Granisetron hydrochloride

MSDS
Granisetron Hydrochloride Revision number: 5
SAFETY DATA SHEET
Section1. IDENTIFICATION

Product name:Granisetron Hydrochloride

Revision number:5
Section2. HAZARDS IDENTIFICATION

GHS classification
PHYSICAL HAZARDSNot classified
HEALTH HAZARDS
Acute toxicity (Oral)Category 4
Not classified
ENVIRONMENTAL HAZARDS
GHS label elements, including precautionary statements
Pictograms or hazard symbols
Signal wordWarning
Hazard statementsHarmful if swallowed
Precautionary statements:
[Prevention]Do not eat, drink or smoke when using this product.
Wash hands thoroughly after handling.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
[Response]
Rinse mouth.
Dispose of contents/container through a waste management company authorized by
[Disposal]
the local government.
Section3. COMPOSITION/INFORMATION ON INGREDIENTS

Substance/mixture:Substance
Components:Granisetron Hydrochloride
Percent:>98.0%(LC)(T)
CAS Number:107007-99-8
Synonyms:1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-
carboxamide Hydrochloride
Chemical Formula:C18H24N4O·HCl
Section4. FIRST AID MEASURES

Inhalation:Remove victim to fresh air and keep at rest in a position comfortable for breathing.
Get medical advice/attention if you feel unwell.
Skin contact:Remove/Take off immediately all contaminated clothing. Rinse skin with
water/shower. If skin irritation or rash occurs: Get medical advice/attention.
Granisetron Hydrochloride
Section4. FIRST AID MEASURES

Eye contact:Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. If eye irritation persists: Get medical
advice/attention.
Ingestion:Call a POISON CENTER or doctor/physician if you feel unwell. Rinse mouth.
Protection of first-aiders:A rescuer should wear personal protective equipment, such as rubber gloves and air-
tight goggles.
Section5. FIRE-FIGHTING MEASURES

Dry chemical, foam, water spray, carbon dioxide.
Suitable extinguishing
media:
Precautions for firefighters: Fire-extinguishing work is done from the windward and the suitable fire-extinguishing
method according to the surrounding situation is used. Uninvolved persons should
evacuate to a safe place. In case of fire in the surroundings: Remove movable
containers if safe to do so.
Special protectiveWhen extinguishing fire, be sure to wear personal protective equipment.
equipment for firefighters:
Section6. ACCIDENTAL RELEASE MEASURES

Personal precautions,Use personal protective equipment. Keep people away from and upwind of spill/leak.
protective equipment and Entry to non-involved personnel should be controlled around the leakage area by
emergency procedures: roping off, etc.
Environmental precautions: Prevent product from entering drains.
Methods and materials for Sweep dust to collect it into an airtight container, taking care not to disperse it.
containment and cleaning Adhered or collected material should be promptly disposed of, in accordance with
up: appropriate laws and regulations.
Section7. HANDLING AND STORAGE

Precautions for safe handling
Technical measures:Handling is performed in a well ventilated place. Wear suitable protective equipment.
Prevent dispersion of dust. Wash hands and face thoroughly after handling.
Use a local exhaust if dust or aerosol will be generated.
Advice on safe handling: Avoid contact with skin, eyes and clothing.
Conditions for safe storage, including any
incompatibilities
Storage conditions:Keep container tightly closed. Store in a cool and dark place.
Store away from incompatible materials such as oxidizing agents.
Packaging material:Comply with laws.
Section8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Engineering controls:Install a closed system or local exhaust as possible so that workers should not be
exposed directly. Also install safety shower and eye bath.
Personal protective equipment
Respiratory protection: Dust respirator. Follow local and national regulations.
Hand protection:Protective gloves.
Eye protection:Safety glasses. A face-shield, if the situation requires.
Skin and body protection: Protective clothing. Protective boots, if the situation requires.
Section9. PHYSICAL AND CHEMICAL PROPERTIES

Solid
Physical state (20°C):
Form:Crystal- Powder
Colour:White - Almost white
No data available
Odour:
pH: No data available
Melting point/freezing point:292°C (dec.)
Boiling point/range:No data available
No data available
Flash point:
Granisetron Hydrochloride
Section9. PHYSICAL AND CHEMICAL PROPERTIES

Flammability or explosive
limits:
Lower:No data available
Upper:No data available
Relative density:No data available
Solubility(ies):
[Water]No data available
No data available
[Other solvents]
Section10. STABILITY AND REACTIVITY

Chemical stability:Stable under proper conditions.
Possibility of hazardous No special reactivity has been reported.
reactions:
Incompatible materials: Oxidizing agents
Hazardous decomposition Carbon monoxide, Carbon dioxide, Nitrogen oxides (NOx), Hydrogen chloride
products:
Section11. TOXICOLOGICAL INFORMATION

orl-rat LD50:350 mg/kg
Acute Toxicity:
ivn-rat LD50:14 mg/kg
Skin corrosion/irritation: No data available
Serious eyeNo data available
damage/irritation:
Germ cell mutagenicity: mmo-sat 5 gm/L (+S9)
cyt-hmn-lym 1500 mg/L
Carcinogenicity:
No data available
IARC =
NTP =No data available
No data available
Reproductive toxicity:
RTECS Number:NK7882200
Section12. ECOLOGICAL INFORMATION

Ecotoxicity:
Fish:No data available
Crustacea:No data available
Algae:No data available
Persistence / degradability: No data available
No data available
Bioaccumulative
potential(BCF):
Mobility in soil
Log Pow:No data available
Soil adsorption (Koc):No data available
Henry's LawNo data available
constant(PaM3/mol):
Section13. DISPOSAL CONSIDERATIONS

Recycle to process, if possible. Consult your local regional authorities. You may be able to dissolve or mix material
with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber system.
Observe all federal, state and local regulations when disposing of the substance.
Section14. TRANSPORT INFORMATION

Hazards Class:Does not correspond to the classification standard of the United Nations
UN-No:Not listed
Granisetron Hydrochloride
Section15. REGULATORY INFORMATION

Safe management ordinance of dangerous chemical product (State Council announces on January 26, 2002
and revised on February 16,2011): Safe use and production, the storage of a dangerous chemical, transport,
loading and unloading were prescribed.

SECTION 16 - ADDITIONAL INFORMATION

N/A
Toxicological Information
CHEMICAL IDENTIFICATION
RTECS NUMBER :
NK7882200
CHEMICAL NAME :
1H-Indazole-3-carboxamide, 1-methyl-N-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-, monohydrochloride, endo-
CAS REGISTRY NUMBER :
107007-99-8
LAST UPDATED :
199612
DATA ITEMS CITED :
12
MOLECULAR FORMULA :
C18-H24-N4-O.Cl-H
MOLECULAR WEIGHT :
348.92
HEALTH HAZARD DATA
ACUTE TOXICITY DATA

TYPE OF TEST :
LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Rodent - rat
DOSE/DURATION :
350 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
TYPE OF TEST :
LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE :
Intravenous
SPECIES OBSERVED :
Rodent - rat
DOSE/DURATION :
14 mg/kg
TOXIC EFFECTS :
Behavioral - convulsions or effect on seizure threshold Behavioral - ataxia Behavioral - muscle contraction or spasticity
TYPE OF TEST :
LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
350 mg/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
TYPE OF TEST :
LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE :
Intravenous
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
17 mg/kg
TOXIC EFFECTS :
Behavioral - altered sleep time (including change in righting reflex) Behavioral - convulsions or effect on seizure threshold Lungs, Thorax, or Respiration - respiratory stimulation
TYPE OF TEST :
LDLo - Lowest published lethal dose
ROUTE OF EXPOSURE :
Intravenous
SPECIES OBSERVED :
Mammal - dog
DOSE/DURATION :
3 mg/kg
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - effect, not otherwise specified Behavioral - tremor Gastrointestinal - nausea or vomiting
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Rodent - rat
DOSE/DURATION :
4500 mg/kg/30D-I
TOXIC EFFECTS :
Liver - changes in liver weight Blood - changes in leukocyte (WBC) count Related to Chronic Data - death
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Rodent - rat
DOSE/DURATION :
18200 mg/kg/26W-I
TOXIC EFFECTS :
Liver - changes in liver weight Blood - changes in platelet count Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - phosphatases
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Mammal - dog
DOSE/DURATION :
325 mg/kg/30D-I
TOXIC EFFECTS :
Sense Organs and Special Senses (Eye) - lacrimation Sense Organs and Special Senses (Eye) - ptosis Behavioral - tremor
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
52 mg/kg
SEX/DURATION :
male 10 week(s) pre-mating female 2 week(s) pre-mating - 19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)
MUTATION DATA

TYPE OF TEST :
Cytogenetic analysis
TEST SYSTEM :
Human Lymphocyte
DOSE/DURATION :
1500 mg/L
REFERENCE :
KSRNAM Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan) V.1- 1960- Volume(issue)/page/year: 24,6795,1990
Safety Information
[ Symbol ]: GHS07
GHS07
[ Signal Word ]: Warning
[ Hazard Statements ]: H302
[ Precautionary Statements ]: P301 + P312 + P330
[ Personal Protective Equipment ]: dust mask type N95 (US);Eyeshields;Faceshields;Gloves
[ Hazard Codes ]: Xn: Harmful;Xi: Irritant;
[ Risk Phrases ]: R22
[ Safety Phrases ]: 26-36-37
[ RIDADR ]: NONH for all modes of transport
[ RTECS ]: NK7882200
[ HS Code ]: 2933990090
Synthetic RouteTotal: 1 Page
9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine结构式
CAS#:76272-41-8

9-Methyl-9-azab...

1-methylindazole-3-carbonyl chloride结构式
CAS#:106649-02-9

1-methylindazol...

~%

Granisetron hydrochloride Structure
CAS#:107007-99-8

Granisetron hyd...

Literature: US4886808 A1, ;
Granisetron结构式
CAS#:109889-09-0

Granisetron

~74%

Granisetron hydrochloride Structure
CAS#:107007-99-8

Granisetron hyd...

Literature: INKE, S.A. Patent: WO2008/151677 A1, 2008 ; Location in patent: Page/Page column 13 ;
Precursor & DownStream
Precursor 3
Granisetron Structure CAS#:109889-09-0
Granisetron
9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine Structure CAS#:76272-41-8
9-Methyl-9-azab...
1-methylindazole-3-carbonyl chloride Structure CAS#:106649-02-9
1-methylindazol...
DownStream 1
Granisetron structure CAS#:109889-09-0
Granisetron
Customs
[ HS Code ]: 2933990090
[ Summary ]: 2933990090. heterocyclic compounds with nitrogen hetero-atom(s) only. VAT:17.0%. Tax rebate rate:13.0%. . MFN tariff:6.5%. General tariff:20.0%
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Synonyms
Granisetron hydrochloride
1-méthyl-N-[(3-endo)-9-méthyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide chlorhydrate
1H-Indazole-3-carboxamide, 1-methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-, hydrochloride (1:1)
1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride (1:1)
1H-indazole-3-carboxamide, 1-methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-, monohydrochloride
MFCD01747034
Granisetron HCl
1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride
1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]indazole-3-carboxamide,hydrochloride
1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazol-3-carboxamidhydrochlorid