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Guidance on Safe Use

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

generation.

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

C.

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

Shipping

SpecialProvisions

Shipping

Remarks

Marine transport (UN RTDG/IMDG)

Shipping

Remarks

Air transport (UN RTDG/ICAO/IATA)

Shipping

Special provisions / remarks

Remarks:

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.

SpecialProvisions

Exposure controls / personal protection

Appropriate engineering

controls

An Exposure Control Approach (ECA) is established for operations involving this material based

upon the OEL/Occupational Hazard Category and the outcome of a site- or operation-specific risk

assessment. Refer to the Exposure Control Matrix for more information about how ECA's are

assigned and how to interpret them. Open handling should be limited to small quantities. Consider

use of enclosures. Local exhaust ventilation (LEV) should be applied at the source to capture

contaminants from open or semi-enclosed operations. Entry to the working area should be

controlled.

Individual protection measures, such as personal protective equipment

General information

Use personal protective equipment as required.

Eye/face protection

Wear approved safety glasses with side shields or cover goggles if eye contact is possible. (eg.

EN 166)

Skin protection

- Hand protection

Glove selection must take into account any solvents and other hazards present. Care must be

exercised if insufficient data are available and further guidance should be sought from your local

EHS department. The selection of gloves for a specific activity must be based on the material's

properties and on possible permeation and degradation that may occur under the circumstances of

use. Potential allergic reactions can occur with certain glove materials (e.g. Latex) and therefore

these should be avoided. Select suitable chemical resistant protective gloves (EN 374) with a

protective index 6 (>480min permeation time).

- Other

Wear appropriate chemical resistant clothing. (EN 14605 for splashes, EN ISO 13982 for dust)

Respiratory protection

If respiratory protective equipment (RPE) is used, the type of RPE will depend upon air

concentrations present, required protection factor as well as hazards, physical properties and

warning properties of substances present. Where breathable aerosols/dust are formed, use

suitable combination filter for gases/vapours of organic, inorganic, acid inorganic, alkaline

compounds and toxic particles (eg. EN 14387).

Thermal hazards

Not available.

Hygiene measures

An eye wash station should be available. Wear appropriate clothing to avoid skin contact. Follow

all local regulations if personal protective equipment (PPE) is used in the workplace.

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)

environment.

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

formed.

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.