Registration Dossier

Administrative data

First-aid measures

Description of 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.

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
Get medical attention immediately. Call a poison center or physician. 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. 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
No known significant effects or critical hazards.

Inhalation
Toxic if inhaled.

Skin contact
May cause an allergic skin reaction.

Ingestion
Toxic if swallowed.

Over-exposure signs/symptoms
Eye contact
No specific data.

Inhalation
Adverse symptoms may include the following:
reduced foetal weight
increase in foetal deaths
skeletal malformations

Skin contact
Adverse symptoms may include the following:
irritation
redness
reduced foetal weight
increase in foetal deaths
skeletal malformations

Ingestion
Adverse symptoms may include the following:
reduced foetal weight
increase in foetal deaths
skeletal malformations

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 an extinguishing agent suitable for the surrounding fire.

Unsuitable extinguishing media
None known.

Special hazards arising from the substance or mixture
Hazards from the substance or mixture
No specific fire or explosion hazard.

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.

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. 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 in Section 8 of the SDS 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 materials for containment and cleaning up
Small spill
Move containers from spill area. Avoid dust generation. Do not dry sweep. Vacuum dust with equipment fitted with a HEPA filter and place in a closed, labelled waste container. Place spilled material in a designated, labeled waste container. Dispose of via a licensed waste disposal contractor.

Large spill
Move containers from spill area. 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. 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 sensitization problems should not be employed in any process in which this product is used. Avoid exposure - obtain special instructions before use. Avoid exposure during pregnancy. Do not handle until all safety precautions have been read and understood. Do not get in eyes or on skin or clothing. Do not ingest. 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. 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 original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials and food and drink. Store locked up. 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.

Seveso Directive - Reporting thresholds (in tonnes)
Danger criteria
Category H2: Acute toxicity 2 any route of entry or Acute toxicity 3 Inhalation route of entry
Notification and MAPP threshold: 50
Safety report threshold: 200
Category C2: Toxic
Notification and MAPP threshold: 50
Safety report threshold: 200

Transport information

Land transport (ADR/RID)

UN number:
UN1544
Proper shipping name and description:
ALKALOIDS, SOLID, N.O.S. (7,8-dihydromorphine)
Class:
6.1
Packaging group:
III
Special Provisions:
Hazard identification number: 60
Limited quantity: 5 kg
Special provisions: 43 274
Tunnel code (E)

Inland waterway transport (ADN(R))

UN number:
UN1544
Proper shipping name and description:
ALKALOIDS, SOLID, N.O.S. (7,8-dihydromorphine)
Class:
6.1
Packaging group:
III
Remarks
Special Provisions: 43 274 802

Marine transport (IMDG)

UN number:
UN1544
Proper shipping name and description:
ALKALOIDS, SOLID, N.O.S. (7,8-dihydromorphine)
Class:
6.1
Packaging group:
III
EmS code:
F-A, S-A
Remarks
Special Provisions: 43 223 274

Air transport ICAO/IATA

UN number:
UN1544
Proper shipping name and description:
Alkaloids, solid, n.o.s. (7,8-dihydromorphine)
Class:
6.1
Packaging group:
III
Remarks
Passenger and Cargo Aircraft
Quantity limitation: 100 kg
Packaging instructions: 670

Cargo Aircraft Only
Quantity limitation: 200 kg
Packaging instructions: 677

Limited Quantities -
Passenger Aircraft
Quantity limitation:10 kg
Packaging instructions: Y645

Special Provisions: A3 A5 A6 A801

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 (8 hour TWA) In house exposure limit 0.1mg/m³ (15 min STEL).

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.

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.

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.

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

Conditions to avoid
No specific data.

Incompatible materials
No specific data.

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 disposal
The 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.