Registration Dossier

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:
- Danger
Danger of apnea.
Danger of Hypotonie.
Danger of disturbed cardiac rhythm.
up to 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.

Fire-fighting measures

- 5.1 Extinguishing media
- Suitable extinguishing agents Use fire fighting measures that suit the environment.
- 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.
- 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
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.
Send for recovery or disposal in suitable containers.

Handling and storage

- 7.1 Precautions for safe handling
Open and handle container with care.
Prevent formation of dust.
This product is to handle exclusive under strictly controlled conditions in accordance with Regulation (EC)
No.1907/2006 (REACH), article 18(4).
- 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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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 (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 eat, drink or smoke while working.
Do not inhale dust
- Breathing equipment: Use breathing protection only if dust is formed.
- Recommended filter device for short term use:
Filter P1
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.
The times listed are suggested by measurements taken at 22 degree C and constant contact. Temperatures
raised by warmed substances, body heat, etc. and a weakening of the effective layer thickness caused by
expansion can lead to a significantly shorter breakthrough time.
In case of doubt contact the gloves' manufacturer.
A 1.5-times increase / decrease in the layer thickness doubles / halves the breakthrough time. This data only
applies to the pure substance. Transferred to mixtures of substances, these figures should only be taken as an
aid to orientation.
- Remark:
This recommendation applies only to the product stated in the safety data sheet. When dissolving in or mixing
this substance with other substances and under conditions deviating from those stated in EN 374, please
contact the supplier of CE –approved gloves.
- Eye protection:
Tightly sealed safety glasses.
- Body protection:
Protective work clothing.
Protective clothing should be selected specifically for the working place, depending on concentration and
quantity of the hazardous substances handeld. The resistance of the protective clothing to chemicals should
be ascertained with the respective supplier.

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.