HDS Clorhidrato de Dexmetomidina

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SAFETY DATA SHEET Page: 1 of

Dexmedetomidine (hydrochloride) Revision: 02/15/2019


Supersedes Revision: 08/08/2018
according to Regulation (EC) No. 1907/2006 as amended by (EC) No. 2015/830 and US OSHA HCS 2015

Section 1. Identification of the Substance/Mixture and of the Company/Undertaking


1.1
Product Code: 15581
Product Name: Dexmedetomidine (hydrochloride)
Synonyms: 5-[(1S)-1-(2,3-dimethylphenyl)
]-1H-imidazole, monohydrochloride; Dex; Precedex;
1.2
Relevant identified uses of the substance or mixture and uses advised against:
Relevant identified uses: For research use only, not for human or veterinary use.
1.3
Details of the Supplier of the Safety Data Sheet:
Company Name: Cayman Chemical Company
1180 E. Ellsworth Rd.
Ann Arbor, MI 48108
Web site address: www.caymanchem.com
Information: Cayman Chemical Company +1 (734)971-3335
1.4
Emergency telephone number:
Emergency Contact: CHEMTREC Within USA and Canada: +1 (800)424-9300
CHEMTREC Outside USA and Canada: +1 (703)527-3887

Section 2. Hazards Identification


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Dexmedetomidine (hydrochloride) Revision: 02/15/2019
Supersedes Revision: 08/08/2018

2.1 Classification of the Substance or Mixture:


Acute Toxicity: Oral, Category 4
Skin Corrosion/Irritation, Category 2
Serious Eye Damage/Eye Irritation, Category 2
Specific Target Organ Toxicity (single exposure), Category 3
2.2 Label Elements:

GHS Signal Word: Warning


GHS Hazard Phrases:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
GHS Precaution Phrases:
P261: Avoid breathing {dust/fume/gas/mist/vapors/spray}.
P264: Wash {hands} thoroughly after handling.
P280: Wear {protective gloves/protective clothing/eye protection/face protection}.
GHS Response Phrases:
P301+312: IF SWALLOWED: P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy
to do. Continue rinsing.
P330: Rinse mouth.
P332+313: If skin irritation occurs, get medical advice/attention.
P337+313: If eye irritation persists, get medical advice/attention.
P362+364: Take off contaminated clothing and wash it before reuse.

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GHS Storage and Disposal Phrases:
Please refer to Section 7 for Storage and Section 13 for Disposal information.
2.3 Adverse Human Health Causes serious eye irritation.
Effects and Symptoms: Causes skin irritation.
Harmful if swallowed.
Material may be irritating to the mucous membranes and upper respiratory tract.
May be harmful by inhalation or skin absorption.
May cause respiratory system irritation.
To the best of our knowledge, the toxicological properties have not been thoroughly investigated.

Section 3. Composition/Information on Ingredients


CAS # / Hazardous Components (Chemical Name)/ Concentration EC No./ GHS Classification
RTECS # REACH Registration No. EC Index No.
145108-58-3 1H-Imidazole,5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, 100.0 % 682-047-2 Acute Tox.(O) 4: H302
NI5156750 hydrochloride (1:1) NA Skin Corr. 2: H315
Eye Damage 2: H319
STOT (SE) 3: H335 H336

Section 4. First Aid Measures


4.1 Description of First Aid
Measures:
In Case of Inhalation: Remove to fresh air. If not breathing, give artificial respiration or give oxygen by trained personnel.
Get immediate medical attention.
In Case of Skin Contact: Immediately wash skin with soap and plenty of water for at least 15 minutes. Remove contaminated
clothing. Get medical attention if symptoms occur. Wash clothing before reuse.
In Case of Eye Contact: Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Have eyes examined
and tested by medical personnel.
In Case of Ingestion: Wash out mouth with water provided person is conscious. Never give anything by mouth to an
unconscious person. Get medical attention. Do NOT induce vomiting unless directed to do so by
medical personnel.

Section 5. Fire Fighting Measures


5.1 Suitable Extinguishing Use alcohol-resistant foam, carbon dioxide, water, or dry chemical spray.
Media: Use water spray to cool fire-exposed containers.
Unsuitable Extinguishing A solid water stream may be inefficient.
Media:
5.2 Flammable Properties andNo data available.
Hazards:
No data available.
Flash Pt: No data.
Explosive Limits: LEL: No data. UEL: No data.
Autoignition Pt: No data.
5.3 Fire Fighting Instructions: As in any fire, wear self-contained breathing apparatus pressure-demand (NIOSH approved
or equivalent), and full protective gear to prevent contact with skin and eyes.

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Section 6. Accidental Release Measures


6.1 Protective Precautions, Avoid raising and breathing dust, and provide adequate ventilation.
Protective Equipment and As conditions warrant, wear a NIOSH approved self-contained breathing apparatus, or respirator,
Emergency Procedures: and appropriate personal protection (rubber boots, safety goggles, and heavy rubber gloves).
6.2 Environmental Take steps to avoid release into the environment, if safe to do so.
Precautions:
6.3 Methods and Material For Contain spill and collect, as appropriate.
Containment and CleaningTransfer to a chemical waste container for disposal in accordance with local regulations.
Up:

Section 7. Handling and Storage


7.1 Precautions To Be Taken Avoid breathing dust/fume/gas/mist/vapours/spray.
in Handling: Avoid prolonged or repeated exposure.
7.2 Precautions To Be Taken Keep container tightly closed.
in Storing: Store in accordance with information listed on the product insert.

Section 8. Exposure Controls/Personal Protection


8.1 Exposure Parameters:
8.2 Exposure Controls:
8.2.1 Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to control airborne
(Ventilation etc.): levels below recommended exposure limits.
8.2.2 Personal protection equipment:
Eye Protection: Safety glasses
Protective Gloves: Compatible chemical-resistant gloves
Other Protective Clothing:Lab coat
Respiratory Equipment NIOSH approved respirator, as conditions warrant.
(Specify Type):
Work/Hygienic/Maintenan Do not take internally.
ce Practices: Facilities storing or utilizing this material should be equipped with an eyewash and a safety shower.
Wash thoroughly after handling.
No data available.

Section 9. Physical and Chemical Properties


9.1 Information on Basic Physical and Chemical Properties
Physical States: [ ] Gas [ ] Liquid [X]
Solid
Appearance and Odor: A white to off-white solid
pH: No data.
Melting Point: No data.
Boiling Point: No data.
Flash Pt: No data.
Evaporation Rate: No data.
Flammability (solid, gas): No data available.
Explosive Limits: LEL: No data. UEL: No data.
Vapor Pressure (vs. Air or mm No data.
Hg):
Vapor Density (vs. Air = 1): No data.

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Specific Gravity (Water = 1): No data.
Solubility in Water: No data.
Solubility Notes: ~2 mg/ml in PBS (pH 7.2); ~30 mg/ml in EtOH; ~25 mg/ml in DMSO & DMF;
Octanol/Water Partition No data.
Coefficient:
Autoignition Pt: No data.
Decomposition Temperature: No data.
Viscosity: No data.
9.2 Other Information
Percent Volatile: No data.
Molecular Formula & Weight: C13H16N2 • HCl 236.7

Section 10. Stability and Reactivity


10.1 Reactivity: No data available.
10.2 Stability: Unstable [ ] Stable [ X ]
10.3 Stability Note(s): Stable if stored in accordance with information listed on the product insert.
Polymerization: Will occur [ ] Will not occur [ X ]
10.4 Conditions To Avoid: No data available.
10.5 Incompatibility - Materials strong oxidizing agents
To Avoid:
10.6 Hazardous carbon dioxide
Decomposition or carbon monoxide
Byproducts: hydrogen chloride gas
nitrogen oxides

Section 11. Toxicological Information


11.1 Information on The toxicological effects of this product have not been thoroughly studied.
Toxicological Effects: Dexmedetomidine (hydrochloride) - Toxicity Data: Intraperitoneal TDLO (mouse): 100 µg/kg;
Subcutaneous TDLO (mouse): 3 µg/kg; Subcutaneous TDLO (rat): 40 µg/kg;
Chronic Toxicological Dexmedetomidine (hydrochloride) - Investigated as a drug.
Effects: Only select Registry of Toxic Effects of Chemical Substances (RTECS) data is presented
here. See actual entry in RTECS for complete information.
Dexmedetomidine (hydrochloride) RTECS Number: NI5156750

CAS # Hazardous Components (Chemical Name) NTP IARC ACGIH OSHA


145108-58-3 1H-Imidazole,5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-, n.a. n.a. n.a. n.a.
hydrochloride (1:1)

Section 12. Ecological Information


12.1 Toxicity: Avoid release into the environment.
Runoff from fire control or dilution water may cause pollution.
12.2 Persistence and No data available.
Degradability:
12.3 Bioaccumulative No data available.
Potential:
12.4 Mobility in Soil: No data available.
12.5 Results of PBT and vPvB No data available.
assessment:
12.6 Other adverse effects: No data available.

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Dexmedetomidine (hydrochloride) Revision: 02/15/2019
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Section 13. Disposal Considerations


13.1 Waste Disposal Method: Dispose in accordance with local, state, and federal regulations.

Section 14. Transport Information


14.1 LAND TRANSPORT (US DOT):
DOT Proper Shipping Name: Not dangerous goods.
DOT Hazard Class:
UN/NA Number:
14.1 LAND TRANSPORT (European ADR/RID):
ADR/RID Shipping Name: Not dangerous goods.
UN Number:
Hazard Class:
14.3 AIR TRANSPORT (ICAO/IATA):
ICAO/IATA Shipping Name: Not dangerous goods.
Additional Transport Transport in accordance with local, state, and federal regulations.
Information:

Section 15. Regulatory Information


EPA SARA (Superfund Amendments and Reauthorization Act of 1986) Lists
CAS # Hazardous Components (Chemical Name) S. 302 (EHS) S. 304 RQ S. 313 (TRI)
145108-58-3 1H-Imidazole,5-[(1S)-1-(2,3-dimethylphenyl)ethyl]- No No No
, hydrochloride (1:1)
CAS # Hazardous Components (Chemical Name) Other US EPA or State Lists
145108-58-3 1H-Imidazole,5-[(1S)-1-(2,3-dimethylphenyl)ethyl]- CAA HAP,ODC: No; CWA NPDES: No; TSCA: No; CA
, hydrochloride (1:1) PROP.65: No

Regulatory Information This SDS was prepared in accordance with 29 CFR 1910.1200 and Regulation (EC)
Statement: No.1272/2008.

Section 16. Other Information


Revision Date: 02/15/2019
Additional Information About No data
available. This Product:
Company Policy or Disclaimer: DISCLAIMER: This information is believed to be accurate and represents the best information
currently available to us. However, we make no warranty of merchantability or any other warranty,
express or implied, with respect to such information, and we assume no liability resulting from its
use. Users should make their own investigations to determine the suitability of the information for
their particular purposes.

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