safety data sheet - Ultradent

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® SECTION 1 : Identification of the substance/preparation and of the company/undertaking 1.1. Product identifier Product code

: AS/10308, AX/10309, VS/64500

Product name

: Astringedent®, Astringedent® X, and Viscostat®

Product description

: Hemostatic solution

1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses

: Professional Dental Hemostatic Agent

1.3. Details of the supplier of the safety data sheet Manufacturer Ultradent Products, Inc. 505 W. 10200 S. South Jordan, UT 84095

Distributor Ultradent Products GmbH Am Westhover Berg 30 51149 Cologne Germany Email: [email protected] Emergency Phone : +49(0)2203-35-92-0

1.4. Emergency telephone number CHEMTREC (NORTH AMERICA) :(800) 424 - 9300 (INTERNATIONAL) :+1(703) 527 - 3887 SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Directive 1999/45/EC : The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Danger symbols

: Xn

R phrases

: R22

Classification according to Regulation (EC) No 1272/2008 [CLP] Health

: Acute Toxicity (Oral), Category 4 Skin Corrosion, Category 1B

Physical

: Metal Corrosion, Category 1

2.2. Label elements Classification according to Directive 1999/45/EC Hazard pictogram(s)

:

Xn

Harmful R&S statement(s)

: R22: Harmful if swallowed.

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® Classification according to Regulation (EC) No 1272/2008 [CLP] Hazard pictogram(s)

:

Exclamation mark Signal Word

: DANGER

Hazard statement(s)

: H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H290: May be corrosive to metals.

Precautionary statement(s) Prevention

: P280: Wear protective gloves/protective clothing/eye protection/face protection.

Response

: P305: IF IN EYES: P351: Rinse cautiously with water for several minutes. P313: Get medical advice/attention. P302+P352: IF ON SKIN: Wash with plenty of soap and water. P361: Take off immediately all contaminated clothing. P315: Get immediate medical advice/attention. P301: IF SWALLOWED: P310: Immediately call a POISON CENTER or doctor/physician. P331: Do NOT induce vomiting.

Storage

: P273: Avoid release to the environment.

Disposal

: P501: Dispose of in compliance with governmental regulation. (EC1975L0442-20/11/2003)

2.3. Other hazards Immediate concerns

: Corrosive

SECTION 3: Composition / information on ingredients 3.1. Substances Not Applicable 3.2. Mixtures

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat®

Chemical Name

CAS

Iron Anion-Sulfate and Subsulfate

EINECS No.

10028-22-5 233-072-9

Classification Classification according to according to Regulation Wt.% Directive (EC) No 67/548/EEC 1272/2008 [CLP]

< 70

Xn; R22; R36/38

Acute Tox. (O),Cat. 4; Skin Corr.,Cat. 1B; Met. Corr.,Cat. 1; H290; H302; H314

For full text of H-statements and R-phrases: see SECTION 16. SECTION 4: First aid measures 4.1. Description of first aid measures Following eyes

: Immediately flush eyes with plenty of water for at least 15 minutes. Get immediate medical attention.

Following skin

: Immediately flush skin with plenty of water. Remove clothing. Get medical attention immediately. Wash clothing separately before reuse.

Following ingestion

: If swallowed, rinse mouth with water, Do NOT Induce Vomiting. Give victim a glass of water or milk. Call a physician or poison control center immediately. Never give anything by mouth to an unconscious person.

Following inhalation

: No specific treatment is necessary since this material is not likely to be hazardous by inhalation. If exposed to excessive levels of dusts or fumes, remove to fresh air and get medical attention if cough or other symptoms develop.

4.2. Most important symptoms and effects, both acute and delayed Eyes

: Irritating to eyes.

Skin

: May cause skin burns.

Ingestion

: Harmful if swallowed.

Inhalation

: None expected for this product.

4.3. Indication of any immediate medical attention and special treatment needed Notes to physician

: Corrosive

SECTION 5: Fire fighting measures 5.1. Extinguishing media Extinguishing media

: Please see Fire Fighting Equipment under Section 5.3.

5.2. Special hazards arising from the substance or mixture

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® Explosion hazards

: Not Determined

Fire explosion

: Not Determined

Sensitive to static discharge

: Not Determined

Sensitivity to impact

: Not Determined

5.3. Advice for firefighters Fire fighting procedures

: As in any fire, wear self-contained breathing apparatus pressuredemand, (MSHA/NIOSH approved or equivalent) and full protective gear.

Fire fighting equipment

: Water spray, alcohol - resistant foam,dry chemical or carbon dioxide

SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General procedures

: Refer to Section 8 for Personal Protective Equipment.

6.2. Environmental precautions Water spill

: Do not allow to enter sewers or drains that may lead to waterways.

6.3. Methods and material for containment and cleaning up Small spill

: Wipe up with cloth, soap and water.

Large spill

: Collect in tightly closed containers.

6.4. Reference to other sections Reference to other sections

: Not Applicable

SECTION 7: Handling and storage 7.1. Precautions for safe handling Handling

: Use suitable protective equipment.

Storage

: See product labeling.

7.2. Conditions for safe storage, including any incompatibilities Shelf life

: See product labeling

7.3. Specific end use(s) Specific end use(s)

: Professional Dental Hemostatic Solution

SECTION 8: Exposure controls / personal protection 8.1. Control parameters Control parameters

: Not Determined

8.2. Exposure controls Eye/face protection

: Wear eye protection

Skin protection

: Wear suitable protective clothing and gloves.

SECTION 9: Physical and chemical properties

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® 9.1. Information on basic physical and chemical properties Physical state

: Viscostat is a Gel, Astringedent & Astringedent X are liquids.

Colour

: Brown

Odour

: Slight iron odor

Solubility in water

: Partially Soluble

9.2. Other information Percent volatile

: Not Determined

SECTION 10: Stability and reactivity 10.1. Reactivity Reactivity

: Stable

10.2. Chemical stability Chemical stability

: Sensitive to light.

10.3. Possibility of hazardous reactions Hazardous polymerization

: None

10.4. Conditions to avoid Conditions to avoid

: None known.

10.5. Incompatible materials Incompatible materials

: Strong acids, strong bases, and oxidizing agents.

10.6. Hazardous decomposition products Hazardous decomposition products

: None known.

SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute Notes

: Device is biocompatible when used as directed by dental professionals per ISO 10993-1.

SECTION 12: Ecological information 12.1. Toxicity Toxicity

: Not Determined

Aquatic toxicity (acute)

: Do not allow to enter sewers or drains that may lead to waterways.

96-hour LC50

: Not Determined

48-hour EC50

: Not Determined

96-hour EC50

: Not Determined

12.2. Persistence and degradability

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® Persistence and degradability

: Not Determined

12.3. Bioaccumulative potential Bioaccumulative potential

: Not Determined

12.4. Mobility in soil Mobility in soil

: Not Determined

12.5. Results of PBT and vPvB assessment Results of PBT and vPvB assessment

: Not Determined

12.6. Other adverse effects Environmental data

: Not Available

SECTION 13: Disposal considerations 13.1. Waste treatment methods Disposal method

: Dispose of in compliance with governmental regulation.(EC 1975L0442-20/11/2003)

SECTION 14: Transport information 14.1. UN number UN number

: 3264

14.2. UN proper shipping name UN proper shipping name

: Corrosive Liquid, Acidic, Inorganic, N.O.S. (Ferric sulfate mixture)

14.3. Transport hazard class(es) Primary hazard class/division

:8

Hazard classification

:8

14.4. Packing group Packing group

: II

14.5. Environmental hazards Marine pollutant #1

: N/A

14.6. Special precautions for user ADR - road

: N/A

RID - rail

: N/A

IMDG - sea

: N/A

IATA - air

: N/A

14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Transport in bulk

: N/A

SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture

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SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No :

01/19/2006 8-001.12 05/19/2015 15

Astringedent®, Astringedent® X, and Viscostat® RoHS

: Please refer to Medical Devices Directive 93/42/EEC

15.2. Chemical safety assessment Chemical safety assessment

: See Section 11

SECTION 16: Other information Relevant R-phrases and/or Hstatements (number and full text)

: R22: Harmful if swallowed. R36/38: Irritating to eyes and skin. Acute Tox. (O), Cat. 4: Acute Toxicity (Oral), Category 4 Met. Corr., Cat. 1: Metal Corrosion, Category 1 Skin Corr., Cat. 1B: Skin Corrosion, Category 1B H290: May be corrosive to metals. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage.

Prepared by

: Anu Kattoju

Revision summary

: This SDS replaces the 02/26/2015 SDS. Revised: Section 1: . Section 2: EMERGENCY OVERVIEW - IMMEDIATE CONCERNS. Section 4: NOTES TO PHYSICIAN, SIGNS AND SYMPTOMS OF OVEREXPOSURE - SKIN SKIN.

General statements

: N/A= Not Applicable

Manufacturer disclaimer

: FOR DENTAL USE ONLY: Use as directed. The information and recommendations are taken from sources (raw material SDS(s) and manufacturer's knowledge) believed to be accurate; however,the manufacturer, makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof. Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate.

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safety data sheet - Ultradent

Page 1 of 7 SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use Date Issued : SDS No : Date Revised : Revision No : 01/19/2006 8-...

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