Registration Dossier

Administrative data

First-aid measures

General notes: Seek medical attention if feel unwell. Delayed effects can be expected after exposure.
Following inhalation: If breathed in, move person into fresh air. Give water to drink. If not breathing, give artificial respiration.
Following skin contact: Wash off with soap and plenty of water at least for 20 minutes. Contaminated clothing and footwear should be laundered before reuse.
Following eye contact: Flush eyes with water as a precaution at least for 20 minutes.
Following ingestion: Never give anything by mouth to an unconscious person. Rinse mouse with water. If ingestion of a large amount does occur, call the ambulance or provide medical attention immediately.
Self-protection of the firs aider: Attention! Making the "mouth to mouth" artificial respiration may be dangerous. Make a contactless artificial respiration.
Most important symptoms and effects, both acute and delayed:
Inhalation causes irritation of the lungs and respiratory system. Inflammation of the eye is characterized by redness, watering and itching. Skin inflammation is characterized by itching, scaling, reddening or, occasionally, blistering. May be harmful if swallowed. Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea. To the best of our knowledge the acute and chronic toxicity of this product is not fully investigated.


Fire-fighting measures

Extinguishing media:
Suitable extinguishing media: Water spray. Carbon dioxide (CO2). Dry chemical. Chemical foam.
Unsuitable extinguishing media: None.
Special hazards arising from the substance or mixture: Thermal decomposition can lead to release of acrid smoke or irritating gases and vapours. Emits toxic fumes under fire conditions: carbon monoxide (CO), carbon dioxide (CO2) and other pyrolysis products typical of burning organic material. May emit corrosive fumes.
Advice for fire fighters: Fire fighter’s clothing conforming to European standard EN469 provides a basic level of protection for chemical incidents and includes helmets, protective boots and gloves. Clothing not conforming to EN469 may not be suitable in any chemical incident.
Use water delivered as a fine spray to control fire and cool adjacent area. Equipment should be thoroughly decontaminated after use.

Accidental release measures

Personal precautions, protective equipment and emergency procedures
Use personal protective equipment: wear self-contained breathing apparatus, rubber boots and heavy rubber gloves. Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation.
For non-emergency personnel
Protective equipment: Use personal protective equipment.
Emergency procedures: Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation.
For emergency responders: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Environmental precautions – do not let product enter drains and environment.
Methods and material for containment and cleaning up
For containment: Remove all ignition sources. Clean up all spills immediately. Avoid contact with skin and eyes. Control personal contact by using protective equipment. In case of major spills alert Emergency Responders and tell them location and nature of hazard. Prevent, by any means available, spillage from entering drains or watercourses.
For cleaning up: Use dry clean up procedures and avoid generating dust. Place in a suitable, labelled container for waste disposal. Recover product wherever possible. Wash area down with large amounts of water. If contamination of drains or waterways occurs, advise emergency services.

Handling and storage

Measures to prevent fire: Avoid contact with incompatible materials, heat, direct sunlight, water and moisture. Keep away from sources of ignition.
Measures to prevent aerosol and dust generation: Use in a well-ventilated area. Prevent concentration in hollows and sumps. DO NOT enter confined spaces until atmosphere has been checked. Avoid all personal contact, including inhalation.
Measures to protect the environment: Wear protective clothing when risk of exposure occurs. Keep containers securely sealed when not in use. Avoid physical damage to containers.
Advice on general occupational hygiene: Use good occupational work practice. Observe manufacturer's storing and handling recommendations. Always wash hands with soap and water after handling. Work clothes should be laundered separately. Launder contaminated clothing before re-use.
Conditions for safe storage, including any incompatibilities
Technical measures and storage conditions: Store in original containers at dark and dry place. Protect from moisture and light. Keep container tightly closed when not in use. Check that all containers are clearly labelled. Protect containers against physical damage and check regularly for leaks.
Packing materials: For small quantities – dark glass by polyethylene cover; for large quantities –polyethylene bag placed in plastic barrel.
Requirements for storage rooms and vessels: For quality assurance protect from light and moisture.
Further information on storage conditions: none.

Transport information

Land transport (ADR/RID)

UN number:
Not dangerous goods
Shippingopen allclose all
Class:
Not dangerous goods
Classification code:
Not dangerous goods
Packaging group:
Not dangerous goods
Labels:
Not dangerous goods
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Inland waterway transport (ADN(R))

UN number:
Not dangerous goods
Shippingopen allclose all
Class:
Not dangerous goods
Classification code:
Not dangerous goods
Packaging group:
Not dangerous goods
Labels:
Not dangerous goods
Remarksopen allclose all

Marine transport (IMDG)

UN number:
Not dangerous goods
Proper shipping name and description:
Not dangerous goods
Chemical name:
Not dangerous goods
Class:
Not dangerous goods
Packaging group:
Not dangerous goods
EmS code:
Not dangerous goods
Labels:
Not dangerous goods
Remarksopen allclose all

Air transport ICAO/IATA

UN number:
Not dangerous goods
Proper shipping name and description:
Not dangerous goods
Chemical name:
Not dangerous goods
Class:
Not dangerous goods
Packaging group:
Not dangerous goods
Labels:
Not dangerous goods
Remarksopen allclose all
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Exposure controls:
Occupational exposure to amantadine hydrochloride may occur through inhalation and dermal contact with this compound at workplaces where it is produced or used. Individual protection measures, such as personal protective equipment.
Appropriate engineering controls – Choose the working organization, technology and equipment in order to prevent or minimize any exposure.
Organisational measures to prevent exposure: only trained and instructed staff may work with the substance.
Technical measures to prevent exposure: Local exhaust ventilation is required where solids are handled as powders or crystals; even when particulates are relatively large, a certain proportion will be powdered by mutual friction. Exhaust ventilation should be designed to prevent recirculation of particulates and accumulation in the workplace.
Individual protection equipment:
Eye/face protection – For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs - chemical goggles.
Full-face shield may be required for supplementary but never for primary protection of eyes.
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. This should include a review of lens absorption and adsorption for the class of chemicals in use and an account of injury experience. DO NOT wear contact lenses.
Skin protection – Choose body protection according to the amount and concentration of the dangerous substance at the work place.
Hand protection: The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 and US F739. Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include such as frequency and duration of contact, chemical resistance of glove material, glove thickness and dexterity.
When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater than 240 minutes according to EN 374) is recommended.
When only brief contact is expected, a glove with a protection class of 3 or higher (breakthrough time greater than 60 minutes according to EN 374) is recommended. Contaminated gloves should be replaced.
Glove material – natural rubber, nitrile rubber, neoprene or PVC.
Other skin protection: Barrier cream, skin-cleansing cream, eye wash unit.
Respiratory protection – Where risk assessment shows air-purifying respirators are appropriate use a dust mask type N95 (US) or type P1 (EN 143) respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures. The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered, positive flow, full face apparatus may be an option). Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete respiratory protection program. Use approved positive flow mask if significant quantities of dust becomes airborne.
Thermal hazards – None.

Stability and reactivity

Reactivity – No dangerous reactions known.
Chemical stability – Stable under normal ambient and anticipated storage and handling conditions.
Possibility of hazardous reactions – Hazardous decomposition products formed under fire conditions (see 10.6.). Avoid contamination with oxidizing agents i.e. nitrates, oxidizing acids, chlorine bleaches, pool chlorine etc. as ignition may result.
Conditions to avoid – Sources of ignition, moisture, light, heat.
Incompatible materials – Strong oxidizing and reducing agents, acid, bases.

Disposal considerations

Waste treatment methods
Product / Packaging disposal:
Contact a licensed professional waste disposal service to dispose of this material. All waste must be handled in accordance with local, state and federal regulations. Legislation addressing waste disposal requirements may differ by country, state and/or territory. Each user must refer to laws operating in their area. Decontaminate empty glass jars.
Waste classification codes:
160508 – Discarded organic chemicals consisting of or containing hazardous substances.
150102 – Plastic packaging.
150107 – Glass containers.
Waste treatment-relevant information:
Note that properties of a material may change in use, and recycling or reuse may not always be appropriate. Recycle wherever possible.
Sewage disposal-relevant information:
Disposal via sewage is strongly prohibited.
Other disposal recommendations:
Consult Waste Management Authority for disposal if no suitable treatment or disposal facility can be identified. Dispose in Incineration in a licensed apparatus (after admixture with suitable combustible material). Observe all label safeguards until jars are cleaned and destroyed.
EU legislation:
Council Directive 91/689/EEC of 12 December 1991 on hazardous waste.
Council Directive 94/31/EC of 27 June 1994 amending Directive 91/689/EEC on hazardous waste.
Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste.
Commission regulation (EU) No 1357/2014 of 18 December 2014 replacing Annex III to Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives.