Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

Emergency measure - Inhalation: Remove to fresh air. Administer artificial respiration if

breathing has ceased. Get IMMEDIATE medical attention

Emergency measure - Eyes: In case of eye contact, IMMEDIATELY rinse eyes thoroughly

with plenty of water. If wearing contact lenses, remove only

after initial rinse, and continue rinsing eyes for at least

15 minutes. Get IMMEDIATE medical attention.

Emergency measure - Skin: In case of skin contact, while wearing protective gloves,

carefully remove any contaminated clothing, including shoes,

and wash skin thoroughly with soap and water. If irritation

or symptoms occur or persist, consult a physician.

Emergency measure - Ingestion: DO NOT induce vomiting. Do not attempt to give anything by

mouth to a seizing, drowsy or unconscious person. If alert,

rinse mouth, drink a glass of water and IMMEDIATELY consult

a physician.

Fire-fighting measures

Recommended extinguishing agent: Carbon dioxide (CO2), extinguishing powder or water spray.

Product arising from burning: Carbon oxides (COx). Nitrogen oxides (NOx). Hydrogen

chloride (HCl).

Product determined by test: N

Protective equipment: Wear full protective clothing and self-contained breathing

apparatus (SCBA).

Accidental release measures

Emergency measures in case of spillage: All spills should be handled according to site requirements

and based on precautions cited in the MSDS. In the case of

liquids, use proper absorbent materials. For laboratories

and small-scale operations, incidental spills within a hood

or enclosure should be cleaned by using a HEPA filtered

vacuum or wet cleaning methods as appropriate. For large dry

or liquid spills or those spills outside enclosure or hood,

appropriate emergency response personnel should be

notified. In manufacturing and large-scale operations, HEPA

vacuuming prior to wet mopping or cleaning is required.

Handling and storage

Handling: Sampling and splitting the material in the Warehouse is

performed within laminar airflow booths with appropriate

Personal Protective Equipment (PPE).  On the plant, a

charging funnel, supplemented by local exhaust ventilation

(LEV) and PPE are used for all manual handling operations.

Finally, reaction mixture solution sampling via Top Reactor

Sampler (Rapid Transfer Port).  Contained sampling unit,

minimal exposure to reaction mixture.

Schering-Plough Global Industrial Hygiene Services (GIHS)

has established standards for the Schering-Plough Industrial

Hygiene Risk Management (IHRM) Program to provide guidance

for protection of persons who handle Schering-Plough

materials, as well as materials purchased, for the research

and manufacture of Schering-Plough substances and

preparations. This program is used at all Schering-Plough

facilities worldwide. Key features of the IHRM include, but

are not limited to, Industrial Hygiene Risk Assessment

(IHRA) and Risk-Based Exposure Control Strategies (R-BECS).

IHRA is designed to evaluate each task or operation by

assessment of the hazard and potential degrees of exposure

to establish the actual risk of exposure by a worker

performing specific tasks. The health hazard of a material

is determined by Schering-Plough Global Occupational &

Environmental Toxicology and is used as the 'hazard'

component of the two-dimensional model. The hazard is

assessed against potential degrees of exposure that include

such elements as physical form of the substance, volume or

quantity used, duration and frequency of handling, etc. From

this assessment, the use of the substance is classified as

a low to high exposure risk which is then used to determine

exposure control strategies, need for industrial hygiene

monitoring, and appropriate personal protective equipment

usage. All personal protective equipment (PPE) is chosen in

accordance to local requirements and regulations and is

documented in the IHRA for that process.

The principles of the IHRA are communicated on Schering-

Plough Safety Data Sheets (SDSs) in appropriate sections

(e.g. section 8). Because of the global use of the SDSs at

all Schering-Plough facilities, specifics for PPE are not

provided on the SDS. Other operating procedures at each site

are used to communicate the use of appropriate PPE or other

handling guidance on a local level. Specific questions

associated with health hazards, handling, and disposal are

handled by appropriate safety and environmental

professionals at each site or at the corporate level.

Storage: Store in a cool, dry, well ventilated area.

Packaging of the substance and or preparation: Two Polyethylene lined bags within fibre-board drums.

Typical weight of 25 kg per drum.

Transport information

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Marine transport (UN RTDG/IMDG)

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Air transport (UN RTDG/ICAO/IATA)

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Special provisions / remarks
Remarks:
Transport code: UN Number: UN 1759
Transport: Proper Shipping Name: Corrosive solids, n.o.s. ((1-Methyl-4-
piperidinyl)-[3-(2-[3-chlorophenyl] ethyl)-2-pyridinyl]-
methanone hydrochloride)


Hazard Class: 8


Packing Group: I
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Exposure controls / personal protection

Stability and reactivity

Danger other than fire: None known.

Chemical reaction with water: None.

Dust explosion: Under normal conditions of use, this material does not

present a significant fire or explosion hazard. This

material has been shown to present a moderate dust

deflagration hazard. This hazard may exist where sufficient

quantities of finely divided material are (or may become)

suspended in air during typical process operations. An

assessment of each operation should be conducted and

suitable deflagration prevention and protection techniques

employed. This material has been shown to be sensitive to

ignition by electrostatic discharges. All conductive plant

items and operations personnel handling this material should

be suitably grounded. Consideration should also be given to

the possibility of ignition due to electrostatic discharges

from accumulating powder.

Dust explosion determined by test: N

Disposal considerations

Industry - Possibility of recovery/recycling: The test item is designed for use in virtually closed

systems as an intermediate in the synthesis of an active

pharmaceutical ingredient.  Therefore it is expected that it

will be consumed in the processes where it is employed.

Hence the need for receovery/recycling of the substance does

not apply in this case.

Industry - Possibility of neutralisation: Unknown.

Industry - Possibility of destruction: controlled discharge: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Industry - Possibility of destruction - incineration: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Industry - Possibility of destruction - water purification: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Industry - Possibility of destruction - other: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of recovery/recycling: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of neutralisation: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of destruction: controlled discharge: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of destruction - incineration: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of destruction - water purification: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.

Public at large - Possibility of destruction - others: Not applicable as substance is a pharmaceutical intermediate

which is consumed in the reaction or remains in organic

solution waste streams.