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Chemwatch Australian MSDS 22-5369 - Dentsply

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DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 1 of 6<br />

Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION<br />

PRODUCT NAME<br />

DENTSPLY ORAQIX<br />

PRODUCT USE<br />

Indicated for adults who require localized anesthesia in periodontal pockets during scaling and / or root planning.<br />

SUPPLIER<br />

Company: DENTSPLY (AUSTRALIA) PTY LTD<br />

Address:<br />

11 - 21 Gilby Road<br />

Mount Waverley<br />

VIC 3149<br />

AUSTRALIA<br />

Telephone: 1300 55 29 29<br />

Emergency Tel: 1300 55 29 29 (Hours of operation:<br />

Monday - Friday 9:00 am - 5:00 pm EST; General<br />

information only)<br />

Fax: +61 3 9538 8260<br />

Section 2 - HAZARDS IDENTIFICATION<br />

STATEMENT OF HAZARDOUS NATURE<br />

HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. According to NOHSC Criteria, and ADG Code.<br />

POISONS SCHEDULE<br />

S2<br />

RISK<br />

SAFETY<br />

■ Limited evidence of a carcinogenic<br />

■ Do not breathe gas/fumes/vapour/spray.<br />

effect.<br />

■ May cause SENSITISATION by skin<br />

■ Avoid contact with eyes.<br />

contact.<br />

■ Cumulative effects may result<br />

■ Wear suitable protective clothing.<br />

following exposure*.<br />

■ May produce discomfort of the eyes,<br />

■ To clean the floor and all objects contaminated by this<br />

respiratory tract and skin*.<br />

material use water.<br />

* (limited evidence). ■ Keep away from food drink and animal feeding stuffs.<br />

■ In case of contact with eyes rinse with plenty of water<br />

and contact Doctor or Poisons Information Centre.<br />

■ If swallowed IMMEDIATELY contact Doctor or Poisons<br />

Information Centre. (show this container or label).<br />

Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS<br />

NAME CAS RN %<br />

lignocaine 137-58-6 2.5<br />

prilocaine 721-50-6 2.5<br />

water 7732-18-5 notspec<br />

Section 4 - FIRST AID MEASURES<br />

SWALLOWED<br />

• Immediately give a glass of water.<br />

• First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.<br />

EYE<br />

■ If this product comes in contact with the eyes:<br />

• Wash out immediately with fresh running water.<br />

• Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the upper and lower<br />

lids.<br />

• Seek medical attention without delay; if pain persists or recurs seek medical attention.<br />

• Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.<br />

continued...


DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 2 of 6<br />

Section 4 - FIRST AID MEASURES<br />

SKIN<br />

■ If skin contact occurs:<br />

• Immediately remove all contaminated clothing, including footwear.<br />

• Flush skin and hair with running water (and soap if available).<br />

• Seek medical attention in event of irritation.<br />

INHALED<br />

• If fumes or combustion products are inhaled remove from contaminated area.<br />

• Lay patient down. Keep warm and rested.<br />

• Prostheses such as false teeth, which may block airway, should be removed, where possible, prior to initiating first aid procedures.<br />

• Apply artificial respiration if not breathing, preferably with a demand valve resuscitator, bag-valve mask device, or pocket mask as trained.<br />

Perform CPR if necessary.<br />

NOTES TO PHYSICIAN<br />

■ When systemic reaction to local anaesthetic occurs, steps should be taken to maintain circulation and respiration and control convulsions. A clear<br />

airway should be established and oxygen given together with assisted ventilation if necessary.<br />

Metabolism of amide-type anaesthetics occurs in the liver and in some cases in the kidney. Because these undergo extensive and rapid hepatic<br />

metabolism, only about 1/3 of an oral dose reaches the systemic circulation.<br />

Section 5 - FIRE FIGHTING MEASURES<br />

EXTINGUISHING MEDIA<br />

• There is no restriction on the type of extinguisher which may be used.<br />

• Use extinguishing media suitable for surrounding area.<br />

FIRE FIGHTING<br />

• Alert Fire Brigade and tell them location and nature of hazard.<br />

• Wear full body protective clothing with breathing apparatus.<br />

• Prevent, by any means available, spillage from entering drains or water course.<br />

• Use water delivered as a fine spray to control fire and cool adjacent area.<br />

FIRE/EXPLOSION HAZARD<br />

• The material is not readily combustible under normal conditions.<br />

• However, it will break down under fire conditions and the organic component may burn.<br />

• Not considered to be a significant fire risk.<br />

• Heat may cause expansion or decomposition with violent rupture of containers.<br />

Combustion products include: carbon dioxide (CO2), carbon monoxide (CO), hydrogen chloride, phosgene, nitrogen oxides (NOx), other pyrolysis products<br />

typical of burning organic material.<br />

May emit poisonous fumes.<br />

May emit corrosive fumes.<br />

FIRE INCOMPATIBILITY<br />

• Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result.<br />

HAZCHEM<br />

None<br />

PERSONAL PROTECTION<br />

Glasses:<br />

Chemical goggles.<br />

Respirator:<br />

Particulate<br />

Section 6 - ACCIDENTAL RELEASE MEASURES<br />

MINOR SPILLS<br />

• Remove all ignition sources.<br />

• Clean up all spills immediately.<br />

• Avoid breathing vapours and contact with skin and eyes.<br />

• Control personal contact by using protective equipment.<br />

MAJOR SPILLS<br />

■ Moderate hazard.<br />

• Clear area of personnel and move upwind.<br />

• Alert Fire Brigade and tell them location and nature of hazard.<br />

• Wear breathing apparatus plus protective gloves.<br />

• Prevent, by any means available, spillage from entering drains or water course.<br />

Personal Protective Equipment advice is contained in Section 8 of the <strong>MSDS</strong>.<br />

continued...


DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 3 of 6<br />

Section 7 - HANDLING AND STORAGE<br />

PROCEDURE FOR HANDLING<br />

• DO NOT allow clothing wet with material to stay in contact with skin.<br />

• Avoid all personal contact, including inhalation.<br />

• Wear protective clothing when risk of exposure occurs.<br />

• Use in a well-ventilated area.<br />

• Prevent concentration in hollows and sumps.<br />

SUITABLE CONTAINER<br />

• Packaging as recommended by manufacturer.<br />

STORAGE INCOMPATIBILITY<br />

• Avoid storage with reducing agents.<br />

STORAGE REQUIREMENTS<br />

• Store in original containers.<br />

• Keep containers securely sealed.<br />

• No smoking, naked lights or ignition sources.<br />

• Store in a cool, dry, well-ventilated area.<br />

Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION<br />

EXPOSURE CONTROLS<br />

The following materials had no OELs on our records<br />

• lignocaine: CAS:137- 58- 6<br />

• prilocaine: CAS:721- 50- 6<br />

• water: CAS:7732- 18- 5<br />

PERSONAL PROTECTION<br />

RESPIRATOR<br />

Particulate<br />

EYE<br />

• Safety glasses with side shields.<br />

• Chemical goggles.<br />

• Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document, describing the<br />

wearing of lens or restrictions on use, should be created for each workplace or task. This should include a review of lens absorption and<br />

adsorption for the class of chemicals in use and an account of injury experience. Medical and first-aid personnel should be trained in their<br />

removal and suitable equipment should be readily available. In the event of chemical exposure, begin eye irrigation immediately and remove contact<br />

lens as soon as practicable. Lens should be removed at the first signs of eye redness or irritation - lens should be removed in a clean environment<br />

only after workers have washed hands thoroughly. [CDC NIOSH Current Intelligence Bulletin 59].<br />

HANDS/FEET<br />

■ NOTE:<br />

• The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and other protective equipment, to<br />

avoid all possible skin contact.<br />

• Contaminated leather items, such as shoes, belts and watch-bands should be removed and destroyed.<br />

• Impervious gloves.<br />

OTHER<br />

• Overalls.<br />

• P.V.C. apron.<br />

• Barrier cream.<br />

• Skin cleansing cream.<br />

■ None under normal operating conditions.<br />

ENGINEERING CONTROLS<br />

■ Local exhaust ventilation usually required. If risk of overexposure exists, wear approved respirator.<br />

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES<br />

APPEARANCE<br />

Clear odourless liquid; mixes with water.<br />

PHYSICAL PROPERTIES<br />

Liquid.<br />

continued...


DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 4 of 6<br />

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES<br />

Mixes with water.<br />

State Liquid Molecular Weight Not Available<br />

Melting Range (°C) Not Available Viscosity Not Available<br />

Boiling Range (°C) Not Available Solubility in water (g/L) M iscible<br />

Flash Point (°C) Not Available pH (1% solution) Not Availabl e<br />

Decomposition Temp (°C) Not Available pH (as supplied) 3.3- 5.5<br />

Autoignition Temp (°C) Not Available Vapour Pressure (kPa) Not Available<br />

Upper Explosive Limit (%) Not Available Specific Gravity (water=1) 1.0<br />

Lower Explosive Limit (%) Not Available Relative Vapour Density Not Available<br />

(air=1)<br />

Volatile Component (%vol) Not Available Evaporation Rate Not Available<br />

Section 10 - CHEMICAL STABILITY AND REACTIVITY INFORMATION<br />

CONDITIONS CONTRIBUTING TO INSTABILITY<br />

• Presence of incompatible materials.<br />

• Product is considered stable.<br />

• Hazardous polymerisation will not occur.<br />

For incompatible materials - refer to Section 7 - Handling and Storage.<br />

Section 11 - TOXICOLOGICAL INFORMATION<br />

POTENTIAL HEALTH EFFECTS<br />

ACUTE HEALTH EFFECTS<br />

■ May produce discomfort of the eyes, respiratory<br />

tract and skin*.<br />

■ * (limited evidence).<br />

CHRONIC HEALTH EFFECTS<br />

■ May cause SENSITISATION by skin contact.<br />

■ Limited evidence of a carcinogenic<br />

effect.<br />

■ Cumulative effects may result following<br />

exposure*.<br />

■ * (limited evidence).<br />

TOXICITY AND IRRITATION<br />

PRILOCAINE:<br />

LIGNOCAINE:<br />

■ unless otherwise specified data extracted from RTECS - Register of Toxic Effects of Chemical Substances.<br />

■ unless otherwise specified data extracted from RTECS - Register of Toxic Effects of Chemical Substances.<br />

■ Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of contact eczema<br />

involves a cell-mediated (T lymphocytes) immune reaction of the delayed type.<br />

Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a non-allergenic condition known<br />

as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high levels of highly irritating compound.<br />

LIGNOCAINE:<br />

TOXICITY<br />

Oral (rat) LD50: 317 mg/kg<br />

Subcutaneous (rat) LD50: 335 mg/kg<br />

Intravenous (Human) TDLo: 16 mg/kg<br />

Intravenous (Human) TDLo: 23 mg/kg<br />

Oral (Mouse) LD50: <strong>22</strong>0 mg/kg<br />

Intraperitoneal (Mouse) LD50: 102 mg/kg<br />

Subcutaneous (Mouse) LD50: 238 mg/kg<br />

Oral (Human) TDLo: 39 mg/kg<br />

Oral (Human) TDLo: 300 mg/kg<br />

Intraperitoneal (Rat) LD50: 133 mg/kg<br />

Intravenous (Rat) LD50: 18 mg/kg<br />

Intravenous (Rabbit) LD: 41 mg/kg<br />

Subcutaneous (Guinea pig) LD50: 120 mg/kg<br />

Intravenous (Guinea pig) LD: 65 mg/kg<br />

Dermal (Rabbit) TDLo: 0.024 mg/kg<br />

Intravenous (Mouse) LD50: 39.4 mg/kg<br />

IRRITATION<br />

Nil Reported<br />

PRILOCAINE:<br />

TOXICITY<br />

Intraperitoneal (rat) LD50: 148 mg/kg<br />

Subcutaneous (rat) LD50: 790 mg/kg<br />

Intravenous (rat) LD50: 56.6 mg/kg<br />

Intraperitoneal (mouse) LD50: 30 mg/kg<br />

IRRITATION<br />

continued...


DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 5 of 6<br />

Section 11 - TOXICOLOGICAL INFORMATION<br />

Subcutaneous (mouse) LD50: 632 mg/kg<br />

Intravenous (mouse) LD50: 55 mg/kg<br />

Intravenous (rabbit) LD50: 18 mg/kg<br />

Intratracheal (rabbit) LD50: 65 mg/kg<br />

■ Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of contact eczema<br />

involves a cell-mediated (T lymphocytes) immune reaction of the delayed type.<br />

for prilocaine hydrochloride:<br />

Parenteral (man) LDLo: 12.43 mg/kg/1h - I Nil reported<br />

Altered sleep-time, convulsions recorded.<br />

CARCINOGEN<br />

Anaesthetics, International Agency for Research on Cancer Group 3<br />

volatile<br />

(IARC) - Agents Reviewed by the IARC<br />

Monographs<br />

No data<br />

Section 12 - ECOLOGICAL INFORMATION<br />

Ecotoxicity<br />

Ingredient Persistence: Persistence: Air Bioaccumulation Mobility<br />

Water/Soil<br />

lignocaine HIGH LOW MED<br />

prilocaine HIGH LOW MED<br />

water LOW LOW HIGH<br />

Section 13 - DISPOSAL CONSIDERATIONS<br />

• Containers may still present a chemical hazard/ danger when empty.<br />

• Return to supplier for reuse/ recycling if possible.<br />

Otherwise:<br />

• If container can not be cleaned sufficiently well to ensure that residuals do not remain or if the container cannot be used to store the same<br />

product, then puncture containers, to prevent re-use, and bury at an authorised landfill.<br />

• Where possible retain label warnings and <strong>MSDS</strong> and observe all notices pertaining to the product.<br />

Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating in their<br />

area.<br />

A Hierarchy of Controls seems to be common - the user should investigate:<br />

• Reduction.<br />

Consult State Land Waste Management Authority for disposal.<br />

Section 14 - TRANSPORTATION INFORMATION<br />

HAZCHEM:<br />

None (ADG7)<br />

NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS: ADG7, UN, IATA, IMDG<br />

Section 15 - REGULATORY INFORMATION<br />

POISONS SCHEDULE<br />

S2<br />

REGULATIONS<br />

Regulations for ingredients<br />

lignocaine (CAS: 137-58-6) is found on the following regulatory lists;<br />

"Australia Inventory of Chemical Substances (AICS)"<br />

prilocaine (CAS: 721-50-6) is found on the following regulatory lists;<br />

"Australia Inventory of Chemical Substances (AICS)"<br />

TAP WATER (CAS: 7732-18-5) is found on the following regulatory lists;<br />

"Australia Inventory of Chemical Substances (AICS)","IMO IBC Code Chapter 18: List of products to which the Code does not apply","OECD Representative<br />

List of High Production Volume (HPV) Chemicals"<br />

continued...


DENTSPLY ORAQIX<br />

<strong>Chemwatch</strong> Independent Material Safety Data Sheet<br />

Issue Date: 25-Nov-2009 CHEMWATCH <strong>22</strong>-<strong>5369</strong><br />

C9317TC<br />

Version No:2.0<br />

CD 2010/2 Page 6 of 6<br />

Section 15 - REGULATORY INFORMATION<br />

No data for <strong>Dentsply</strong> Oraqix (CW: <strong>22</strong>-<strong>5369</strong>)<br />

Section 16 - OTHER INFORMATION<br />

Denmark Advisory list for selfclassification of dangerous substances<br />

Substance CAS Suggested codes<br />

lignocaine 137- 58- 6 Xn Carc3; R40<br />

prilocaine 721- 50- 6 Xn Carc3; R40<br />

■ Classification of the preparation and its individual components has drawn on official and authoritative sources as well as independent review by<br />

the <strong>Chemwatch</strong> Classification committee using available literature references.<br />

A list of reference resources used to assist the committee may be found at:<br />

www.chemwatch.net/references.<br />

■ The (M)SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards<br />

are Risks in the workplace or other settings.<br />

This document is copyright. Apart from any fair dealing for the purposes of private study, research, review or<br />

criticism, as permitted under the Copyright Act, no part may be reproduced by any process without written<br />

permission from CHEMWATCH. TEL (+61 3) 9572 4700.<br />

Issue Date: 25-Nov-2009<br />

Print Date: 8-Jul-2010<br />

This is the end of the <strong>MSDS</strong>.

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