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EC number: 474-310-3 | 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: 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
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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 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.
SpecialProvisionsopen allclose all
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.
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.
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