Registration Dossier

Guidance on Safe Use

Guidance on Safe Use

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Administrative data

First-aid measures

First aid general principles - Important information
In case of doubt or in the presence of symptoms contact a physician, and show him/her the material safety data sheet. In case of severe symptoms, call your local health care emergency number. Call a poison control center in order to receive toxicological advice for the clinical management of poisoning. Do not administer anything by mouth to an unconscious person.

First aid general principles - Inhalation
In the case of respiratory symptoms (cough, dyspnea) move the person to fresh air, place in a semi-seated position, and administer oxygen. Provide artificial respiration if the person is not breathing.

First aid general principles - Skin contact
Flush the skin with copious amounts of water (and soap, if possible) for at least 15 minutes. Consult a physician if there are symptoms of skin irritation and/or pain.

First aid general principles - Eye contact
Remove contact lenses. Flush the eyes, kept open, with copious amounts of running water for at least 15 minutes. Consult a physician, especially if there are symptoms of eye irritation and/or pain.

First aid general principles – Ingestion
Do not administer anything by mouth unless advised to do so by a poison control center. Do not induce emesis. Rinse the mouth and consult a physician.

Fire-fighting measures

General information
Move all people away and stay upwind of the fire. Do not enter closed rooms without adequate protection.

Suitable extinguishing media
Water, Carbon dioxide, Dry chemical extinguisher.

Extinguishing media which shall not be used for safety reasons
None.

Exposure hazards arising from the substance itself, combustion products, resulting gases
In the case of fire, irritant or toxic fumes may develop from the substance and from the other materials involved in the fire. Carbon monoxide poisoning may occur.
In the event of fire the following can be released: Carbon dioxide (CO2) Nitrogen oxides (NOx

Protective equipment for fire-fighters
- Special protective equipment for firefighting: Wear full protective suit. Use self-contained breathing apparatus.
- Further information: Fire residues and contaminated firefighting water must be disposed of in accordance with the local regulations.

Accidental release measures

General measures
In case of spills, do not allow the substance entering drains and watercourses.

Personal precautions
Wear protective clothes and respiratory protection.

Environmental precautions
Cover the drains to prevent the product from entering the environment. If the product contaminates rivers, lakes or drains inform local authorities.

Methods for cleaning up
Remove large spills using inert absorbent material if needed. The material must be disposed in accordance with local and national regulations.

Handling and storage

Take the necessary measures to avoid human and environmental exposure. Store in original containers or other appropriately labelled, suitable containers in an environment away from heat sources, drains and watercourses. Handling and storage may be done at environmental temperature and in a dry place.

Precautions for safe handling:
- Advice on safe handling (industrial scale): Avoid the formation and deposition of dust. Observe the usual precautions for handling chemicals Keep away from sources of ignition --- No smoking.
- Advice on protection against fire and explosion: Take precautionary measures against electrostatic loading. The product is combustible.

Conditions for safe storage, including any incompatibilities:
- Requirements for storage rooms and vessels: Keep only in the original container
- Advice on common storage: Keep away from chemicals as it is a pharmaceutical substance
- Further information on storage conditions: The storage temperature should lie between 10 °C and 30 °C. Store in a dry place.

Transport information

Land transport (ADR/RID)

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Exposure controls / personal protection

According to the Company internal procedures, the substance is used under strictly controlled condition (SCC) during its whole lifecycle:

(a) the substance is rigorously controlled from its arrival to its use and transformation:

(b) procedural (Standard Operating Procedures for use) and control technologies are used to minimize emission and any resulting exposure;

(c) the substance is handled only by trained and authorized personnel;

(d) in the case of cleaning and maintenance works, special procedures such as equipment washing are applied before the system is opened and entered;

(e) in cases of accident and where waste is generated, there is an Emergency Plan to minimize emissions and the resulting exposure;

(f) substance-handling procedures are well documented and strictly supervised by the site operator.

A periodic environmental monitoring confirms the efficacy of the above practices.

Details about SCC, exposure controls and personal protection are given in the "RMM_details" document which is attached in section 13 of the Registration Dossier.



Personal protective equipment
- General protective measures: Do not inhale dust Avoid contact with eyes and skin. Protective clothing should be selected specifically for the working place, depending on concentration and quantity of the hazardous substances handled. The resistance of the protective clothing to chemicals should be ascertained with the respective supplier. A workplace risk assessment must be carried out in order to determine the correct engineering control measures and personal protective equipment.
- Respiratory protection: Particle filter half mask, filter P2.
- Hand protection: Nitrile rubber gloves. Glove material : Nitrile rubber; Layer thickness : 0,5 mm; Break through time: > 480 min
The protective gloves to be used must comply with the specifications of EC directive 89/686/EEC and the resultant standart EN374. This recommandation applies only to the product stated in this safety data sheet and supplied by us as well as to the purpose specified by us. When dissolving in or mixing with other substances and under conditions deviating from those stated in EN374 please contact the supplier of CE-approved gloves.
- Eye protection: Safety glasses with side protection shield.
- Body Protection: protective overalls
- Additional advice on system design: Used in closed system
- Hygiene measures: Do not eat or drink during work time. Wash hands before breaks and after work.

Stability and reactivity

The substance is stable under normal conditions of use.
Reactivity: No decomposition if used as directed.

Chemical stability: No decomposition if stored normally.

Hazardous reactions: Reactions with oxidising agents. Accumulation of fine dust may entail the risk of a dust explosion in the presence of air.

Incompatible materials: None known.

Hazardous decomposition products: No hazardous decomposition products if stored and handled as prescribed

Disposal considerations

For disposal purposes, the substance is considered as special waste. If needed, contact a center authorized to dispose of this type of waste. Do not dispose of the product in the environment.

Disposal procedures are detailed in the "RMM_details" document which is attached in section 13 of the Registration Dossier.