sdb gb sr adoro incisal, dentin, deep dentin, neck ... · page 1/7 safety data sheet according to...

50
Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Revision: 11.04.2013 Version number 3 1 Identification of the substance/mixture and of the company/undertaking · Product identifier · Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal, Special Incisal, Inter Incisal, Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge, Transpa, Transpa Clear, Add-On · Relevant identified uses of the substance or mixture and uses advised against No further relevant information available. · Application of the substance / the preparation Crowns- and bridges material · Details of the supplier of the safety data sheet · Manufacturer/Supplier: Ivoclar Vivadent AG Bendererstrasse 2 FL-9494 Schaan PRINCIPALITY OF LIECHTENSTEIN Tel: +423 235 35 35 Fax: +423 235 33 60 · Further information obtainable from: Regulatory Affairs [email protected] · Emergency telephone number: +423 / 235 33 13 (Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein) 2 Hazards identification · Classification of the substance or mixture · Classification according to Directive 67/548/EEC or Directive 1999/45/EC Xi; Sensitising R43: May cause sensitisation by skin contact. · Classification system: The classification is according to the latest editions of the EU-lists, and extended by company and literature data. · Label elements · Labelling according to EU guidelines: · Code letter and hazard designation of product: Xi Irritant · Hazard-determining components of labelling: urethane dimethacrylate decamethylene dimethacrylate · Risk phrases: 43 May cause sensitisation by skin contact. · Safety phrases: 23 Do not breathe vapour. 24 Avoid contact with skin. (Contd. on page 2) GB

Upload: others

Post on 20-May-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 1/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

36.0.5

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

· Relevant identified uses of the substance or mixture and uses advised againstNo further relevant information available.

· Application of the substance / the preparation Crowns- and bridges material

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

Ivoclar Vivadent AGBendererstrasse 2FL-9494 SchaanPRINCIPALITY OF LIECHTENSTEIN

Tel: +423 235 35 35Fax: +423 235 33 60

· Further information obtainable from:Regulatory [email protected]

· Emergency telephone number: +423 / 235 33 13 (Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein)

2 Hazards identification

· Classification of the substance or mixture

· Classification according to Directive 67/548/EEC or Directive 1999/45/ECXi; Sensitising

R43: May cause sensitisation by skin contact.· Classification system:

The classification is according to the latest editions of the EU-lists, and extended by company and literaturedata.

· Label elements

· Labelling according to EU guidelines:

· Code letter and hazard designation of product:

Xi Irritant

· Hazard-determining components of labelling:urethane dimethacrylatedecamethylene dimethacrylate

· Risk phrases:43 May cause sensitisation by skin contact.

· Safety phrases:23 Do not breathe vapour.24 Avoid contact with skin.

(Contd. on page 2) GB

Page 2: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 2/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 1)

36.0.5

37 Wear suitable gloves.60 This material and its container must be disposed of as hazardous waste.

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:CAS: 72869-86-4EINECS: 276-957-5

urethane dimethacrylate Xi R36; Xi R43R52/53

10-<20%

CAS: 6701-13-9 decamethylene dimethacrylate Xi R36; Xi R43 2.5-10%

CAS: 43048-08-4EINECS: 256-062-6

tricyclodocane dimethanol dimethacrylate Xi R38-41 < 2.5%

· Additional information: For the wording of the listed risk phrases refer to section 16.

4 First aid measures

· Description of first aid measures· After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact: Rinse with water.· After eye contact:

Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.· After swallowing:

Rinse out mouth and then drink plenty of water.If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment needed

No further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.· Special hazards arising from the substance or mixture No further relevant information available.

(Contd. on page 3) GB

Page 3: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 3/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 2)

36.0.5

· Advice for firefighters· Protective equipment: No special measures required.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.· Environmental precautions: Do not allow to enter sewers/ surface or ground water.· Methods and material for containment and cleaning up: Pick up mechanically.· Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling

Only adequately trained personnel should handle this product.For use in dentistry only.

· Information about fire - and explosion protection: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: Store only in the original receptacle.· Information about storage in one common storage facility: Not required.· Further information about storage conditions:

Protect from exposure to the light.Protect from heat and direct sunlight.Keep container tightly sealed.

· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters· Ingredients with limit values that require monitoring at the workplace:

The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Usual hygienic measures for dental practice.Wash hands before breaks and at the end of work.Keep away from foodstuffs, beverages and feed.Avoid contact with the skin.

(Contd. on page 4) GB

Page 4: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 4/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 3)

36.0.5

· Respiratory protection: Not required.· Protection of hands:

Protective gloves

After use of gloves apply skin-cleaning agents and skin cosmetics.· Material of gloves

Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Not suitable are gloves made of the following materials:Commercial medical gloves do not provide protection against the sensitizing effect of methacrylates.

· Eye protection: Safety glasses

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: PastyColour: According to product specification

· Odour: Characteristic· Odour threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not applicable.

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Product does not present an explosion hazard.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapour pressure: Not determined.

· Density: Not determined.· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.

(Contd. on page 5) GB

Page 5: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 5/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 4)

36.0.5

· Solubility in / Miscibility withwater: Nearly insoluble.

· Partition coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.Kinematic: Not determined.

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.· Chemical stability

Stable under normal handling and storage conditions.Photoreactive (Danger of polymerization).

· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid

Protect from exposure to the light.Keep away from heat and direct sunlight.

· Incompatible materials: No further relevant information available.· Hazardous decomposition products: None under normal conditions of storage and use.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: No irritant effect.· on the eye: Irritating effect.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:

The product shows the following dangers according to the calculation method of the General EUClassification Guidelines for Preparations as issued in the latest version:Irritant

12 Ecological information

· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.

(Contd. on page 6) GB

Page 6: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 6/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 5)

36.0.5

· Additional ecological information:· General notes:

Water hazard class 2 (German Regulation) (Self-assessment): hazardous for waterDo not allow product to reach ground water, water course or sewage system.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation

Take to an approved landfill or a waste incineration plant, under conditions approved by the localauthority.

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

14 Transport information

· UN-Number· ADR, ADN, IMDG, IATA Void

· UN proper shipping name· ADR, ADN, IMDG, IATA Void

· Transport hazard class(es)

· ADR, ADN, IMDG, IATA· Class Void

· Packing group· ADR, IMDG, IATA Void

· Environmental hazards:· Marine pollutant: No

· Special precautions for user Not applicable.

· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture

· National regulations:· Other regulations, limitations and prohibitive regulations

The product is a medical device according to the EC-directive 93/42/EEC.(Contd. on page 7)

GB

Page 7: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 7/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Incisal, Dentin, Deep Dentin, Neck, Transpa Incisal,Special Incisal, Inter Incisal,Occlusal Dentin, Mamelon, Effect, Opal Effect, Incisal Edge,Transpa,Transpa Clear, Add-On

(Contd. of page 6)

36.0.5

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.

· Relevant phrasesR36 Irritating to eyes.R38 Irritating to skin.R41 Risk of serious damage to eyes.R43 May cause sensitisation by skin contact.R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

GB

Page 8: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 1/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

36.0.5

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: SR Adoro Liner, Stains· Relevant identified uses of the substance or mixture and uses advised against

No further relevant information available.· Application of the substance / the preparation Crowns- and bridges material

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

Ivoclar Vivadent AGBendererstrasse 2FL-9494 SchaanPRINCIPALITY OF LIECHTENSTEIN

Tel: +423 235 35 35Fax: +423 235 33 60

· Further information obtainable from:Regulatory [email protected]

· Emergency telephone number: +423 / 235 33 13 (Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein)

2 Hazards identification

· Classification of the substance or mixture

· Classification according to Directive 67/548/EEC or Directive 1999/45/ECXi; Irritant

R36: Irritating to eyes.

Xi; Sensitising

R43: May cause sensitisation by skin contact.

R52/53: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.· Classification system:

The classification is according to the latest editions of the EU-lists, and extended by company and literaturedata.

· Label elements

· Labelling according to EU guidelines:

· Code letter and hazard designation of product:

Xi Irritant

· Hazard-determining components of labelling:urethane dimethacrylatedecamethylene dimethacrylate

· Risk phrases:36 Irritating to eyes.43 May cause sensitisation by skin contact.52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

· Safety phrases:23 Do not breathe vapour.

(Contd. on page 2) GB

Page 9: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 2/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Liner, Stains

(Contd. of page 1)

36.0.5

24 Avoid contact with skin.26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.27 Take off immediately all contaminated clothing.37 Wear suitable gloves.60 This material and its container must be disposed of as hazardous waste.

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:CAS: 72869-86-4EINECS: 276-957-5

urethane dimethacrylate Xi R36; Xi R43R52/53

25-50%

CAS: 6701-13-9 decamethylene dimethacrylate Xi R36; Xi R43 10-<20%

CAS: 43048-08-4EINECS: 256-062-6

tricyclodocane dimethanol dimethacrylate Xi R38-41 5-<10%

· Additional information: For the wording of the listed risk phrases refer to section 16.

4 First aid measures

· Description of first aid measures· After inhalation:

Supply fresh air and to be sure call for a doctor.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact: Rinse with water.· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.· After swallowing:

Rinse out mouth and then drink plenty of water.If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.· Indication of any immediate medical attention and special treatment needed

No further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.· Special hazards arising from the substance or mixture No further relevant information available.· Advice for firefighters· Protective equipment: No special measures required.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Not required.(Contd. on page 3)

GB

Page 10: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 3/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Liner, Stains

(Contd. of page 2)

36.0.5

· Environmental precautions: Do not allow to enter sewers/ surface or ground water.· Methods and material for containment and cleaning up: Pick up mechanically.· Reference to other sections

See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling

Only adequately trained personnel should handle this product.For use in dentistry only.

· Information about fire - and explosion protection: No special measures required.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: Store only in the original receptacle.· Information about storage in one common storage facility: Not required.· Further information about storage conditions:

Protect from exposure to the light.Protect from heat and direct sunlight.Keep container tightly sealed.

· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters· Ingredients with limit values that require monitoring at the workplace:

The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Usual hygienic measures for dental practice.Wash hands before breaks and at the end of work.Keep away from foodstuffs, beverages and feed.Avoid contact with the eyes and skin.

· Respiratory protection: Not required.· Protection of hands:

Protective gloves

After use of gloves apply skin-cleaning agents and skin cosmetics.· Material of gloves

Selection of the glove material on consideration of the penetration times, rates of diffusion and thedegradation

(Contd. on page 4) GB

Page 11: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 4/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Liner, Stains

(Contd. of page 3)

36.0.5

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to beobserved.

· Not suitable are gloves made of the following materials:Commercial medical gloves do not provide protection against the sensitizing effect of methacrylates.

· Eye protection: Safety glasses

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: PastyColour: According to product specification

· Odour: Characteristic· Odour threshold: Not determined.

· pH-value: Not applicable.

· Change in conditionMelting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.

· Flammability (solid, gaseous): Not applicable.

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Product does not present an explosion hazard.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapour pressure: Not determined.

· Density: Not determined.· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Nearly insoluble.

· Partition coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.Kinematic: Not determined.

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.· Chemical stability

Stable under normal handling and storage conditions.Photoreactive (Danger of polymerization).

(Contd. on page 5) GB

Page 12: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 5/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Liner, Stains

(Contd. of page 4)

36.0.5

· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid

Protect from exposure to the light.Keep away from heat and direct sunlight.

· Incompatible materials: No further relevant information available.· Hazardous decomposition products: None under normal conditions of storage and use.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: No irritant effect.· on the eye: Irritating effect.· Sensitization: Sensitization possible through skin contact.· Additional toxicological information:

The product shows the following dangers according to the calculation method of the General EUClassification Guidelines for Preparations as issued in the latest version:Irritant

12 Ecological information

· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:

Water hazard class 3 (German Regulation) (Self-assessment): extremely hazardous for waterDo not allow product to reach ground water, water course or sewage system, even in small quantities.Danger to drinking water if even extremely small quantities leak into the ground.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation

Take to an approved landfill or a waste incineration plant, under conditions approved by the localauthority.

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

GB

(Contd. on page 6)

Page 13: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 6/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 11.04.2013 Revision: 11.04.2013Version number 3

Trade name: SR Adoro Liner, Stains

(Contd. of page 5)

36.0.5

14 Transport information

· UN-Number· ADR, ADN, IMDG, IATA Void

· UN proper shipping name· ADR, ADN, IMDG, IATA Void

· Transport hazard class(es)

· ADR, ADN, IMDG, IATA· Class Void

· Packing group· ADR, IMDG, IATA Void

· Environmental hazards:· Marine pollutant: No

· Special precautions for user Not applicable.

· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture

· National regulations:· Other regulations, limitations and prohibitive regulations

The product is a medical device according to the EC-directive 93/42/EEC.· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.

· Relevant phrasesR36 Irritating to eyes.R38 Irritating to skin.R41 Risk of serious damage to eyes.R43 May cause sensitisation by skin contact.R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

GB

Page 14: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 1/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

37.0.5

1 Bezeichnung des Stoffs bzw. des Gemischs und des Unternehmens

· Produktidentifikator

· Handelsname: SR Adoro Opaquer, Gingiva Opaquer· Relevante identifizierte Verwendungen des Stoffs oder Gemischs und Verwendungen, von denen

abgeraten wirdKeine weiteren relevanten Informationen verfügbar.

· Verwendung des Stoffes / des Gemisches Kronen- und Brückenmaterial

· Einzelheiten zum Lieferanten, der das Sicherheitsdatenblatt bereitstellt· Hersteller/Lieferant:

Ivoclar Vivadent AGBendererstrasse 2FL-9494 SchaanFÜRSTENTUM LIECHTENSTEIN

Tel: +423 235 35 35Fax: +423 235 33 60

· Auskunftgebender Bereich:Regulatory [email protected]

· Notrufnummer: +423 / 235 33 13 (Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein)

2 Mögliche Gefahren

· Einstufung des Stoffs oder Gemischs

· Einstufung gemäß Richtlinie 67/548/EWG oder Richtlinie 1999/45/EGXi; Reizend

R36/38: Reizt die Augen und die Haut.

Xi; Sensibilisierend

R43: Sensibilisierung durch Hautkontakt möglich.· Klassifizierungssystem:

Die Klassifizierung entspricht den aktuellen EG-Listen, ist jedoch ergänzt durch Angaben aus derFachliteratur und durch Firmenangaben.

· Kennzeichnungselemente

· Kennzeichnung nach EWG-Richtlinien:

· Kennbuchstabe und Gefahrenbezeichnung des Produktes:

Xi Reizend

· Gefahrbestimmende Komponenten zur Etikettierung:Bis-GMADecamethylendimethacrylatTriethylenglycoldimethacrylatUrethandimethacrylat

· R-Sätze:36/38 Reizt die Augen und die Haut.43 Sensibilisierung durch Hautkontakt möglich.

· S-Sätze:23 Dampf nicht einatmen.

(Fortsetzung auf Seite 2) DE

Page 15: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 2/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 1)

37.0.5

24 Berührung mit der Haut vermeiden.26 Bei Berührung mit den Augen sofort gründlich mit Wasser abspülen und Arzt konsultieren.37 Geeignete Schutzhandschuhe tragen.60 Dieses Produkt und sein Behälter sind als gefährlicher Abfall zu entsorgen.

· Sonstige Gefahren· Ergebnisse der PBT- und vPvB-Beurteilung· PBT: Nicht anwendbar.· vPvB: Nicht anwendbar.

3 Zusammensetzung/Angaben zu Bestandteilen

· Chemische Charakterisierung: Gemische· Beschreibung: Gemisch aus nachfolgend angeführten Stoffen mit ungefährlichen Beimengungen.

· Gefährliche Inhaltsstoffe:CAS: 1565-94-2 Bis-GMA Xi R36/38; Xi R43 25-50%

CAS: 6701-13-9 Decamethylendimethacrylat Xi R36; Xi R43 2,5-10%

CAS: 109-16-0 Triethylenglycoldimethacrylat Xi R36/37/38; Xi R43 2,5-10%

CAS: 72869-86-4EINECS: 276-957-5

Urethandimethacrylat Xi R36; Xi R43R52/53

1-<2,5%

· Zusätzliche Hinweise: Der Wortlaut der angeführten Gefahrenhinweise ist dem Abschnitt 16 zu entnehmen.

4 Erste-Hilfe-Maßnahmen

· Beschreibung der Erste-Hilfe-Maßnahmen· Nach Einatmen:

Reichlich Frischluftzufuhr und sicherheitshalber Arzt aufsuchen.Bei Bewußtlosigkeit Lagerung und Transport in stabiler Seitenlage.

· Nach Hautkontakt: Mit Wasser abwaschen.· Nach Augenkontakt:

Augen bei geöffnetem Lidspalt mehrere Minuten unter fließendem Wasser abspülen und Arzt konsultieren.· Nach Verschlucken:

Mund ausspülen und reichlich Wasser nachtrinken.Bei anhaltenden Beschwerden Arzt konsultieren.

· Hinweise für den Arzt:· Wichtigste akute und verzögert auftretende Symptome und Wirkungen

Keine weiteren relevanten Informationen verfügbar.· Hinweise auf ärztliche Soforthilfe oder Spezialbehandlung

Keine weiteren relevanten Informationen verfügbar.

5 Maßnahmen zur Brandbekämpfung

· Löschmittel· Geeignete Löschmittel:

CO2, Löschpulver oder Wassersprühstrahl. Größeren Brand mit Wassersprühstrahl oderalkoholbeständigem Schaum bekämpfen.

· Besondere vom Stoff oder Gemisch ausgehende GefahrenKeine weiteren relevanten Informationen verfügbar.

(Fortsetzung auf Seite 3) DE

Page 16: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 3/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 2)

37.0.5

· Hinweise für die Brandbekämpfung· Besondere Schutzausrüstung: Keine besonderen Maßnahmen erforderlich.

6 Maßnahmen bei unbeabsichtigter Freisetzung

· Personenbezogene Vorsichtsmaßnahmen, Schutzausrüstungen und in Notfällen anzuwendende VerfahrenNicht erforderlich.

· Umweltschutzmaßnahmen: Nicht in die Kanalisation/Oberflächenwasser/Grundwasser gelangen lassen.· Methoden und Material für Rückhaltung und Reinigung: Mechanisch aufnehmen.· Verweis auf andere Abschnitte

Informationen zur sicheren Handhabung siehe Abschnitt 7.Informationen zur persönlichen Schutzausrüstung siehe Abschnitt 8.Informationen zur Entsorgung siehe Abschnitt 13.

7 Handhabung und Lagerung

· Handhabung:· Schutzmaßnahmen zur sicheren Handhabung

Handhabung dieses Produkts nur durch ausreichend geschultes Personal.Nur für zahnärztlichen oder zahntechnischen Gebrauch.

· Hinweise zum Brand- und Explosionsschutz: Keine besonderen Maßnahmen erforderlich.

· Bedingungen zur sicheren Lagerung unter Berücksichtigung von Unverträglichkeiten· Lagerung:· Anforderung an Lagerräume und Behälter: Nur im Originalgebinde aufbewahren.· Zusammenlagerungshinweise: Nicht erforderlich.· Weitere Angaben zu den Lagerbedingungen:

Vor Lichteinwirkung schützen.Vor Hitze und direkter Sonnenbestrahlung schützen.Behälter dicht geschlossen halten.

· Lagerklasse:· Klassifizierung nach Betriebssicherheitsverordnung (BetrSichV): - · Spezifische Endanwendungen Keine weiteren relevanten Informationen verfügbar.

8 Begrenzung und Überwachung der Exposition/Persönliche Schutzausrüstungen

· Zusätzliche Hinweise zur Gestaltung technischer Anlagen: Keine weiteren Angaben, siehe Abschnitt 7.

· Zu überwachende Parameter· Bestandteile mit arbeitsplatzbezogenen, zu überwachenden Grenzwerten:

Das Produkt enthält keine relevanten Mengen von Stoffen mit arbeitsplatzbezogenen zu überwachendenGrenzwerten.

· Zusätzliche Hinweise: Als Grundlage dienten die bei der Erstellung gültigen Listen.

· Begrenzung und Überwachung der Exposition· Persönliche Schutzausrüstung:· Allgemeine Schutz- und Hygienemaßnahmen:

Berufsübliche Hygienemassnahmen einhalten.Vor den Pausen und bei Arbeitsende Hände waschen.Von Nahrungsmitteln, Getränken und Futtermitteln fernhalten.Berührung mit den Augen und der Haut vermeiden.

· Atemschutz: Nicht erforderlich.(Fortsetzung auf Seite 4)

DE

Page 17: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 4/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 3)

37.0.5

· Handschutz:

Schutzhandschuhe

Nach der Verwendung von Handschuhen Hautreinigung- und Hautpflegemittel einsetzen.· Handschuhmaterial

Auswahl des Handschuhmaterials unter Beachtung der Durchbruchzeiten, Permeationsraten und derDegradation.

· Durchdringungszeit des HandschuhmaterialsDie genaue Durchbruchzeit ist beim Schutzhandschuhhersteller zu erfahren und zu beachten.

· Nicht geeignet sind Handschuhe aus folgenden Materialen:Handelsübliche medizinische Handschuhe bieten keinen Schutz gegen den sensibilisierenden Effekt vonMethacrylaten.

· Augenschutz: Schutzbrille

9 Physikalische und chemische Eigenschaften

· Angaben zu den grundlegenden physikalischen und chemischen Eigenschaften· Allgemeine Angaben· Aussehen:

Form: PastösFarbe: Gemäß Produktbezeichnung

· Geruch: Charakteristisch· Geruchsschwelle: Nicht bestimmt.

· pH-Wert: Nicht anwendbar.

· ZustandsänderungSchmelzpunkt/Schmelzbereich: Nicht bestimmt.Siedepunkt/Siedebereich: Nicht bestimmt.

· Flammpunkt: Nicht anwendbar.

· Entzündlichkeit (fest, gasförmig): Nicht anwendbar.

· Selbstentzündlichkeit: Das Produkt ist nicht selbstentzündlich.

· Explosionsgefahr: Das Produkt ist nicht explosionsgefährlich.

· Explosionsgrenzen:Untere: Nicht bestimmt.Obere: Nicht bestimmt.

· Dampfdruck: Nicht bestimmt.

· Dichte: Nicht bestimmt.· Relative Dichte Nicht bestimmt.· Dampfdichte Nicht bestimmt.· Verdampfungsgeschwindigkeit Nicht bestimmt.

· Löslichkeit in / Mischbarkeit mitWasser: Praktisch unlöslich

· Verteilungskoeffizient (n-Octanol/Wasser): Nicht bestimmt.

· Viskosität:Dynamisch: Nicht bestimmt.

(Fortsetzung auf Seite 5) DE

Page 18: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 5/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 4)

37.0.5

Kinematisch: Nicht bestimmt.· Sonstige Angaben Keine weiteren relevanten Informationen verfügbar.

10 Stabilität und Reaktivität

· Reaktivität Keine weiteren relevanten Informationen verfügbar.· Chemische Stabilität

Stabil bei normaler Handhabung und Lagerung.Reaktionen mit Licht (Polymerisationsgefahr).

· Thermische Zersetzung / zu vermeidende Bedingungen:Keine Zersetzung bei bestimmungsgemäßer Verwendung.

· Möglichkeit gefährlicher Reaktionen Keine gefährlichen Reaktionen bekannt.· Zu vermeidende Bedingungen

Vor Lichteinwirkung schützen.Vor Hitze und direkter Sonnenbestrahlung schützen.

· Unverträgliche Materialien: Keine weiteren relevanten Informationen verfügbar.· Gefährliche Zersetzungsprodukte: Keine unter normalen Lager- und Handhabungsbedingungen.

11 Toxikologische Angaben

· Angaben zu toxikologischen Wirkungen· Akute Toxizität:· Primäre Reizwirkung:· an der Haut: Reizt die Haut und die Schleimhäute.· am Auge: Reizwirkung.· Sensibilisierung: Durch Hautkontakt Sensibilisierung möglich.· Zusätzliche toxikologische Hinweise:

Das Produkt weist aufgrund des Berechnungsverfahrens der Allgemeinen Einstufungsrichtlinie der EG fürZubereitungen in der letztgültigen Fassung folgende Gefahren auf:Reizend

12 Umweltbezogene Angaben

· Toxizität· Aquatische Toxizität: Keine weiteren relevanten Informationen verfügbar.· Persistenz und Abbaubarkeit Keine weiteren relevanten Informationen verfügbar.· Verhalten in Umweltkompartimenten:· Bioakkumulationspotenzial Keine weiteren relevanten Informationen verfügbar.· Mobilität im Boden Keine weiteren relevanten Informationen verfügbar.· Weitere ökologische Hinweise:· Allgemeine Hinweise:

Wassergefährdungsklasse 2 (Selbsteinstufung): wassergefährdendNicht in das Grundwasser, in Gewässer oder in die Kanalisation gelangen lassen.

· Ergebnisse der PBT- und vPvB-Beurteilung· PBT: Nicht anwendbar.· vPvB: Nicht anwendbar.· Andere schädliche Wirkungen Keine weiteren relevanten Informationen verfügbar.

DE

(Fortsetzung auf Seite 6)

Page 19: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 6/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 5)

37.0.5

13 Hinweise zur Entsorgung

· Verfahren der Abfallbehandlung· Empfehlung:

Unter Beachtung der örtlichen, behördlichen Vorschriften einer geordneten Deponie oderVerbrennungsanlage zuführen.

· Ungereinigte Verpackungen:· Empfehlung: Entsorgung gemäß den behördlichen Vorschriften.

14 Angaben zum Transport

· UN-Nummer· ADR, ADN, IMDG, IATA entfällt

· Ordnungsgemäße UN-Versandbezeichnung· ADR, ADN, IMDG, IATA entfällt

· Transportgefahrenklassen

· ADR, ADN, IMDG, IATA· Klasse entfällt

· Verpackungsgruppe· ADR, IMDG, IATA entfällt

· Umweltgefahren:· Marine pollutant: Nein

· Besondere Vorsichtsmaßnahmen für den Verwender Nicht anwendbar.

· Massengutbeförderung gemäß Anhang II desMARPOL-Übereinkommens 73/78 und gemäß IBC-Code Nicht anwendbar.

15 Rechtsvorschriften

· Vorschriften zu Sicherheit, Gesundheits- und Umweltschutz/spezifische Rechtsvorschriften für den Stoffoder das Gemisch

· Nationale Vorschriften:· Klassifizierung nach Betriebssicherheitsverordnung (BetrSichV): -

· Wassergefährdungsklasse: WGK 2 (Selbsteinstufung): wassergefährdend.· Sonstige Vorschriften, Beschränkungen und Verbotsverordnungen

Das Produkt fällt unter die EG-Richtlinie 93/42/EWG für Medizinprodukte.· Stoffsicherheitsbeurteilung: Eine Stoffsicherheitsbeurteilung wurde nicht durchgeführt.

16 Sonstige AngabenDie Angaben stützen sich auf den heutigen Stand unserer Kenntnisse, sie stellen jedoch keine Zusicherungvon Produkteigenschaften dar und begründen kein vertragliches Rechtsverhältnis.

· Relevante SätzeR36 Reizt die Augen.R36/37/38 Reizt die Augen, die Atmungsorgane und die Haut.R36/38 Reizt die Augen und die Haut.

(Fortsetzung auf Seite 7) DE

Page 20: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Seite: 7/7

Sicherheitsdatenblattgemäß 1907/2006/EG, Artikel 31

Druckdatum: 19.07.2013 überarbeitet am: 19.07.2013Versionsnummer 3

Handelsname: SR Adoro Opaquer, Gingiva Opaquer

(Fortsetzung von Seite 6)

37.0.5

R43 Sensibilisierung durch Hautkontakt möglich.R52/53 Schädlich für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen haben.

DE

Page 21: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 10.03.2005 hotErsetzt Fassung vomDruckdatum Blatt Nr. 159820.09.2005

SR Adoro Thermo Guard

Seite 1 von 5

Firma Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 SchaanFürstentum Liechtenstein

Hersteller Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 SchaanFürstentum Liechtenstein

Lieferant

1.1

1.2

1.3

1.4

1.5

Handelsname / Warenkennzeichnung

Anwendung / Einsatz

TOX NOTRUF

Handelsname und Lieferant1

Brennhilfspaste

2.1

2.2

2.3

Chemische Charakterisierung

Zusammensetzung2

Weitere Angaben Keine.

SR Adoro Thermo Guard

Paste aus Quarz, anorganischen Füllstoffen und Wasser.

Notfall-No: +423 / 235 35 35 oder 373 40 40Ivoclar, FL-9494 Schaan, Liechtenstein

Gefährliche Bestandteile

< 20 % Siliziumdioxid (Quarzpulver)Xn: Gesundheitsschädlich. R48/20: Gesundheitsschädlich : Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Einatmen.

CAS Nr. 14808-60-7

Mögliche Gefahren3 Keine.

Erste Hilfe4

Augenkontakt4.1

Hautkontakt4.2

Verschlucken4.3

Einatmen4.4

Weitere Angaben4.5

Brandbekämpfung5

Geeignete Löschmittel5.1

Ungeeignete Löschmittel5.2

Mit viel Wasser spülen. Arzt hinzuziehen, wenn die Reizung andauert.

Gründlich mit Wasser und Seife waschen.

Grosse Mengen Wasser zu trinken geben. Versehentliches Verschlucken kleinster Mengen dürfte keine gesundheitliche Schädigung hervorrufen.

An die frische Luft bringen.

Bei Unwohlsein ärztlichen Rat einholen (dieses Sicherheitsdatenblatt vorzeigen).

Wassernebel, Kohlendioxid, Schaum, Trockenlöschmittel.

Keine bekannt.

Page 22: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 10.03.2005 hotErsetzt Fassung vomDruckdatum Blatt Nr. 159820.09.2005

SR Adoro Thermo Guard

Seite 2 von 5

Weitere Angaben5.3

Handhabung und Lagerung7

Handhabung7.1

Arbeitshygiene7.2

Lagerung7.3

Lagerplatz7.4

7.5

6

Expositionsbegrenzung und Schutzausrüstung8

Technische Massnahmen8.1

8.2

Keine.

Mechanisch aufnehmen.Unter Beachtung der massgeblichen Vorschriften und Regelungen entsorgen.

Handhabung dieses Produkts nur durch ausreichend geschultes Personal.Darf nicht in die Hände von Kindern gelangen.

Berufsübliche Hygienemassnahmen einhalten.Bei der Arbeit nicht essen, trinken oder rauchen.

Lagerung bei 2-28 °C

Nicht direktem Sonnenlicht aussetzen.

Keine.

Für ausreichende örtliche Absaugung sorgen.

Kein Grenzwert festgelegt.

Persönliche Schutzausrüstung8.3

Handschutz8.3.2

Augenschutz8.3.3

Atemschutz8.3.1

Andere8.3.4

Atemschutzgerät bei unzureichender Lüftung.

Schutzhandschuhe.

Schutzbrille.

Keine.

Grenzwertüberwachung

Brand- und Ex-Schutz

Massnahmen bei unbeabsichtigter Freisetzung

Physikalische und chemische Eigenschaften9

Erscheinungsform9.1

Geruch9.3

Farbe9.2

Paste

beige

neutral

Zustandsänderung9.4 Geprüft nach:

nicht bestimmt

Dichte9.5nicht bestimmt

Dampfdruck9.6

nicht bekannt

Page 23: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 10.03.2005 hotErsetzt Fassung vomDruckdatum Blatt Nr. 159820.09.2005

SR Adoro Thermo Guard

Seite 3 von 5

Viskosität9.7nicht bestimmt

Löslichkeit9.8

mischbarWasser

pH-Wert9.9 nicht bekannt

Flammpunkt9.10

Zündtemperatur9.11

nicht anwendbar

nicht brennbar

Untere:Obere:

Explosionsgrenzen9.12

nicht anwendbar.

Weitere Angaben9.13

Stabilität und Reaktivität10

Thermische Zersetzung10.1

Gefährliche Zersetzungsprodukte10.2 Keine.

Keine bei bestimmungsgemässer Verwendung.

Gefährliche Reaktionen10.3

Weitere Angaben10.4

Keine.

Keine.

Angaben zur Toxikologie11

Akute Toxizität11.1

Subakute / Chronische Toxizität11.2

Keine Daten verfügbar.

Keine Daten verfügbar.

Weitere Angaben11.3 Keine.

Angaben zur Ökologie12 Bei sachgemässer Handhabung und Verwendung sind keine ökologischen Probleme zu erwarten.

Entsorgung13 Unter Beachtung abfallrechtlicher Gesetze und Verordnungen entsorgen.

EU waste key13.1

Swiss waste code13.2

Origin13.3 Dentallabor

18 01 06

---

Page 24: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 10.03.2005 hotErsetzt Fassung vomDruckdatum Blatt Nr. 159820.09.2005

SR Adoro Thermo Guard

Seite 4 von 5

Vorschriften15

15.1

Das Produkt ist nicht kennzeichnungspflichtig im Sinne der Gefahrstoffverordnung und EG-Richtlinien.

UN-Nummer

Transport14

Landtransport14.1

GGVEGGVS

RIDADR

UN Nummer Kemler ZahlVerpackungsgr.Korrekte Versandbezeichn. #Fehler

Klassifizierungscode

Schiffstransport14.2GGVSee

IMDG

EMS MFAG

ADNR

UN Nummer

Verpackungsgr.Korrekte Versandbezeichn.

Lufttransport14.3 ICAO / IATA-DGR

Korrekte Versandbezeichn.

Packing Instructions

Max.Packing Instructions

Max.

UN Nummer

Verpackungsgr.Passagierflugzeug

Frachtflugzeug

Weitere Angaben14.4 Kein Gefahrgut im Sinne der Transportvorschriften.

Subsidiary RiskLabels

Nationale Vorschriften15.2

EU Nummer15.3

Gefahrensymbole15.4

Gefahrenbezeichnung15.5

R-Sätze (Gefahrenhinweise)15.6

S-Sätze (Sicherheitsratschläge)15.7

15.8

BVD-Klassierung (CH)15.9

VbF (D)15.10

15.11

MAK-Wert

Keine.Weitere Angaben

Page 25: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 10.03.2005 hotErsetzt Fassung vomDruckdatum Blatt Nr. 159820.09.2005

SR Adoro Thermo Guard

Seite 5 von 5

Weitere Hinweise16 Version: 1

Alle vorstehenden Angaben entsprechen dem heutigen Stand unserer Kenntnisse und Erfahrungen. Das Sicherheitsdatenblatt dient der Beschreibung der Produkte im Hinblick auf Sicherheitserfordernisse. Die Angaben haben nicht die Bedeutung von Eigenschaftszusicherungen.

91/155/EWGDieses Datenblatt wurde mit der Datenbank 'ChemManager' erstellt, © ASSiST Applied Software Solutions in Science and Technology AG, Weiherweg 3, CH-4104 Oberwil, Schweiz

Page 26: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 03.12.2004 hotErsetzt Fassung vomDruckdatum Blatt Nr. 158020.09.2005

SR Gel

Seite 1 von 5

Firma Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 SchaanFürstentum Liechtenstein

Hersteller Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 SchaanFürstentum Liechtenstein

Lieferant

1.1

1.2

1.3

1.4

1.5

Handelsname / Warenkennzeichnung

Anwendung / Einsatz

TOX NOTRUF

Handelsname und Lieferant1

Kronen- und Brückenmaterial - System

2.1

2.2

2.3

Chemische Charakterisierung

Zusammensetzung2

Weitere Angaben

Keine.

Keine.

SR Gel

Mischung aus > 90 % Glyzerin (CAS Nr. 56-81-5), Siliziumdioxid und Aluminiumoxid

Notfall-No: +423 / 235 35 35 oder 373 40 40Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein

Gefährliche Bestandteile

Mögliche Gefahren3 Keine.

Erste Hilfe4

Augenkontakt4.1

Hautkontakt4.2

Verschlucken4.3

Einatmen4.4

Weitere Angaben4.5

Brandbekämpfung5

Geeignete Löschmittel5.1

Ungeeignete Löschmittel5.2

Weitere Angaben5.3

Sofort die Augen mit viel Wasser spülen (10-15 Min.). Bei anhaltender Reizung Arzt konsultieren.

Gründlich mit Wasser und Seife waschen.

Grosse Mengen Wasser zu trinken geben.

Zufuhr von Frischluft.

Bei Unwohlsein ärztlichen Rat einholen (dieses Sicherheitsdatenblatt vorzeigen).

Wassernebel, Kohlendioxid, Schaum, Trockenlöschmittel.

Keine bekanntKeine.

Keine.

Page 27: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 03.12.2004 hotErsetzt Fassung vomDruckdatum Blatt Nr. 158020.09.2005

SR Gel

Seite 2 von 5

Handhabung und Lagerung7

Handhabung7.1

Arbeitshygiene7.2

Lagerung7.3

Lagerplatz7.4

7.5

6

Expositionsbegrenzung und Schutzausrüstung8

Technische Massnahmen8.1

8.2

Mechanisch aufnehmen.Unter Beachtung der massgeblichen Vorschriften und Regelungen entsorgen.

Handhabung dieses Produkts nur durch ausreichend geschultes Personal.Darf nicht in die Hände von Kindern gelangen.

Berufsübliche Hygienemassnahmen einhalten.Bei der Arbeit nicht essen, trinken oder rauchen.

Lagerung bei 2-28 °C

Vor Lichteinwirkung schützen.

Nicht erforderlich.

Gute allgemeine Belüftung ist ausreichend.

ACGIH (USA) Threshold Limit Value (TLV): 10 mg/m3 (8 h-Schichtmittelwert).

Persönliche Schutzausrüstung8.3

Handschutz8.3.2

Augenschutz8.3.3

Atemschutz8.3.1

Andere8.3.4

Nicht erforderlich.

Schutzhandschuhe.

Schutzbrille.

Keine.

Grenzwertüberwachung

Brand- und Ex-Schutz

Massnahmen bei unbeabsichtigter Freisetzung

Physikalische und chemische Eigenschaften9

Erscheinungsform9.1

Geruch9.3

Farbe9.2

Gel

weisslich

praktisch geruchlos

Zustandsänderung9.4 Geprüft nach:

---

Dichte9.5nicht anwendbar

Dampfdruck9.6

nicht anwendbar

Viskosität9.7nicht bestimmt

Page 28: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 03.12.2004 hotErsetzt Fassung vomDruckdatum Blatt Nr. 158020.09.2005

SR Gel

Seite 3 von 5

Löslichkeit9.8

löslichWasser

pH-Wert9.9 nicht bestimmt

Flammpunkt9.10

Zündtemperatur9.11

> 150 °C

> 400 °C

Untere:Obere:

Explosionsgrenzen9.12

nicht bestimmt

Weitere Angaben9.13

Stabilität und Reaktivität10

Thermische Zersetzung10.1

Gefährliche Zersetzungsprodukte10.2 Keine unter normalen Lager- und Handhabungsbedingungen.

Keine bei bestimmungsgemässer Verwendung.

Gefährliche Reaktionen10.3

Weitere Angaben10.4

Keine.

Keine.

Angaben zur Toxikologie11

Akute Toxizität11.1

Subakute / Chronische Toxizität11.2

Orale LD50 / Ratte: > 10'000 mg/kg

Längerer oder wiederholter Hautkontakt kann Austrocknung oder Reizung der Haut verursachen. Verschlucken, längerer Haut- und Augenkontakt sowie Einatmen jeglicher entstehender Dämpfe vermeiden.

Weitere Angaben11.3 Versehentliches Verschlucken kleinster Mengen dürfte keine gesundheitliche Schädigung hervorrufen.

Angaben zur Ökologie12 Bei sachgemässer Handhabung und Verwendung sind keine ökologischen Probleme zu erwarten.

Entsorgung13 Unter Beachtung der örtlichen, behördlichen Vorschriften einer Verbrennungsanlage zuführen.

EU waste key13.1

Swiss waste code13.2

Origin13.3 Dentallabor

16 05 09

---

Transport14

Page 29: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 03.12.2004 hotErsetzt Fassung vomDruckdatum Blatt Nr. 158020.09.2005

SR Gel

Seite 4 von 5

Vorschriften15

15.1

Das Produkt fällt unter die EG-Richtlinie 93/42 für Medizinprodukte.

UN-Nummer

Landtransport14.1

GGVEGGVS

RIDADR

UN Nummer Kemler ZahlVerpackungsgr.Korrekte Versandbezeichn.

Klassifizierungscode

Schiffstransport14.2GGVSee

IMDG

EMS MFAG

ADNR

UN Nummer

Verpackungsgr.Korrekte Versandbezeichn.

Lufttransport14.3 ICAO / IATA-DGR

Korrekte Versandbezeichn.

Packing Instructions

Max.Packing Instructions

Max.

UN Nummer

Verpackungsgr.Passagierflugzeug

Frachtflugzeug

Weitere Angaben14.4 Kein Gefahrgut im Sinne der Transportvorschriften.

Subsidiary RiskLabels

Nationale Vorschriften15.2

EU Nummer15.3

Gefahrensymbole15.4

Gefahrenbezeichnung15.5

R-Sätze (Gefahrenhinweise)15.6

S-Sätze (Sicherheitsratschläge)15.7

15.8

BVD-Klassierung (CH)15.9

VbF (D)15.10

15.11

MAK-Wert

Keine.Weitere Angaben

Page 30: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

EU-SicherheitsdatenblattAusgabedatum / Referenz 03.12.2004 hotErsetzt Fassung vomDruckdatum Blatt Nr. 158020.09.2005

SR Gel

Seite 5 von 5

Weitere Hinweise16 Version: 1

Alle vorstehenden Angaben entsprechen dem heutigen Stand unserer Kenntnisse und Erfahrungen. Das Sicherheitsdatenblatt dient der Beschreibung der Produkte im Hinblick auf Sicherheitserfordernisse. Die Angaben haben nicht die Bedeutung von Eigenschaftszusicherungen.

91/155/EWGDieses Datenblatt wurde mit der Datenbank 'ChemManager' erstellt, © ASSiST Applied Software Solutions in Science and Technology AG, Weiherweg 3, CH-4104 Oberwil, Schweiz

Page 31: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 1/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

DR

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: SR Link

· Relevant identified uses of the substance or mixture and uses advised against· Application of the substance / the preparation Bonding agent

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

Ivoclar Vivadent AG

Bendererstrasse 2

FL-9494 Schaan

PRINCIPALITY OF LIECHTENSTEIN

Tel: +423 235 35 35

Fax: +423 235 33 60

· Further information obtainable from:Regulatory Affairs

[email protected]

· Emergency telephone number: +423 / 235 33 13

2 Hazards identification

· Classification of the substance or mixture

· Classification according to Directive 67/548/EEC or Directive 1999/45/EC

Xn; Harmful

R20: Harmful by inhalation.

Xi; Irritant

R36/37: Irritating to eyes and respiratory system.

Xi; Sensitising

R43: May cause sensitisation by skin contact.

F; Highly flammable

R11: Highly flammable.

· Information concerning particular hazards for human and environment:The product has to be labelled due to the calculation procedure of the "General Classification guideline for

preparations of the EU" in the latest valid version.

· Classification system:The classification is according to the latest editions of the EU-lists, and extended by company and literature

data.

· Label elements

· Labelling according to EU guidelines:The product has been classified and marked in accordance with EU Directives / Ordinance on Hazardous

Materials.

· Code letter and hazard designation of product:

Xn Harmful

F Highly flammable

· Hazard-determining components of labelling:dibenzoyl peroxide

2-methylpropan-2-ol(Contd. on page 2)

GB

Page 32: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 2/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 1)

DR

4-methylpentan-2-one

· Risk phrases:11 Highly flammable.

20 Harmful by inhalation.

36/37 Irritating to eyes and respiratory system.

43 May cause sensitisation by skin contact.

· Safety phrases:9 Keep container in a well-ventilated place.

16 Keep away from sources of ignition - No smoking.

23 Do not breathe fumes/aerosol.

24 Avoid contact with skin.

37 Wear suitable gloves.

60 This material and its container must be disposed of as hazardous waste.

26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:

CAS: 75-65-0

EINECS: 200-889-7

2-methylpropan-2-ol

Xn R20; Xi R36/37; F R11

50-100%

CAS: 108-10-1

EINECS: 203-550-1

4-methylpentan-2-one

Xn R20; Xi R36/37; F R11

R66

10-25%

CAS: 94-36-0

EINECS: 202-327-6

dibenzoyl peroxide

Xi R36; Xi R43; E R3; O R7≤ 2.5%

· Additional information: For the wording of the listed risk phrases refer to section 16.

4 First aid measures

· Description of first aid measures· After inhalation:

Supply fresh air and to be sure call for a doctor.

In case of unconsciousness place patient stably in side position for transportation.

· After skin contact: Immediately wash with water and soap and rinse thoroughly.

· After eye contact:Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

· After swallowing: Do not induce vomiting; call for medical help immediately.

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.(Contd. on page 3)

GB

Page 33: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 3/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 2)

DR

· For safety reasons unsuitable extinguishing agents: Water with full jet

· Special hazards arising from the substance or mixture No further relevant information available.

· Advice for firefighters· Protective equipment: Mouth respiratory protective device.

· Additional information Cool endangered receptacles with water spray.

6 Accidental release measures

· Personal precautions, protective equipment and emergency proceduresWear protective equipment. Keep unprotected persons away.

· Environmental precautions: Do not allow to enter sewers/ surface or ground water.

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).

Dispose contaminated material as waste according to item 13.

Ensure adequate ventilation.

Do not flush with water or aqueous cleansing agents

· Reference to other sectionsSee Section 7 for information on safe handling.

See Section 8 for information on personal protection equipment.

See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling

Only adequately trained personnel should handle this product.

Ensure good ventilation/exhaustion at the workplace.

· Information about fire - and explosion protection:Keep ignition sources away - Do not smoke.

Protect against electrostatic charges.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: Store in a cool location.

· Information about storage in one common storage facility:Store away from oxidizing agents.

Store away from reducing agents.

· Further information about storage conditions:Keep container tightly sealed.

Store in cool, dry conditions in well sealed receptacles.

Protect from heat and direct sunlight.

· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters

· Ingredients with limit values that require monitoring at the workplace:

75-65-0 2-methylpropan-2-ol

WEL Short-term value: 462 mg/m³, 150 ppm

Long-term value: 308 mg/m³, 100 ppm

(Contd. on page 4)

GB

Page 34: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 4/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 3)

DR

108-10-1 4-methylpentan-2-one

WEL Short-term value: 416 mg/m³, 100 ppm

Long-term value: 208 mg/m³, 50 ppm

Sk

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Usual hygienic measures for dental practice.

Keep away from foodstuffs, beverages and feed.

Immediately remove all soiled and contaminated clothing

Wash hands before breaks and at the end of work.

Do not inhale gases / fumes / aerosols.

Avoid contact with the eyes and skin.

· Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure

use self-contained respiratory protective device.

· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.

Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/

the chemical mixture.

Selection of the glove material on consideration of the penetration times, rates of diffusion and the

degradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of quality

and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the

resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the

application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to be

observed.

· Eye protection:

Tightly sealed goggles

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: Fluid

Colour: Colourless

· Odour: Ether-like

· Odour threshold: Not determined.

· pH-value: Not determined.

· Change in conditionMelting point/Melting range: Undetermined.

(Contd. on page 5)

GB

Page 35: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 5/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 4)

DR

Boiling point/Boiling range: Undetermined.

· Flash point: 11°C

· Ignition temperature: 460°C

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Product is not explosive. However, formation of explosive air/

vapour mixtures are possible.

· Explosion limits:Lower: 1.7 Vol %

Upper: 9.0 Vol %

· Vapour pressure at 20°C: 40 hPa

· Density: Not determined.

· Relative density at 20°C 0.9 g/cm³

· Vapour density Not determined.

· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Not miscible or difficult to mix.

· Segregation coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.

Kinematic: Not determined.

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.

· Chemical stability Stable under normal handling and storage conditions.

· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.

· Conditions to avoid No further relevant information available.

· Incompatible materials: No further relevant information available.

· Hazardous decomposition products: None under normal conditions of storage and use.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:

· LD/LC50 values relevant for classification:

75-65-0 2-methylpropan-2-ol

Oral LD50 3500 mg/kg (rat)

108-10-1 4-methylpentan-2-one

Oral LD50 2080 mg/kg (rat)

Dermal LD50 16000 mg/kg (rab)

Inhalative LC50/4 h 8.3-16.6 mg/l (rat)

· Primary irritant effect:· on the skin: No irritant effect.

· on the eye: Irritating effect.

· Sensitization: Sensitization possible through skin contact.(Contd. on page 6)

GB

Page 36: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 6/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 5)

DR

· Additional toxicological information:The product shows the following dangers according to the calculation method of the General EU

Classification Guidelines for Preparations as issued in the latest version:

Harmful

Irritant

· Sensitisation May cause sensitisation by skin contact.

12 Ecological information

· Toxicity· Acquatic toxicity: No further relevant information available.

· Persistence and degradability No further relevant information available.

· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.

· Mobility in soil No further relevant information available.

· Additional ecological information:· General notes:

Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water

Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage

system.

· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.

· European waste catalogue

18 01 06* chemicals consisting of or containing dangerous substances

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

14 Transport information

· Land transport ADR/RID (cross-border)

· ADR/RID class: 3 (F1) Flammable liquids.

· Danger code (Kemler): 33

· UN-Number: 1993

· Packaging group: II

· Hazard label: 3

· UN proper shipping name: 1993 FLAMMABLE LIQUID, N.O.S. (BUTANOLS, METHYL ISOBUTYL

KETONE)

(Contd. on page 7)

GB

Page 37: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 7/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 29.03.2011 Revision: 29.03.2011Version number 7

Trade name: SR Link

(Contd. of page 6)

DR

· Tunnel restriction code D/E

· Maritime transport IMDG:

· IMDG Class: 3

· UN Number: 1993

· Label 3

· Packaging group: II

· EMS Number: F-E,S-E

· Marine pollutant: No

· Proper shipping name: FLAMMABLE LIQUID, N.O.S. (BUTANOLS, METHYL ISOBUTYL KETONE)

· Air transport ICAO-TI and IATA-DGR:

· ICAO/IATA Class: 3

· UN/ID Number: 1993

· Label 3

· Packaging group: II

· Proper shipping name: FLAMMABLE LIQUID, N.O.S. (BUTANOLS, METHYL ISOBUTYL KETONE)

· Special precautions for user Warning: Flammable liquids.

· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information

· Safety, health and environmental regulations/legislation specific for the substance or mixture

· National regulations:

· Other regulations, limitations and prohibitive regulationsThe product is a medical device according to the EC-directive 93/42/EEC.

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information

This information is based on our present knowledge. However, this shall not constitute a guarantee for any

specific product features and shall not establish a legally valid contractual relationship.

· Relevant phrasesR11 Highly flammable.

R20 Harmful by inhalation.

R3 Extreme risk of explosion by shock, friction, fire or other sources of ignition.

R36 Irritating to eyes.

R36/37 Irritating to eyes and respiratory system.

R43 May cause sensitisation by skin contact.

R66 Repeated exposure may cause skin dryness or cracking.

R7 May cause fire. GB

Page 38: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 1/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

DR

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: SR Model Separator

· Relevant identified uses of the substance or mixture and uses advised against· Application of the substance / the preparation Auxiliary for dental technology

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

Ivoclar Vivadent AG

Bendererstrasse 2

FL-9494 Schaan

PRINCIPALITY OF LIECHTENSTEIN

Tel: +423 235 35 35

Fax: +423 235 33 60

· Further information obtainable from:Regulatory Affairs

[email protected]

· Emergency telephone number: +423 / 235 33 13

2 Hazards identification

· Classification of the substance or mixture

· Classification according to Directive 67/548/EEC or Directive 1999/45/EC

R10: Flammable.

· Information concerning particular hazards for human and environment:The product has to be labelled due to the calculation procedure of the "General Classification guideline for

preparations of the EU" in the latest valid version.

· Classification system:The classification is according to the latest editions of the EU-lists, and extended by company and literature

data.

· Label elements

· Labelling according to EU guidelines:The product has been classified and marked in accordance with EU Directives / Ordinance on Hazardous

Materials.

· Risk phrases:10 Flammable.

· Safety phrases:7 Keep container tightly closed.

16 Keep away from sources of ignition - No smoking.

60 This material and its container must be disposed of as hazardous waste.

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:

CAS: 64-17-5

EINECS: 200-578-6

ethanol F R11 50-100%

(Contd. on page 2)

GB

Page 39: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 2/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

Trade name: SR Model Separator

(Contd. of page 1)

DR

· Additional information: For the wording of the listed risk phrases refer to section 16.

4 First aid measures

· Description of first aid measures· After inhalation: Supply fresh air; consult doctor in case of complaints.

· After skin contact: Generally the product does not irritate the skin.

· After eye contact: Rinse opened eye for several minutes under running water.

· After swallowing: If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

· For safety reasons unsuitable extinguishing agents: Water with full jet

· Special hazards arising from the substance or mixture No further relevant information available.

· Advice for firefighters· Protective equipment: No special measures required.

· Additional information Cool endangered receptacles with water spray.

6 Accidental release measures

· Personal precautions, protective equipment and emergency proceduresWear protective equipment. Keep unprotected persons away.

· Environmental precautions: Do not allow to enter sewers/ surface or ground water.

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).

· Reference to other sectionsSee Section 7 for information on safe handling.

See Section 8 for information on personal protection equipment.

See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling Only adequately trained personnel should handle this product.

· Information about fire - and explosion protection:Keep ignition sources away - Do not smoke.

Protect against electrostatic charges.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: No special requirements.

· Information about storage in one common storage facility: Not required.

· Further information about storage conditions: Keep container tightly sealed.

· Specific end use(s) No further relevant information available. GB

(Contd. on page 3)

Page 40: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 3/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

Trade name: SR Model Separator

(Contd. of page 2)

DR

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters

· Ingredients with limit values that require monitoring at the workplace:

64-17-5 ethanol

WEL () Long-term value: 1920 mg/m³, 1000 ppm

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Wash hands before breaks and at the end of work.

Usual hygienic measures for dental practice.

· Respiratory protection: Not required.

· Protection of hands:The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.

Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/

the chemical mixture.

Selection of the glove material on consideration of the penetration times, rates of diffusion and the

degradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of quality

and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the

resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the

application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to be

observed.

· Eye protection:

Tightly sealed goggles

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: Fluid

Colour: Colourless

· Odour: Alcohol-like

· Odour threshold: Not determined.

· pH-value: Not determined.

· Change in conditionMelting point/Melting range: Undetermined.

Boiling point/Boiling range: Undetermined.

· Flash point: 23°C

· Ignition temperature: 425°C

(Contd. on page 4)

GB

Page 41: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 4/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

Trade name: SR Model Separator

(Contd. of page 3)

DR

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Product is not explosive. However, formation of explosive air/

vapour mixtures are possible.

· Explosion limits:Lower: 3.5 Vol %

Upper: 15.0 Vol %

· Vapour pressure at 20°C: 59 hPa

· Density: Not determined.

· Relative density Not determined.

· Vapour density Not determined.

· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Soluble.

· Segregation coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.

Kinematic: Not determined.

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.

· Chemical stability Stable under normal handling and storage conditions.

· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.

· Conditions to avoid No further relevant information available.

· Incompatible materials: No further relevant information available.

· Hazardous decomposition products: None under normal conditions of storage and use.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:· Primary irritant effect:· on the skin: No irritant effect.

· on the eye: No irritating effect.

· Sensitization: No sensitizing effects known.

12 Ecological information

· Toxicity· Acquatic toxicity: No further relevant information available.

· Persistence and degradability No further relevant information available.

· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.

· Mobility in soil No further relevant information available.

· Additional ecological information:· General notes:

Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water(Contd. on page 5)

GB

Page 42: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 5/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

Trade name: SR Model Separator

(Contd. of page 4)

DR

Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage

system.

· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.

· European waste catalogue

18 01 06* chemicals consisting of or containing dangerous substances

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

14 Transport information

· Land transport ADR/RID (cross-border)

· ADR/RID class: 3 (F1) Flammable liquids.

· Danger code (Kemler): 33

· UN-Number: 1170

· Packaging group: II

· Hazard label: 3

· UN proper shipping name: 1170 ETHANOL (ETHYL ALCOHOL), solution

· Tunnel restriction code D/E

· Maritime transport IMDG:

· IMDG Class: 3

· UN Number: 1170

· Label 3

· Packaging group: II

· EMS Number: F-E,S-D

· Marine pollutant: No

· Proper shipping name: ETHANOL (ETHYL ALCOHOL), solution

· Air transport ICAO-TI and IATA-DGR:

· ICAO/IATA Class: 3

· UN/ID Number: 1170

· Label 3

· Packaging group: II

(Contd. on page 6)

GB

Page 43: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 6/6

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 25.03.2011 Revision: 25.03.2011Version number 6

Trade name: SR Model Separator

(Contd. of page 5)

DR

· Proper shipping name: ETHANOL, solution

· Special precautions for user Warning: Flammable liquids.

· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information

This information is based on our present knowledge. However, this shall not constitute a guarantee for any

specific product features and shall not establish a legally valid contractual relationship.

· Relevant phrasesR11 Highly flammable.

GB

Page 44: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 1/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

DR

1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: SR Retentions Adhesive

· Relevant identified uses of the substance or mixture and uses advised against· Application of the substance / the preparation Adhesive for micro and macro retention

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:

Ivoclar Vivadent AG

Bendererstrasse 2

FL-9494 Schaan

PRINCIPALITY OF LIECHTENSTEIN

Tel: +423 235 35 35

Fax: +423 235 33 60

· Further information obtainable from:Regulatory Affairs

[email protected]

· Emergency telephone number: +423 / 235 33 13

2 Hazards identification

· Classification of the substance or mixture

· Classification according to Directive 67/548/EEC or Directive 1999/45/EC

Xi; Irritant

R36: Irritating to eyes.

F; Highly flammable

R11: Highly flammable.

R66-67: Repeated exposure may cause skin dryness or cracking. Vapours may cause drowsiness and

dizziness.

· Information concerning particular hazards for human and environment:The product has to be labelled due to the calculation procedure of the "General Classification guideline for

preparations of the EU" in the latest valid version.

At long or repeated contact with skin it may cause dermatitis due to the degreasing effect of the solvent.

· Classification system:The classification is according to the latest editions of the EU-lists, and extended by company and literature

data.

· Label elements

· Labelling according to EU guidelines:The product has been classified and marked in accordance with EU Directives / Ordinance on Hazardous

Materials.

· Code letter and hazard designation of product:

Xi Irritant

F Highly flammable

· Risk phrases:11 Highly flammable.

36 Irritating to eyes.

66 Repeated exposure may cause skin dryness or cracking.

67 Vapours may cause drowsiness and dizziness.(Contd. on page 2)

GB

Page 45: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 2/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 1)

DR

· Safety phrases:9 Keep container in a well-ventilated place.

16 Keep away from sources of ignition - No smoking.

23 Do not breathe fumes/aerosol.

26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

33 Take precautionary measures against static discharges.

60 This material and its container must be disposed of as hazardous waste.

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterization: Mixtures· Description: Mixture of substances listed below with nonhazardous additions.

· Dangerous components:

CAS: 67-64-1

EINECS: 200-662-2

acetone Xi R36; F R11

R66-67

50-100%

· Additional information: For the wording of the listed risk phrases refer to section 16.

4 First aid measures

· Description of first aid measures· General information: Immediately remove any clothing soiled by the product.

· After inhalation:Supply fresh air; consult doctor in case of complaints.

In case of unconsciousness place patient stably in side position for transportation.

· After skin contact: Wash with water and acidic soap.

· After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.

· After swallowing:Rinse out mouth and then drink plenty of water.

If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayed No further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:

CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

· For safety reasons unsuitable extinguishing agents: Water with full jet

· Special hazards arising from the substance or mixture No further relevant information available.

· Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.

6 Accidental release measures

· Personal precautions, protective equipment and emergency proceduresWear protective equipment. Keep unprotected persons away.

· Environmental precautions: Do not allow to enter sewers/ surface or ground water.(Contd. on page 3)

GB

Page 46: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 3/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 2)

DR

· Methods and material for containment and cleaning up:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).

Ensure adequate ventilation.

Do not flush with water or aqueous cleansing agents

· Reference to other sectionsSee Section 7 for information on safe handling.

See Section 8 for information on personal protection equipment.

See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handling Ensure good ventilation/exhaustion at the workplace.

· Information about fire - and explosion protection:Keep ignition sources away - Do not smoke.

Protect against electrostatic charges.

· Conditions for safe storage, including any incompatibilities· Storage:· Requirements to be met by storerooms and receptacles: Store in a cool location.

· Information about storage in one common storage facility: Not required.

· Further information about storage conditions:Keep container tightly sealed.

Store in cool, dry conditions in well sealed receptacles.

· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical facilities: No further data; see item 7.

· Control parameters

· Ingredients with limit values that require monitoring at the workplace:

67-64-1 acetone

WEL () Short-term value: 3620 mg/m³, 1500 ppm

Long-term value: 1210 mg/m³, 500 ppm

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:

Usual hygienic measures for dental practice.

Keep away from foodstuffs, beverages and feed.

Immediately remove all soiled and contaminated clothing

Wash hands before breaks and at the end of work.

Do not inhale gases / fumes / aerosols.

Avoid contact with the eyes and skin.

· Respiratory protection:In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure

use self-contained respiratory protective device.

· Protection of hands:

Protective gloves

The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.(Contd. on page 4)

GB

Page 47: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 4/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 3)

DR

Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/

the chemical mixture.

Selection of the glove material on consideration of the penetration times, rates of diffusion and the

degradation

· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks of quality

and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the

resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the

application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and has to be

observed.

· Eye protection:

Tightly sealed goggles

9 Physical and chemical properties

· Information on basic physical and chemical properties· General Information· Appearance:

Form: Fluid

Colour: Yellow tint

· Odour: Acetone-like

· Odour threshold: Not determined.

· pH-value: Not determined.

· Change in conditionMelting point/Melting range: Undetermined.

Boiling point/Boiling range: 55°C

· Flash point: -19°C

· Ignition temperature: 465°C

· Self-igniting: Product is not selfigniting.

· Danger of explosion: Product is not explosive. However, formation of explosive air/

vapour mixtures are possible.

· Explosion limits:Lower: 2.6 Vol %

Upper: 13.0 Vol %

· Vapour pressure at 20°C: 233 hPa

· Density: Not determined.

· Relative density Not determined.

· Vapour density Not determined.

· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Partly miscible.

· Segregation coefficient (n-octanol/water): Not determined.

· Viscosity:Dynamic: Not determined.

Kinematic: Not determined.

(Contd. on page 5)

GB

Page 48: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 5/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 4)

DR

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity No further relevant information available.

· Chemical stability Stable under normal handling and storage conditions.

· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.

· Possibility of hazardous reactions Reacts with strong oxidizing agents.

· Conditions to avoid No further relevant information available.

· Incompatible materials: No further relevant information available.

· Hazardous decomposition products: None under normal conditions of storage and use.

11 Toxicological information

· Information on toxicological effects· Acute toxicity:

· LD/LC50 values relevant for classification:

67-64-1 acetone

Oral LD50 5800 mg/kg (rat)

Dermal LD50 20000 mg/kg (rabbit)

· Primary irritant effect:· on the skin: No irritant effect.

· on the eye: Irritating effect.

· Sensitization: No sensitizing effects known.

· Additional toxicological information:The product shows the following dangers according to the calculation method of the General EU

Classification Guidelines for Preparations as issued in the latest version:

Irritant

12 Ecological information

· Toxicity· Acquatic toxicity: No further relevant information available.

· Persistence and degradability No further relevant information available.

· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.

· Mobility in soil No further relevant information available.

· Additional ecological information:· General notes:

Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water

Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage

system.

· Results of PBT and vPvB assessment· PBT: Not applicable.

· vPvB: Not applicable.

· Other adverse effects No further relevant information available.

13 Disposal considerations

· Waste treatment methods· Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system.(Contd. on page 6)

GB

Page 49: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 6/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 5)

DR

· European waste catalogue

18 01 06* chemicals consisting of or containing dangerous substances

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.

14 Transport information

· Land transport ADR/RID (cross-border)

· ADR/RID class: 3 (F1) Flammable liquids.

· Danger code (Kemler): 33

· UN-Number: 1090

· Packaging group: II

· Hazard label: 3

· UN proper shipping name: 1090 ACETONE

· Tunnel restriction code D/E

· Maritime transport IMDG:

· IMDG Class: 3

· UN Number: 1090

· Label 3

· Packaging group: II

· EMS Number: F-E,S-D

· Marine pollutant: No

· Proper shipping name: ACETONE

· Air transport ICAO-TI and IATA-DGR:

· ICAO/IATA Class: 3

· UN/ID Number: 1090

· Label 3

· Packaging group: II

· Proper shipping name: ACETONE

· Special precautions for user Warning: Flammable liquids.

· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out. GB

(Contd. on page 7)

Page 50: sdb GB SR Adoro Incisal, Dentin, Deep Dentin, Neck ... · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 11.04.2013 Version number 3 Revision: 11.04.2013

Page 7/7

Safety data sheetaccording to 1907/2006/EC, Article 31

Printing date 04.03.2011 Revision: 04.03.2011Version number 8

Trade name: SR Retentions Adhesive

(Contd. of page 6)

DR

16 Other information

This information is based on our present knowledge. However, this shall not constitute a guarantee for any

specific product features and shall not establish a legally valid contractual relationship.

· Relevant phrasesR11 Highly flammable.

R36 Irritating to eyes.

R66 Repeated exposure may cause skin dryness or cracking.

R67 Vapours may cause drowsiness and dizziness. GB