Registration Dossier

Administrative data

First-aid measures

Eye contact
Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention if irritation occurs.

Inhalation
Remove victim to fresh air and keep at rest in a position comfortable for breathing. If it is suspected that fumes are still present, the rescuer should wear an appropriate mask or self-contained breathing apparatus. If not breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation. Get medical attention. If necessary, call a poison center or physician. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband. In case of inhalation of decomposition products in a fire, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours. In the event of any complaints or symptoms, avoid further exposure.

Skin contact
Wash with plenty of soap and water. Remove contaminated clothing and shoes. Wash contaminated clothing thoroughly with water before removing it, or wear gloves. Continue to rinse for at least 10 minutes. Get medical attention. In the event of any complaints or symptoms, avoid further exposure. Wash clothing
before reuse. Clean shoes thoroughly before reuse.

Ingestion
Wash out mouth with water. Remove dentures if any. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been
swallowed and the exposed person is conscious, give small quantities of water to drink. Stop if the exposed person feels sick as vomiting may be dangerous. Do not induce vomiting unless directed to do so by medical personnel. If vomiting occurs, the head should be kept low so that vomit does not enter the lungs. Get medical attention. If necessary, call a poison center or physician. Never give anything by mouth to an unconscious person. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband.

Protection of first-aiders
No action shall be taken involving any personal risk or without suitable training. If it is suspected that fumes are still present, the rescuer should wear an appropriate mask or self-contained breathing apparatus. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation. Wash contaminated clothing thoroughly with water before removing it, or wear gloves.

Most important symptoms and effects, both acute and delayed
Potential acute health effects
Eye contact
Exposure to airborne concentrations above statutory or recommended exposure limits may cause irritation of the eyes.

Inhalation
Harmful if inhaled. Exposure to airborne concentrations above statutory or recommended exposure limits may cause irritation of the nose, throat and lungs.
May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Skin contact
May cause an allergic skin reaction.

Ingestion
Harmful if swallowed.

Over-exposure signs/symptoms
Eye contact
Adverse symptoms may include the following:
irritation
redness

Inhalation
Adverse symptoms may include the following:
respiratory tract irritation
coughing
wheezing and breathing difficulties
asthma

Skin contact
Adverse symptoms may include the following:
irritation
redness

Ingestion
No specific data.

Indication of any immediate medical attention and special treatment needed
Notes to physician
In case of inhalation of decomposition products in a fire, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours.

Specific treatments
No specific treatment.

Fire-fighting measures

Extinguishing media
Suitable extinguishing media
Use dry chemical powder.

Unsuitable extinguishing media
Avoid high pressure media which could cause the formation of a potentially explosible dust-air mixture.

Special hazards arising from the substance or mixture
Hazards from the substance or mixture
May form explosible dust-air mixture if dispersed.

Hazardous thermal decomposition products
Decomposition products may include the following materials:
carbon dioxide
carbon monoxide
nitrogen oxides

Advice for firefighters
Special protective actions for fire-fighters
Promptly isolate the scene by removing all persons from the vicinity of the incident if there is a fire. No action shall be taken involving any personal risk or without suitable training. Move containers from fire area if this can be done without risk. Use water spray to keep fire-exposed containers cool.

Special protective equipment for fire-fighters
Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode. Clothing for fire-fighters (including helmets, protective boots and gloves) conforming to European standard EN 469 will provide a basic level of protection for chemical incidents.

Accidental release measures

Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
No action shall be taken involving any personal risk or without suitable training. Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilt material. Shut off all ignition sources. No flares, smoking or flames in hazard area. Avoid breathing dust. Provide adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal protective equipment.

For emergency responders
If specialised clothing is required to deal with the spillage, take note of any information on suitable and unsuitable materials. See also the information in "For non-emergency personnel".

Environmental precautions
Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).

Methods and material for containment and cleaning up
Small spill
Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Avoid dust generation. Using a vacuum with HEPA filter will reduce dust dispersal. Place spilled material in a designated, labeled waste container. Dispose of via a licensed waste disposal contractor.

Large spill
Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Approach the release from upwind. Prevent entry into sewers, water courses, basements or confined areas. Avoid dust generation. Do not dry sweep. Vacuum dust with equipment fitted with a HEPA filter and place in a closed, labeled waste container. Avoid creating dusty conditions and prevent wind dispersal. Dispose of via a licensed waste disposal contractor.

Handling and storage

Precautions for safe handling
Protective measures
Put on appropriate personal protective equipment. Persons with a history of skin sensitisation problems or asthma, allergies or chronic or recurrent respiratory disease should not be employed in any process in which this product is used. Do not get in eyes or on skin or clothing. Do not ingest. Avoid breathing dust. Avoid the creation of dust when handling and avoid all possible sources of ignition (spark or flame). Prevent dust accumulation. Use only with adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Electrical equipment and lighting should be protected to appropriate standards to prevent dust coming into contact with hot surfaces, sparks or other ignition sources. Take precautionary measures against electrostatic discharges. To avoid fire or explosion, dissipate static electricity during transfer by earthing and bonding containers and equipment before transferring material. Empty containers retain product residue and can be hazardous. Do not reuse container.

Advice on general occupational hygiene
Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating, drinking and smoking. Remove contaminated clothing and protective equipment before entering eating areas. See also additional information on hygiene measures.

Conditions for safe storage, including any incompatibilities
Store in accordance with local regulations. Store in a segregated and approved area. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials and food and drink. Eliminate all ignition sources. Separate from oxidizing materials. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabelled containers. Use appropriate containment to avoid environmental contamination.

Specific end use(s)
Recommendations
Pharmaceuticals

Industrial sector specific solutions
Pharmaceuticals - (medicine, pharmacia) - Pharmaceuticals for the central nervous system

Transport information

Land transport (ADR/RID)

UN number:
Not regulated
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Inland waterway transport (ADN(R))

UN number:
Not regulated
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Marine transport (IMDG)

UN number:
Not regulated
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Air transport ICAO/IATA

UN number:
Not regulated
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Additional transport information

Additional transport information
Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.

Exposure controls / personal protection

Control parameters
Occupational exposure limits
No exposure limit value known.
In house exposure limit 0.1mg/m3 (15 min STEL)In house exposure limit 0.1mg/m3 (8 hour TWA).

Recommended monitoring procedures
If this product contains ingredients with exposure limits, personal, workplace atmosphere or biological monitoring may be required to determine the effectiveness of the ventilation or other control measures and/or the necessity to use respiratory protective equipment. Reference should be made to monitoring standards, such as the following: European Standard EN 689 (Workplace atmospheres - Guidance for the assessment of exposure by inhalation to chemical agents for comparison with limit values and measurement strategy) European Standard EN 14042 (Workplace atmospheres - Guide for the application and use of procedures for the assessment of exposure to chemical and biological agents) European Standard EN 482 (Workplace atmospheres - General requirements for the performance of procedures for the measurement of chemical agents) Reference to national guidance documents for methods for the determination of hazardous substances will also be required.

Exposure controls
Appropriate engineering controls
Use only with adequate ventilation. Use process enclosures, local exhaust ventilation or other engineering controls to keep worker exposure to airborne contaminants below any recommended or statutory limits. The engineering controls also need to keep gas, vapour or dust concentrations below any lower explosive limits. Use explosion-proof ventilation equipment.

Individual protection measures
Hygiene measures
Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Appropriate techniques should be used to remove potentially contaminated clothing. Contaminated work clothing should not be allowed out of the workplace. Wash contaminated clothing before reusing. Ensure that eyewash stations and safety showers are close to the workstation location.

Eye/face protection
Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists, gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses with side-shields. If operating conditions cause high dust concentrations to be produced, use dust goggles. Recommended: safety glasses with side-shields.

Skin protection
Hand protection
Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. Considering the parameters specified by the glove manufacturer, check during use that the gloves are still retaining their protective properties. It should be noted that the time to breakthrough for any glove material may be different for different glove manufacturers. In the case of mixtures, consisting of several substances, the protection time of the gloves cannot be accurately estimated.

Body protection
Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

Other skin protection
Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

Respiratory protection
Based on the hazard and potential for exposure, select a respirator that meets the appropriate standard or certification. Respirators must be used according to a respiratory protection program to ensure proper fitting, training, and other important aspects of use. Recommended: Respiratory protection should conform to AS/NZS 1715 and AS/NZS 1716.

Environmental exposure controls
Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation.
In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels.

Stability and reactivity

Reactivity
No specific test data related to reactivity available for this product or its ingredients.

Chemical stability
The product is stable.

Possibility of hazardous reactions
Under normal conditions of storage and use, hazardous reactions will not occur.

Conditions to avoid
Avoid the creation of dust when handling and avoid all possible sources of ignition (spark or flame). Take precautionary measures against electrostatic discharges. To avoid fire or explosion, dissipate static electricity during transfer by earthing and bonding containers and equipment before transferring material. Prevent dust accumulation.

Incompatible materials
Reactive or incompatible with the following materials: Oxidizing materials

Hazardous decomposition products
Under normal conditions of storage and use, hazardous decomposition products should not be produced.

Disposal considerations

Waste treatment methods
Product
Methods of disposalThe generation of waste should be avoided or minimised wherever possible. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and nonrecyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction.

Hazardous waste
The classification of the product may meet the criteria for a hazardous waste.

Packaging
Methods of disposal
The generation of waste should be avoided or minimised wherever possible. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible.

Special precautions
This material and its container must be disposed of in a safe way. Care should be taken when handling emptied containers that have not been cleaned or rinsed out. Empty containers or liners may retain some product residues. Avoid dispersal of spilt material and runoff and contact with soil, waterways, drains and sewers.