing strategies of quantitative exposure measurement should be 
obtained as required by the workplace risk assessment.  All RPE must conform to local and regional 
specifications for efficacy and performance.  Consult your site or corporate health and safety professional 
for additional guidance.
 
 
Skin Protection:
Gloves that provide an appropriate barrier to the skin are recommended if there is potential for contact with 
this material.  Consult your site safety staff for guidance.
 
 
Eye Protection:
Safety glasses with side shields.  Use of goggles or full face protection may be required based on hazard, 
potential for contact, or level of exposure.  Consult your site safety staff for guidance.
 
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 4 of 8 
Published Date:  18-Nov-2005
 
Body Protection:
In small-scale or laboratory operations, lab coats or equivalent protection is required.  Disposable Tyvek or 
other dust impermeable suit should be considered based on procedure or level of exposure.  Use of 
additional PPE such as shoe coverings, gauntlets, hood, or head covering may be necessary.  Consult 
your site safety staff for guidance. 
In large-scale or manufacturing operations, disposable Tyvek or other dust impermeable suit is 
recommended and based on level of exposure.  Use of additional PPE such as shoe coverings, gauntlets, 
hood, or head covering may be necessary.  Consult your site safety staff for guidance.
 
EXPOSURE LIMIT VALUES
CHEMICAL NAME
CAS NUMBER
ACGIH TLV (TWA)
OSHA PEL (TWA)
Isopropyl Alcohol
67-63-0
200 ppm
980 mg/m3 400 ppm
 
CHEMICAL NAME
CAS NUMBER
ACGIH TLV (STEL / 
SKIN) 
ACGIH TLV (CEIL) 
OSHA PEL 
(STEL / SKIN) 
OSHA PEL 
(CEIL) 
Isopropyl Alcohol
67-63-0
400 ppm
 
 
 
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
  
FORM:
Solution
COLOR: 
Clear, Colorless to light yellow
ODOR: 
Odor unknown
pH:
3.0-4.5
SOLUBILITY: 
 
Water:
Not determined
 
  
See Section 5 for flammability/explosivity information.  
 
SECTION 10. STABILITY AND REACTIVITY
  
STABILITY/ REACTIVITY:
Stable under normal conditions.
 
INCOMPATIBLE MATERIALS / CONDITIONS TO AVOID:
Open flames and high temperatures.
 
HAZARDOUS DECOMPOSITION PRODUCTS / REACTIONS:
Carbon monoxide. Carbon dioxide (CO2).
  
SECTION 11. TOXICOLOGICAL INFORMATION
  
The information presented below pertains to the following individual ingredients in this formulation, unless indicated otherwise. The information 
presented below for the active ingredient in this formulation, betamethasone valerate, is either for betamethasone or the dipropionate salt.  The toxicity is 
considered to be equivalent to the betamethasone valerate form.
 
ACUTE TOXICITY DATA 
  
 
  
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 5 of 8 
Published Date:  18-Nov-2005
INHALATION: 
Gentamicin sulfate:  LC50:  > 0.20 mg/L (rat) 
In an acute inhalation toxicity study in rats at 0.20 mg/L, animals exhibited labored breathing and eye closure during exposure to gentamicin sulfate.  
Nasal discharge was noted for several days followed by recovery. 
In an acute inhalation toxicity study in rats at 0.59 mg/l betamethasone dipropionate (maximum attainable concentration), animals exhibited labored 
breathing, eye closure and decreased activity during exposure.  All animals recovered within one day after exposure. 
Rats and mice were exposed by inhalation to an aerosol containing 0.3 mg of betamethasone dipropionate per liter over a 5-hour period.  Both species 
exhibited body weight decreases during the 4 day post treatment period.  During exposure the mice exhibited transient central nervous system 
stimulation including excitation, tremors and convulsions.  Recovery was prompt.  Upon microscopic examination,  partial thymic involution was seen in 
both species.  This finding together with the loss in body weight was attributed to the known pharmacological activity of a corticosteroid. 
Propylene glycol caused no adverse effects in monkeys or rats following exposure to saturated atmospheres for prolonged periods of time. 
Isopropanol:  Inhalation LC50 (8hr): 16,000 ppm (rat) 
Isopropanol caused reduced ciliary activity in the nasal mucosa and trachea at 400 ppm for 24 hours and severe pathological degeneration of the 
respiratory mucosa at 5500 ppm for 24 hours in guinea pigs.
 
SKIN: 
Gentamicin sulfate was slightly irritating to the skin of rabbits (PII 1.0).   
Betamethasone produced erythema which was present five hours after dosing in a skin irritation study in rabbits but resolved by 96 hours after dosing.  
There were no adverse skin changes detected in dermal toxicity studies of betamethasone diproprionate cream (0.05% or 0.1%) in hairless mice, rats, 
rabbits or dogs.  A betamethasone dipropionate (0.05%) ointment formulation was determined to be a potentially weak sensitizer in guinea pigs.   Local 
irritation at the intradermal injection sites was observed during the induction phase. 
Propylene glycol:  Dermal LD50: 20.8 g/kg (rabbit) 
Propylene glycol was irritating in a human patch test.  Propylene glycol was not irritating to the skin of rabbits, guinea pigs and swine. 
Isopropanol: Dermal LD50: 12.9 g/kg (rabbit) 
Isopropanol was practically not irritating to the skin of rabbits and guinea pigs.
 
EYE: 
Gentamicin sulfate was slightly irritating to the eyes of rabbits. 
Betamethasone dipropionate produced mild, reversible ocular irritation consisting of slight to moderate conjunctival irritation and corneal ulceration.  One 
animal had a slight dulling of the corneal surface. All animals were normal by Day 7. 
Propylene glycol was slightly irritating to the eyes of rabbits. 
Isopropanol was moderately irritating and caused mild transitory injury to the eyes of rabbits.  Exposure to isopropanol (50%) for three minutes has been 
shown to cause eye irritation.  Isopropanol (70%) caused conjunctivitis, iritis, and corneal opacity.
 
ORAL: 
Gentamicin sulfate:  Oral LD50:  > 5000 mg/kg (rat) 
Betamethasone dipropionate:  Oral LD50: >1000 mg/kg (dog); >5000 mg/kg (rat); >50 mg/kg (mice) 
One male and one female dog were each administered a single oral dose of 1000 mg/kg of betamethasone dipropionate and observed for five weeks.  
Urine output and water consumption were increased and eosinophil counts decreased during the week post treatment.    
Propylene glycol:  Oral LD50: 21 to 33.7 g/kg (rat), 10 to 20 g/kg (dog) 
Propylene glycol caused dyspnea, cramps, loss of equilibrium, depression, analgesia, and death after prolonged moribund state in mice at doses 
ranging from 23.9 to 31.8 g/kg.  In rabbits, 1 to 1.5 g/kg propylene glycol reduced intraocular pressure by raising the osmotic pressure of blood.  
Isopropanol:  Oral LD50: 4.7 to 5.84 g/kg (rat); 4.8 g/kg (dog)
 
SENSITIZATION: 
A betamethasone dipropionate (0.05%) ointment formulation was determined to be a potentially weak sensitizer in guinea pigs.   Local irritation at the 
intradermal injection sites was observed during the induction phase. 
Propylene glycol did not cause sensitization in a human patch test.
 
ADDITIONAL INFORMATION:
Gentamicin sulfate:  Intravenous LD50:  96 mg/kg 
Gentamicin sulfate:  Intramuscular LD50:  371-384 mg/kg (rat) 
Clinical signs included hypoactivity, increased water consumption, and irregular respiration.  
 
REPEAT DOSE TOXICITY DATA  
 
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 6 of 8 
Published Date:  18-Nov-2005
SUBCHRONIC / CHRONIC TOXICITY: 
Two subchronic dermal toxicity studies were conducted in dogs using a gentamicin sulfate and betamethasone valerate combination.  In one study,  
Gentocin Topical Spray was applied topically for 28 days.  Each spray actuation delivered approximately 0.7 ml of the topical solution.   Treatment 
resulted in organ weight and histopathological changes typical of corticosteriod therapy known  to be reversible upon cessation of treatment.  In the 
second study, an aerosol containing gentamicin sulfate and betamethasone valerate (6:1) was used.  Approximately 10% of the dog body surface was 
sprayed either 4 or 9 times daily for 21 days.  Dermal doses were approximately 1.84 to 4.14 mg/day for gentamicin sulfate and 0.32 to 0.72 mg/day for 
betamethasone valerate.   Adrenal and kidney weights were decreased in treated dogs.  Treatment-related microscopic changes occured in the 
adrenals, kidney, and liver.  No treatment-related toxicological changes in the skin were observed.     
 
REPRODUCTIVE / DEVELOPMENTAL TOXICITY: 
A reproduction study with gentamicin sulfate was conducted in rabbits.  On gestation days 6-16, dose levels of 0.8 and 3.6 mg/kg were injected 
intramuscularly. There were no adverse findings in the offspring noted.  In rats and guinea pigs, fetal renal abnormalities have been reported after 
administration of gentamicin to the dam.  In guinea pigs, transient renal abnormalities were observed in the fetus after the administration of 4 mg/kg of 
gentamicin to the mother.  In two reproduction studies, rats were administered 75 mg/kg of gentamicin in saline by intraperitoneal or intramuscular 
injection for 12 days from day 10 of gestation to delivery or on days 7-11 and 14-18 of pregnancy, respectively.  Adverse effects reported included focal 
tubular lesions in the developing kidney, reduced rate of early nephrogenesis, general growth retardation, and alterations of the glomeruli and proximal 
tubules. Other animal reproduction studies in rats and rabbits did not exhibit any evidence of impaired fertility or harm to the fetus following exposure to 
gentamicin sulfate.   
Corticosteroids are known teratogens in rodent species with some teratogenic effects having been observed in non-human primates. They are generally 
teratogenic in laboratory animals when administered systemically at low dosages. 
Subcutaneous administration of up to 0.42 mg of a mixture of betamethasone/sodium phosphate and betamethasone/acetate suspension, on days 12 
and 13 of gestation in pregnant rats, caused decreases in maternal and fetal weight gain, occurence of cleft palate and omphalocele (umbilical hernia), 
and impaired growth of fetal heart, liver, adrenals, kidneys, and skeletal muscle.  Dose-related increases in fetal resorptions in rabbits and mice following 
single intramuscular doses up to 1 and 33 mg/kg, respectively were observed.  Additionally, betamethasone diproprionate has been shown to produce 
umbilical hernias, cephalocele (cranial protrusion) and cleft palate in rabbits when given intramuscular doses of 0.05 mg/kg/day during gestation.  
Suppression of adrenocorticotropic hormone (ACTH), following intramuscular administration of betamethasone in monkeys during gestation resulted in 
decreases in fetal adrenal weight, cortical cell size, appearance of apoptosis and cellular disorganization.  Propylene glycol caused decreased food 
consumption, retarded growth, smaller litters, changes in breeding patterns, and inhibited weaning in rats that were fed 30% propylene glycol through six 
generations; however, this may have been due to nutritional insufficiency.  Propylene glycol was not teratogenic in rabbits, monkeys or chickens. 
Isopropanol (2.5%) in drinking water had no effect on the reproduction and growth of rats in a three-generation study.  In a two-generation study, rats 
were dosed by oral gavage with dosages up to 1000 mg/kg/day of isopropanol. No reproductive toxicity was observed except for a statistically significant 
reduction in the mating index of the high-dose first generation males.  Toxicity was observed in the first-generation offspring at 1000 mg/kg/day, as 
evidenced by reduced body weight and increased mortality.  Isopropanol was not teratogenic in rats given dosages up to 1200 mg/kg/day on gestation 
days 6 through 15 or in rabbits given dosages up to 480 mg/kg/day on gestation days 6 through 18. No evidence of developmental toxicity, as 
determined by pathological findings, organ weights, or behavioral tests was observed in rats administered up to 1200 mg/kg/day on gestation day 6 
through postnatal day 21. Teratogenic effects were reported in rats exposed to 3500, 7000, or 10,000 ppm isopropanol for 7 hours daily on gestation 
days 1 to 19 .  Reported maternal and fetal effects observed in animals dosed at 7000 ppm and greater included malformations, resorptions, skeletal 
defects, and fetal deaths at maternally toxic doses. 
 
MUTAGENICITY / GENOTOXICITY: 
Betamethasone was negative in a bacterial mutagenicity study (Ames) and mammalian cell mutagenicity assay (CHO/HGPRT) and positive in the in vitro 
human lymphocyte chromosome abberation assay.  Equivocal results were seen in the in vivo mouse bone marrow micronucleus assay. 
Propylene glycol was negative in a bacterial mutagenicity study (Ames). 
Isopropanol was negative in a sister chromatid exchange assay, in a bacterial mutagenicity study (Ames) with activation, in an in vitro CHO/HGPRT 
gene mutation assay, in an in vivo bone marrow micronucleus assay in mice, and in mutagenicity tests in Neurospora crassa. 
 
CARCINOGENICITY: 
This material or product has not been evaluated for carcinogenicity. 
Propylene glycol was not carcinogenic when applied to the skin, or when given orally in mice and rats. 
Male mice exposed to 7.5 ppm isopropanol for 3 to 7 hours daily, 5 days per week for 5 to 8 months showed no significant increase in the number of lung 
tumors observed.  No increases in lung tumors were observed in the same strains of mice that received subcutaneous injections of isopropanol once 
weekly for 20 to 40 weeks.  However, isopropanol has not been tested adequately in animals to assess carcinogenicity. 
  
 
SECTION 12. ECOLOGICAL INFORMATION
  
ECOTOXICITY DATA 
 
INGREDIENT ECOTOXICITY 
Isopropanol: 96-hr LC50 (Fathead minnow): 6.12 to 10.4 g/L
Isopropanol: Cell multiplication test (algae): 1000 mg/L
Isopropanol: Cell multiplication test (green algae): 1800 mg/L
Propylene glycol: 48-hr EC50 (daphnid): >43,500 mg/L
Propylene glycol: 72-hr EC50 (green algae): >19,000 mg/L
Propylene glycol: 96-hr LC50 (sheepshead minnow): 23,800 mg/L
 
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 7 of 8 
Published Date:  18-Nov-2005
ENVIRONMENTAL DATA 
 
 
 
OTHER INGREDIENT ENVIRONMENTAL DATA: 
Propylene glycol is expected to be readily biodegradable.
  
SECTION 13. DISPOSAL CONSIDERATIONS
  
MATERIAL WASTE:
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 involve the 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.
  
SECTION 14. TRANSPORT INFORMATION
  
This material is not subject to the transportation regulations of DOT, ICAO, IMO, and the ADR.
  
SECTION 15. REGULATORY INFORMATION
  
  
TSCA LISTING
CHEMICAL NAME
TSCA
Propylene Glycol
Listed
Isopropyl Alcohol
Listed
 
U.S. STATE REGULATIONS
CHEMICAL NAME
California 
Proposition 65
CARTK
NJRTK
CTRTK
MARTK
Isopropyl Alcohol
Listed.
Listed.
Listed.
 
CHEMICAL NAME
PARTK
MNRTK
MIRTK
ILRTK
LARTK
RIRTK
Propylene Glycol
Listed.
Listed.
Listed.
Isopropyl Alcohol
Listed.
Listed.
Listed.
 
 
 
SECTION 16. OTHER INFORMATION
  
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 consequence of its use.  Each individual should make a determination as to the suitability of the information for their particular 
purpose(s).
 
DEPARTMENT ISSUING MSDS:
Global Safety and Environmental Affairs 
Occupational and Environmental Toxicology 
Schering-Plough Corporation 
1095 Morris Avenue 
Union, 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:
03-Mar-1992
SUPERSEDES DATE:
26-Mar-2004
  
  
MSDS NUMBER: SP000071
Gentamicin Sulfate Topical Sprays (with 
Betamethasone Valerate)
Latest Revision Date: 18-Nov-2005
 
Page 8 of 8 
Published Date:  18-Nov-2005