Ark Pharm, Inc.
MATERIAL SAFETY DATA SHEET
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
2. COMPOSITION, INFORMATION ON INGREDIENTS
3. HAZARDS IDENTIFICATIONEMERGENCY OVERVIEW
3.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP]
Specific target organ toxicity - single exposure (Category 3)
Classification according to EU Directives 67/548/EEC or 1999/45/EC
Harmful if swallowed. Irritating to eyes, respiratory system and skin.
3.2 Label elements
Labelling according Regulation (EC) No 1272/2008 [CLP]
IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if present and easy to do.
Ark Pharm, Inc.
According to European Directive 67/548/EEC as amended
Irritating to eyes, respiratory system and skin.
immediately with plenty of water and seek medical advice.
Wear suitable protective clothing and gloves.
3.3 Other hazards
4. FIRST AID MEASURES
Flush eyes with plenty of water occasionally lifting the upper and lower lids. Get medical aid.
Get medical aid. Flush skin with plenty of water while removing contaminated clothing and shoes.
Get medical aid. Wash mouth out with water.
Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is
5. FIRE FIGHTING MEASURES
As in any fire, wear a self-contained breathing apparatus and full protective gear.
Use water spray, dry chemical, carbon dioxide or chemical foam.
6. ACCIDENTAL RELEASE MEASURES
Use proper personal protective equipment.
Vacuum or sweep up material and place into suitable disposalcontainer. Avoid generating dusty conditions.
7. HANDLING AND STORAGE
Avoid breathing dust, vapor, mist or gas. Avoid contact with eyes, skin.
Storage temperature: 2 - 4 °C and Keep container tightly closed in a dry and well-ventilated place.
8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Facilities storing or utilizing this material should be equipped with an eyewash facility and safety
shower. Use adequate ventilation to keep airborne concentrations low.
Personal Protective Equipment
Wear chemical safety goggles.
Wear appropriate protective gloves to prevent skin exposure.
Wear appropriate protective clothing to prevent skin exposure.
Wear appropriate respirators where necessary.
9. PHYSICAL AND CHEMICAL PROPERTIES
Ark Pharm, Inc.
10. STABILITY AND REACTIVITY
This product is relatively unstable under normal temperature.
Incompatibilities with Other Materials:
Strong oxidizing agents.
Hazardous combustion or Decomposition products:
Carbon monoxide, carbon dioxide.
11. TOXICOLOGICAL INFORMATION
11.1 Information on toxicological effects
Serious eye damage/eye irritation
Respiratory or skin sensitization
Germ cell mutagenicity
No component of this product present at levels greater than or equal to 0.1% is identified as probable,
possible or confirmed human carcinogen by IARC.
Specific target organ toxicity - single exposure
Specific target organ toxicity - repeated exposure
To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
12. ECOLOGICAL INFORMATION
12.2 Persistence and degradability
12.3 Bioaccumulative potential
12.4 Mobility in soil
12.5 Results of PBT and vPvB assessment
12.6 Other adverse effects
Ark Pharm, Inc.
13. DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Offer surplus and non-recyclable solutions to a licensed disposal company. 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.
14. TRANSPORT INFORMATION
14.1 UN number
14.2 UN proper shipping name
14.3 Transport hazard class(es)
14.4 Packaging group
14.5 Environmental hazards
14.6 Special precautions for user
15. REGULATORY INFORMATION
This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.
Safety, health and environmental regulations/legislation specific for the substance or mixture:
Chemical Safety Assessment:
No data available.
16. ADDITIONAL INFORMATION
The above information pertains to this product as currently formulated, and is based on the information available at this time.
Addition of reducers or other additives to this product may substantially alter the composition and hazards of the product. Since
conditions of use are outside our control, we make no warranties, express or implied, and assume no liability in connection
Aetna Precertification Notification 503 Sunport Lane, Orlando, FL 32809 Page 1 of 2 (Please complete & return only page 1 if Aetna Specialty Pharmacy is NOT the dispensing provider.) No Does DNA Analysis confirm evidence of genetic If this Precert is request for Elaprase: No Is the patient diagnosed with Hunter syndrome MPS II? If this Precert request is for Aldurazyme: If this Precer
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