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Dentsplymea.com

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
COMPANY/UNDERTAKING

'XYLOCAINE' INJECTIONS WITH ADRENALINE
Address/Phone No.
: DENTSPLY Ltd
2. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical Composition
Contains: adrenaline/epinephrine (0.0005-0.001%) : Local anaesthetic solution for use in infiltration anaesthesia, peripheral and central nerve blocks. HAZARDOUS INGREDIENT(S)
R Phrases
3. HAZARDS IDENTIFICATION
As a result of the physical presentation of the product, the risk to health in the normal handling of the product is expected to be low. 4. FIRST-AID MEASURES
Inhalation : Unlikely route of exposure. Remove patient from exposure. Obtain medical attention if ill effects : Remove contaminated clothing. Wash skin with soap and water. If symptoms (irritation or blistering) : Irrigate with eyewash solution or clean water, holding the eyelids apart, for at least 10 minutes. Obtain Ingestion : Wash out mouth with water and give 200-300ml of water to drink. Do not induce vomiting. Obtain Further Medical Treatment
Symptomatic treatment and supportive therapy as indicated. For further detail consult the prescribing information. 5. FIRE-FIGHTING MEASURES
If involved in a fire, it may burn and emit noxious and toxic fumes. : A self contained breathing apparatus and suitable protective clothing should be worn 6. ACCIDENTAL RELEASE MEASURES
Ensure suitable personal protection during removal of spillages. Clear up spillages. Wash the spillage area with water. Transfer spilled vials to a suitable container for disposal. Take care to avoid needles and broken containers. 7. HANDLING AND STORAGE
7.1 HANDLING
No special precautions are necessary when handling packed product. In case of accident, avoid contact with skin and eyes. Do not breathe mist. 7.2 STORAGE
Keep container tightly closed. Protect from light. : Total storage life at recommended conditions: 18 months 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Occupational Exposure Limits
LTEL 8hr TWA
STEL 15min
HAZARDOUS INGREDIENT(S)
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
: Incompatible materials: Water reactive materials. Adrenaline is unstable in alkaline 11. TOXICOLOGICAL INFORMATION
The following information refers to active ingredient: Inhalation : Unlikely route of exposure. May cause tingling/numbness in exposed areas (paraesthesia). High atmospheric concentrations may lead to anaesthetic effects. May produce a reduced heart rate and reduction in blood pressure with a resulting feeling of dizziness. : May cause numbness. Repeated and/or prolonged contact may cause skin sensitisation in a small Eye Contact : May cause excessive watering of the eye (lachrymation). Ingestion : By analogy with a similar substance this material is likely to be harmful. Lidocaine: Oral Median Lethal Dose 317mg/kg (rat). May produce numbness of the tongue and anaesthetic effects on the stomach Long Term : Repeated exposure of animals to high levels produces adverse effects on the : liver , central nervous Exposure 12. ECOLOGICAL INFORMATION
No information on this formulation. The product is soluble in water. The following information refers to active ingredient: Environmental Fate and Distribution
The substance has low potential for bioaccumulation. Persistence and Degradation
Not readily biodegradable. (ISO 7827-1984(E)) Toxicity
Low toxicity to aquatic organisms. LC50 (zebra fish) (96 hour) 106mg/l. EC50 (Daphnia magna) (48 hour) 112mg/l. EC50 (green algae) (72 hour) 780mg/l. EC50 (Microtox test) (15 minutes) >1000mg/l. Effect on Effluent Treatment
Effect on Atmospheric Ozone
13. DISPOSAL CONSIDERATIONS
Disposal should be in accordance with local, state or national legislation. 14. TRANSPORT INFORMATION
Not Classified as Dangerous for Transport.
15. REGULATORY INFORMATION
16. OTHER INFORMATION
This data sheet was prepared in accordance with Directive 91/155/EEC (93/112/EC). The information and recommendations in this data sheet are to the best of our knowledge, information and belief accurate at the date of issue. Nothing herein is to be construed as a warranty, expressed or implied. In all cases it is the responsibility of the users to determine the applicability of such information or the suitability of any products for their own particular purpose. GLOSSARY OES : Occupational Exposure Standard (UK HSE EH40) MEL : Maximum Exposure Limit (UK HSE EH40) COM : The company aims to control exposure in its workplace to this limit LTEL : Long-term exposure limit (8-hour TWA) STEL : Short-term exposure limit (15-minute) TLV : The company aims to control exposure in its workplace to the ACGIH limit TLV-C: The company aims to control exposure in its workplace to the ACGIH Ceiling limit MAK : The company aims to control exposure in its workplace to the German limit Sk : Can be absorbed through skin Sen : Capable of causing respiratory sensitisation ( Revision: 03

Source: http://www.dentsplymea.com/sites/default/files/xylocaine.pdf

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