Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

Description of first aid measures:
Pay attention to self-protection.
Remove victims from hazardous area.
Immediately remove soiled or soaked clothing and remove it to a safe distance.
Keep victim warm, in a stabilized position and covered.
Do not leave victims unattended.
If the casualty is unconscious: Place the victim in the recovery position.

Inhalation:
Inhalation is possible if aerosols, mists, dusts, or smoke form.
Move victims into fresh air.
With labored breathing: Provide with oxygen. Consult a doctor.
If the casualty is not breathing: Perform mouth-to-mouth resuscitation, notify emergency physician immediately.

Skin contact:
Wash off affected area immediately with plenty of water for at least 15 minutes.
If symptoms persist, consult a physician for treatment.

Eye contact:
With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.
In case of persistent discomfort: Consult an ophthalmologist.

Ingestion:
Rinse mouth.
Immediately give large quantities of water to drink.
Obtain medical attention.

Most important symptoms and effects, both acute and delayed:
Hazards:
Other dangerous properties can not be excluded.

Indication of any immediate medical attention and special treatment needed:
This substance does not have any noteworthy noxious potential. Damage to health is thus not expected.

Fire-fighting measures

Extinguishing media:
Suitable extinguishing media:
- Water spray
- Foam, CO2
- Dry powder

Unsuitable extinguishing media:
Do not use a solid water stream as it may scatter and spread fire.

Special hazards arising from the substance or mixture:
Hazard-determining flue gases might develop in case of fire:
- Carbon oxides
- Nitrogen oxides (NOx)
- Hydrogen fluoride
- Sulphur oxides

Advice for firefighters:
Contaminated extinguishing water must be treated at a suitable disposal plant in accordance with waste management laws.
In case of fire, remove the endangered containers and bring to a safe place, if this can be done safely.
Keep out unprotected persons.
In the event of fire, wear self-contained breathing apparatus.
Full protective suit.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:
Keep unauthorized persons away.
Avoid dust formation.

Environmental precautions:
Observe regulations on prevention of water pollution (check, dam up, cover up).
Do not allow entrance in sewage water, soil, stretches of water, drainage systems, surface water.
If the product contaminates rivers and lakes or drains inform respective authorities.

Methods and material for containment and cleaning up:
Pick up mechanically and collect in a suitable container.
Avoid formation of dust.
To absorb spilled substance an approved industrial vacuum cleaner is recommended.
If necessary, the spilled substance should be moistened.
Pack and label wastes like the pure substance.
Do not detach label from the delivery containers prior to disposal.
Before disposal consult producer.

Reference to other sections:
Wear personal protective equipment; see section Exposure controls/personal protection.

Handling and storage

Precautions for safe handling:
Decant and handle product in separate areas only, e.g. use glove boxes, cabinets with differential pressure switch etc.
Ensure that apparatus and pipelines are free from leaks.
Do not ventilate into the open.
Dedicated loading/unloading stations required.

Conditions for safe storage, including any incompatibilities:
Storage:
Store dry.
Close container tightly.
Store at room temperature.

Further information:
In the event of internal transportation, already-opened containers are to be kept closed in order to avoid spillage.
In order to ensure due transportation, make certain that stacks are of the correct height, containers are securely fastened so as not to fall off, and labelled according to the regulations.

German storage class:
11 - Combustible Solids.

Dust explosion class:
Considerable danger of dust explosion.
Must be rendered inert for grinding.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
3077
Shipping information
Proper shipping name and description:
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Chemical name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Language:
English
Labels:
9
Special provisions / remarks
Special provisions:
Tunnel Restriction Code (ADR)
Remarks:
Environmentally Hazardous

Inland waterway transport (UN RTDG/ADN(R))

UN number:
3077
Shipping information
Proper shipping name and description:
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Chemical name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Language:
English
Labels:
9
Special provisions / remarks
Remarks:
Environmentally Hazardous

Marine transport (UN RTDG/IMDG)

UN number:
3077
Shipping information
Proper shipping name and description:
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Chemical name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Labels:
9
Marine pollutant
Special provisions / remarks
Remarks:
Environmentally Hazardous

Air transport (UN RTDG/ICAO/IATA)

UN number:
3077
Shipping information
Proper shipping name and description:
Environmentally hazardous substance, solid, n.o.s.
Chemical name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5S)-5-(4-amino-5-fluoro-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Labels:
9
Special provisions / remarks
Remarks:
Environmentally Hazardous

Additional transport information

Additional information
Special provisions / remarks / other:
Labelling of containers / shipping units following main product run as per sea or air transport regulations.

Exposure controls / personal protection

Control parameters:
DNEL/DMEL values:
Remarks: No substance-related safety assessment is necessary / has been conducted for this product.

PNEC values:
Remarks: No substance-related safety assessment is necessary / has been conducted for this product.

Exposure controls:
Engineering measures:
Decant and handle product in separate areas only, e.g. use glove boxes, cabinets with differential pressure switch etc.
Do not lead exhaust air back to workplace areas unfiltered.
Exhaust filter or scrubber.
Exhaust air filter (HEPA-filter).
Do not add wastewater to a biological wastewater treatment plant.
In case of dissolved solids:
Minimization of emissions by means of suitable technical measures such as flanges and valves with low leakage rates, recirculation of vapours.
Ensure that dust-handling systems (such as exhaust ducts, dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into the work area (i.e., there is no leakage from the equipment).
All precautionary measures indicated have to be observed.

Exposure controls:
The substance must be handled under strictly controlled conditions in accordance with Article 17/18 of the REACH regulation.

Personal protective equipment:
Respiratory protection:
Accidental release measures
Use respiratory equipment with suitable filter (filter type P3) or wear a self contained respiratory apparatus.
Note time limit for wearing respiratory protective equipment.

Hand protection:
Glove material: Nitrile, for example, Dermatril 740, Kächele-Cama Latex GmbH (KCL), Germany
Material thickness: 0.11 mm
Method: DIN EN 374.

Accidental release measures:
Glove material: Nitrile/Chloroprene, for example, Nitopren 717, Kächele-Cama Latex GmbH (KCL), Germany
Material thickness: 0.65 mm
Method: DIN EN 374.

Eye protection:
Safety glasses with side-shields conforming to EN166
or
When handling larger quantities: basket-shaped glasses.

Skin and body protection:
Suitable protective clothing - Use disposable clothing if appropriate.

Hygiene measures:
Avoid contact with skin, eyes and clothing.
Wash contact areas after handling.
Take off clothing and shoes contaminated with product. Clean before reuse.
Do not eat, drink, smoke, or sniff while at work.
Wash your hands and/or face before breaks and before termination of work.

Protective measures:
The personal protective equipment used must meet the requirements of directive 89/686/EEC and amendments (CE certification).
It should be defined in the work place in the form of a risk analysis according to directive 89/686/EEC and amendments.
All precautionary measures indicated have to be observed.
Risk assessment and risk monitoring of all work places required.
Health, Safety and Emergency Management System recommended.
Regular safety training is a must.
Written approval necessary in case of non-routine jobs, e.g. maintenance activities.

Environmental exposure controls:
In some cases, exhaust air scrubbers, filters or technical changes to the processing plant will be required in order to decrease emissions to acceptable values.

Stability and reactivity

Reactivity:
No further information available.

Chemical stability:
No further information available

Possibility of hazardous reactions:
No further information available.

Conditions to avoid:
No dangerous reaction known under conditions of normal use.

Incompatible materials:
No further information available.

Hazardous decomposition products:
No further information available.

Disposal considerations

Waste treatment methods:
Product:
Strictly controlled conditions during disposal or treatment to air, wastewater and waste.
Do not add wastewater to a biological wastewater treatment plant.
Bring wastewater containing AOX for professional disposal.
Bring used exhaust air filter for incineration.
Disposal according to local authority regulations.

Uncleaned packaging:
Do not reuse empty containers and dispose of in accordance with the regulations issued by the appropriate local authorities.

Waste Key Number:
The waste key number must be determined as per the European Waste Types List (decision on EU Waste Types List 2000/532/EC) in cooperation with the disposal firm / producing firm / official authority.

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