Registration Dossier

Administrative data

First-aid measures

Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately

Fire-fighting measures

Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.
Special Hazards Arising from the Substance or Mixture
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire. May include oxides of carbon and nitrogen.
Fire / Explosion Hazards: Very strong dust explosion characteristic. Very high sensitivity of a dust cloud to ignition, based on minimum ignition energy.

Advice for Fire-Fighters: During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

Accidental release measures

Personnel involved in clean-up should wear appropriate personal protective equipment. Minimize exposure.

Environmental Precautions
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning Up Measures for Cleaning /Collecting:
Contain the source of the spill if it is safe to do so. Collect spilled material by a method that controls dust generation. Avoid use of a filtered vacuum to clean spills of dry solids, due to the potential for electrostatic discharge and the very strong dust explosion characteristic and very high sensitivity to ignition.

Additional Consideration for
Large Spills: Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel

Handling and storage

All conductive elements of the system that contact the dry substance should be properly bonded and grounded and equipped with proper explosion relief or suppression systems. This material should not be flowed through nonconductive ducts or pipes because of the potential for electrostatic discharge ignition. Restricting the use of high resistivity materials, such as plastics, should be considered. Avoid open handling. Minimize dust generation. Use local exhaust ventilation or perform work under fume hood/fume cupboard. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the
atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls.

Conditions for Safe Storage, Including any Incompatibilities
Storage Conditions: Store at room temperature in properly labeled containers. Keep away from heat, sparks and flames.

Transport information

Land transport (ADR/RID)

UN number:
UN 2811
Proper shipping name and description:
Toxic solid, organic, n.o.s. (fesoterodine mandelate intermediate)
Language:
English
Class:
6.1
Packaging group:
III
Labels:
For small quantities, packed in combination packaging [limited to inner packaging less than or equal to 5.0 kg (11 lbs) and outer packaging less than or equal to 30 kg (66 lb.) gross weight], the following will apply.
SpecialProvisionsopen allclose all

Inland waterway transport (ADN(R))

UN number:
Not regulated for ADN
Shippingopen allclose all
Remarksopen allclose all

Marine transport (IMDG)

UN number:
UN 2811
Proper shipping name and description:
Toxic Solid, organic, n.o.s. (fesoterodine mandelate intermediate), Ltd. Qty.
Class:
6.1
Packaging group:
III
Remarksopen allclose all

Air transport ICAO/IATA

UN number:
UN 2811
Proper shipping name and description:
Toxic solid, organic, n.o.s. (fesoterodine mandelate intermediate), Ltd. Qty.
Class:
6.1
Packaging group:
III
Remarksopen allclose all

Additional transport information

Additional transport information
DOT UN / ID No: UN 2811
DOT Proper shipping name: Toxic Solid, organic, n.o.s. (fesoterodine mandelate intermediate), Ltd. Qty.
DOT Hazard Class: 6.1
DOT Packing Group: III

Exposure controls / personal protection

Pfizer Occupational Exposure Band (OEB):
OEB 3 - Sensitizer (control exposure to the range of 10ug/m3 to < 100ug/m3, provide additional
precautions to protect from skin contact

Exposure Controls
Engineering Controls: Engineering controls should be used as the primary means to control exposures. Use process containment, local exhaust ventilation, or other engineering controls to maintain airborne levels within the OEB range.
Personal Protective Equipment:
Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE).
Hands: Wear impervious gloves to prevent skin contact.
Eyes: Wear safety glasses as minimum protection.
Skin: Wear impervious protective clothing to prevent skin contact - consider use of disposable clothing where appropriate.
Respiratory protection: If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wear an appropriate respirator with a protection factor sufficient to control exposures to the bottom of the OEB range.

Stability and reactivity

Reactivity: No data available
Chemical Stability: Stable under normal conditions of use.

Possibility of Hazardous Reactions
Oxidizing Properties: No data available
Conditions to Avoid: Keep away from heat and other sources of ignition, including electrostatic discharge.
Incompatible Materials: As a precautionary measure, keep away from strong oxidizers
Hazardous Decomposition Products: No data available

Disposal considerations

Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater