Registration Dossier

Administrative data

First-aid measures

INHALATION
Remove the injured from the contaminated zone. If not breathing give artificial respiration. If breathing is difficult give oxygen and take the injured to the hospital. Avoid the cooling of the subject covering him with a blanket. The product inhalation induces asthma.

CONTACT WITH THE SKIN
In case of skin contact, remove all contaminated clothing and shoes and wash the skin with copious amount of water and soap. Contact a dermatologist/physician if necessary. Reddening with itching is often observed.

CONTACT WITH THE EYES
In case of contact with eyes flush immediately with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with finger. If the symptoms persist, contact an ophthalmologist/physician. The contact of the product with eyes induces a burning sensation.

INGESTION
Contact local poison control centre or physician immediately. Never make an unconscious person vomit or drink fluids. When vomiting occurs, keep head lower than hips to help prevent aspiration. If person is unconscious, turn head to side. Get medical attention immediately. For ingestion, consider gastric lavage and catharsis.
After short term exposure, symptoms are nausea, vomiting, ringing in the ears, stomach pain, irregular heartbeat, headache, drowsiness, dizziness, disorientation, hearing loss, blurred vision, kidney damage, convulsions, coma.
Long term exposure: allergic reactions, rash, digestive disorders, fainting, blood disorders, liver damage.

Fire-fighting measures

EXTINGUISHING MEDIA
- SUITABLE Dry chemical powder, carbon dioxide or appropriate foams.
- UNSUITABLE Water spray

SPECIAL HAZARDS ARISING FROM THE SUBSTANCE OR MIXTURE
The thermal decomposition and ignition of the product can produce toxic fumes COx. Slight fire hazard. Dust/air mixtures may ignite or explode.

ADVICE FOR FIREFIGHTERS
For large amounts (multiple packages/pallets) of product: since toxic, corrosive or flammable vapours might be evolved from fires involving the product and
associated packaging, self contained breathing apparatus a full protective equipment are recommended for fire fighters. (Full facial mask with “Universal” filter). If possible, contain and collect fire fighting water for later disposal.

Accidental release measures

PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES
Wear protective clothing, protective glasses, rubber boots .
Wear an independent respirator. Evacuate the area and aerate the zone contaminated by the spilt product after cleaning it away completely. Avoid forming clouds of dust/powder.

ENVIRONMENTAL PRECAUTIONS
Do not allow the product to enter water or the soil. Prevent it from entering the drains or sewers. Use suitable
containers for preventing environmental pollution. Alert neighbourhood: Not necessary

METHODS AND MATERIAL FOR CONTAINMENT AND CLEANING UP
Use of absorbent material, as vermiculite, dry sand, earth.
Cleaning methods: sweep up the product to minimize the generation of dust. Using the broom cotton wet, damp sponge or high-efficiency aspirator (HEPA). It is preferable to dry cleaning, and then lay in a suitable container for disposal. Decontaminate the areas polluted by the product by washing with abundant water, subsequent elimination by adsorption with sawdust, bentonite or silica gel, and then collect the material in special containers and delivered by the personnel responsible for its disposal in accordance with the existing laws.

Handling and storage

HANDLING
The premises set up for the handling of the product must be fitted out with localised and controlled aeration systems (laminar flow hoods, etc.) capable of confining the dispersion of the active ingredient in the form of air-dispersed powder. Use hoods with interchangeable filters
Use suitable personal protection devices including certified respirators, protective safety glasses and compatible gloves resistant against chemical agents. Wash yourself with care after each handling operation. Never eat, drink or smoke during handling. Safety shower and washing stations for rinsing eyes must be provided.

STORAGE
Make appropriate connections to earth to disperse the electrostatic charge.
Store in a cool, dry and well ventilated at room temperature, low humidity to avoid the packaging of the product.
Pack the product in double polythene bags, individually sealed and store in cardboard bins fitted with an aluminium safety locking ring.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
UN2811
Shipping information
Proper shipping name and description:
toxic solid, organic, N.O.S. (dexketoprofen acid)
Chemical name:
(2S)-2-(3-benzoylphenyl)propanoic acid
Language:
English
Labels:
6.1
Special provisions / remarks
Remarks:
If the product has leaked and been spilled in a vehicle or container, it may not be re-used until after it has been thoroughly cleaned and, if necessary, disinfected or decontaminated (CV13)
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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

EYE/ FACE PROTECTION
Wear protective glasses (EN 166) during the execution of any industrial type of operations. If necessary, wear a protective face shield.

SKIN PROTECTION
Use work overalls and/or coat, or dustproof overalls in Tyvek with hood for industrial type operations.

HAND PROTECTION
Type of material and thickness: wear nitrile or rubber gloves (neoprene). #Minimum thickness of gloves: 0,11 mm.
Typical or minimum breakthrough times of the glove material: permeability is not anticipated with dry solid substances and therefore the duration of the protective gloves has not been calculated. The selected protective gloves have to satisfy the specifications of the EU Directive 89/686/EEC and the standard EN 374 derived from it.

RESPIRATORY PROTECTION
Wear an FFP3 dustproof mask or a Respirator connected to the air supply (if necessary, use a mask with an P3 type filter EN143).

Stability and reactivity

CHEMICAL STABILITY
Stability studies show that the product is stable in normal conditions of storing (room temperature, relative humidity and light).

POSSIBILITY OF HAZARDOUS REACTIONS
No hazardous polymerisations occur.

CONDITIONS TO AVOID Avoid heat, flames, sparks and other sources of ignition. Dust/air mixtures may ignite or explode. Minimal explosiveness energy: 11,4 mJ (raceme)

INCOMPATIBLE MATERIALS Strongly oxidizing and reducing agents.

HAZARDOUS DECOMPOSITION PRODUCTS
The thermal decomposition and ignition of the product can produce toxic fumes COx.

Disposal considerations

WASTE TREATMENT METHODS
Dissolve or mix the product with a combustible solvent then incinerate in an incinerator for chemical products equipped with a postcombustion and destruction system.
This material and its containers must be disposed of as hazardous waste products.
The combined packaging materials must be disposed of as hazardous waste products.