CAS : 549-18-8
ProductName : Amitriptyline hydrochloride
1 - Product and Company Information
Product Name AMITRIPTYLINE HYDROCHLORIDE
Product Number A8404
2 - Composition/Information on Ingredients
Product Name CAS # EC no Annex I
Index Number
AMITRIPTYLINE HYDROCHLORIDE 549-18-8 208-964-6 None
Formula C20H23N.ClH
Molecular Weight 313.87 AMU
Synonyms Amitriptyline chloride * Amitriptyline
hydrochloride * Damilen hydrochloride * Deprex *
Domical *
10,11-Dihydro-N,N-dimethyl-5H-dibenzo(a,d)cyclohe
ptene-delta(sup 5,gamma)-propylamine HCl *
5-(3-Dimethylaminopropylidene)dibenzo(a,d)(1,4)cy
cloheptadiene hydrochloride * Elavil
hydrochloride * Endep * Etrafon * Laroxyl *
Lentizol * Limbitrol DS * Miketorin *
Proheptadien monohydrochloride * 1-Propanamine,
3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-yli
dene)-N,N-dimethyl-, hcl * Rantoron * Saroten *
SK-Amitriptyline * Triavil * Tryptizol *
Yamanouchi
3 - Hazards Identification
SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT
Toxic by inhalation, in contact with skin and if swallowed.
Irritating to eyes, respiratory system and skin. May cause
sensitization by inhalation and skin contact. Possible risk of
harm to the unborn child.
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 immediately.
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. Do not get in
eyes, on skin, on clothing. Avoid prolonged or repeated exposure.
STORAGE
Conditions of Storage: Keep tightly closed.
Store at 2-8?C
8 - Exposure Controls / Personal Protection
ENGINEERING CONTROLS
Safety shower and eye bath. Use only in a chemical fume hood.
GENERAL HYGIENE MEASURES
Wash contaminated clothing before reuse. Wash thoroughly after
handling.
PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Government approved respirator.
SIGMA - A8404 www.-aldrich.com 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 198 - 200 ?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,
Nitrogen oxides, Hydrogen chloride gas.
HAZARDOUS POLYMERIZATION
Hazardous Polymerization: Will not occur
11 - Toxicological Information
RTECS NUMBER: HO9450000
ACUTE TOXICITY
LDLO
Oral
Child
62.5 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Vascular:BP lowering not charactertized in autonomic section.
Lungs, Thorax, or Respiration:Respiratory depression.
LDLO
SIGMA - A8404 www.-aldrich.com Oral
Child
62.5 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration:Cyanosis.
LDLO
Oral
Woman
19 mg/kg
Remarks: Behavioral:Coma. Lungs, Thorax, or Respiration:Dyspnea.
LD50
Oral
Rat
240 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Behavioral:Ataxia. Lungs, Thorax, or Respiration:Dyspnea.
LD50
Intraperitoneal
Rat
67 MG/KG
LD50
Subcutaneous
Rat
385 MG/KG
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration:Cyanosis.
LD50
Intravenous
Rat
14 MG/KG
LD50
Oral
Mouse
140 mg/kg
LD50
Intraperitoneal
Mouse
65 MG/KG
Remarks: Behavioral:Somnolence (general depressed activity).
Behavioral:Convulsions or effect on seizure threshold. Lungs,
Thorax, or Respiration:Dyspnea.
LD50
Subcutaneous
Mouse
80 MG/KG
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Behavioral:Ataxia. Lungs, Thorax, or Respiration:Cyanosis.
LD50
Intravenous
Mouse
21 MG/KG
LD50
SIGMA - A8404 www.-aldrich.com Intravenous
Dog
>27 MG/KG
LD50
Intramuscular
Dog
>23 MG/KG
LD50
Oral
Cat
37 mg/kg
LD50
Intravenous
Rabbit
9900 UG/KG
SENSITIZATION
Sensitization: May cause allergic reaction.
ROUTE OF EXPOSURE
Skin Contact: May cause skin irritation.
Skin Absorption: Toxic if absorbed through skin.
Eye Contact: May cause eye irritation.
Inhalation: Toxic if inhaled. Material may be irritating to
mucous membranes and upper respiratory tract.
Ingestion: Toxic if swallowed.
TARGET ORGAN INFORMATION
Central nervous system. Heart.
CHRONIC EXPOSURE - MUTAGEN
Mouse
70 MG/KG
Oral
5 sperm
CHRONIC EXPOSURE - TERATOGEN
Result: May cause congenital malformation in the fetus.
Species: Mouse
Dose: 60 MG/KG
Route of Application: Subcutaneous
Exposure Time: (9D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Effects on Embryo or Fetus: Fetal death.
Specific Developmental Abnormalities: Central nervous system.
Species: Mouse
Dose: 60 MG/KG
Route of Application: Subcutaneous
Exposure Time: (9D PREG)
Result: Specific Developmental Abnormalities: Craniofacial
(including nose and tongue).
Species: Hamster
Dose: 60 MG/KG
Route of Application: Intraperitoneal
SIGMA - A8404 www.-aldrich.com Exposure Time: (8D PREG)
Result: Specific Developmental Abnormalities: Central nervous
system. Specific Developmental Abnormalities: Body wall.
Specific Developmental Abnormalities: Musculoskeletal system.
Species: Hamster
Dose: 70300 UG/KG
Route of Application: Intraperitoneal
Exposure Time: (8D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Specific Developmental Abnormalities:
Central nervous system. Specific Developmental Abnormalities:
Musculoskeletal system.
Species: Hamster
Dose: 60 MG/KG
Route of Application: Parenteral
Exposure Time: (8D PREG)
Result: Specific Developmental Abnormalities: Central nervous
system. Specific Developmental Abnormalities: Body wall.
CHRONIC EXPOSURE - REPRODUCTIVE HAZAR
Species: Rat
Dose: 220 MG/KG
Route of Application: Subcutaneous
Exposure Time: (1-22D PREG)
Result: Effects on Newborn: Stillbirth. Effects on Newborn:
Behavioral.
Species: Mouse
Dose: 70 MG/KG
Route of Application: Oral
Exposure Time: (5D MALE)
Result: Paternal Effects: Spermatogenesis (including genetic
material, sperm morphology,motility, and count).
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
RID/AD UN#: 2811
Class: 6.1
PG: III
Proper Shipping Name: Toxic solid, organic, n.o.s.
IMDG
UN#: 2811
Class: 6.1
PG: III
SIGMA - A8404 www.-aldrich.com Proper Shipping Name: Toxic solid, organic, n.o.s.
Marine Pollutant: No
Severe Marine Pollutant: No
Technical Name: Required
IATA
UN#: 2811
Class: 6.1
PG: III
Proper Shipping Name: Toxic solid, organic, n.o.s.
Inhalation Packing Group I: No
Technical Name: Required
15 - Regulatory Information
CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES
INDICATION OF DANGER: T
Toxic.
R-PHRASES: 23/24/25 36/37/38 42/43 63
Toxic by inhalation, in contact with skin and if swallowed.
Irritating to eyes, respiratory system and skin. May cause
sensitization by inhalation and skin contact. Possible risk of
harm to the unborn child.
S-PHRASES: 45 26 36/37/39 22
In case of accident or if you feel unwell, seek medical advice
immediately (show the label where possible). In case of contact
with eyes, rinse immediately with plenty of water and seek
medical advice. Wear suitable protective clothing, gloves, and
eye/face protection. Do not breathe dust.
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 2004 Sigma-Aldrich Co. License granted to make unlimited
paper copies for internal use only.
DISCLAIME For R&D use only. Not for drug, household or other uses.
SIGMA - A8404 www.-aldrich.com
Product Name AMITRIPTYLINE HYDROCHLORIDE
Product Number A8404
2 - Composition/Information on Ingredients
Product Name CAS # EC no Annex I
Index Number
AMITRIPTYLINE HYDROCHLORIDE 549-18-8 208-964-6 None
Formula C20H23N.ClH
Molecular Weight 313.87 AMU
Synonyms Amitriptyline chloride * Amitriptyline
hydrochloride * Damilen hydrochloride * Deprex *
Domical *
10,11-Dihydro-N,N-dimethyl-5H-dibenzo(a,d)cyclohe
ptene-delta(sup 5,gamma)-propylamine HCl *
5-(3-Dimethylaminopropylidene)dibenzo(a,d)(1,4)cy
cloheptadiene hydrochloride * Elavil
hydrochloride * Endep * Etrafon * Laroxyl *
Lentizol * Limbitrol DS * Miketorin *
Proheptadien monohydrochloride * 1-Propanamine,
3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-yli
dene)-N,N-dimethyl-, hcl * Rantoron * Saroten *
SK-Amitriptyline * Triavil * Tryptizol *
Yamanouchi
3 - Hazards Identification
SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT
Toxic by inhalation, in contact with skin and if swallowed.
Irritating to eyes, respiratory system and skin. May cause
sensitization by inhalation and skin contact. Possible risk of
harm to the unborn child.
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 immediately.
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. Do not get in
eyes, on skin, on clothing. Avoid prolonged or repeated exposure.
STORAGE
Conditions of Storage: Keep tightly closed.
Store at 2-8?C
8 - Exposure Controls / Personal Protection
ENGINEERING CONTROLS
Safety shower and eye bath. Use only in a chemical fume hood.
GENERAL HYGIENE MEASURES
Wash contaminated clothing before reuse. Wash thoroughly after
handling.
PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Government approved respirator.
SIGMA - A8404 www.-aldrich.com 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 198 - 200 ?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,
Nitrogen oxides, Hydrogen chloride gas.
HAZARDOUS POLYMERIZATION
Hazardous Polymerization: Will not occur
11 - Toxicological Information
RTECS NUMBER: HO9450000
ACUTE TOXICITY
LDLO
Oral
Child
62.5 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Vascular:BP lowering not charactertized in autonomic section.
Lungs, Thorax, or Respiration:Respiratory depression.
LDLO
SIGMA - A8404 www.-aldrich.com Oral
Child
62.5 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration:Cyanosis.
LDLO
Oral
Woman
19 mg/kg
Remarks: Behavioral:Coma. Lungs, Thorax, or Respiration:Dyspnea.
LD50
Oral
Rat
240 mg/kg
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Behavioral:Ataxia. Lungs, Thorax, or Respiration:Dyspnea.
LD50
Intraperitoneal
Rat
67 MG/KG
LD50
Subcutaneous
Rat
385 MG/KG
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Lungs, Thorax, or Respiration:Cyanosis.
LD50
Intravenous
Rat
14 MG/KG
LD50
Oral
Mouse
140 mg/kg
LD50
Intraperitoneal
Mouse
65 MG/KG
Remarks: Behavioral:Somnolence (general depressed activity).
Behavioral:Convulsions or effect on seizure threshold. Lungs,
Thorax, or Respiration:Dyspnea.
LD50
Subcutaneous
Mouse
80 MG/KG
Remarks: Behavioral:Convulsions or effect on seizure threshold.
Behavioral:Ataxia. Lungs, Thorax, or Respiration:Cyanosis.
LD50
Intravenous
Mouse
21 MG/KG
LD50
SIGMA - A8404 www.-aldrich.com Intravenous
Dog
>27 MG/KG
LD50
Intramuscular
Dog
>23 MG/KG
LD50
Oral
Cat
37 mg/kg
LD50
Intravenous
Rabbit
9900 UG/KG
SENSITIZATION
Sensitization: May cause allergic reaction.
ROUTE OF EXPOSURE
Skin Contact: May cause skin irritation.
Skin Absorption: Toxic if absorbed through skin.
Eye Contact: May cause eye irritation.
Inhalation: Toxic if inhaled. Material may be irritating to
mucous membranes and upper respiratory tract.
Ingestion: Toxic if swallowed.
TARGET ORGAN INFORMATION
Central nervous system. Heart.
CHRONIC EXPOSURE - MUTAGEN
Mouse
70 MG/KG
Oral
5 sperm
CHRONIC EXPOSURE - TERATOGEN
Result: May cause congenital malformation in the fetus.
Species: Mouse
Dose: 60 MG/KG
Route of Application: Subcutaneous
Exposure Time: (9D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Effects on Embryo or Fetus: Fetal death.
Specific Developmental Abnormalities: Central nervous system.
Species: Mouse
Dose: 60 MG/KG
Route of Application: Subcutaneous
Exposure Time: (9D PREG)
Result: Specific Developmental Abnormalities: Craniofacial
(including nose and tongue).
Species: Hamster
Dose: 60 MG/KG
Route of Application: Intraperitoneal
SIGMA - A8404 www.-aldrich.com Exposure Time: (8D PREG)
Result: Specific Developmental Abnormalities: Central nervous
system. Specific Developmental Abnormalities: Body wall.
Specific Developmental Abnormalities: Musculoskeletal system.
Species: Hamster
Dose: 70300 UG/KG
Route of Application: Intraperitoneal
Exposure Time: (8D PREG)
Result: Effects on Embryo or Fetus: Fetotoxicity (except death,
e.g., stunted fetus). Specific Developmental Abnormalities:
Central nervous system. Specific Developmental Abnormalities:
Musculoskeletal system.
Species: Hamster
Dose: 60 MG/KG
Route of Application: Parenteral
Exposure Time: (8D PREG)
Result: Specific Developmental Abnormalities: Central nervous
system. Specific Developmental Abnormalities: Body wall.
CHRONIC EXPOSURE - REPRODUCTIVE HAZAR
Species: Rat
Dose: 220 MG/KG
Route of Application: Subcutaneous
Exposure Time: (1-22D PREG)
Result: Effects on Newborn: Stillbirth. Effects on Newborn:
Behavioral.
Species: Mouse
Dose: 70 MG/KG
Route of Application: Oral
Exposure Time: (5D MALE)
Result: Paternal Effects: Spermatogenesis (including genetic
material, sperm morphology,motility, and count).
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
RID/AD UN#: 2811
Class: 6.1
PG: III
Proper Shipping Name: Toxic solid, organic, n.o.s.
IMDG
UN#: 2811
Class: 6.1
PG: III
SIGMA - A8404 www.-aldrich.com Proper Shipping Name: Toxic solid, organic, n.o.s.
Marine Pollutant: No
Severe Marine Pollutant: No
Technical Name: Required
IATA
UN#: 2811
Class: 6.1
PG: III
Proper Shipping Name: Toxic solid, organic, n.o.s.
Inhalation Packing Group I: No
Technical Name: Required
15 - Regulatory Information
CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES
INDICATION OF DANGER: T
Toxic.
R-PHRASES: 23/24/25 36/37/38 42/43 63
Toxic by inhalation, in contact with skin and if swallowed.
Irritating to eyes, respiratory system and skin. May cause
sensitization by inhalation and skin contact. Possible risk of
harm to the unborn child.
S-PHRASES: 45 26 36/37/39 22
In case of accident or if you feel unwell, seek medical advice
immediately (show the label where possible). In case of contact
with eyes, rinse immediately with plenty of water and seek
medical advice. Wear suitable protective clothing, gloves, and
eye/face protection. Do not breathe dust.
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 2004 Sigma-Aldrich Co. License granted to make unlimited
paper copies for internal use only.
DISCLAIME For R&D use only. Not for drug, household or other uses.
SIGMA - A8404 www.-aldrich.com
Amitriptyline hydrochloride
China (Mainland)] 
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
Assessed
United States] 
Hong Kong,China] 
Premium
Premium
India]