Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 478-710-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
Shippingopen allclose all
SpecialProvisionsopen allclose all
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Remarksopen allclose all
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
SpecialProvisionsopen allclose all
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.