SIGMA-ALDRICH
Material Safety Data Sheet
Date Printed: 21/FEB/2005
Date Updated: 22/MAR/2004
Version 1.1
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 (+/-)-SOTALOL HYDROCHLORIDE
Product Number S0278
Company Sigma-Aldrich Pty, Ltd
Unit 2, 14 Anella Avenue
Castle Hill NSW 1765
Australia
Technical Phone # +61 2 9841 0555
Fax +61 2 9841 0500
Emergency Phone # +61 2 9841 0566
2 - Composition/Information on Ingredients
Product Name CAS # EC no Annex I
Index Number
(+)-SOTALOL HYDROCHLORIDE 959-24-0 213-496-0 None
Formula C12H20N2O3S.ClH
Molecular Weight 308.8 AMU
Synonyms 4'-(1-Hydroxy-2-(isopropylamino)ethyl)methanesulf
onanilide monohydrochloride *
4-(2-Isopropylamino-1-hydroxyaethyl)methanesulfon
ailid hydrochlorid (German) *
Isopropylaminohydroxyethylmethanesulfonanilide
hydrochloride *
N-Isopropyl-beta-(4-methanesulfonamidophenyl)etha
nolamine hydrochloride * Mead johnson 1999 * MJ
1999 * Sotacor * Sotalex * Sotalol hydrochloride
3 - Hazards Identification
SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT
Irritating to eyes, respiratory system and skin.
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 contact, immediately wash skin with soap and copious
amounts of water.
AFTER EYE CONTACT
In case of contact, immediately flush eyes with copious amounts
of water for at least 15 minutes.
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
PROCEDURE(S) OF PERSONAL PRECAUTION(S)
Wear respirator, chemical safety goggles, 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.
STORAGE
Conditions of Storage: Keep tightly closed. Store in a cool dry
place.
8 - Exposure Controls / Personal Protection
ENGINEERING CONTROLS
Safety shower and eye bath. Mechanical exhaust required.
GENERAL HYGIENE MEASURES
Wash thoroughly after handling. Wash contaminated clothing before
reuse.
PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Government approved respirator.
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 N/A
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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
Materials to Avoid: Strong oxidizing agents.
HAZARDOUS DECOMPOSITION PRODUCTS
Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide,
Nitrogen oxides, Sulfur oxides, Hydrogen chloride gas.
11 - Toxicological Information
RTECS NUMBER: PB0826000
ACUTE TOXICITY
LDLO
Oral
Man
45.714 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Behavioral:Excitement. Lungs, Thorax, or Respiration:Dyspnea.
LD50
Oral
Rat
3450 mg/kg
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Etosis. Behavioral:Somnolence (general depressed
activity). Behavioral:Ataxia.
LD50
Intraperitoneal
Rat
680 MG/KG
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Etosis. Behavioral:Change in motor activity (specific
assay). Behavioral:Ataxia.
LD50
Oral
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Mouse
2600 mg/kg
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Etosis. Behavioral:Change in motor activity (specific
assay). Behavioral:Ataxia.
LD50
Intraperitoneal
Mouse
670 MG/KG
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Etosis. Behavioral:Change in motor activity (specific
assay). Behavioral:Ataxia.
LD50
Intraperitoneal
Dog
330 MG/KG
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Lacrimation. Behavioral:Change in motor activity
(specific assay). Behavioral:Ataxia.
LD50
Oral
Rabbit
1000 mg/kg
Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and
Taste):Eye:Etosis. Behavioral:Change in motor activity (specific
assay). Behavioral:Ataxia.
SIGNS AND SYMPTOMS OF EXPOSURE
Cardioselective beta-adrenergic blocker exposure can cause
nausea, vomiting, diarrhea, fatigue, dizziness, bradycardia,
congestive heart failure, hypotension, cold extremities,
depression, sleep and vision disturbances, blood disorders, skin
rash, fluid retention, and muscle cramps.
ROUTE OF EXPOSURE
Inhalation: Material is irritating to mucous membranes and upper
respiratory tract.
Multiple Routes: May be harmful by inhalation, ingestion, or
skin absorption. Causes eye and skin irritation.
TARGET ORGAN INFORMATION
Heart. Nerves. Liver.
CHRONIC EXPOSURE - TERATOGEN
Species: Rat
Dose: 8085 MG/KG
Route of Application: Oral
Exposure Time: (7-17D PREG)
Result: Effects on Embryo or Fetus: Fetal death. Effects on
Newborn: Live birth index (# fetuses per litter; measured after
birth). Effects on Newborn: Viability index (e.g., # alive at
day 4 per # born alive).
Species: Rabbit
Dose: 2340 MG/KG
Route of Application: Oral
Exposure Time: (6-18D PREG)
Result: Effects on Embryo or Fetus: Fetal death.
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CHRONIC EXPOSURE - REPRODUCTIVE HAZARD
Species: Rat
Dose: 35520 MG/KG
Route of Application: Oral
Exposure Time: (1-3W PREG/3W POST)
Result: Maternal Effects: Other effects. Effects on Newborn:
Growth statistics (e.g., reduced weight gain).
Species: Rat
Dose: 126 GM/KG
Route of Application: Oral
Exposure Time: (9W MALE/2W PRE-7D PREG)
Result: Paternal Effects: Testes, epididymis, sperm duct.
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: 280 MG/KG
Route of Application: Oral
Exposure Time: (8-21D PREG)
Result: Effects on Newborn: Growth statistics (e.g., reduced
weight gain). Effects on Newborn: Behavioral.
Species: Rat
Dose: 24960 MG/KG
Route of Application: Oral
Exposure Time: (17-21D PREG/21D POST)
Result: Maternal Effects: Other effects. Effects on Newborn:
Growth statistics (e.g., reduced weight gain).
12 - Ecological Information
No data available.
13 - Disposal Considerations
SUBSTANCE DISPOSAL
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
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: Xi
Irritant.
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R-PHRASES: 36/37/38
Irritating to eyes, respiratory system and skin.
S-PHRASES: 26 36
In case of contact with eyes, rinse immediately with plenty of
water and seek medical advice. 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.
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