Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

4.1. Description of first aid measures:

IN CASE OF INGESTION:

Measures:

- Do not give the victim anything to eat or drink, and do not induce vomiting if the victim is unconscious.

- Induce vomiting immediately as directed by medical personnel.

IN CASE OF INHALATION:

Measures:

- Take the victim into fresh air, loosen his clothes and let him rest.

- If not breathing, give artificial respiration.

- If breathing is difficult, give oxygen.

- Obtain medical help.

IN CASE OF SKIN CONTACT:

Measures:

- Remove the contaminated clothes and shoes!

- Immediately wash the contaminated area with plenty of water and soap (for 15 minutes)!

- Obtain immediate medical help.

- Wash clothing before reuse.

IN CASE OF EYE CONTACT:

Measures:

- In case of contact with eyes flush immediately with plenty of flowing water for 15 minutes holding eyelids apart (for at least 15

minutes)!

- Obtain immediate medical help.

4.2. Most important symptoms and effects, both acute and delayed:

Inhalation: no data available.

Ingestion: Narcotic. May cause (in order of increasing dose) lightheadedness, nausea, vomiting, sedation, constipation, constricted

pupils (miosis), sweating, respiratory depression, and circulatory collapse.

In case of skin contact: not expected to cause health effects, although the possibility of absorption exists under conditions of skin

breakage or inflammation.

Eye Contact: Mild irritant but will also have a strong narcotic effect (pupil constriction) and the eye may serve as an absorption

route to the body in general.

Chronic Exposure:

Caution, may be habit forming. Chronic exposure may lead to tolerance, dependence, and unpleasant withdrawal symptoms upon

abrupt discontinuation of use (e.g., sweating, restlessness, irritability, hallucinations).

Aggravation of Pre-existing Conditions:

Some individuals may become sensitized from exposure and develop skin rashes, coughs, stuffy nose, asthma, and other allergic

complaints. Sensitivity may develop soon after immediate contact or after years of exposure. Note: While there are no reports

directly linking this material to allergic reactions, several other compounds form this chemical category have been associated with

skin and respiratory allergic reactions associated with occupational exposure.

4.3. Indication of any immediate medical attention and special treatment needed:

No data available.

Fire-fighting measures

5.1. Extinguishing media:

5.1.1. Suitable extinguishing media:

Water fog, alcohol resistant foam, dry chemical, carbon dioxide.

5.1.2. Unsuitable extinguishing media:

None known.

5.2. Special hazards arising from the substance or mixture:

As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.

Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.

Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosion

hazard.

5.3. Advise for fire fighters

In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full facepiece

operated in the pressure demand or other positive pressure mode. Follow handling guidance appropriate for OEB-3 potent

compounds,

Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures:

6.1.1 For non-emergency personnel:

Keep unprotected people away, allow only well trained experts wearing suitable protective clothing to abide in the field of

accident.

6.1.2. For emergency responders:

Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal protective equipment as specified in

Section 8, and follow handling guidance appropriate for OEB-3 potent compounds, (see Section 7). Isolate hazard area. Keep

unnecessary and unprotected personnel from entering. All clean-up operations should be witnessed by more than one individual.

6.2. Environmental precautions:

Dispose of spillage and waste (product/packaging) in accordance with all applicable environmental laws. Do not allow to enter

sewers/soil/surface or ground water. Notify the respective authorities in accordance with local law in the case of environmental

pollution immediately.

6.3. Methods and material for containment and cleaning up:

Carefully sweep up material into an appropriate container and save for reclamation or disposal. Use non-sparking tools and

equipment. Do not flush to sewer! The amount of material collected should be assessed and documented.

Handling and storage

7.1. Precautions for safe handling:

Precautions for safe handling:

Observe conventional hygiene precautions.

Use appropriate protective equipment.

Technical measures:

To prevent contamination and overexposure, no open handling of powder should be allowed. Powder handling operations are to

be done in a powders weighing hood, a glove box, or other equivalent ventilated containment system. In situations where these

ventilated containment hoods have not been installed, a non-ventilated enclosed containment hood should be used. Pending

changes resulting from additional air monitoring data, up to 300 mg can be handled outside of an enclosure provided that no

grinding, crushing or other dust-generating process occurs.

Precautions against fire and explosion:

No specific prescription.

7.2. Conditions for safe storage, including any incompatibilities:

Technical measures and storage condition:

Keep in a tightly closed container, stored in a cool, dry, ventilated area.

Protect from physical damage and direct sunlight.

Containers of this material may be hazardous when empty since they retain product residues (dust, solids); observe all warnings

and precautions listed for the product.

Oxymorphone has potent pharmacological activity and is classified as an OEB-3* material.

Incompatible materials: Alkalis, tannin, strong oxidizing agents, borax, ferric chloride, iodides, lead acetate, mercuric chloride,

gold salts.

Packaging material: no special prescriptions.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
none
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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

8.2. Exposure controls:

In case of a hazardous material with no controlled concentration limit it is the employer’s duty to keep concentration levels down

to a minimum achievable by existing scientific and technological means, where the hazardous substance poses no harm to workers.

8.2.1 Appropriate engineering controls:

In pursuance of work is proper foresight needed to avoid spilling onto clothes and floors and to avoid contact with eyes and skin.

Ventilation System: to prevent contamination and overexposure, no open handling of powder should be allowed. Powder handling

operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated containment system. In

situations where these ventilated containment hoods have not been installed, a non-ventilated enclosed containment hood should

be used. Pending changes resulting from additional air monitoring data, up to 300 mg can be handled outside of an enclosure

provided that no grinding, crushing or other dust-generating process occurs.

Allergic responses in sensitive individuals will disappear if removed from exposure.

Maintain eye wash fountain and quick-drench facilities in work area.

8.2.2. Individual protection measures, such as personal protective equipment:

1. Eye/face protection: use appropriate chemical safety goggles.

2. Skin protection:

a. Hand protection: use appropriate protective gloves.

b. Other: wear appropriate clean body-covering clothing.

3. Respiratory protection: See Section 7 for information on proper handling and specific respirator recommendations for potent

compounds.

4. Thermal hazard: None known.

8.2.3. Environmental exposure controls:

No specific prescription.

Stability and reactivity

10.1. Reactivity:

None known.

10.2. Chemical stability:

At normal temperature and general conditions of work stabile.

10.3. Possibility of hazardous reactions

Hazardous polymerisation will not occur.

10.4. Conditions to avoid

Discolours on exposure to light.

10.5. Incompatible materials:

Alkalis, tannin, strong oxidizing agents, borax, ferric chloride, iodides, lead acetate, mercuric chloride, gold salts.

10.6. Hazardous decomposition products:

Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.

Disposal considerations

13.1. Waste treatment methods:

Disposal according to the local regulations.

13.1.1. Information regarding the disposal of the product:

Processing, use or contamination of this product may change the waste management options State and local disposal regulations

may differ from federal disposal regulations. Follow handling guidance appropriate for OEB-3 potent compounds, (see Section

7).

During the disposal of the product, its residue and its packaging the national and local prescriptions should be observed. The EWC

codes indicated below are only recommendations, but they may have to be changed due to special circumstances, in such cases new

classification may be needed.

13.1.2. Information regarding the disposal of the packaging:

Dispose of container and unused contents in accordance with federal, state and local requirements.

13.1.3. Physical/chemical properties that may affect waste treatment options shall be specified:

None known.

13.1.4. Sewage disposal:

None known.

13.1.5. Special precautions for any recommended waste treatment:

No data available.