1. PRODUCT IDENTIFICATION
Product Name(s):
Psorcon E Cream
Dermik Laboratories, Inc.
500 Arcola Road
Collegeville, PA 19426-0107
24-Hour Emergency Phone: (610) 454-8000
2. COMPOSITION / INFORMATION ON INGREDIENTS
Common Name CAS No. Exposure Limits
Diflorasone Diacetate 33564-31-7
Propylene Glycol 57-55-6 AIHA WEEL: Vapor + aerosol = 50 ppm
aerosol =10 mg/m3
Stearyl Alcohol 112-92-5
Cetyl Alcohol 124-29-8
Sorbitan Monostearate 1338-41-6 8 hr TWA 10 mg/m3 total dust TLV
Polysorbate 60 9005-67-8
Mineral Oil 8012-95-1 8 hr TWA 5 mg/m3 PEL and TLV
(as sampled by a method that does
not collect vapor)
Purified Water 7732-18-5
3. HAZARDS IDENTIFICATION
Potential Health Effects
Emergency Overview:
R36 Irritating to the eyes. May be irritating to the skin.
Eye
R36 Irritating to the eyes. Exposure to the eye may cause dilated pupils
and long-term eye exposure could result in glaucoma.
Inhalation
As a gel, not an expected route of exposure.
Skin Contact
Certain individuals may be hypersensitive to some ingredients. Potentially
irritating to skin. Absorption of active ingredient may occur.
Ingestion
If ingested long term in significant quantities this product could result
in allergic reactions, nausea, vomiting, digestive disorders, headache,
emotional disturbances, glaucoma, menstrual disorders, heart damage and/or
convulsions (see section 11). R 64 May cause harm to breastfed babies.
Chronic Effects/Carcinogenicity
See section 11 for chronic health effects. The active ingredient is not
listed as a carcinogen by OSHA, NTP or IARC.
4. FIRST AID MEASURES
Eyes
S26 In case of contact with eyes, rinse immediately with plenty of
water and seek medical advice.
Skin
If not being used therapeutically, after contact with skin, wash
immediately with plenty of soap and water. Seek medical attention if
symptoms appear.
Ingestion
S46 If inadvertently swallowed (in significant quantity), seek
medical advice immediately and show this MSDS.
Inhalation
Not an expected route of exposure.
Note to Physician
Additional details are available on the package insert or in the
Physicians' Desk Reference.
5. FIRE FIGHTING MEASURES
FLAMMABLE LIMITS
Flash Pt: Unspecified
Flammable Limits in Air-Lower: Unspecified
Flammable Limits in Air-Upper: Unspecified
Auto-Ignition Temperature: Unspecified
General Hazards
CO, CO2, HF and oxides of nitrogen and fluorine may be generated in a fire.
Fire Fighting Extinguishing Media
Water spray or fog, carbon dioxide, or dry chemical.
Fire Fighting Instructions
S43 In case of fire, use full firefighting turnout gear and
self-contained breathing apparatus (SCBA). Keep personnel upwind and away
from fire.
Hazardous Combustion Products
CO, CO2, HF and oxides of nitrogen and fluorine may be generated
in a fire.
6. ACCIDENTAL RELEASE MEASURES
Large Spill
Absorb on suitable medium and deposit in suitable container for
disposal. Mop area with detergent and water.
Small Spill
Wipe up with disposable towels and deposit in suitable container for
disposal. Wipe down area with detergent and water.
7. HANDLING AND STORAGE
Special Handling
Protect package from physical damage.
Special Storage
Store at controlled room temperature. Do not freeze.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Eye Protection
For manufacturing and packaging operations, S25 avoid contact with
eyes. S39 Wear eye/face protection.
Skin Protection
For manufacturing and packaging operations, S24 avoid contact with
skin. S36 Wear suitable protective clothing.
Respiratory Protection
As packaged, none required. Manufacturing and packaging operations
may require respiratory protection based upon potential exposures to
individual ingredients.
Engineering Controls
Maintain employee exposures below exposure limits. Manufacturing and
packaging operations should be designed so as to offer no significant
exposure to this material.
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical Form: Gel
Odor: Distinct fragrance
Boiling Point: Unspecified
Melting Point: Unspecified
Freezing Point: Unspecified
pH: Unspecified
Solubility in Water: Slight
Specific Gravity: Unspecified
Decomposition Temperature:
430-433( F (221-223( C) (for active ingredient)
Evaporation Rate: Unspecified
Vapor Pressure: Unspecified
Vapor Density: Unspecified
Molecular Weight: 494.58 (for active ingredient)
10. STABILITY AND REACTIVITY
Stability
Stable.
Incompatibility
Light. Strong oxidizers. Alkalis.
Hazardous Decomposition Products
No data.
Hazardous Polymerization
Will not occur.
General Information
No additional information.
11. TOXICOLOGICAL INFORMATION
DIFLORASONE DIACETATE:
ANIMAL TOXICITY DATA:
The oral, intraperitoneal and subcutaneous-LD50 in both mice and rats is
reported in the literature to be >3 g/kg. The lowest published toxic dose
(TDLo) by continuous dermal application in rats is 3.5 mg/kg/5 week(s) and
produced changes in thymus weight and leukocyte counts. A 7-day dermal
application of 1 and 4 mg/kg b.i.d. to the abraded skin of rats caused
decreased body weight gain, decreased food consumption, decreased organ
weights of adrenals, thymus and spleen, and atrophy of the adrenal cortex
and thymus. A 28-day dermal application of 1, 2 and 4 mg/kg b.i.d. to the
shaved skin of rats caused decreased body weight gain, decreased food
consumption, decreased leukocytes and increased erythrocyte parameters,
decreased organ weights of adrenals, thymus and spleen, atrophy of the
adrenal cortex, thymus and lymphoid tissue and reduced hematopoiesis. A
13-week dermal application of 0.1, 0.3 and 1.0 mg/kg/day to the skin of
monkeys caused a slight decrease in body weight, decreased lymphocyte and
eosinophil counts, increased heterophil counts, decreased thymus weight,
atrophy of the adrenal cortex, thymus and lymphoid tissue and reduced
hematopoiesis. Single oral doses of glucocorticoids ranging from 0.5 to
8.0 gm/kg suppressed the immune response in mice to the extent that high
mortality occurred as a result of intercurrent infections over 1 to 3
weeks.
There have been no long-term studies to evaluate the carcinogenic
potential of diflorasone diacetate. Diflorasone diacetate was not found
to be mutagenic in a micronucleus test in rats at doses of 2400 mg/kg.
ANIMAL REPRODUCTIVE DATA:
Studies in the rat following topical administration at doses up to 0.5
mg/kg revealed no effects on fertility.
Subcutaneous administration of diflorasone diacetate produced both
maternal and fetal effects in the rat. In one study, a TDLo of 495 and
4950 (g/kg by subcutaneous administration during gestation days 7-17
produced effects of extra embryonic structures and fetotoxicity,
respectively. In another study, a TDLo of 225 and 4500 (g/kg by
subcutaneous administration during gestation days 17-21 produced effects
on parturition and newborn viability index, respectively. Diflorasone
diacetate has been shown to cause cleft palate in rats when applied
dermally at a dose of approximately 0.001 mg/kg/day to the shave thorax of
pregnant animals. When pregnant rats were treated topically with
approximately 0.5 mg/kg/day, uterine deaths were higher in the treated
animals than in the control animals.
In addition, subcutaneous administration of diflorasone diacetate
produced fetal effects in the rabbit. A TDLo of 208 and 3250 (g/kg by
dermal application during gestation days 6-18 produced effects of
fetotoxicity/cardiovascular developmental abnormalities and
musculoskeletal developmental abnormalities, respectively. Also, dermal
application as low as 20 mg/kg/day of diflorasone diacetate produced cleft
palate, depression of fetal weight and smaller litter sizes.
ADDITIONAL DATA: Interactions with other drugs may occur. May be excreted
in breast milk. May cross the placenta.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Bone, joint or tooth disorders,
convulsive disorders, diabetes, eye disorders, gastrointestinal disorders,
heart or cardiovascular disorders, hormonal disorders, kidney disorders,
liver disorders, personality disorders, skin disorders and allergies
SKIN CONTACT: Allergic contact dermatitis may develop in previously
exposed persons. Repeated topical application may cause irritation,
itching, burning erythema, dryness, folliculitis, and epidermal and dermal
atrophy manifested by thinning of the skin, telangiectasia, purpura,
striae and possibly pustulation, perioral dermatitis, impeded healing,
local hypertrichosis and masking or spread of preexisting infections.
Repeated application, especially to inflamed or damaged skin, or
application to large areas may cause systemic poisoning as described in
chronic ingestion. Absorption is greatly enhanced by occlusive covering.
Sensitization may develop in susceptible individuals.
INGESTION: A large single dose of corticosteroid is reported to be
virtually without harmful effects. Anaphylactoid or hypersensitivity
reactions to corticosteroids have been reported in previously exposed
individuals. Repeated ingestion of corticosteroids may cause sodium and
fluid retention, edema, hypovolemia, hypokalemic alkalosis, hypocalcemia,
hypotension or shock-like reactions. Other effects of corticosteroids are
listed below. Endocrine System: Effects on metabolism and the endocrine
system may include redisposition of fat may result in moonface, buffalo
hump, supraclavicular fat pad enlargement and central obesity, secondary
adrenocortical and pituitary suppression and unresponsiveness, increased
sweating, decreased carbohydrate tolerance, increased gluconeogenesis,
hyperglycemia, glycosuria, manifestations of latent diabetes mellitus,
steroid diabetes, and negative nitrogen balance. Life-threatening acute
adrenal insufficiency and other symptoms of withdrawal may occur after
cessation of long-term administration of corticosteroids. Blood and the
Immune System: Effects on blood include relative neutrophilia, a decrease
in circulating eosinophils and transient lymphocytopenia may occur.
Effects on the immune system may include activation, aggravation, masking
or increased susceptibility to infections. Cardiovascular System:
Cardiovascular effects may include embolism, thrombophlebitis, necrotizing
angitis, cardiac arrhythmias or ECG changes, syncope, arterial
hypertension and congestive heart failure. Musculoskeletal System:
Effects on the musculoskeletal system may include muscle weakness,
myopathy with loss of muscle mass, arthopathy, Achilles tendon rupture,
osteoporosis, aseptic bone necrosis and spontaneous fractures. Nervous
System and Behavioral Effects: Effects on the nervous system may include
malaise, decrease in pain sensation, vertigo, headache, insomnia, neuritis
or paresthesias, convulsions. Effects on behavior and mental status may
include nervousness, depression or euphoria, aggravation of preexisting
psychiatric conditions, psychoses, delusions, hallucinations and
catatonia. Suicidal tendencies are not uncommon. Reproductive System and
Teratological Effects: Corticosteroids may also cause amenorrhea,
postmenopausal bleeding, and other menstrual irregularities. Steroids may
increase or decrease motility and number of spermatozoa. Corticosteroids
are excreted in breast milk and may suppress growth or interfere with
endogenous corticosteroid production in the nursing infant. Chronic
maternal ingestion during the first trimester has shown a 1% incidence of
cleft palate in humans. Gastrointestinal System: Gastrointestinal effects
may include ulcerative esophagitis, gastric irritation, abdominal
distension, nausea, vomiting, increased appetite, peptic ulcer with
perforation and hemorrhage and possibly perforation of the bowel and
pancreatitis may occur. Cutaneous Effects: Effects on the skin may
include impaired wound healing, thin fragile skin, petechiae and
ecchymoses, erythema, lupus erythematosus-like lesions, suppression of
skin test reactions, subcutaneous fat atrophy, purpura, striae,
hyperpigmentation, hirsutism in women, acne, allergic dermatitis,
urticaria, angioneurotic edema and perineal irritation may occur. Effects
on the Eye: Ocular effects may include exophthalmos, posterior
subcapsular cataracts, increased intraocular pressure and glaucoma,
possibly resulting in blindness.
12. ECOLOGICAL INFORMATION
No information for determination of unusual environmental fate or toxicity
(in addition to toxicity data presented in section 11) is available at
this time.
13. DISPOSAL CONSIDERATIONS
Disposal Information
Waste must be disposed of in accordance with federal, state and
local environmental regulations. Waste may be placed in a leakproof,
puncture resistant container which is then placed in a disposable wire-tie
or sealable 4 mil-thick polyethylene or 2 mil-thick propylethylene bags.
Waste Disposal Methods
Dissolve or mix the material with a combustible solvent and burn
in a chemical incinerator equipped with an afterburner and scrubber.
Observe all federal, state and local environmental regulations.
14. TRANSPORT INFORMATION
Proper Shipping Name:
Not Regulated
Transportation of Hazardous Material Description
Not a regulated material. Ship according to DOT and/or IATA
regulations.
15. REGULATORY INFORMATION
TSCA
This material is a pharmaceutical agent and as such is regulated by
the United States Food and Drug Administration (FDA).
CERCLA NA
SARA 302 NA
SARA 313 NA
16. OTHER INFORMATION
Prepared By: David Eherts CIH
Approved By: ITAC
Approved Date: 12/18/98
Supersedes Date: Original Version
Other Information
The information contained herein is based upon data considered true
and accurate. Rhone-Poulenc Rorer makes no warranties, express or
implied, as to the adequacy of the information contained herein. This
information is offered solely for the user's consideration, investigation
and verification. Report to the manufacturer any allegations of health
effects resulting from handling or accidental contact with this material.
Revision Summary
Original version.
Material Safety Data Sheet
Effective Date: 12/15/98
Date Printed: 12/15/98