company information xylan® 8110/d0378 white #910 company … sds/sds... · company information...

1 – IDENTIFICATION

PRODUCT NAME: XYLAN® 8110/D0378 WHITE #910

CODE: D0378

PRODUCT USE: Orthodontic Archwire and Auxiliary Coating

2 – HAZARDS IDENTIFICATION

OSHA/HCS STATUSThis material is considered hazardous by the OSHA Hazard Communica-tion Standard (29 CFR 1910.1200).

CLASSIFICATION OF THE SUBSTANCE OR MIXTURE:FLAMMABLE LIQUIDS - CATEGORY 2SERIOUS EYE DAMAGE/ EYE IRRITATION - CATEGORY 2ASKIN SENSITIZATION - CATEGORY 1CARCINOGENICITY - CATEGORY 2

GHS LABEL ELEMENTS:HAZARD PICTOGRAMS

SINGLE WORD: Danger

HAZARD STATEMENTS: Highly fl ammable liquid and vapor. Causes serious eye irritation. May cause an allergic skin reaction. Suspected of causing cancer.

PRECAUTIONARY STATEMENTS:PREVENTION:Obtain special instructions before use. Do not handle until all safety pre-cautions have been read and understood. Use personal protective equip-ment as required. Wear protective gloves. Wear eye or face protection. Keep away from heat, sparks, open fl ames and hot surfaces. - No smok-ing. Use explosion-proof electrical, ventilating,lighting and all material-handling equipment. Use only non-sparking tools. Take precautionary measures against static discharge. Keep container tightly closed. Avoid breathing vapor. Wash hands thoroughly after handling. Contaminated work clothing should not be allowed out of the workplace.

RESPONSE: If exposed or concerned: Get medical attention. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water or shower. IF ON SKIN:Wash with plenty of soap and water. If skin irritation or rash occurs: Get medical attention. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention.

STORAGE: Store locked up. Store in a well-ventilated place. Keep cool.

DISPOSAL: Dispose of contents and container in accordance with all local, regional, national and international regulations.Ingestion is not a typical route of industrial exposure.

HAZARDS NOT OTHERWISE CLASSIFIED: None known

COMPANY INFORMATIONCOMPANY NAME: ORTHO SPECIALTIESCOMPANY ADDRESS: 3820 OHIO AVE - SUITE 15 ST. CHARLES, IL 60174

COMPANY PHONE: 630-443-0225COMPANY FAX: 630-443-0224COMPANY WEB ADDRESS: www.orthospecialties.com

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DOCUMENT NUMBER: SDS8

REVISION DATE: 06/03/2014

REVISION: REV. D

NUMBER OF PAGES: 14

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SDS8 Printed: 06.04.2014 3:44PM This Document is uncontrolled in print form. of 14

3 – COMPOSITION / INFORMATION ON INGREDIENTS

SUBSTANCE/MIXTURE: Mixture

INGREDIENT NAME % BY WEIGHT CAS NUMBER

N-methyl-2-pyrrolidone 30 - 60 872-50-4titanium dioxide 5 - 10 13463-67-7xylene 5 - 10 1330-20-74-methylpentan-2-one 1 - 5 108-10-1ethylbenzene 1 - 5 100-41-4Solvent naphtha (petroleum), light arom 1 - 5 64742-95-6dipentene 0.1 - 1 138-86-3

Occupational exposure limits, if available, are listed in Section 8.

4– FIRST AID MEASURES

DESCRIPTION OF NECESSARY FIRST AID MEASURES:INHALATION:Remove victim to fresh air and keep at rest in a position comfortable for breathing. If not breathing, if breathing is irregular or if respiratory arrest oc-curs, provide artifi cial respiration or oxygen by trained personnel. It may be dangerous to the person providing aid to give mouth-to-mouth resuscita-tion. Get medical attention. 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 fi re, 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 expo-sure. Wash clothing before reuse. Clean shoes thoroughly before reuse.

EYE CONTACT:Immediately fl ush 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.

INGESTION: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 mate-rial has been swallowed and the exposed person is conscious, give small quantities of water to drink. Stop if the exposed person feels sick as vomit-ing 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. Get medical attention. 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.

5 – FIRE-FIGHTING MEASURES

EXTINGUISHING MEDIA

SUITABLE EXTINGUISHING MEDIA: Use dry chemical, CO�, water spray (fog) or foam.

UNSUITABLE EXTINGUISHING MEDIA:Do not use water jet.

SPECIFIC HAZARDS ARISING FROM THE CHEMICAL:Highly fl ammable liquid and vapor. In a fi re or if heated, a pressure increase will occur and the container may burst, with the risk of a subsequent explo-sion. Runoff to sewer may create fi re or explosion hazard.

NATIONAL FIRE PROTECTION ASSOCIATION (U.S.A.)

HEALTH

FLAMMABILITY

INSTABILITY/REACTIVITY

SPECIAL

HAZARDOUS THERMAL DECOMPOSITION PRODUCTS:Decomposition products may include the following materials:carbon dioxidecarbon monoxidenitrogen oxideshalogenated compoundsmetal oxide/oxides

SPECIAL PROTECTIVE ACTIONS FOR FIRE-FIGHTERS:Promptly isolate the scene by removing all persons from the vicinity of the incident if there is a fi re. No action shall be taken involving any personal risk or without suitable training. Move containers from fi re area if this can be done without risk. Use water spray to keep fi re-exposed containers cool.

SPECIAL PROTECTIVE EQUIPMENT FOR FIRE-FIGHTERS:Fire-fi ghters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.

6 – ACCIDENTAL RELEASE MEASURES

PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT ANDEMERGENCY PROCEDURES:

FOR NON-EMERGENCY PERSONNEL:No action shall be taken involving any personal risk or without suitable train-ing.Evacuate surrounding areas. Keep unnecessary and unprotected per-sonnel from entering. Do not touch or walk through spilled material. Shut off all ignition sources.No fl ares, smoking or fl ames in hazard area. Avoid breathing vapor or mist. Provide adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal protective equipment.

4– FIRST AID MEASURES continued...

MOST IMPORTANT SYMPTOMS/EFFECTS, ACUTE AND DELAYED

POTENTIAL ACUTE HEALTH EFFECTS:

INHALATION: Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.

SKIN CONTACT: May cause an allergic skin reaction.

EYE CONTACT: Causes serious eye irritation.

INGESTION: Irritating to mouth, throat and stomach.

OVER-EXPOSURE SIGNS/SYMPTOMS:

INHALATION: No specifi c data.

SKIN CONTACT: Adverse symptoms may include the following: irritation redness

EYE CONTACT: Adverse symptoms may include the following: pain or irritation watering redness

INGESTION: No specifi c data.

INDICATION OF IMMEDIATE MEDICAL ATTENTION AND SPECIAL TREATMENT NEEDED, IF NECESSARY

NOTES TO PHYSICIAN: In case of inhalation of decomposition products in a fi re, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours. Exposure,in suffi cient quantities, to the thermal decomposition vapors of fl uorinated polymers may cause “polymer fume fever” with fl u-like symptoms in humans. The symptoms of “polymer fume fever” are chills / fever / chest pains / shortness of breath / coughing. The symptoms usually pass in 48 to 72 hours and have no lasting or cumulative effect.

SPECIFIC TREATMENTS: No specifi c treatment.

See toxicological information (Section 11)






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6 – ACCIDENTAL RELEASE MEASURES Continued...

FOR EMERGENCY PERSONNEL:If specialised clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in “For non-emergency personnel”.

ENVIRONMENTAL PRECAUTIONS:Avoid dispersal of spilled material and runoff and contact with soil, water-ways, 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:Stop leak if without risk. Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Dilute with water and mop up if water-soluble. Alternatively,or if water-insoluble, absorb with an inert dry material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor.

LARGE SPILL:Stop leak if without risk. Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Approach release from upwind. Prevent entry into sewers,water courses, basements or confi ned areas. Wash spillages into an effl uent treatment plant or proceed as follows. Contain and collect spillage with non-combustible,absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13). Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilled product. Note: see Section 1 for emergency contact information and Section 13 for waste disposal. Spill-age onto the outside of container will make the container slippery. Hazard of slipping on spilled product.

7 – HANDLING AND STORAGE

CONDITIONS FOR SAFE STORAGE,INCLUDING ANY INCOMPATIBILITIES:Store between the following temperatures: 5 to 30°C (41 to 86°F). Store in accordance with local regulations. Store in a segregated and approved area. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Store locked up.Eliminate all ignition sources. Separate from oxidizing materials. 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 unlabeled containers. Use appropriate containment to avoid environmen-tal contamination.






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PRECAUTIONS FOR SAFE HANDLING:

PROTECTIVE MEASURES:Put on appropriate personal protective equipment (see Section 8). 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 in-structions before use. 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. Avoid breathing vapor or mist. Use only with adequate ventilation. Wear appropriate respirator when ventilation is inadequate. Do not enter storage areas and confi ned spaces unless adequately ventilated. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Store and use away from heat, sparks, open fl ame or any other ignition source. Use explosion-proof electrical (ventilating, lighting and material handling) equipment. Use only non-sparking tools. Take precautionary measures against electrostatic discharges. Empty containers retain product residue and can be hazard-ous. 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 cloth-ing and protective equipment before entering eating areas. Contamination of tobacco products must be avoided. Polymer Fume fever is particularly associated with the smoking of contaminated tobacco products. See also Section 8 for additional information on hygiene measures.

8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

CONTROL PARAMETERS:OCCUPATIONAL EXPOSURE LIMITS:

INGREDIENT NAME CAS# EXPOSURE LIMITS

N-methyl-2-pyrrolidone 872-50-4 AIHA WEEL (United States,10/2011). Absorbed through skin. TWA: 10 ppm 8 hours.titanium dioxide 13463-67-7 ACGIH TLV (United States, 3/2012). TWA: 10 mg/m³ 8 hours. OSHA PEL 1989 (United States, 3/1989). TWA: 10 mg/m³ 8 hours. Form: Total dust OSHA PEL (United States, 6/2010). TWA: 15 mg/m³ 8 hours. Form: Total dustxylene 1330-20-7 ACGIH TLV (United States, 3/2012). TWA: 100 ppm 8 hours. TWA: 434 mg/m³ 8 hours. STEL: 150 ppm 15 minutes. STEL: 651 mg/m³ 15 minutes. OSHA PEL 1989 (United States, 3/1989). TWA: 100 ppm 8 hours. TWA: 435 mg/m³ 8 hours. STEL: 150 ppm 15 minutes. STEL: 655 mg/m³ 15 minutes. OSHA PEL (United States, 6/2010). TWA: 100 ppm 8 hours. TWA: 435 mg/m³ 8 hours.4-methylpentan-2-one 08-10-1 ACGIH TLV (United States, 3/2012). TWA: 20 ppm 8 hours. STEL: 75 ppm 15 minutes. OSHA PEL 1989 (United States, 3/1989). TWA: 50 ppm 8 hours. TWA: 205 mg/m³ 8 hours. STEL: 75 ppm 15 minutes. STEL: 300 mg/m³ 15 minutes. NIOSH REL (United States, 1/2013). TWA: 50 ppm 10 hours. TWA: 205 mg/m³ 10 hours. STEL: 75 ppm 15 minutes. STEL: 300 mg/m³ 15 minutes. OSHA PEL (United States, 6/2010). TWA: 100 ppm 8 hours. TWA: 410 mg/m³ 8 hours.ethylbenzene 100-41-4 ACGIH TLV (United States, 3/2012). TWA: 20 ppm 8 hours. OSHA PEL 1989 (United States, 3/1989). TWA: 100 ppm 8 hours. TWA: 435 mg/m³ 8 hours. STEL: 125 ppm 15 minutes. STEL: 545 mg/m³ 15 minutes. NIOSH REL (United States, 1/2013). TWA: 100 ppm 10 hours. TWA: 435 mg/m³ 10 hours. STEL: 125 ppm 15 minutes. STEL: 545 mg/m³ 15 minutes. OSHA PEL (United States, 6/2010). TWA: 100 ppm 8 hours. TWA: 435 mg/m³ 8 hours.






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8 – EXPOSURE CONTROLS / PERSONAL PROTECTION Continued...

CONTROL PARAMETERS:OCCUPATIONAL EXPOSURE LIMITS:

INGREDIENT NAME CAS# EXPOSURE LIMITS

Solvent naphtha (petroleum), light arom. 64742-95-6 NIOSH REL (United States, 1/2013). TWA: 5 mg/m³ 10 hours. Form: Mist STEL: 10 mg/m³ 15 minutes. Form: Mistdipentene 138-86-3 AIHA WEEL (United States, 10/2011). TWA: 30 ppm 8 hours.

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. The engineering controls also need to keep gas,vapor or dust concentrations below any lower explosive limits. Use explosion-proof ventilation equipment.

ENVIRONMENTAL EXPOSURE CONTROLS:Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legis-lation. In some cases, fume scrubbers, fi lters or engineering modifi cations to the process equipment will be necessary to reduce emissions to acceptable levels.

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.

RESPIRATORY PROTECTION:Use a properly fi tted, air-purifying or air-fed respirator complying with an approved standard if a risk assessment indicates this is necessary. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator.

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 assess-ment indicates this is necessary. Considering the parameters specifi ed 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. When there is a risk of ignition from static electricity, wear anti-static protective clothing. For the greatest protec-tion from static discharges, clothing should include anti-static overalls, boots and gloves.

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.

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 pro-tection: chemical splash goggles.

9 – PHYSICAL AND CHEMICAL PROPERTIES

Physical state: Liquid. [Viscous Liquid.]Color: White.Odor: Amine-like.Odor Threshold: Not Available.pH: Not Available.Melting Point: Not Available.Boiling Point: 116 to 204°C (240.8 to 399.2°F) Flash Point: Closed cup: 16°C (60.8°F) [Setafl ash.]Evaporation Rate: <1 (ether (anhydrous) = 1)Flammability (solid, gas): Not available.Lower and Upper Explosive Lower: 0.9%(Flammable) Limits: Upper: 11.5%Vapor Pressure: Not available.Vapor Density: Not available.Relative Density: 1.19Solubility: Not available.Solubility in Water: Not available. Auto-Ignition Temperature: Not available.Decomposition Temperature: Not available.Viscosity: Not available.

10 – STABILITY AND REACTIVITY

REACTIVITY:No specifi c test data related to reactivity available for this product or its ingredients.

CHEMICAL STABILITY:The product is stable.

POSSIBILITY OF HAZARDOUS REACTIONS:Under normal conditions of storage and use, hazardous reactions will not occur.

CONDITIONS TO AVOID:Avoid all possible sources of ignition (spark or fl ame). Do not pressurize, cut, weld,braze, solder, drill, grind or expose containers to heat or sources of ignition.

INCOMPATIBLE MATERIALS:Reactive or incompatible with the following materials:oxidizing materials.

HAZARDOUS DECOMPOSITION PRODUCTS:The fl uoropolymer resins used in this coating begin to decompose, very slowly, at temperatures above 625°F (330°C). Thermal decomposition is more rapid at temperatures above 750°F (400°C). Above 800°F (425°C) fl uoropolymer resins give off small amounts of tetrafl uoroethylene / hexafl uoropro-pylene / perisofl uorobutylene /carbonyl fl uoride / hydrogen fl uoride. These are toxic and if inhaled, in suffi cient quantities, may be harmful. The actual decomposition products depend on temperature and the amount of oxygen.






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11 – TOXICOLOGICAL INFORMATION

Information on toxicological effects:Acute toxicity:

PRODUCT / INGREDIENT NAME RESULT SPECIES DOSE EXPOSURE

N-methyl-2-pyrrolidone LD50 Derma Rabbit 8 g/kg - LD50 Oral Rat 3914 mg/kg -xylene LC50 Inhalation Gas. Rat 5000 ppm 4 hours LD50 Oral Rat 4300 mg/kg -4-methylpentan-2-one LD50 Oral Rat 2080 mg/kg - ethylbenzene LD50 Dermal Rabbit >5000 mg/kg - LD50 Oral Rat 3500 mg/kg -Solvent naphtha (petroleum), LD50 Oral Rat 8400 mg/kg - light arom. dipentene LD50 Oral Rat 5300 mg/kg -

Irritation/Corrosion:

PRODUCT / INGREDIENT NAME RESULT SPECIES SCORE EXPOSURE OBSERVATION

N-methyl-2-pyrrolidone Eyes - Moderate irritant Rabbit - 100 milligrams -

titanium dioxide Skin - Mild irritant Human - 72 hours 300 Micrograms Intermittent -

xylene Eyes - Mild irritant Rabbit - 87 milligrams - Eyes - Severe irritant Rabbit - 24 hours 5 milligrams - Skin - Mild irritant Rat - 8 hours 60 microliters -

Skin - Moderate irritant Rabbit - 24 hours 500 milligrams - Skin - Moderate irritant Rabbit - 100 Percent -

4-methylpentan-2-one Eyes - Moderate irritant Rabbit - 24 hours 100 microliters - Eyes - Severe irritant Rabbit - 40 milligrams - Skin - Mild irritant Rabbit - 24 hours 500 milligrams -

ethylbenzene Eyes - Severe irritant Rabbit - 500 milligrams -

Skin - Mild irritant Rabbit - 24 hours 15 milligrams -

Solvent naphtha (petroleum), Eyes - Mild irritant Rabbit - 24 hours 100 microliters - light arom.

dipentene Skin - Moderate irritant Rabbit - 24 hours 500 milligrams -

Sensitization:No specifi c data.

Mutagenicity:No specifi c data.






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11 – TOXICOLOGICAL INFORMATION Continued...

Carcinogenicity:No specifi c data.

Classifi cation:

PRODUCT / INGREDIENT NAME OSHA IARC NTP

titanium dioxide - 2B -xylene - 3 -4-methylpentan-2-one - 2B -ethylbenzene - 2B -

Reproductive Toxicity:No specifi c data.

Teratogenicity:No specifi c data.

Specifi c target organ toxicity (single exposure):

NAME CATEGORY ROUTE OF EXPOSURE TARGET ORGANS

4-methylpentan-2-one Category 3 Not Applicable Respiratory Tract Irritation

Specifi c target organ toxicity (repeated exposure):

NAME RESULT

ethylbenzene ASPIRATION HAZARD - Category 1Solvent naphtha (petroleum), light arom. ASPIRATION HAZARD - Category 1 dipentene ASPIRATION HAZARD - Category 1

INFORMATION ON THE LIKELY ROUTES OF EXPOSURE: Not Available

Potential acute health effects:

EYE CONTACT: Causes serious eye irritation.INHALATION: Exposure to decomposition products may cause a health hazard. Serious effects may be delayed following exposure.SKIN CONTACT: May cause an allergic skin reaction.INGESTION: Irritating to mouth, throat and stomach.

Symptoms related to the physical, chemical and toxicological characteristics:

EYE CONTACT: Adverse symptoms may include the following: pain or irritation watering rednessINHALATION: No specifi c data.SKIN CONTACT: Adverse symptoms may include the following: irritation rednessINGESTION: No specifi c data.

11 – TOXICOLOGICAL INFORMATION Continued...

Delayed and immediate effects and also chronic effects from short and long term exposure

Short term exposure:Potential immediate effects: Not Available.Potential delayed effects: Not Available.

Long term exposure:Potential immediate effects: Not Available.Potential delayed effects: Not Available.

Potential chronic health effects:No specifi c data.

GENERAL: Once sensitized, a severe allergic reaction may occur when subsequently exposed to very low levels. CARCINOGENICITY: Suspected of causing cancer. Risk of cancer depends on duration and level of exposure..MUTAGENICITY: No known signifi cant effects or critical hazards.TERATOGENICITY: No known signifi cant effects or critical hazards.DEVELOPMENTAL EFFECTS: No known signifi cant effects or critical hazards.FERTILITY EFFECTS: No known signifi cant effects or critical hazards.






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Numerical measures of toxicity

Acute toxicity estimates:

ROUTE ATE Value

Oral 4037.7 mg/kgInhalation (gases) 47403.3 ppmInhalation (vapors) 264.1 mg/l

12 – ECOLOGICAL INFORMATION


PRODUCT / INGREDIENT NAME RESULT SPECIES EXPOSURE

titanium dioxide Acute LC50 1000000 µg/l Marine water Fish - Fundulus heteroclitus 96 hoursxylene Acute LC50 8.5 ppm Marine water Crustaceans - Palaemonetes pugio - Adult 48 hours

4-methylpentan-2-one Acute LC50 20870 µg/l Fresh water Fish - Lepomis macrochirus 96 hours Acute LC50 505000 µg/l Fresh water Fish - Pimephales promelas 96 hours Chronic NOEC 78 mg/l Fresh water Daphnia - Daphnia magna 21 days Chronic NOEC 168 mg/l Fresh water Fish - Pimephales promelas -Embryo 33 days

ethylbenzene Acute EC50 13300 µg/l Fresh water Crustaceans - Artemia sp. -Nauplii 48 hours Acute LC50 13900 µg/l Fresh water Daphnia - Daphnia magna -Neonate 48 hours

dipentene Acute EC50 28.2 µg/l Fresh water Daphnia - Daphnia magna 48 hours Acute EC50 20.2 µg/l Fresh water Fish - Pimephales promelas 96 hours






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12 – ECOLOGICAL INFORMATION Continued...

Persistence and degradabilityNo specifi c data.

Bioaccumulative potential:

PRODUCT / INGREDIENT NAME LogPOW BCF POTENTIAL

N-methyl-2-pyrrolidone -0.38 - lowtitanium dioxide - 352 lowxylene 3.12 8.1 to 25.9 low 4-methylpentan-2-one 1.31 - lowSolvent naphtha (petroleum), - 10 lowlight arom.dipentene 4.57 - high

MOBILITY IN SOIL:

SOIL/WATER PARTITION COEFFICIENT (KOC): Not Available.

OTHER ADVERSE EFFECTS: No known signifi cant effects or critical hazards.

13 – DISPOSAL CONSIDERATIONS

DISPOSAL METHODS:The generation of waste should be avoided or minimized 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 non-recyclable 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. Waste packaging should be recycled. Incineration or landfi ll should only be considered when recycling is not feasible. 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. Vapor from product residues may create a highly fl ammable or explosive atmosphere inside the container. Do not cut, weld or grind used containers unless they have been cleaned thoroughly internally. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.

RCRA CLASSIFICATION: D001 [Ignitable materials]






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11 – TRANSPORTATION INFORMATION


DOT TDG MEXICO CLASSIFICATION CLASSIFICATION CLASSIFICATION IMDG IATA

UN NUMBER UN1139 UN1139 UN1139 UN1139 UN1139

UN PROPER COATING SOLUTION COATING SOLUCIONES PARA COATING COATINGSHIPPING NAME RQ(XYLENE) SOLUTION REVESTIMIENTOS SOLUTION SOLUTION

TRANSPORT 3 3 3 3 3 HAZARD CLASS(ES)

PACKING GROUP II II II II II

ENVIORNMENTAL No. No. No. No. No.HAZARDS

ADDITIONAL Reportable Explosive Limit - Emergency Passenger andINFORMATION quantity and Limited schedules (EmS) Cargo Aircraft 1470.6 lbs / 667. Quantity Index F-E, _S-E_ Quantity limitation: 67 kg [148.22 gal / 5 5 L 561.07 L] Packaging Package sizes Passenger instructions: 353 shipped in quantities less Carrying Road or Cargo Aircraft than the product Rail Index Only Quantity reportable quantity 5 limitation: 60 L are not subject to Packaging the RQ instructions: 364 (reportable quantity) Limited Quantities transportation - Passenger requirements. Aircraft Quantity limitation: 1 L Limited quantity Packaging Yes. instructions: Y341 Packaging instruction Passenger aircraft Quantity limitation: 5 L

Cargo aircraft Quantity limitation: 60 L

Special provisions 149, IB2, T4, TP1,TP8

SPECIAL PRECAUTIONS FOR USER: 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.

15 – REGULATORY INFORMATION U.S. FEDERAL REGULATIONS: TSCA 4(a) fi nal test rules: Ethene, 1,1,2,2-tetrafl uoro-, homopolymer;4-methylpentan-2-one TSCA 8(a) CDR Exempt/Partial exemption: Not determined TSCA 12(b) one-time export: Ethene, 1,1,2,2-tetrafl uoro-, homopolymer United States inventory (TSCA 8b): All components are listed or exempted. Clean Water Act (CWA) 307: ethylbenzene Clean Water Act (CWA) 311: xylene; ethylbenzene

CLEAN AIR ACT SECTION 112 Listed(B) HAZARDOUS AIRPOLLUTANTS (HAPS)

CLEAN AIR ACT SECTION 602 Not ListedCLASS I SUBSTANCES

CLEAN AIR ACT SECTION 602 Not ListedCLASS II SUBSTANCES

SARA 302/304COMPOSITION/INFORMATION ON INGREDIENTSNo Products Were Found.

SARA 304 RQ Not Applicable

SARA 311/312CLASSIFICATION Fire hazard Immediate (acute) health hazard Delayed (chronic) health hazard

COMPOSITION/INFORMATION ON INGREDIENTS






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XYLAN® 8110/D0378 WHITE #910


NAME % FIRE SUDDEN REACTIVE IMMEDIATE DELAYED HAZARD RELEASE OF (ACUTE) (CHRONIC) PRESSURE HEALTH HAZARD HEALTH HAZARD

N-methyl-2-pyrrolidone 30 - 60 No. No. No. Yes. Yes. titanium dioxide 5 - 10 No. No. No. No. Yes.xylene 5 - 10 Yes. No. No. Yes. No.4-methylpentan-2-one 1 - 5 Yes. No. No. Yes. No.ethylbenzene 1 - 5 Yes. No. No. Yes. Yes.Solvent naphtha (petroleum), 1 - 5 Yes. No. No. No. No.light arom.dipentene 0.1 - 1 Yes. No. No. Yes. No.


15 – REGULATORY INFORMATION Continued...

SARA 313:

PRODUCT NAME CAS NUMBER %

Form R - Reporting requirements N-methyl-2-pyrrolidone 872-50-4 30 - 60 xylene 1330-20-7 5 - 10 4-methylpentan-2-one 108-10-1 1 - 5 ethylbenzene 100-41-4 1 - 5

SARA 313 notifi cations must not be detached from the SDS and any copying and redistribution of the SDS shall include copying and redistribution of the notice attached to copies of the SDS subsequently redistributed.

STATE REGULATIONS

MASSACHUSETTS The following components are listed: 1-METHYL-2-PYRROLIDONE; XYLENE; ETHYL BENZENE; TITANIUM DIOXIDE; METHYL ISOBUTYL KETONE

NEW YORK The following components are listed: Xylene (mixed); Ethylbenzene; Methyl isobutyl ketone; Hexone

NEW JERSEY The following components are listed: 1-METHYL-2-PYRROLIDONE;2-PYRROLIDINONE, 1-METHYL-; XYLENES; BENZENE, DIMETHYL-; ETHYL BENZENE; BENZENE, ETHYL-; MINERAL OIL (UNTREATED and MILDLY TREATED);TITANIUM DIOXIDE; TITANIUM OXIDE (TiO2); METHYL ISOBUTYL KETONE;2-PENTANONE, 4-METHYL-

PENNSYLVANIA The following components are listed: 2-PYRROLIDINONE, 1-METHYL-; ETHENE,TETRAFLUORO-, HOMOPOLYMER; BENZENE, DIMETHYL-; BENZENE, ETHYL-;TITANIUM OXIDE (TIO2); 2-PENTANONE, 4-METHYL-

MINNESOTA HAZARDOUS None of the components are listed.SUBSTANCES

CALIFORNIA PROP. 65 WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.




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XYLAN® 8110/D0378 WHITE #910COMPANY INFORMATIONCOMPANY NAME: ORTHO SPECIALTIESCOMPANY ADDRESS: 3820 OHIO AVE - SUITE 15 ST. CHARLES, IL 60174



INGREDIENT NAME CANCER REPRODUCTIVE NO SIGNIFICANT MAXIMUM ACCEPTABLE RISK LEVEL DOSAGE LEVEL

N-methyl-2-pyrrolidone No. Yes. No. 3200 µg/day (inhalation)titanium dioxide Yes. No. No. No.4-methylpentan-2-one Yes. No. No. No.ethylbenzene Yes. No. 41 µg/day (ingestion) No. 54 µg/day (inhalation)

CANADA INVENTORY All components are listed or exempted. INTERNATIONAL REGULATIONS

INTERNATIONAL LISTS Australia inventory (AICS): Not determined. China inventory (IECSC): All components are listed or exempted. Japan inventory: All components are listed or exempted. Korea inventory: All components are listed or exempted. Malaysia Inventory (EHS Register): Not determined. New Zealand Inventory of Chemicals (NZIoC): All components are listed or exempted. Philippines inventory (PICCS): All components are listed or exempted. Taiwan inventory (CSNN): Not determined.




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XYLAN® 8110/D0378 WHITE #910COMPANY INFORMATIONCOMPANY NAME: ORTHO SPECIALTIESCOMPANY ADDRESS: 3820 OHIO AVE - SUITE 15 ST. CHARLES, IL 60174



SUBSTANCES OF VERY HIGH CONCERN

INGREDIENT NAME INTRINSIC PROPERTY STATUS REFERENCE DATE OF NUMBER REVISION

N-methyl-2-pyrrolidone Toxic to reproduction Candidate ED/31/2011 6/30/2011

16 – OTHER INFORMATION

KEY TO ABBREVIATIONS ATE = Acute Toxicity Estimate BCF = Bioconcentration Factor GHS = Globally Harmonized System of Classifi cation and Labelling of Chemicals IATA = International Air Transport Association IBC = Intermediate Bulk Container IMDG = International Maritime Dangerous Goods LogPow = logarithm of the octanol/water partition coeffi cient MARPOL 73/78 = International Convention for the Prevention of Pollution From Ships,1973 as modifi ed by the Protocol of 1978. (“Marpol” = marine pollution) UN = United Nations

REFERENCES Indicates information that has changed from previously issued version.

NOTICE TO READER NON-WARRANTY: The information presented in this publication is based upon the research and experience of Whitford. No representation or warranty is made, however, concerning the accuracy or completeness of the information presented in this publication. Whitford makes no warranty or representation of any kind, express or implied, including without limitation any warranty of merchantability or fi tness for any particular purpose, and no warranty or representation shall be implied by law or otherwise. Any products sold by Whitford are not warranted as suitable for any particular purpose to the buyer. The suitability of any products for any purpose particular to the buyer is for the buyer to determine. Whitford assumes no responsibility for the selection of products suitable to the particular purposes of any particular buyer. Whitford shall in no event be liable for any special, incidental,or consequential damages.

SECTION 5 – FIRE AND EXPLOSION HAZARD DATAIGNITION POINT: Not known

FLAMMABLE LIMITS IN AIR (% by volume) N. Av.

EXTINGUISHING MEDIA: Dry table salt, sand or Type D fi re extinguisher

FIRE FIGHTING PROCEDURES: If alloys of small sizes, i.e., foil or fi ne wire, become ignited, it is advisable to allow the material to burn out. Fires can be controlled by smothering with dry table salt, sand or us-ing Type D dry-powder fi re extinguishing material. Do not use water.

UNUSUAL FIRE AND EXPLOSION HAZARDS: Toxic fumes may be evolved in a fi re. Firemen should wear self-contained breathing ap-paratus in enclosed areas.

SECTION 6 – HEALTH HAZARD DATAROUTES OF ENTRY

INHALATION: Yes

INGESTION: No

SKIN ABSORPTION: No

SKIN/EYE CONTACT: No

TARGET ORGANS: None Known

TOXICITY DATA: These alloys are non-toxic. The binary NiTi alloys are used for medical applications within the human body. However, if the alloys are acid-dissolved or treated chemically to form water-soluble compounds of nickel, then the possibly toxic behavior of the resulting water-soluble materials must be considered in any handling, processing, or disposal procedures.

CORROSIVE: No

CARCINOGEN: Not in solid form. Only if Ni ions formed by acid dissolution.

SENSITIZER: No

COMMENTS: None

ACUTE EFFECTS FROM EXPOSURE: None Known

CHRONIC EFFECTS FROM EXPOSURE: None Known

REFERENCES:

Plunkett, Handbook of Industrial Toxicology, 2nd Ed. NIOSH, Regis-try of Toxic Effects of Chemical Substances ITI, Toxic and Hazardous Industrial Chemical Safety Manual CRC Handbook of Chemistry and Physics, 61st Ed. Sax, Dangerous Properties of Industrial Materials, 7th Ed. Encyclopedia of Occupational Health and Safety, 3rd Ed. Patty’s Industrial Hygiene and Toxicology, 3rd Ed., Vol. 2A OSHA Oc-cupational Health Guidelines for Chemical Materials Umetco MSDS for Vanadium Pentoxide.

SECTION 7– EMERGENCY & FIRST AID PROCEDURES

INHALATION: Normal procedure for inert dust.

EYE CONTACT: Normal procedure for foreign object.

SKIN CONTACT: N. Ap.

INGESTION: N. Ap.

SECTION 1 – PRODUCT IDENTIFICATION

PRODUCT NAME: Niti, Nickel Titanium, Shape Memory Alloy, Superelastic Alloy

PRODUCT USE: Orthodontic Wires, Springs, Straights & Spools

SECTION 2 – INGREDIENTS

CHEMICAL COMPONENTS % C.A.S. NO. OSHA EXPOSURE LIMITS (MG/M³)

TWA STELNickel, Ni 35-60 7440-02-0 1 --Titainum, Ti 20-50 7440-32-6 5 as respirable TiO2 dust --Iron 0-6 7439-89-6 10 as FeO2 dust --Hafnium, Hf 0-40 7440-58-6 0.5 as Hf --Copper, Cu 0-15 7440-50-8 1.0 as dust --Vanadium, V 0-10 7440-62-2 0.5 as V2O2 --Niobium, Nb 0-20 7440-03-1 -- --Boron, B 0-1 7440-42-8 -- --

SECTION 3 – PHYSICAL DATABOILING POINT: @760 MM HG N. AP.

VAPOR DENSITY: (Air = 1) N. Ap.

SPECIFIC GRAVITY: (H2O = 1) 5.8 - 7.5

pH of SOLUTIONS: N. Ap.

FREEZING/MELTING POINT: ABOVE 1000°C

SOLUBILITY (Weight % in Water) Insoluble.

BULK DENSITY: 360 - 470 lb/ft3

% VOLATILE BY VOLUME: Nonvolatile

VAPOR PRESSURE: 0 @ 20°C

EVAPORATION RATE: None

HEAT OF SOLUTION: N. Ap.

APPEARANCE and ODOR: Metallic Silver-Gray odorless solids

N. Ap. = Not Applicable N. Av. = Not Available

SECTION 4 – REACTIVITY DATASTABILITY: Stable

HAZARDOUS POLYMERIZATION: Will not occur.

CONDITIONS TO AVOID: Acids amd strong oxidizing agents

INCOMPATIBILITY (Materials to avoid): Nickel-titanium base alloys are attacked by hydrofl uoric acid or hydrohfl uoric-nitric mixtures. Bromine and iodine solutions in methanol attack the alloys.

HAZARDOUS DECOMPOSITION PRODUCTS: Nickel Titanium alloys do not decompose. The above reactions with incompatible materials will generate liquids containing nickel ions in solution that are not considered carcinogenic.






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NICKEL TITANIUM BASE ALLOYS

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SECTION 8 – EMPLOYEE PROTECTION

RESPIRATORY PROTECTION: Wear appropriate NIOSH-approved respi-rator if dust or fume exposure levels are exceeded.

PROTECTIVE CLOTHING: None

EYE PROTECTION: Safety glasses if potentially exposed to fl ying particles.

ADDITIONAL PROTECTIVE MEASURES: None

SECTION 9 – SPECIAL PROCEDURES

PRECAUTIONS TO BE TAKEN DURING HANDLING AND STORAGE:Normally none. Thin foils may have sharp edges.

SECTION 10 – TOXICOLOGICAL INFORMATION

SPILL OR LEAK PROCEDURES: N. Ap.

WASTE DISPOSAL: Fine non recyclable scrap should be placed in a sealed container and should be disposed of in an EPA-approved landfi ll.

ENVIORNMENTAL HAZARDS: None in alloy form.

SECTION 11 – TRANSPORTATION REQUIREMENTS

DEPARTMENT OF TRANSPORTATION CLASSIFICATION: Metal Alloy.

D.O.T. PROPER SHIPPING NAME D.O.T. I.D. NUMBER N. Ap. N. Ap.

SECTION 12 – OTHER REGULATORY CONTROLS






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NICKEL TITANIUM BASE ALLOYS

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