SIGMA-ALDRICH
Material Safety Data Sheet
Date Printed: 07/JUN/2005
Date Updated: 14/MAR/2004
Version 1.3
According to 91/155/EEC
Classified as Hazardous according to the criteria of EU Annex 1 and
NOHSC.
1 - Product and Company Information
Product Name IBUPROFEN
Product Number I4883
Company Sigma-Aldrich Pty. Ltd.
12 Anella Avenue
Castle Hill NSW 2154
Australia
Technical Phone # +61 2 9841 0555 (1800 800 097)
Fax +61 2 9841 0500 (1800 800 096)
Emergency Phone # +44 8701906777 (1800 448 465)
2 - Composition/Information on Ingredients
Product Name CAS # EC no Annex I
Index Number
4-ISOBUTYL-ALPHA-METHYLPHENYLACETI 15687-27-1 239-784-6 None
C ACID
Formula C13H18O2
Molecular Weight 206.29 AMU
Synonyms Acide (isobutyl-4 phenyl)-2 propionique (French)
* Adran * Advil * Anflagen * Artril 300 *
Benzeneacetic acid,
alpha-methyl-4-(2-methylpropyl)- * Bluton *
Brufanic * Brufen * Buburone * Butylenin *
Dolgin * Epobron * Ibufen * Ibuprocin *
Ibuprofen * IP-82 * p-Isobutylhydratropic acid *
4-Isobutylhydratropic acid *
2-(4-Isobutylphenyl)propanoic acid *
alpha-p-Isobutylphenylpropionic acid *
alpha-(4-Isobutylphenyl)propionic acid *
2-(p-Isobutylphenyl)propionic acid * Lamidon *
Liptan * Motrin * Mynosedin * Napacetin *
Nobfelon * Nobfen * Nobgen * Nuprin * Nurofen *
Paduden * Proflex * RD 13621 * Rebugen *
Roidenin * Rufin * Unipron
3 - Hazards Identification
SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT
Harmful if swallowed.
4 - First Aid Measures
AFTER INHALATION
If inhaled, remove to fresh air. If not breathing give
artificial respiration. If breathing is difficult, give oxygen.
AFTER SKIN CONTACT
In case of skin contact, flush with copious amounts of water for
at least 15 minutes. Remove contaminated clothing and shoes.
Call a physician.
AFTER EYE CONTACT
In case of contact with eyes, flush with copious amounts of
water for at least 15 minutes. Assure adequate flushing by
separating the eyelids with fingers. Call a physician.
AFTER INGESTION
If swallowed, wash out mouth with water provided person is
conscious. Call a physician.
5 - Fire Fighting Measures
EXTINGUISHING MEDIA
Suitable: Water spray. Carbon dioxide, dry chemical powder, or
appropriate foam.
SPECIAL RISKS
Specific Hazard(s): Emits toxic fumes under fire conditions.
SPECIAL PROTECTIVE EQUIPMENT FOR FIREFIGHTERS
Wear self-contained breathing apparatus and protective clothing
to prevent contact with skin and eyes.
6 - Accidental Release Measures
PERSONAL PRECAUTION PROCEDURES TO BE FOLLOWED IN CASE OF LEAK OR SPILL
Evacuate area.
PROCEDURE(S) OF PERSONAL PRECAUTION(S)
Wear self-contained breathing apparatus, rubber boots, and heavy
rubber gloves.
METHODS FOR CLEANING UP
Sweep up, place in a bag and hold for waste disposal. Avoid
raising dust. Ventilate area and wash spill site after material
pickup is complete.
7 - Handling and Storage
HANDLING
Directions for Safe Handling: Do not breathe dust. Avoid contact
with eyes, skin, and clothing. Avoid prolonged or repeated
exposure.
STORAGE
Conditions of Storage: Keep tightly closed.
8 - Exposure Controls / Personal Protection
ENGINEERING CONTROLS
Safety shower and eye bath. Mechanical exhaust required.
GENERAL HYGIENE MEASURES
Wash thoroughly after handling.
PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Government approved respirator.
SIGMA - I4883 www.sigma-aldrich.com Page 2
Hand Protection: Compatible chemical-resistant gloves.
Eye Protection: Chemical safety goggles.
9 - Physical and Chemical Properties
Appearance Physical State: Solid
Property Value At Temperature or Pressure
pH N/A
BP/BP Range N/A
MP/MP Range 77 - 78 掳C
Flash Point N/A
Flammability N/A
Autoignition Temp N/A
Oxidizing Properties N/A
Explosive Properties N/A
Explosion Limits N/A
Vapor Pressure N/A
SG/Density N/A
Partition Coefficient N/A
Viscosity N/A
Vapor Density N/A
Saturated Vapor Conc. N/A
Evaporation Rate N/A
Bulk Density N/A
Decomposition Temp. N/A
Solvent Content N/A
Water Content N/A
Surface Tension N/A
Conductivity N/A
Miscellaneous Data N/A
Solubility N/A
10 - Stability and Reactivity
STABILITY
Stable: Stable.
Materials to Avoid: Strong oxidizing agents.
HAZARDOUS DECOMPOSITION PRODUCTS
Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide.
HAZARDOUS POLYMERIZATION
Hazardous Polymerization: Will not occur
11 - Toxicological Information
RTECS NUMBER: MU6640000
ACUTE TOXICITY
LDLO
Oral
Man
171 mg/kg
Remarks: Behavioral:General anesthetic. Vascular:BP lowering not
charactertized in autonomic section.
LDLO
Oral
Child
SIGMA - I4883 www.sigma-aldrich.com Page 3
469 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration:Dyspnea.
LD50
Oral
Rat
636 mg/kg
LD50
Intraperitoneal
Rat
626 MG/KG
Remarks: Behavioral:Analgesia. Biochemical:Metabolism
(intermediary): Effect on inflammation or mediation of
inflammation. Nutritional and Gross Metabolic:Changes in:Body
temperature decrease.
LD50
Subcutaneous
Rat
740 MG/KG
LD50
Rectal
Rat
530 MG/KG
Remarks: Behavioral:Altered sleep time (including change in
righting reflex). Behavioral:Change in motor activity (specific
assay). Gastrointestinal:Hypermotility, diarrhea.
LD50
Oral
Mouse
740 mg/kg
Remarks: Behavioral:Analgesia.
LD50
Intraperitoneal
Mouse
320 MG/KG
Remarks: Behavioral:Altered sleep time (including change in
righting reflex). Gastrointestinal:Ulceration or bleeding from
stomach.
LD50
Subcutaneous
Mouse
395 MG/KG
LD50
Rectal
Mouse
620 MG/KG
Remarks: Behavioral:Altered sleep time (including change in
righting reflex). Behavioral:Change in motor activity (specific
assay). Gastrointestinal:Hypermotility, diarrhea.
LD50
Oral
Rabbit
1400 mg/kg
SIGMA - I4883 www.sigma-aldrich.com Page 4
LD50
Rectal
Rabbit
830 MG/KG
LD50
Oral
Guinea pig
495 mg/kg
LD50
Oral
Hamster
1690 mg/kg
LD50
Oral
Mammal
1000 mg/kg
SENSITIZATION
Sensitization: Prolonged or repeated exposure may cause allergic
reactions in certain sensitive individuals.
SIGNS AND SYMPTOMS OF EXPOSURE
Clinical trials have shown the following possible adverse
reactions: gastrointestinal disturbances including nausea,
vomiting, cramps, diarrhea, constipation, bloating, central
nervous system effects which include dizziness, headache,
depression, insomnia, aseptic meningitis, somnolence,
dermatological effects of maculopapular and vesiculobullous
eruptions, urticaria, alopecia, erythema multiforme,
stevens-johnson syndrome, hematologic effects of neutropenia,
aplastic and hemolytic anemia, thrombocytopenia, decreases in
hemoglobin and hematocrit. To the best of our knowledge, the
chemical, physical, and toxicological properties have not been
thoroughly investigated.
ROUTE OF EXPOSURE
Skin Contact: May cause skin irritation.
Skin Absorption: May be harmful if absorbed through the skin.
Eye Contact: May cause eye irritation.
Inhalation: Material may be irritating to mucous membranes and
upper respiratory tract. May be harmful if inhaled.
Ingestion: Harmful if swallowed.
TARGET ORGAN INFORMATION
Kidneys.
CHRONIC EXPOSURE - MUTAGEN
Mouse
1470 MG/KG
Oral
7D
Cytogenetic analysis
Mouse
50 MG/KG
Intraperitoneal
Sister chromatid exchange
SIGMA - I4883 www.sigma-aldrich.com Page 5
Mouse
270 MG/KG
Oral
Sister chromatid exchange
CHRONIC EXPOSURE - TERATOGEN
Result: Laboratory experiments have shown teratogenic effects.
Species: Rat
Dose: 840 MG/KG
Route of Application: Oral
Exposure Time: (8-14D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Effects on Newborn: Growth statistics
(e.g., reduced weight gain).
Species: Rat
Dose: 10 MG/KG
Route of Application: Oral
Exposure Time: (21D PREG)
Result: Effects on Embryo or Fetus: Other effects to embryo.
Species: Rat
Dose: 810 MG/KG
Route of Application: Rectal
Exposure Time: (60D MALE/2W PRE-7D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus).
Species: Mouse
Dose: 1260 MG/KG
Route of Application: Oral
Exposure Time: (7-13D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Effects on Embryo or Fetus: Fetal death.
CHRONIC EXPOSURE - REPRODUCTIVE HAZARD
Species: Woman
Dose: 8 MG/KG
Route of Application: Oral
Exposure Time: (1D PRE)
Result: Maternal Effects: Menstrual cycle changes or disorders.
Species: Rat
Dose: 600 MG/KG
Route of Application: Oral
Exposure Time: (3-5D PREG)
Result: Effects on Fertility: Pre-implantation mortality (e.g.,
reduction in number of implants per female; total number of
implants per corpora lutea). Effects on Fertility: Litter size
(e.g.; # fetuses per litter; measured before birth).
Species: Rat
Dose: 9750 MG/KG
Route of Application: Oral
Exposure Time: (65D MALE)
Result: Paternal Effects: Spermatogenesis (including genetic
material, sperm morphology,motility, and count). Paternal
Effects: Testes, epididymis, sperm duct.
SIGMA - I4883 www.sigma-aldrich.com Page 6
Species: Rat
Dose: 2 MG/KG
Route of Application: Intrauterine
Exposure Time: (4D PREG)
Result: Effects on Fertility: Pre-implantation mortality (e.g.,
reduction in number of implants per female; total number of
implants per corpora lutea).
Species: Rat
Dose: 270 MG/KG
Route of Application: Rectal
Exposure Time: (17-21D PREG)
Result: Maternal Effects: Parturition. Effects on Newborn: Live
birth index (# fetuses per litter; measured after birth).
Species: Rat
Dose: 891 MG/KG
Route of Application: Rectal
Exposure Time: (17-21D PREG/21D POST)
Result: Effects on Newborn: Weaning or lactation index (e.g., #
alive at weaning per # alive at day 4).
Species: Rat
Dose: 1 GM/KG
Route of Application: Rectal
Exposure Time: (17-21D PREG/4D POST)
Result: Effects on Newborn: Viability index (e.g., # alive at
day 4 per # born alive).
Species: Rat
Dose: 8100 MG/KG
Route of Application: Rectal
Exposure Time: (60D MALE/2W PRE-7D PREG)
Result: Effects on Fertility: Pre-implantation mortality (e.g.,
reduction in number of implants per female; total number of
implants per corpora lutea). Effects on Fertility: Litter size
(e.g.; # fetuses per litter; measured before birth).
Species: Mouse
Dose: 420 MG/KG
Route of Application: Oral
Exposure Time: (7-13D PREG)
Result: Effects on Fertility: Pre-implantation mortality (e.g.,
reduction in number of implants per female; total number of
implants per corpora lutea). Effects on Fertility: Litter size
(e.g.; # fetuses per litter; measured before birth).
12 - Ecological Information
No data available.
13 - Disposal Considerations
SUBSTANCE DISPOSAL
Contact a licensed professional waste disposal service to dispose
of this material. 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
SIGMA - I4883 www.sigma-aldrich.com Page 7
RID/ADR
Non-hazardous for road transport.
IMDG
Non-hazardous for sea transport.
IATA
Non-hazardous for air transport.
15 - Regulatory Information
CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES
INDICATION OF DANGER: Xn
Harmful.
R-PHRASES: 22
Harmful if swallowed.
S-PHRASES: 36
Wear suitable protective clothing.
16 - Other Information
WARRANTY
The above information is believed to be correct but does not
purport to be all inclusive and shall be used only as a guide. The
information in this document is based on the present state of our
knowledge and is applicable to the product with regard to
appropriate safety precautions. It does not represent any
guarantee of the properties of the product. Sigma-Aldrich Inc.,
shall not be held liable for any damage resulting from handling or
from contact with the above product. See reverse side of invoice
or packing slip for additional terms and conditions of sale.
Copyright 2005 Sigma-Aldrich Co. License granted to make unlimited
paper copies for internal use only.
DISCLAIMER
For R&D use only. Not for drug, household or other uses.
SIGMA - I4883 www.sigma-aldrich.com Page 8
|