Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

- 4.1 Description of first aid measures

- General information Instantly remove any clothing soiled by the product.

- 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.

Use eye protection.

- After swallowing In case of persistent symptoms consult doctor.

- 4.2 Most important symptoms and effects, both acute and delayed

Nausea

Headache

Dizziness

Vomiting

Spasms, convulsions

Fever

Shivering fit

Pain

CNS depression

Visual defect/blurred vision

trembling (tremor)

prickling

- Information for doctor Pharmacological group: Local anesthetic

- Danger

Danger of apnea.

Danger of Hypotonie.

Danger of disturbed cardiac rhythm.

cardiac arrest

urinary 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.

- For safety reasons unsuitable extinguishing agents Do not use a heavy water stream.

- 5.2 Special hazards arising from the substance or mixture

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.

Accidental release measures

- 6.1 Personal precautions, protective equipment and emergency procedures

Do not inhale dust.

Avoid causing dust.

Avoid contact with substance.

- 6.2 Environmental precautions:

Do not allow product to reach sewage system or water bodies.

Inform respective authorities in case product reaches water or sewage system.

Do not allow to enter drainage system, surface or ground water.

- 6.3 Methods and material for containment and cleaning up:

Collect mechanically.

Dispose of contaminated material as waste according to item 13.

Ensure adequate ventilation.

Handling and storage

- 7.1 Precautions for safe handling

Open and handle container with care.

Prevent formation of dust.

- 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:

Store at 15 - 30 °C.

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 (UN RTDG/IMDG)

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Exposure controls / personal protection

- 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 (intern): 90 ug/m³ (Ropivacain HCl)

The lists that were valid during the compilation were used as basis.

- 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 P3

- 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.

To avoid skin problems reduce the wearing of gloves to the required minimum.

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:

Tightly sealed 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 No dangerous reactions known

- 10.4 Conditions to avoid No further relevant information available.

- 10.5 Incompatible materials: Alkali

- 10.6 Hazardous decomposition products: No dangerous decomposition products known

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.