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                                       HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 1 of 15

Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION


PRODUCT NAME

HEPATITIS B VIRUS

CAS RN

Not avail

SUPPLIER

Company: Health Canada
Address:
Al 0900c2
Ottawa
Ontario, KIA OK9
CAN
Telephone: +1 613 957 2991
Fax: +1 613 941 5366


HAZARD RATINGS


Flammability:
Toxicity:
Body Contact:
Reactivity:
Chronic:

SCALE: Min/Nil=0 Low=1 Moderate=2 High=3 Extreme=4

PRODUCT USE

Enveloped Hepadnaviridae, double stranded DNA with a lipoprotein coat containing HBsAg and
a diameter of 42 nm.

SYNONYMS

Serum Hepatitis Type B Hepatitis
Homologous Serum Jaundice HBV
Australian Antigen Hepatitis


Section 2 - COMPOSITION / INFORMATION ON INGREDIENTS


NAME CAS RN INT HAZ %
Hepatitis B virus Not avail. B 100




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HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 2 of 15

Section 3 - HAZARDS IDENTIFICATION


STATEMENT OF HAZARDOUS NATURE

CONSIDERED A DANGEROUS SUBSTANCE ACCORDING TO DIRECTIVE
67/548/EEC, POINT 4; AND HAZARDOUS ACCORDING TO OSHA 29 CFR
1910.1200 (USA).

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED
Although ingestion is not thought to produce harmful effects (as classified
under EC Directives), the material may still be damaging to the health of the
individual, following ingestion, especially where pre-existing organ (e.g liver,
kidney) damage is evident. Present definitions of harmful or toxic substances
are generally based on doses producing mortality rather than those producing
morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce
nausea and vomiting. In an occupational setting however, ingestion of
insignificant quantities is not thought to be cause for concern.

EYE
Although the material is not thought to be an irritant (as classified by EC
Directives), direct contact with the eye may produce transient discomfort
characterised by tearing or conjunctival redness (as with windburn).

SKIN
The material is not thought to produce adverse health effects or skin irritation
following contact (as classified by EC Directives using animal models).
Nevertheless, good hygiene practice requires that exposure be kept to a minimum
and that suitable gloves be used in an occupational setting.

INHALED
The material is not thought to produce adverse health effects or irritation of
the respiratory tract (as classified by EC Directives using animal models).
Nevertheless, good hygiene practice requires that exposure be kept to a minimum
and that suitable control measures be used in an occupational setting.

CHRONIC HEALTH EFFECTS

Principal routes of exposure are by skin contact, accidental injection (needle stick),
ingestion and/or inhalation of aerosols. Symptoms and longer term effects are related to
the pathology of the infection.


Section 4 - FIRST AID MEASURES


SWALLOWED
Transport to hospital or doctor and seek immediate attention.

EYE
鈥? If material containing a biological agent comes in contact with the eyes:
鈥? Seek immediate medical attention
鈥? Removal of contact lenses should only be undertaken by skilled personnel.

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ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 3 of 15

Section 4 - FIRST AID MEASURES ...


SKIN
鈥? For any suspected contact with a material containing a biological agent
鈥? Rinse thoroughly with water and perform approved disinfection procedures
鈥? Seek medical attention.

INHALED
鈥? If fumes or combustion products are inhaled remove from contaminated area.
鈥? Lay patient down. Keep warm and rested.
鈥? Prostheses such as false teeth, which may block airway, should be removed,
where possible, prior to initiating first aid procedures.
鈥? Apply artificial respiration if not breathing, preferably with a demand valve
resuscitator, bag-valve mask device, or pocket mask as trained. Perform CPR if
necessary.
鈥? Transport to hospital, or doctor.

NOTES TO PHYSICIAN
Protective vaccination/immunisation should be provided to workers depending on
the organism being worked with.
for infectious organisms:

----------------------------------------------------------------------------------------
BASIC TREATMENT
----------------------------------------------------------------------------------------
鈥? Establish a patent airway with suction where necessary.
鈥? Watch for signs of respiratory insufficiency and assist ventilation as
necessary.
鈥? Administer oxygen by non-rebreather mask at 10 to 15 l/min.
----------------------------------------------------------------------------------------
ADVANCED TREATMENT
----------------------------------------------------------------------------------------
鈥? Consider orotracheal or nasotracheal intubation for airway control in
unconscious patient or where respiratory arrest has occurred.
鈥? Monitor and treat, where necessary, for arrhythmias.
鈥? Start an IV D5W TKO.
----------------------------------------------------------------------------------------
SPECIAL CONSIDERATIONS
----------------------------------------------------------------------------------------
鈥? Symptomatic and supportive care should not be delayed.
BRONSTEIN, A.C. and CURRANCE, P.L.
EMERGENCY CARE FOR HAZARDOUS MATERIALS EXPOSURE: 2nd Ed. 1994
SURVEILLANCE on the organism being worked with.
Test patient blood for the presence of HBsAg.
FIRST AID / TREATMENT
Alpha interferon is the licenced treatment of chronic infection.
This treatment is approximately 30% effective in the elimination of "e"
antigenemia.
IMMUNIZATION
An inactivated vaccine is available and is recommended for those persons
exposed to an increased risk of infection (laboratory workers and other
health care workers exposed to blood).
PROPHYLAXIS
Hepatitis B immunoglobulin (HBIG).
LABORATORY ACQUIRED INFECTIONS:
This the most frequently occurring laboratory acquired infection. The

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HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 4 of 15

Section 4 - FIRST AID MEASURES ...

incidence of infection in some catergories of laboratory workers is 7
times greater than that of the general population. There have been 234
(3921 total infections surveyed) reported cases up to 1974 resulting in
one death. In the UK there have been 26 reported cases of laboratory
acquired infections from 1980-1987.
infection.
DRUG SUSCEPTIBILITY:
There is no specific antiviral.


Section 5 - FIRE FIGHTING MEASURES


EXTINGUISHING MEDIA
鈥? Water spray or fog.
鈥? Foam.
鈥? Dry chemical powder.
鈥? BCF (where regulations permit).
鈥? Carbon dioxide.

FIRE FIGHTING
鈥? Alert Fire Brigade and tell them location and nature of hazard.
鈥? Wear breathing apparatus plus protective gloves.
鈥? Prevent, by any means available, spillage from entering drains or water
course.
鈥? Use water delivered as a fine spray to control fire and cool adjacent area.
鈥? Avoid spraying water onto liquid pools.
鈥? Do not approach containers suspected to be hot.
鈥? Cool fire exposed containers with water spray from a protected location.
鈥? If safe to do so, remove containers from path of fire.
Decontamination to be carried out in accordance with instructions from
supplier/emergency contact.

FIRE/EXPLOSION HAZARD
鈥? Non combustible.
鈥? Not considered a significant fire risk, however containers may burn.

FIRE INCOMPATIBILITY
None known


Section 6 - ACCIDENTAL RELEASE MEASURES




MINOR SPILLS
Action to be taken in the event of damage or leakage:
鈥? If any person responsible for the carriage or opening of packages containing
infectious substances (Class 6.2) becomes aware of damage to or leakage from
such packages he/she should:
鈥? Avoid handling the package or keep handling to a minimum
鈥? Inspect adjacent packages for contamination and put aside any that may have
been contaminated.
鈥? Inform the appropriate Health or Veterinary Authority, and provide information

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ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 5 of 15

Section 6 - ACCIDENTAL RELEASE MEASURES ...

on any other countries of transit where persons may have been exposed to danger;
and
鈥? Notify the consignor and/or consignee.
鈥? A Public Health or Veterinary Authority to which actual or suspected leakage
from or damage to an infectious substance package is reported, should notify the
authorities of any countries in which the package may have been handled
including countries in transit. [IMDG Code p. 6309]
鈥? Allow aerosols to settle.
鈥? Cover spill with paper towel.
鈥? Apply a 1% sodium hypochlorite solution.
鈥? Start application from the perimeter of the spill and work towards the centre.
鈥? Allow sufficient contact time (30 minutes) before beginning clean-up.


MAJOR SPILLS
Not applicable

PROTECTIVE ACTIONS FOR SPILL

PROTECTIVE ACTION ZONE

half
evacuation
downwind
direction
distance
down wind distance
wind isolation
direction distance

half
evacuation downwind
INITIAL direction distance
ISOLATION
ZONE

From IERG (Canada/Australia)
Isolation Distance -
Downwind Protection Distance 25 metres

FOOTNOTES
1 PROTECTIVE ACTION ZONE is defined as the area in which people are at risk
of harmful exposure. This zone assumes that random changes in wind direction
confines the vapour plume to an area within 30 degrees on either side of the
predominant wind direction, resulting in a crosswind protective action distance
equal to the downwind protective action distance.
2 PROTECTIVE ACTIONS should be initiated to the extent possible, beginning with
those closest to the spill and working away from the site in the downwind
direction. Within the protective action zone a level of vapour concentration
may exist resulting in nearly all unprotected persons becoming incapacitated
and unable to take protective action and/or incurring serious or irreversible
health effects.
3 INITIAL ISOLATION ZONE is determined as an area, including upwind of the
incident, within which a high probability of localised wind reversal may
expose nearly all persons without appropriate protection to life-threatening
concentrations of the material.
4 SMALL SPILLS involve a leaking package of 200 litres (55 US gallons) or less,
such as a drum (jerrican or box with inner containers). Larger packages leaking

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ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
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Section 6 - ACCIDENTAL RELEASE MEASURES ...

less than 200 litres and compressed gas leaking from a small cylinder are also
considered "small spills".
LARGE SPILLS involve many small leaking packages or a leaking package of
greater than 200 litres, such as a cargo tank, portable tank or a "one-tonne"
compressed gas cylinder.
5 Guide 158 is taken from the US DOT emergency response guide book.
6 IERG information is derived from CANUTEC - Transport Canada.

EMERGENCY RESPONSE PLANNING GUIDLINES (ERPG)

The maximum airborne concentration below which it is believed that nearly all
individuals could be exposed for up to one hour WITHOUT experiencing or developing

life-threatening health effects is:

irreversible or other serious effects or symptoms which could
impair an individual's ability to take protective action is:

other than mild, transient adverse effects
without perceiving a clearly defined odour is:

American Industrial Hygiene Association (AIHA)


Section 7 - HANDLING AND STORAGE


PROCEDURE FOR HANDLING

Laboratories and areas where active biological agents are handled must be
restricted to authorised persons trained to perform specific tasks. Clothing
restrictions must be enforced in these areas and the mandatory equipment worn.
Laboratory Containment or Physical Containment Level 3 (PC 3) must be used for
work with biological agents in Hazard or Risk Group 3.
鈥? Laboratory personnel must receive suitable and sufficient information,
instruction and training in working safely with agents in Group 3.
鈥? A high standard of supervision of the work should be maintained. A list of
employees engaged in work with biological agents in Hazard Group 3 is to be kept
indicating the type of work done and, where known, agents to which they are
exposed. This list must include, as appropriate, a record of exposures (eg those
resulting from accidents and incidents). In general this list must be kept for
at least 10 years but in some cases an extended period up to 40 years may be
necessary (see Schedule 9 of the UK COSHH Act).
鈥? To comply with the requirements for Laboratory or Physical Containment Level 3
(PC 3) the Laboratory must be separated from other activities in the same
building.
鈥? Access to the laboratory is to be restricted to authorised persons.
鈥? The Laboratory must be maintained at an air pressure negative to the
atmosphere. Extracted air must be HEPAR filtered (or equivalent).
鈥? The Laboratory must be sealable to permit disinfection.
鈥? The Laboratory must have an observation window or an alternative so that
occupants can be seen.
鈥? The Laboratory must contain its own equipment, so far as is reasonably
practicable. Where this is not practical, eg deep freezer, cold rooms etc.
material should be transported and stored without spillage in properly labelled

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Section 7 - HANDLING AND STORAGE ...

robust containers which should be opened only in Containment Level 3
accommodation
鈥? There must be specified disinfection procedures.
鈥? Benches or other working surfaces must be impervious to water, easy to clean
and resistant to acids, alkalies, solvents and disinfectants.
鈥? Safe storage must be provided for biological agents.
鈥? Procedures that may give rise to infectious aerosols must be conducted in a
microbiological safety cabinet, isolator, glove box or otherwise suitably
contained.
鈥? Mouth pipetting is forbidden.
鈥? An incinerator must be accessible for the disposal of infected animal
carcasses. ['Access to an incinerator' may be taken to mean an incinerator at
another site but whether local or distant, carcasses for incineration must be
transported in secure containers.]
鈥? There should be adequate space (24m3) in a laboratory for each worker.
Laboratory doors should be closed when work is in progress and locked when the
room is unoccupied. A biohazard sign should be posted at the Laboratory entrance
.
鈥? Eating, chewing, drinking, smoking, taking medication, storing food and
applying cosmetics in the laboratory should be forbidden.
鈥? Bench surfaces should be regularly decontaminated according to the pattern of
the work.
鈥? A Containment Level 3 (PC 3) Laboratory is required to be sealable to permit
disinfection. It may be necessary depending on the assessment of risk, to
decontaminate by fumigating the accommodation if, for example a spillage has
occurred or maintenance work is to be carried out.
鈥? Gloves must be worn for all work with infective materials and hands must be
washed before leaving the laboratory. Gloves should be washed or preferably
removed or changed before touching items likely to be touched by others not
similarly protected, (eg phones, paperwork). Computer keyboards and, where
practicable, equipment controls should be protected by a removable flexible
cover that can be disinfected.
鈥? A means for the safe collection, storage and disposal of contaminated waste
shall be provided. An autoclave for the sterilisation of items to be recycled
and/or waste materials should preferably be situated within the laboratory. If
this is not practicable , an autoclave should be readily accessible in the
laboratory suite.
鈥? Materials for autoclaving should be transported to the autoclave in robust
containers without spillage.
鈥? Contaminated waste should be suitably labelled before removal for
incineration. Carcasses for incineration must be transported in secure
containers to the incinerator site.
鈥? Used laboratory glassware and other materials awaiting sterilisation before
recycling should be stored in a safe manner. Pipettes, if placed in
disinfectant, should be totally immersed.
鈥? All accidents and incidents should be immediately reported to and recorded by
the person responsible for the work or other delegated person
Animal Containment Level 3 is suitable for work with vertebrates that are
deliberately inoculated with biological agents of Hazard Group 3 or viable
material suspected to contain these agents. Animal Room personnel must receive
suitable and sufficient information, instruction and training in working safely
with the animals to be used. A high standard of supervision of the work should
be maintained. Personnel having contact with the animals and waste materials
arising from the work must be made familiar with any local codes of practice and
be aware of any other precautions or procedures that may be required, eg to

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ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 8 of 15

Section 7 - HANDLING AND STORAGE ...

protect them against latent or persistent infections in the species in use. The
person responsible for the animal experiment must ensure that those who need to
know are made aware of the particular hazards concerned.
鈥? A list of employees engaged in work with biological agents in Hazard Group 3
through contact with infected animals or waste materials, is to be kept
indicating the type of work done and, where known, the agents to which they are
exposed. This list must include, as appropriate, a record of exposures (eg those
resulting from accidents and incidents). In general this list must be kept for
at least 10 years but in some cases an extended period up to 40 years may be
necessary (see Schedule 9 of the UK COSHH Act).
鈥? The animal room must be separated from other activities in the same building.
Access to the laboratory is to be limited to authorised persons.
鈥? The room must be easy to clean. Floors, walls, benches and other working
surfaces must be impervious to water, and resistant to acids, alkalies, solvents
and disinfectants.
鈥? The room must be maintained at an air pressure negative to the atmosphere.
Extracted air must be HEPAR filtered (or equivalent).
鈥? The room must be sealable to permit disinfection.
鈥? The room must have an observation window or an alternative so that occupants
can be seen.
鈥? There must be specified disinfection procedures.
鈥? Effective vector control measures (eg against rodents and insects) must be
taken.
鈥? Safe storage facilities must be provided for biological agents.
鈥? The room must contain its own equipment, so far as is reasonably practicable.
鈥? Procedures which involve handling of infective material, including any
infected animal, or where an aerosol may be created, must be conducted in a
microbiological safety cabinet, isolator, glove box or otherwise suitably
contained.
鈥? An incinerator must be accessible for the disposal of infected animal
carcasses. [Access to an incinerator' may be taken to mean an incinerator at
another site but whether local or distant, carcasses for incineration must be
transported in secure containers.]
鈥? The animal room should be separated from any general thoroughfare by an
anteroom with two doors or sited within an animal suite or animal unit. The
anteroom is to have facilities for storage of protective clothing. Showering
facilities should be provided in the anteroom or within the animal suite or
unit.
鈥? A specific biohazard sign indicating the level of work should be posted at the
entrance to the animal room and the room or suite should be locked when staff
are absent.
鈥? A Containment Level 3 Animal Room is required to be sealable to permit
disinfection. It may be necessary depending on the assessment of risk, to
decontaminate by fumigating the accommodation if, for example a spillage has
occurred or maintenance work is to be carried out.
鈥? Where floor drains are installed, the drain traps should be kept filled. They
should be disinfected and cleaned regularly and at the end of each experiment.
鈥? Animals infected with Hazard Group 3 agents should be housed in safety
cabinets or isolators or in other forms of primary containment that are provided
with HEPA-filtered exhaust ventilation or equivalent.
鈥? Where it is not reasonably practical to use primary containment for animals,
personnel should wear a complete change of clothing and use high performance
protective respiratory equipment at all times.
鈥? When undertaking procedures with infected animals that are likely to give rise
to aerosols (eg inoculation procedures, necropsy and harvesting infected tissues

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ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 9 of 15

Section 7 - HANDLING AND STORAGE ...

and fluids), a Class I or Class III Microbiological Safety Cabinet or a unit
offering an equivalent level of protection, or an isolator or other suitable
means of containment is to be used. The containment unit used must exhaust to
the outside air or to the room air extraction system via a HEPA filter or
equivalent.
鈥? Eating, chewing, drinking, smoking, taking medication, storing human food and
applying cosmetics in the animal room should be forbidden.
鈥? Mouth pipetting is forbidden.
鈥? Gloves must be worn for all work with infective materials and hands must be
washed before leaving the animal room. Gloves should be washed or preferably
removed or changed before touching items likely to be touched by others not
similarly protected, (eg phones, paperwork). Computer keyboards and, where
practicable, equipment controls should be protected by a removable flexible
cover that can be disinfected.
鈥? A wash basin should be located near the animal room exit with taps that can be
operated without being touched by hand.
鈥? Hands should be decontaminated immediately when contamination is suspected and
after removal of protective clothing when leaving the anteroom or suite.
鈥? A means for the safe collection, storage and disposal of contaminated waste
shall be provided. An autoclave for the sterilisation of waste materials should
be available on site. The autoclave should be sited in the same building as the
animal room or animal suite. Material for autoclaving or incineration and used
animal cages should be transported without spillage.
鈥? All waste material including animal bedding, should be rendered non-infective
before disposal.
鈥? Used animal cages should be rendered non-infective by disinfection, fumigation
or heat treatment by steaming or autoclaving.
鈥? Work surfaces should be disinfected after use and the animal room disinfected
or fumigated at the end of each experiment
鈥? Infective materials taken into the animal room, or removed from it, should be
transported in sealed containers.
鈥? All accidents and incidents, including animal bites and scratches, should be
reported to and recorded by the person responsible for the work who should then
take the appropriate measures specified in the local code of practice.
Where invertebrates are known to be infected with biological agents, the
principles of containment applying to animal rooms must be applied. Work must be
done at the level of containment appropriate to hazard rating of the agent
concerned*. In adopting the principles used in the containment of animals the
following additional requirements should be considered.
鈥? Separate rooms should be used for infected and non-infected invertebrates.
鈥? Invertebrates should be contained appropriately according to whether they live
in water, are amphibious, crawl or jump, or fly.
鈥? Aquatic or amphibious invertebrates should be kept in tanks with lids to
prevent escape.
鈥? Crawling, jumping or flying invertebrates should be kept in insect-proof
rooms, ventilation inlets and outlets should be screened, entry to rooms should
be through airlocks (insectocutors may be placed in airlocks), measures should
be taken to ensure that escaped invertebrates are easily detected, recaptured
and destroyed, laboratory sinks should be provided with adequate traps, liquid
and solid waste should be treated before disposal (preferably with heat, rather
than by chemical means).
鈥? Insecticidal sprays, although useful in an emergency, may render the room
unfit for invertebrates.
鈥? Arthropods may be chilled to reduce their activity and prevent escape. Flying
or crawling arthropods requiring Containment Level 1 and 2, should be handled on

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Section 7 - HANDLING AND STORAGE ...

white trays to detect escapees.
鈥? Ticks and mites should be kept in containers over trays of oil.
鈥? Flying insects infected with agents in Hazard Groups 2, 3 or 4 should be kept
in double cages; both enclosures should be labelled.
鈥? Experimental cages/containers should be numbered/labelled or otherwise
documented to indicate hazard
鈥? Containment Level 3 or 4, flying or crawling arthropods should be kept in
identified lots and each lot accounted for; they should also be handled in
safety cabinets, isolators or partial containment devices provided with
HEPA-filtered exhaust ventilation or its equivalent.
鈥? Infected invertebrates not known to be dead should be handled in a safety
cabinet or other form of safe enclosure. Records should be made of the number of
individual invertebrates received by a laboratory as soon as is practically
possible. Each invertebrate should be accounted for as the work proceeds through
to final fixation or disposal.
鈥? Where the identification of flying or crawling invertebrates alone is
required, the container may be frozen two hours @ -20 C to kill them. Full
Containment Level 3 is not always required for all work with Hazard Group 3
agents. Non-infective stages in the life-cycle of a parasite and certain agents
for which a derogation has been allowed, may not always demand an inward airflow
or use of a safety cabinet.

SUITABLE CONTAINER
Receptacles with their closures or fittings shall be as approved by the
competent authority of the country of origin.

STORAGE INCOMPATIBILITY
Presence of heat source and direct sunlight (ultra-violet radiation).
Avoid reaction with oxidising agents
Avoid strong acids.

STORAGE REQUIREMENTS
It is required for safe working that the Containment Level selected for any
laboratory suite, storeroom or animal room must match the hazard grouping of the
biological agent as a minimum. (Some exceptions may apply)


Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION


EXPOSURE CONTROLS

Not available. Refer to individual constituents.

PERSONAL PROTECTION




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Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION ...

EYE
鈥? Safety glasses with side shields; or as required,
鈥? Chemical goggles.
鈥? Contact lenses pose a special hazard; soft lenses may absorb irritants and all
lenses concentrate them.

HANDS/FEET
Wear general protective gloves: i.e. Disposable polythene gloves or Cotton
gloves or Light weight rubber gloves, with Barrier cream preferably Safety
footwear.

OTHER
Laboratory coat
鈥? Overalls.
鈥? Barrier cream
鈥? Eyewash unit.
Ensure there is ready access to a safety shower
鈥? Laboratory coats or gowns should be side or back fastening and should be worn
when in and removed when leaving the area.
鈥? Separate storage, set apart from personal clothing, should be available in the
laboratory suite.
鈥? A wash basin should be located near the laboratory exit with taps that can be
operated without being touched by hand.

ENGINEERING CONTROLS

Access to the area is to be restricted to authorised persons. A specific
disinfection procedure must be established and applied. If the area (laboratory,
store, animal room) is mechanically ventilated it must be maintained at an air
pressure negative to atmosphere whilst work is in progress.

If traffic in and out of Containment Level 2-4 rooms interferes with ventilation
airflow patterns and, if the laboratory is ventilated specifically to contain
airborne pathogens in the event of accident, then engineering controls and
working arrangements must be devised to counter the risk of airborne
transmission to other areas.

When undertaking procedures that are likely to give rise to infectious aerosols,
a Class 1 microbiological Safety Cabinet conforming to BS5726 or with an
equivalent, verified protection factor should be used. Cabinets should exhaust
to outside air. Double HEPAR filtering is not necessary biological agents
requiring Containment Level 2.
FUMIGATION:
Microbiological safety cabinets must always be fumigated if a large spill of
infectious material occurs within them, before filters are changed or any
maintenance work is carried out which involves access to the interior of the
cabinet (air duct maintenance for example).
鈥? Fumigation should be conducted with the night door securely sealed and the
non-return valve left closed.
鈥? Passive migration of the fumigant through the filter is allowable. Alternately
the valve may be left open and the fan may be run for 10 to 15 seconds thus
ensuring penetration of filter medium. The valve should then be closed and the
fan switched off allowing the remainder of the fumigant to disperse within the
cabinet. After at least six hours the fumigant should be exhausted to atmosphere
by switching on the fan and allowing room air to enter through, for example, the

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Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION ...

night door bung-hole.
鈥? Ensure that no personnel remain in the vicinity of the exhaust outlet and that
exhaust air does not enter windows or ventilation air intakes.
鈥? Discarded filter units should be bagged and autoclaved prior to disposal.
鈥? There are special difficulties if the cabinet has been used with agents
responsible for causing transmissible spongiform encephalophies as they are
resistant to inactivation by formalin.


Section 9 - PHYSICAL AND CHEMICAL PROPERTIES


PHYSICAL PROPERTIES

Solid.
Infectious.

Molecular Weight: Not applicable Boiling Range (掳C): Not applicable
Melting Range (掳C): Not applicable Specific Gravity (water=1): Not applicable
Solubility in water (g/L): Not applicable pH (as supplied): Not applicable
pH (1% solution): Not applicable Vapour Pressure (kPa): Not applicable
Volatile Component (%vol): Negligible Evaporation Rate: Not applicable
Relative Vapour Density (air=1): Not applicable Flash Point (掳C): Not applicable
Lower Explosive Limit (%): Not applicable Upper Explosive Limit (%): Not applicable
Autoignition Temp (掳C): Not applicable Decomposition Temp (掳C):
State: Divided solid

APPEARANCE

A Biological Agent of Hazard Group 3 that can cause severe human disease,
presents a serious hazard to employees, may present a risk of spreading to the
community, but there is usually effective prophylaxis or treatment available.
A list of workers exposed to this agent is to be kept for 40 years at
the end of the last known exposure.
EPIDEMIOLOGY:
Found throughout the world and is endemic with little seasonal variation.
Incidence is common in young adults of North America and in infancy or
childhood in Africa and Asia. The antigen carrier rate in North America
is less than 1% for the general population and 10-15% in Asia. This is a
common infection in high risk groups such as drug abusers, sexually
promiscuous persons and healthcare workers exposed to blood or serous
fluids.
HOST RANGE:
Humans, chimpanzees are susceptible to the disease.
MODE OF TRANSMISSION:
The virus is spread via percutaneous or permucosal exposure to infectious
body fluids such as blood, serum-derived fluids, semen, vaginal fluids
and saliva. The virus is commonly spread via contaminated needles,
syringes and IV equipment. Other modes of transmission include the
contamination of wounds and lacerations, sexual contact and exposure of
the mucous membranes.
COMMUNICABILITY:
The virus may be communicable for weeks before the onset of the symptoms.
The patient remains infective throughout the clinical and chronic carrier
states. The infectivity of chronically infected persons ranges from

continued...
HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 13 of 15

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES ...

highly infectious to sparingly infectious.
RESERVOIR:
Humans.
SURVIVAL OUTSIDE HOST:
The virus is able to survives well in dried blood for several weeks.
SOURCES AND SPECIMENS:
Blood and blood products, cerebrospinal fluid (CSF), semen, urine and
saliva.


Section 10 - CHEMICAL STABILITY AND REACTIVITY INFORMATION


CONDITIONS CONTRIBUTING TO INSTABILITY

鈥? Presence of incompatible materials.
鈥? Product is considered stable.
鈥? Hazardous polymerisation will not occur.


Section 11 - TOXICOLOGICAL INFORMATION


Hepatitis B virus

No significant acute toxicological data identified in literature search.


Section 12 - ECOLOGICAL INFORMATION


No data for Hepatitis B virus.


Section 13 - DISPOSAL CONSIDERATIONS


鈥? There should be a means for the safe collection, storage and disposal of
contaminated waste.
鈥? An autoclave for sterilisation of waste materials should be readily
accessible, preferably in the same laboratory or building.
鈥? There should be access to an incinerator for disposal of any infected animal
carcasses or combustible waste.
鈥? All infected waste arising from work in laboratories should be made safe to
handle, ideally by autoclaving before disposal by incineration.
鈥? If it is not reasonably practicable to autoclave wastes, it should be disposed
of by incineration. It is essential that the waste is secured in strong,
leak-proof containers and transported direct to the incinerator.
鈥? Infected carcasses or human tissue may be transported to another site for
final disposal provided a suitable form of packaging is used both to protect
handlers and transporters against infection and to avoid public offence.
鈥? In some cases it may be necessary to consult agriculture departments before
carcasses or tissues infected with pathogens are moved; appropriate movement
must comply with regulation/ legislation.
鈥? Infected materials should be placed in yellow waste sacks and suitably

continued...
HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 14 of 15

Section 13 - DISPOSAL CONSIDERATIONS ...

labelled (with permanent marker or tie-on label) showing the source of the
material.
鈥? Sacks should be no more than three quarters full and should be closed with
purpose-made plastic ties or closures or, in the case of light-gauge sacks, may
be tied off at the neck. Heat-sealers, purpose-made for clinical waste may also
be used.
鈥? Sacks should then be stored and transported in a robust secondary container
which is leak-proof and which may be readily decontaminated.
鈥? Alternately animal carcasses which present higher-level risks (for example
material from Animal Containment Levels 3 and 4) may be transported in
purpose-made plastic disposal containers. These are hermetically sealed with
snap-on lids and are designed for safe transportation and incineration in their
entirety.
鈥? After sealing, the container should be externally decontaminated and labelled
before removal to the incinerator.
鈥? It is advisable to use only containers of the type which conform with
drop-tests and leak-tests defined, for example, by the United Nations.
PHYSICAL INACTIVATION:
DISINFECTANT SUSCEPTIBILITY:


Section 14 - TRANSPORTATION INFORMATION




Shipping Name: INFECTIOUS SUBSTANCE, AFFECTING HUMANS
Hazard Class: 6.2
UN/NA Number: 2814
ADR Number: 606
Packing Group: None
Labels Required: infectious substance
Additional Shipping Information:
International Transport Regulations:
IMO: 6.2


Section 15 - REGULATORY INFORMATION




continued...
HEPATITIS B VIRUS
ChemWatch Material Safety Data Sheet (REVIEW) CHEMWATCH 4542-37
Issue Date: Fri 7-Apr-2000 CD 2004/3 Page 15 of 15

Section 15 - REGULATORY INFORMATION ...

RISK


Preparation is WGK 1
Name Score WGK
Hepatitis B virus 0 1

SAFETY

Do not breathe dust. Avoid contact with skin. Use only in well ventilated areas.
Keep container in a well ventilated place. Take off immediately all contaminated
clothing. If you feel unwell contact Doctor or Poisons Information Centre. (Show
the label if possible). In case of accident by inhalation: remove casualty to
fresh air and keep at rest.

REGULATIONS



Section 16 - OTHER INFORMATION


RISK

Explanation of Risk Codes used in the Ingredient Table

This document is copyright. Apart from any fair dealing for the purposes of
private study, research, review or criticism, as permitted under the Copyright
Act, no part may be reproduced by any process without written permission from
CHEMWATCH. TEL (+61 3) 9572 4700.

Issue Date: Fri 7-Apr-2000
Print Date: Tue 28-Sep-2004

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