Registration Dossier

Administrative data

First-aid measures

Emergency measure - Inhalation: Move injured person into fresh air and keep person calm
under observation. If uncomfortable: Seek hospital.
Emergency measure - Eyes: Do not rub eye. Immediately flush with plenty of water for
at least 15 minutes. Remove any contact lenses and open
eyelids widely. If irritation persists: Continue flushing
during transport to hospital.
Emergency measure - Skin: Remove contaminated clothing immediately and wash skin with
soap and water.
Emergency measure - Ingestion: Immediately rinse mounth and drink plenty of water. Keep
person under observation. If uncomfortable: Seek hospital.

Fire-fighting measures

Recommended extinguishing agent: Use fire-extinguishing media appropriate for surrounding
materials.

Product arising from burning: The product in non-combustible. If, heated, corrosive and
toxic vapours may be formed.

Product determined by test: N

Protective equipment: Use protective equipment appropriate for surrounding
materials.

Accidental release measures

Emergency measures in case of spillage: Avoid contact with skin and eyes. Avoid inhalation of dust.
In case of inadequate ventilation or risk of inhalation of
dust, use suitable respiratory equipment with particle
filter (type P2). Wear protective gloves. Butyl rubber
gloves are recommended.


Avoid discharge into the drains, water courses or onto the
ground.


Methods for cleaning up: Use a vacuum cleaner. If not
possible, moisten dust with water before it is collected
with shovel, broom or the like.

Handling and storage

Handling: SST is delivered in closed bags that are used directly for
production of adhesive. Thus there is no exposure.


Mixing:

Mixing of the adhesive takes place in a container and under
vacuum.

The room is ventilated by natural ventilation through
admission of frish air. The personnel have been trained
according to the Quality Management System.


Coating and laminating:

The subsequent coating and laminating take place in an open
system. Coating and laminating take place in clean-room with

pressure above atmospheric.

The personnel have been trained according to the Quality
Management System - including training concerning working in

clean-room.


Conversion of roll adhesives:

Roll adhesives are produced so that direct contact with the
adhesive is avoided. The conversion takes place in clean-
room with pressure above atmospheric. The personnel are
trained according to Quality Management System - including
training concerning working in clean-room.

Storage: 1. Production of bulk adhesive and coating of continuous
sheet adhesives

Natural ventilation in storage room. The roll adhesive is
wrapped in film after production.


2. Conversion of roll adhesives

SST adhesive rolls wrapped in film are stored cold (at 15 °C

and without daylight).

Packaging of the substance and or preparation: 1. SST raw material

SST is packed in transparent low-density polyethylene bags,
200*250*0.03 mm. Each bag contains 200 g. 8 bags of SST are
packed in larger bags. The product is transported to
customer batch wise according to the regulations of the ADR
convention.


2. Wound dressing

A wound dressing is wrapped in a bag of aluminium foil with
the following composition:


Packing components:

PETP (12 lm polyester film)

ALU (9 lm aluminium)

PE (65 lm polyethylene)


The products are packed in bags of aluminium foil, which
follow the size of the products.

Transport information

Shippingopen allclose all
SpecialProvisionsopen allclose all
Shippingopen allclose all
Remarksopen allclose all

Marine transport (UN RTDG/IMDG)

Shippingopen allclose all
Remarksopen allclose all

Air transport (UN RTDG/ICAO/IATA)

Shippingopen allclose all
Special provisions / remarks
Remarks:
Transport code: UN No. 3077, Class 9
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Stability and reactivity

Danger other than fire: None particular

Chemical reaction with water: No danger reactions.

Dust explosion determined by test: N

Disposal considerations

Industry - Possibility of recovery/recycling: 1. Production of bulk adhesive and coating of continuous
sheet adhesives

According to 2.1.60 conc. removal of adhesive by start-up of

coating.



2. Conversion of roll adhesives

The grid waste from the SST adhesive is coated with film and

paper and cannot be reused because of blocking, implying
that it cannot be separated in view of recycling.


The packing foil, the aluminium foil can at the moment not
be reused, as it consists of different layers that cannot be

separated in an environmental way.


Unfortunately, neither can the silicone paper be reused
because it contains silicone.


The polyethylene (PE) film it is possible to reuse.
Collection of the PE film will be organised in the course of

2002.

Industry - Possibility of destruction - incineration: Waste, the aluminium package plus the silicone paper from
the production of the wound dressing are disposed as
combustible waste which is regarded as the best
environmental disposal method.

Public at large - Possibility of recovery/recycling: Hospital refuse must be disposed of through incineration.
Thus it is not possible to reuse neither the product nor the

package.

Public at large - Possibility of destruction - incineration: The refuse is disposed as combustible waste, and is machine
handled. The handling of this refuse implies no risk for the
sanitation workers.