Registration Dossier

Administrative data

First-aid measures

Inhalation: Remove to fresh air. Get medical aid.
Skin contact: Immediately flush skin with plenty of water for at least 15 minutes.Remove contaminated clothing and shoes. Get medical aid.
Eye contact: Flush eye with plenty of water for at least 15 minutes, occasionally lifting the upper and lower lids. Get medical aid.
Ingestion: Do not induce vomiting. Wash out mouth with water.Get medical aid.

Fire-fighting measures

Extinguishing media: Water, carbon dioxide, dry chemical powder, or chemical foam.
Unsuitable extinguishing media: Not known.
Special hazards arising from the substance: Produces oxides of carbon,sulphur and nitrogen on combustion.
Advice for firefighters: Wear self-contained breathing apparatus. Wear protective clothing to prevent contact with skin and eyes.

Accidental release measures

Personal precautions: Use personal protective equipment: gloves (nitril, latex), goggles, respirator with anti-dust filter P3, protective wear and footwear.
Enviromental precautions: Avoid release to the environment. Do not empty into drains.
Methods and material for containment and cleaning up: Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete.

Handling and storage

Precautions for safe handling: Ensure there is exhaust ventilation of the area. Avoid the formation or spread of dust in the air. Wash thoroughly after handling.
Conditions for safe storage, including any incompatibilities: Keep container tightly closed when not in use. Store in a cool, dry place.
Specific end use(s): This substance must be handled under Strictly Controlled Conditions in accordance with Article 18(4) of Regulation (EC) No. 1907/2006 (REACH Regulation).

Transport information

Land transport (ADR/RID)

UN number:
Not classified as dangerous in the meaning of transport regulations.
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Inland waterway transport (ADN(R))

UN number:
Not classified as dangerous in the meaning of transport regulations.
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Marine transport (IMDG)

UN number:
Not classified as dangerous in the meaning of transport regulations.
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Air transport ICAO/IATA

UN number:
Not classified as dangerous in the meaning of transport regulations.
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Exposure controls / personal protection

This substance must be handled under Strictly Controlled Conditions in accordance with Article 18(4) of Regulation (EC) No. 1907/2006 (REACH Regulation).
Personal protective equipment:
Hand protection: protective gloves (nitril, latex)
Body and foot protection: protective wear and footwear
Eye protection: safety goggles.
Respiratory protection: respirator with anti-dust filter P3

Report about strictly controlled conditions of isolated intermediates production.
Registrant (importer / user of intermediate)
Synthon s.r.o.
Brněnská 32
Blansko 678 17
Czech Republic
1. Description of technological process used during production
2-(2-Ethoxyphenoxy)ethanaminium methanesulfonate is processed by neutralization and reductive amination in enameled and stainless steel reactors. The product created is isolated in centrifuge and mother liquors are collected in reservoirs for liquid waste. Solid waste is collected in PE bags in waste container.
2. Substance use description
2-(2-Ethoxyphenoxy)ethanaminium methanesulfonate is after delivery stored in central storehouse and has a quarantine status. After doing the entrance check (with a complying result) is the material given the status “released” and can be used for production. All production areas, where the substance is manipulated with, are air-conditioned.
Workers use designated working wear and personal protection (gloves, goggles, respirator) in working areas.
Weighting of the material for batches is done in designated areas. The production is performed in batches in enclosed device. Material is manipulated between equipment using pressure/vacuum and pumps. Apparatuses are connected with pipelines and hoses. Production device is equipped by CIP systems.
Floors in production area are prepared to retain leak in case of accident (spill or leak). Workers collect spill material to containers and then hand over to authorized firm to disposal. After that area is cleaning and defect is repaired, if it arises.
If preventive maintenance of device should be done, device is always cleaned.
All devices have its own logbook, where production, cleaning, maintenance and repairs etc. are taken. On ever device is attached label, where actual state of device is written.
3. The substance is consistently kept in enclosed environment
The substance is kept in original packaging. Storage temperature in store is monitored. Sampling is done in air-conditioned box.
For substance weighting is used an air-conditioned room, equipped with weighting box. Weighting box is equipped with ventilation.
All areas, where the substance is manipulated with, are disconnected from other areas by material and personnel airlock.
4. In case that emissions have been identified in the production or usage areas there are processing and monitoring technologies for emission and ensuing exposition minimizing
Potential exhalation from device is neutralized and condensed by cooling in central exhaust system equipped by gas absorber.
Outlet air from the weighting area is filtered through HEPA filters.
Solid waste is collected in PE bags in waste container and later on hand over to authorized firm for disposal. Used containers contaminated by raw material are collected in assigned place and later on hand over to authorized firm for disposal. Liquid wastes are collected in designated reservoirs and are sent to authorized company for waste disposal.
Production areas and devices are cleaned regularly. When the production campaign is finished cleaning is done and purity is analytically evaluated (by wiping or washing). Liquids from cleaning are hand over to authorized firm to disposal (so as liquid wastes).
5. Only trained personnel is manipulating with the substance
A system of training is established in the company. All personnel are subject to this schooling. Only personnel, who have been schooled for manipulation with the set substance and its properties (safety data sheet), they are allowed to work with the set substance.
For production, where this substance is being processed, there is a production instruction, batch production record, and SOPs for devices used during the production. Workers are trained in these documents before production is launched.

Stability and reactivity

Chemical stability: No hazardous reaction when handled and stored according to provisions.
Conditons to avoid: Dust generation.
Incompatible materials: Strong oxidizing agents.
Hazardous decomposition products: Does not decompose when used for intended uses.

Disposal considerations

Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in chemical incinerator equipped with an afterburner and scrubber.