SAFETY DATA SHEET

1. Identification
Product identifier Xylometazoline Hydrochloride
Other means of identification
Catalog number 1721002
CAS number 1218-35-5
Chemical name 1H-Imidazole, 2-[[4-(1,1-dimethylethyl)-2,6-dimethylphenyl]methyl]-4,5-dihydro-,
monohydrochloride
Recommended use Specified quality tests and assay use only.
Recommended restrictions Not for use as a drug. Not for administration to humans or animals.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
Company name U. S. Pharmacopeia
Address 12601 Twinbrook Parkway
Rockville
MD
20852-1790
United States
Telephone RS Technical Services 301-816-8129
Website www.usp.org
E-mail RSTECH@usp.org
Emergency phone number CHEMTREC within US & 1-800-424-9300
Canada
CHEMTREC outside US & +1 703-527-3887
Canada

2. Hazard(s) identification
Physical hazards Not classified.
Health hazards Acute toxicity, oral Category 3
Acute toxicity, dermal Category 3
Acute toxicity, inhalation Category 4
Skin corrosion/irritation Category 2
Serious eye damage/eye irritation Category 1
Environmental hazards Not classified.
OSHA defined hazards Not classified.

Label elements

Signal word Danger

Hazard statement Toxic if swallowed. Toxic in contact with skin. Causes skin irritation. Causes serious eye damage.
Harmful if inhaled.
Precautionary statement
Prevention Avoid breathing dust. Wash thoroughly after handling. Wear protective gloves/protective
clothing/eye protection/face protection. Use only outdoors or in a well-ventilated area.
Response If swallowed: Immediately call a poison center/doctor. Rinse mouth. If on skin: Wash with plenty of
water. If skin irritation occurs, seek medical advice/attention. Take off immediately all
contaminated clothing and wash it before reuse. If inhaled: Remove person to fresh air and keep
comfortable for breathing. Call a poison center/doctor if you feel unwell. If in eyes: Rinse
cautiously with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. Immediately call a poison center/doctor.

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 Storage Store locked up.
Disposal Dispose of contents/container in accordance with local/regional/national/international regulations.
Hazard(s) not otherwise This product is supplied in a small quantity which does not constitute a combustible dust hazard.
classified (HNOC) The physical properties of this material indicate that in large quantities accumulated dust may be
hazardous.
Supplemental information Potent pharmacologically active material.

3. Composition/information on ingredients
Substance
Chemical name Common name and synonyms CAS number %
Xylometazoline Hydrochloride 1218-35-5 100

4. First-aid measures
Inhalation If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing.
Do not use mouth-to-mouth method if the substance is inhaled. If experiencing respiratory
symptoms: Call a POISON CENTER or doctor/physician.
Skin contact Take off contaminated clothing and wash before reuse. Rinse skin with water/shower. If skin
irritation occurs: Get medical advice/attention.
Eye contact Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. Call a physician or poison control center immediately.
Ingestion If swallowed: Immediately call a poison center or doctor/physician. Rinse mouth. Do not induce
vomiting without advice from poison control center.
Most important Potent pharmacologically active material. Occupational exposure to small amounts may cause
symptoms/effects, acute and physiological effects.
delayed
Indication of immediate Provide general supportive measures and treat symptomatically.
medical attention and special
treatment needed
General information Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from
an occupational health physician or other licensed health-care provider familiar with workplace
chemical exposures. In the United States, the national poison control center phone number is
1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give
oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must
receive immediate medical attention.

5. Fire-fighting measures
Suitable extinguishing media Water. Foam. Dry chemical or CO2. Use fire-extinguishing media appropriate for surrounding
materials.
Unsuitable extinguishing None known.
media
Specific hazards arising from Explosion hazard: Avoid generating dust; fine dust dispersed in air in sufficient concentrations and
the chemical in the presence of an ignition source is a potential dust explosion hazard.
Special protective equipment Wear suitable protective equipment.
and precautions for firefighters
Fire fighting Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area.
equipment/instructions Firefighters should use self-contained breathing equipment and protective clothing.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
General fire hazards No unusual fire or explosion hazards noted.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Ensure adequate ventilation. Do not touch damaged
protective equipment and containers or spilled material unless wearing appropriate protective clothing. Wear appropriate
emergency procedures personal protective equipment. Avoid inhalation of dust from the spilled material. For personal
protection, see section 8 of the SDS. Dust deposits should not be allowed to accumulate on
surfaces, as these may form an explosive mixture if they are released into the atmosphere in
sufficient concentration.
Methods and materials for Avoid the generation of dusts during clean-up. Sweep up or vacuum up spillage and collect in
containment and cleaning up suitable container for disposal. Clean surface thoroughly to remove residual contamination. For
waste disposal, see section 13 of the SDS.
Environmental precautions Avoid discharge into drains, water courses or onto the ground.

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7. Handling and storage
Precautions for safe handling As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of
dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with
suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin
thoroughly. Avoid significant deposits of material, especially on horizontal surfaces, which may
become airborne and form combustible dust clouds and may contribute to secondary explosions.
Combustible dust clouds may be created where operations produce fine material (dust). Select
and use containment devices and personal protective equipment based on a risk assessment of
material potency and exposure potential.
Conditions for safe storage, Store in tight container as defined in the USP-NF. This material should be handled and stored per
including any incompatibilities label instructions to ensure product integrity.

8. Exposure controls/personal protection

Occupational exposure limits
The following constituents are the only constituents of the product which have a PEL, TLV or other recommended exposure limit.
At this time, the other constituents have no known exposure limits.
Exposure limit values
Industrial Use
Material Type Value
Xylometazoline Hydrochlor TWA 7 micrograms/m3
ide (CAS 1218-35-5)
Biological limit values No biological exposure limits noted for the ingredient(s).
Appropriate engineering No open handling. For laboratory operations, use approved ventilation or containment system
controls (biological safety cabinet, ventilated balance enclosure, glovebox). Control exposures to below the
occupational exposure level (if available). Select and use containment devices and personal
protective equipment based on a risk assessment of exposure potential. Cover all containers for
solutions and slurries while being transferred.
Individual protection measures, such as personal protective equipment
Eye/face protection Wear safety glasses with side shields, chemical splash goggles, or full face shield, if necessary.
Base the choice of protection on the job activity and potential for contact with eyes or face. An
emergency eye wash station should be available.
Skin protection
Hand protection Consider double gloves. Wear nitrile or other impervious gloves if skin contact is possible. When
the material is dissolved or suspended in an organic solvent, wear gloves that provide protection
against the solvent.
Other Train employees in proper gowning and degowning practices. Wear disposable lab coat,
disposable sleeve covers and two pair of gloves as appropriate for the task. Base the choice of
skin protection on the job activity, potential for skin contact and solvents and reagents in use. Do
not wear protective garments in common areas (e.g., cafeterias) or out-of-doors.
Respiratory protection Use a powered air-purifying respirator (PAPR) with HEPA filters, disposable outerware and head
cover for spill cleanup. Choose respiratory protection appropriate to the task and the level of
existing engineering controls.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.

General hygiene Pharmacological effects may be seen with occupational exposure. Handling practices in this SDS
considerations are recommendations for laboratory use of reference standards. Procedures for any other uses or
quantities should be determined after an appropriate assessment.

9. Physical and chemical properties

Appearance Appearance descriptions are general information and not specific to any USP lot.
Physical state Solid.
Form Powder.
Color White. Off-white.
Odor Odorless.
Odor threshold Not available.
pH Not available.
Melting point/freezing point 602.6 - 624.2 °F (317 - 329 °C)
Initial boiling point and boiling Not available.
range

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Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure < 0.0000001 kPa at 25 °C
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Soluble.
Solubility (other) Ethanol: Freely soluble.
Methanol: Soluble.
Chloroform: Sparingly soluble.
Benzene: Practically insoluble.
Ether: Practically insoluble.
Auto-ignition temperature 806 °F (430 °C)
Decomposition temperature Not available.
Viscosity Not available.
Other information
Chemical family Imidazoline.
Dust explosion properties
Minimum ignition 3 - 10 mJ
energy (MIE) - dust
cloud
Molecular formula C16H24N2 . HCl
Molecular weight 280.84

10. Stability and reactivity

Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid Contact with incompatible materials.
Incompatible materials Acids. Bases. Reducing agents. Strong oxidizing agents.
Hazardous decomposition Cl-. NOx. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.
products

11. Toxicological information

Information on likely routes of exposure
Inhalation Harmful if inhaled.
Skin contact Toxic in contact with skin. Causes skin irritation.
Eye contact Causes serious eye damage.
Ingestion Toxic if swallowed.
Symptoms related to the Sneezing. Headache. Dizziness. Drowsiness. Lightheadedness. Nervousness. Difficulty sleeping.
physical, chemical, and Sweating. Nausea. Irregular heartbeat.
toxicological
characteristics
Information on toxicological effects
Acute toxicity Toxic in contact with skin. Toxic if swallowed. Harmful if inhaled.

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Product Species Test Results
Xylometazoline Hydrochloride (CAS 1218-35-5)
Dermal
LD50 Rabbit 267 - 900 mg/kg
Inhalation
LC50 Rat 0.4 - 1.8 mg/l/4h
Oral
LD50 Mouse 75 mg/kg
Rat 230 mg/kg
Skin corrosion/irritation Causes skin irritation.
Serious eye damage/eye Causes serious eye damage.
irritation
Local effects
Skin irritation
Result: Negative.
Species: Rabbit
Skin irritation: TER test
Result: Positive.
Species: Rat
Respiratory or skin sensitization
Respiratory sensitization Knowledge about health hazard is incomplete.
Skin sensitization Based on available data, the classification criteria are not met.
Skin sensitization
Result: Negative.
Species: Rabbit
Germ cell mutagenicity Knowledge about mutagenicity is incomplete.
Mutagenicity
Ames test
Result: Negative.
Micronucleus test
Result: Negative.
Carcinogenicity Knowledge about carcinogenicity is incomplete.
IARC Monographs. Overall Evaluation of Carcinogenicity
Not listed.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1052)
Not regulated.
US. National Toxicology Program (NTP) Report on Carcinogens
Not listed.
Reproductive toxicity Knowledge about health hazard is incomplete.
Specific target organ toxicity - Knowledge about health hazard is incomplete.
single exposure
Specific target organ toxicity - Knowledge about health hazard is incomplete.
repeated exposure
Aspiration hazard Based on available data, the classification criteria are not met.
Further information Potent pharmacologically active material. Occupational exposure to small amounts may cause
physiological effects.

12. Ecological information

Ecotoxicity
Product Species Test Results
Xylometazoline Hydrochloride (CAS 1218-35-5)
Aquatic
Fish LC50 Danio rerio 60.61 mg/l, 96 hours
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential No data available.

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Mobility in soil No data available.
Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.

13. Disposal considerations

Disposal instructions Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the
user of the product to determine, at the time of disposal, whether the product meets RCRA criteria
for hazardous waste.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused Empty containers or liners may retain some product residues. This material and its container must
products be disposed of in a safe manner (see: Disposal instructions).
Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied.

14. Transport information

DOT
UN number UN2811
UN proper shipping name Toxic solid, organic, n.o.s. (Xylometazoline Hydrochloride)
Transport hazard class(es)
Class 6.1
Subsidiary risk -
Packing group III
IATA
UN number UN2811
UN proper shipping name Toxic solid, organic, n.o.s. (Xylometazoline Hydrochloride)
Transport hazard class(es)
Class 6.1
Subsidiary risk -
Packing group III
Other information
Passenger and cargo Allowed with restrictions.
aircraft
Cargo aircraft only Allowed with restrictions.
Transport in bulk according to Not applicable.
Annex II of MARPOL 73/78 and
the IBC Code
DOT; IATA

General information It is the shipper's responsibility to determine the correct transport classification at the time of
shipment.

15. Regulatory information

US federal regulations This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication
Standard, 29 CFR 1910.1200.
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
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 OSHA Specifically Regulated Substances (29 CFR 1910.1001-1052)
Not regulated.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous Yes
chemical
Classified hazard Combustible dust
categories Acute toxicity (any route of exposure)
Skin corrosion or irritation
Serious eye damage or eye irritation
SARA 313 (TRI reporting)
Not regulated.

Other federal regulations

Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act Not regulated.
(SDWA)
US state regulations
California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 2016 (Proposition 65): This material
is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. For
more information go to www.P65Warnings.ca.gov.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) Yes
Canada Domestic Substances List (DSL) No
Canada Non-Domestic Substances List (NDSL) Yes
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical Yes
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) Yes
New Zealand New Zealand Inventory Yes
Philippines Philippine Inventory of Chemicals and Chemical Substances No
(PICCS)
Taiwan Taiwan Chemical Substance Inventory (TCSI) Yes
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory Yes
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).

16. Other information, including date of preparation or last revision

Issue date 04-19-2010
Revision date 10-01-2019
Version # 04
Further information Refer to NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the
Manufacturing, Processing, and Handling of Combustible Particulate Solids, for safe handling.

Material name: Xylometazoline Hydrochloride USP SDS US

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Disclaimer USP Reference Standards are sold for chemical test and assay purposes only, and NOT for
human consumption. The information contained herein is applicable solely to the chemical
substance when used as a USP Reference Standard and does not necessarily relate to any other
use of the substance described, (i.e. at different concentrations, in drug dosage forms, or in bulk
quantities). USP Reference Standards are intended for use by persons having technical skill and
at their own discretion and risk. This information has been developed by USP staff from sources
considered reliable but has not been independently verified by the USP. Therefore, the USP
Convention cannot guarantee the accuracy of the information in these sources nor should the
statements contained herein be considered an official expression. NO REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information contained
herein.

Material name: Xylometazoline Hydrochloride USP SDS US

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