Registration Dossier

Administrative data

First-aid measures

Emergency measure - Inhalation: Using appropriate personal protective equipment, move
exposed subject to fresh air. If breathing is difficult or
ceases, ensure and maintain ventilation. Give oxygen as
appropriate. The exposed subject should be kept warm and at
rest. Obtain medical attention in cases of known or possible
over exposure, or with symptoms including chest pain,
difficulty breathing, loss of consciousness or other adverse
effects, which may be delayed.
Emergency measure - Eyes: Wash immediately with clean and gently flowing water.
Continue for at least 15 minutes. Obtain medical attention.
Emergency measure - Skin: Using appropriate personal protective equipment, remove
contaminated clothing and flush exposed area with large
amounts of water. Obtain medical attention if skin reaction
occurs, which may be immediate or delayed.
Emergency measure - Ingestion: Never attempt to induce vomiting. Do not attempt to give any
solid or liquid by mouth if the exposed subject is
unconscious or semi-conscious. Wash out the mouth with
water. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.

Fire-fighting measures

Recommended extinguishing agent: No special requirements needed. Water is recommended for
fires involving packaging.

Product arising from burning: This material is non-combustible.

Product determined by test: N

Protective equipment: Since toxic, corrosive or flammable vapours might be evolved
from fires involving the notified chemical, self contained
breathing apparatus and full protective equipment are
recommended for fire fighters.

Move containers from the fire area if possible without
increased personal risk.

If possible, contain and collect firefighting water for
later disposal.

Accidental release measures

Emergency measures in case of spillage: Spillage: Fence or cordon the affected area and do not allow
individuals to touch or walk through the spilled material
unless wearing appropriate protective clothing. Avoid dust

Prevent entry into waterways, sewers, surface drainage
systems and poorly ventilated areas. If spill is outdoors,
cover with plastic sheet to minimise spreading or contact
with rain.

Collect and place it in a suitable, properly labelled
container for recovery or disposal. After all solid or
absorbent material has been collected, the area should be
vacuumed with HEPA filter-equipped apparatus.

No specific decontamination or detoxification procedures
have been identified for this material. Consider use of
water, detergent solutions or other soluble solvents for
clean-up and decontamination operations.

Handling and storage

Handling: Handling: Avoid dispersion as a dust cloud.

Depending upon the scale of the operation, use of
appropriate exhaust ventilation is recommended to provide
routine control of fire and explosion hazards during
handling of this material.

Ignition Controls: Bond and earth (ground) all plant and
equipment to ensure that no isolated conductors are present.

Isolated conductors can accumulate sufficient
electrostaticcharge to produce discharges of many hundreds
of milli-Joules. Consider earthing (grounding) personnel
dealing with dusty operations. An isolated (insulated)
human body can readily produce electrostatic discharges in
excess of 50 mJ, but have been recorded up to 100 mJ.

Minimise the use of plastics when handling this material.
Handle and store this material only in conductive or anti-
static plastic liners (bags) since normal plastics are known
to be capable of producing electrostatic discharges of up
to 4 mJ, ensuring any containers into which they are placed
are themselves of a conductive material and earthed
(grounded). The maximum surface temperature of enclosures
potentially exposed to this material should be the lower of
the values obtained by taking 2/3 of the minimum ignition
temperature for a dust cloud or 75 K less than the minimum
ignition temperature of the dust layer, with a maximum
temperature of 325 Deg C.

Protective Systems: Assess operations based upon available
dust explosion information to determine the suitability of
preventive or protective systems as precautionary measures
against possible dust explosions. If prevention is not
possible, consider protection by use of containment, venting
or suppression of dust handling equipment. Where explosion
venting is considered the most appropriate method of
protection, vent areas should preferably be calculated based
on the Kst rather than the St value. If nitrogen purging is
considered as the protective system, it must operate with
an oxygen level below the limiting oxygen concentration. The
system should include an oxygen monitoring and shut down
facility in the event of excessive oxygen being detected.

PPE used to minimise exposure during use are as follows;

Gloves (handling powders) - Nitrile 730 camatril gloves,
Green, non-disposable gloves - complies with EN 374 -
provided by KCL - suitable for chemicals and m/o`s but
limited protection tie against solvents.

Gloves (general non-chemical contact activities) - Nitrile
740 dermatril gloves, light blue, disposable - complies with
EN 374 - provided by KCL - suitable for chemicals and m/o`s
but limited protection tie against solvents. Coveralls -
white nexagen / blue proshield / tyvek type 4,5 or 6 - all
comply with EN 368 and EN 369 - provided by M.A.Healy / GWS
/ Dupont - protection against limited liquid splashes
(acids, bases and solvents) and protection against powder
intrusion - all coveralls are to be disposed of once contact
has been made by liquids.

Safety footwear - leather footwear - complies with EN 346 -
provided by M.A.Healy / LeMaitre - protection against
certain chemicals (oil, petrol), anti-static
protection, steel toe-cap protection - unsuitable for
certain solvents.

Eye Protection - bolle targa safety specs - complies with
EN 166 - provided by bolle - provide impact protection,
limited splash protection, side-arm protection, anti-mist
coating, anti-scratch, UV protection - unsuitable for
pressurised liquids e.g. line breaking activities.

Head protection - MSA Super V-Guard 2 - complies with EN 397
- provided by GWS - protection against collision and
falling objects (of limited weight) - unsuitable for large
falling objects.

RPE (used during powder handling activities) - airhood -
complies with EN 270 and EN 467 - provided by JS Safety /
Respirex - protect against chemicals and m/o`s, anti static
(protection factor (APF) = 40) - unsuitable for highly
odourous chemicals or chemicals with low OELS, CDL 8 / 9
does not fall into this category.

The Carvedilol Stage 8 and Carvedilol phosphate(end product)
are both OHC 3 materials with OELS of 30mcg/m3. The
majority of API materials at GSK Cork are OHC 3 or higher
therefore all PPE is designed and purchased to protect
against this level of contamination.

Storage: Keep tightly closed containers or packages away from
moisture and away from sources of ignition.

The recommended temperature for storage is less than 30 deg

Packaging of the substance and or preparation: Carvedilol Stage 8 is packaged in double anti-static
polyethylene bags as primary packaging in a wide-mouth drum
(120 L). The drums are secured by means of shrink-foil.

Transport information

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Marine transport (IMDG)

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Air transport ICAO/IATA

Transport code: UN 3077
Transport: The SDS should accompany all shipments for reference in the
event of spillage or accidental release. Only authorised
persons trained and competent in accordance with appropriate
national and international regulatory requirements may
prepare dangerous goods for transport.

Limited Quantities: IATA Requirements

When packed in limited quantity recepticals (maximum 2 kg,
but varies according to receptical type) and in packages not
exceeding 30 kg gross complying with Packing Instruction
Y911 and all other relevent IATA provisions, the packages
may be shipped as limited quantity packages. Full labelling,
marking and documentation will be required, and
additionally the package and documentation will need to be
annotated "LTD QTY".

ADR/RID Requirements:

Quantities equal to or less than 6 kg per inner packaging
and 24 kg per package are not subject to the full packaging
and labelling requirements, and transport documents are not
required. Packages must be marked with the UN Number in at
least 6 mm height in a diamond area formed by lines of at
least 2 mm thickness and lenght, if possible, of 100 mm.
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Exposure controls / personal protection

Stability and reactivity

Danger other than fire: Toxic or corrosive thermal decomposition products are
expected when this material is exposed to fire.

Chemical reaction with water: None which is hazardous.

Dust explosion: Dust clouds are potentially very highly sensitive to
ignition from incendive electrostatic discharges. Dust
clouds are of very low sensitivity to ignition from hot
surfaces. No ignition or exotherm of a powder layer
observed up to 400 deg C. Ignition of a dust cloud produces
a strong dust explosion. High pressure between 8 and 10 bar
is produced during an explosion.

At low humidity, this material is of low conductivity.
Generation of electrostatic charge is considered likely to
occur even when handled in an earthed (grounded)

At ambient humidity, this material has an extremely fast
charge relaxation time. Accumulation of electrostatic
charge is considered unlikely to occur when handled in an
earthed (grounded) environment.

At low humidity, this material has a very long charge
relaxation time.

Accumulation of electrostatic charge is considered very
likely to occur even when handled in an earthed (grounded)
environment. Under these conditions, it is considered that
this material might present a very high risk of producing

an electrostatic discharge.

Dust explosion determined by test: N

Disposal considerations

Industry - Possibility of recovery/recycling: It is recommended to collect spillages for recycling and
reuse whenever possible. Recovery from minor spillages or
accidental discharge is not economically or technically
feasible, and such waste material will be disposed of by
incineration. Appropriate PPE should be used when in contact
with spillages, and material should be placed in properly
labelled containers.

Industry - Possibility of neutralisation: No chemical treatment is practicable to neutralise the
hazardous health properties.

The dust hazard will be minimised by appropriate handling
and storage.

No chemical treatment is practicable to neutralise the
hazardous environmental properties.

Industry - Possibility of destruction: controlled discharge: Not recommended.

Industry - Possibility of destruction - incineration: All waste containing the Carvedilol Stage 8 will be disposed
off by incineration by burning under controlled conditions
at a licensed waste treatment processor in accordance with
local regulations. Stack gases should be scrubbed, because
noxious fumes (eg. carbon and nitrogen oxides) could be

Industry - Possibility of destruction - water purification: Carvedilol Stage 8 will not be discharged directly to the
sewage system or aqueous environment under foreseeable uses.

Industry - Possibility of destruction - other: None.

Public at large - Possibility of recovery/recycling: Not applicable as substance will not be made available to
the general public.

Public at large - Possibility of neutralisation: Not applicable as substance will not be made available to
the general public.

Public at large - Possibility of destruction: controlled discharge: Not applicable as substance will not be made available to
the general public.

Public at large - Possibility of destruction - incineration: Not applicable as substance will not be made available to
the general public.

Public at large - Possibility of destruction - water purification: Not applicable as substance will not be made available to
the general public.

Public at large - Possibility of destruction - others: None.