Registration Dossier

Administrative data

First-aid measures

- 4.1 Description of first aid measures
- General information
Instantly remove any clothing soiled by the product.
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48
hours after the accident.
- After inhalation
Supply fresh air. Apply mouth-to mouth resuscitation or mechanical ventilation if necessary. Consult doctor.
Use a respiration bag or breathing device.
In case of unconsciousness bring patient into stable side position for transport.
- After skin contact Instantly wash with water and soap and rinse thoroughly.
- After eye contact Rinse opened eye for several minutes (10 - 15) under running water. Then consult doctor.
- After swallowing Instantly call for doctor.
- 4.2 Most important symptoms and effects, both acute and delayed
itching
Nausea, vomiting
Headache
Dizziness
Spasms, convulsions
Fever
Shivering fit
Pain
CNS depression
Visual defect/blurred vision
Dazed, lightheadedness
trembling (tremor)
- Danger
Danger of chemical pneumonitis.
Harmful to the liver.
Harmful to the kidney.
Danger of apnea.
Danger of Hypotonie.
Danger of disturbed cardiac rhythm.
up to cardiac arrest
Danger of urine retention
- 4.3 Indication of any immediate medical attention and special treatment needed
Monitor circulation, possible shock treatment.
Possibly oxygen respiration treatment
Monitoring or correction of vital functions.
At the first sign of change in mental status, oxygen should be administered.
The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to
unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment
and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a
delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be
assisted as necessary. This may prevent convulsions if they have not already occurred.
If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle
relaxants should only be administered by those familiar with their use. Immediately after the institution of
these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of
circulatory depression may require administration of intravenous fluids, and, when appropriate, a
vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial
contractile force).
If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted
or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician,
may be indicated after initial administration of oxygen by mask.

Fire-fighting measures

- 5.1 Extinguishing media
- Suitable extinguishing agents
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
- 5.2 Special hazards arising from the substance or mixture
Can form explosive gas-air mixtures.
Formation of toxic gases is possible during heating or in case of fire.
Can be released in case of fire
Nitrogen oxides (NOx)
- 5.3 Advice for firefighters
- Protective equipment:
Wear self-contained breathing apparatus.
Do not inhale explosion gases or combustion gases.
Wear full protective suit.
- Additional information
Dispose of fire debris and contaminated fire fighting water in accordance with official regulations.

Accidental release measures

- 6.1 Personal precautions, protective equipment and emergency procedures
Wear protective equipment (described in section 8). Keep unprotected persons away.
Avoid causing dust.
Avoid contact with substance.
Do not inhale fumes/aerosol.
Keep away from ignition sources
- 6.2 Environmental precautions: Do not allow product to reach sewage system or water bodies.
- 6.3 Methods and material for containment and cleaning up:
Dispose of contaminated material as waste according to item 13.
Collect mechanically.
Ensure adequate ventilation.

Handling and storage

- 7.1 Precautions for safe handling
Thorough dedusting.
Ensure good ventilation/exhaustion at the workplace.
Open and handle container with care.
Prevent formation of dust.
Prevent formation of aerosols.
- Information about protection against explosions and fires: Keep breathing equipment ready.
- 7.2 Conditions for safe storage, including any incompatibilities
- Storage
- Requirements to be met by storerooms and containers: No special requirements.
- Information about storage in one common storage facility: Not required.
- Further information about storage conditions:
Keep container tightly closed.
Store in cool, dry conditions in well sealed containers.
- Storage class VCI class 13
- 7.3 Specific end use(s) No further relevant information available.

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

- Additional information about design of technical systems: No further data; see item 7.
- 8.1 Control parameters
- Components with limit values that require monitoring at the workplace: Not required.
- DNELs (Derived no-effect level) No information available
- PNECs (predicted no effect concentration) No information available
- Additional information: OEL ( AstraZeneca TWA): 90 µg/m³ (Ropivacain Hydrochlorid)
- 8.2 Exposure controls
- Personal protective equipment
- General protective and hygienic measures
The usual precautionary measures should be adhered to general rules for handling chemicals.
Keep away from foodstuffs, beverages and food.
Take off immediately all contaminated clothing
Wash hands during breaks and at the end of the work.
Store protective clothing separately.
Avoid contact with the eyes and skin.
Do not inhale dust
- Breathing equipment: Use breathing protection only if dust is formed.
- Recommended filter device for short term use:
Filter P2
- Protection of hands:
Protective gloves (EN 374).
The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/
the chemical mixture.
Selection of the glove material on consideration of the penetration times, rates of diffusion and the
degradation
- Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer.
- Penetration time of glove material
The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be
observed.
- Eye protection:
Safety glasses
- Body protection: Protective work clothing.

Stability and reactivity

- 10.1 Reactivity No further relevant information available.
- 10.2 Chemical stability
- Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
- 10.3 Possibility of hazardous reactions
Possible formation of peroxide
Forms explosive gas mixture with air
- 10.4 Conditions to avoid No further relevant information available.
- 10.5 Incompatible materials:
Alkali
Strong oxidizing materials
Strong acids.
Halogenes
- 10.6 Hazardous decomposition products: No dangerous decomposition products known
- Additional information:
Explosible with air in a vaporous/gaseous state.
Unsuitable working materials: various plastics, rubber.

Disposal considerations

- 13.1 Waste treatment methods
- Recommendation
Hand over to disposers of hazardous waste.
Chemicals must be disposed of in compliance with restrictive national regulations.
- Uncleaned packagings:
- Recommendation:
Disposal must be made according to official regulations.
Packaging must be disposed of in compliance with country-specific regulations or must be passed to a
packaging return system.