Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

First-aid measures

Eye Contact: Irrigate thoroughly for 5-15 minutes with clean water as soon as possible. Obtain medical attention.
Skin Contact: Remove any contaminated clothing and wash skin thoroughly with plenty of water. Obtain medical attention.
Inhalation: Remove to fresh air. Obtain medical attention.
Ingestion: Obtain medical attention.
Note to Physicians: Buprenorphine is an opioid receptor partial agonist; competitive.

In case of suspected exposure, monitor for 2 hours for the following symptoms: respiratory depression, nausea/vomiting, dizziness, pinpoint pupils, euphoria, headache, sweating and drowsiness.

In the event of overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient. Symptomatic treatment of respiratory depression, following standard intensive care measures, should be performed. A patent airway and assisted or controlled ventilation must be assured. The patient should be transferred to an environment within which full resuscitation facilities are available. If the patient vomits, care must be taken to prevent aspiration of the vomitus. Use of an opioid antagonist (e.g., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared to its effects on full agonist opioid agents. If naloxone is used, the long duration of action of buprenorphine should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose. Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary. Ongoing IV infusion rates should be titrated to patient response. If infusion is not possible, repeated dosing with naloxone may be required. Initial naloxone doses may range up to 2mg and be repeated every 2-3 minutes until a satisfactory response is achieved. Patients dosed with initial doses totalling greater than 4mg should be monitored closely.

Fire-fighting measures

Flammable Properties: Not classed as flammable but will burn
Suitable Extinguishing Media: Dry powder
Hazardous Combustion Products: Oxides of carbon and nitrogen may be released.

Accidental release measures

Avoid all contact. Wear protective clothing and equipment to prevent inhalation, ingestion or absorption through the skin. Spillages should be collected by trained personnel only

Personal Precautions: Use personal protection recommended in Section Eight (8).
Environmental Precautions: Prevent product from entering drains, sewers, ditches, and waterways. Notify local authorities if you cannot contain a major spill.
Methods for Containment: Special instructions are not necessary.
Methods for Clean-up:
Minor Spills: The material is only slightly soluble in water. Consider using a vacuum cleaner with an appropriate HEPA filter to pick up dry powder. Mop up with damp cloths, place in a plastic bag and seal. Dispose in accordance with local, state and federal requirements, including Drug Enforcement Administration regulations for controlled substances.
Major Spills: Contain spill. The material is only slightly soluble in water. Consider using a vacuum cleaner with an appropriate HEPA filter to pick up dry powder. Mop up with damp cloths, place in a plastic bag and seal. Dispose in accordance with local, state and federal requirements, including Drug Enforcement Administration regulations for controlled substances.

Handling and storage

Handling: Avoid all exposure.
Storage: Store in a secure place in accordance with relevant local governmental law. Store in well-sealed containers protected from light and moisture. Keep out of reach and sight of children.

Transport information

Land transport (UN RTDG/ADR/RID)

Shipping information
Proper shipping name and description:
No special labelling required for Road, Sea and Air. Not classed as hazardous for transport.
SpecialProvisionsopen allclose all
Shippingopen allclose all
Remarksopen allclose all

Marine transport (UN RTDG/IMDG)

Shippingopen allclose all
Remarksopen allclose all
Shippingopen allclose all
Remarksopen allclose all
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Exposure Guidelines: Avoid contact. Occupational Exposure Limits : 0.002 mg/m3 8 hour TWA.
Engineering Controls: Total enclosure eg use glove box or isolator for dispensing.
Eye / Face Protection: Wear safety glasses to BS 2092/EN 166
Skin Protection: Wear gloves (rubber) and a disposable coverall when handling
Respiratory Protection: Disposable particulate respirator that meets or exceeds the NIOSH N95 standard coverall.
Considerations: Wash hands after handling.

Stability and reactivity

Physical and chemical Stability:
Store below 30°C (86°CF)
Conditions to Avoid: None known.
Incompatible Materials: Strong Oxidisers.
Hazardous Decomposition Products: Products may include oxides of carbon and nitrogen
Possibility of Hazardous Reactions: Will not occur.

Disposal considerations

As this is a controlled drug relevant local governmental law applies.