Porcelain Prep Kit - Pulpdent Corporation

PULPDENT Corporation • 8
0 Oakland Street • Watertown, MA 02472 • U.S.A
www.pulpdent.com • [email protected]
Porcelain Prep Kit
PULPDENT ®
Porcelain Prep Kit
1.2
1.2
1.2
1.2
mL
mL
mL
mL
Porcelain Etch Gel
Kool-Dam™
Dry-Rite™
Silane Bond Enhancer
®
P333+P313: If irritation or rash occurs, get medical advice/attention.
P410+P411: Protect from sunlight. Store at temperature not exceeding 27°C / 80°F.
3.0Composition
3.1
Chemical characterization of the preparation Methacrylate ester monomers in a light-cured, glass-filled paste.
3.2
Hazardous ingredients
CAS Number
Name of the Ingredient
Concentration
Classification per 67/548/EEC
Proprietary
Uncured methacrylate
55-65%
Xi (Irritant)
ester monomers
R36/37/38, R43
112945-52-5
Amorphous silica
5 %
Xi (Irritant), R36/37/38
4.0
4.1
4.2
4.3
4.4
4.5
4.6
4.7
5.0
5.1
5.2
5.3
5.4
PULPDENT
PULPDENT ®
Porcelain Prep Kit
Classification per Regulation
(EC) No.1278/2008 (CLP)
Eye irritation, 2, H319
STOT SE 3, H335
Skin irritation, 2, H315
Skin sensitization, 1, H317
Eye irritation, 2, H319
STOT SE 3, H335
Skin irritation, 2, H315
First Aid Measures
General InformationMinimal health hazard under normal conditions of use. May be irritating to eyes, respiratory system and skin on
contact. Prolonged or repeated contact with methacrylate may cause sensitization. Show this safety data sheet
to medical personnel. Get medical attention in case of uncertainty.
Inhalation
Move to fresh air. If necessary, administer oxygen / artificial respiration; seek medical attention.
Skin Contact
Take off contaminated clothing. Wash skin thoroughly with soap and water for 15 minutes.
Eye Contact
Keep eyelids apart and flush with running water for 15+ minutes. Get medical attention.
IngestionRinse mouth with water. Do not induce vomiting. Get immediate medical attention. May be irritating to mucous
membranes. Never give anything by mouth to an unconscious person.
Precautions for first responders
Ventilate the area. Wear eye and skin protection.
Information for physicians
Symptoms
Irritation or redness in eyes, throat or on skin.
Hazards
May be irritating to eyes, respiratory system and skin. May cause sensitization by skin contact.
Treatment
As above under First Aid.
Fire Fighting Measures
Suitable extinguishing mediaCarbon dioxide, dry chemical, alcohol foam, or water fog. Water spray may be used to keep fire exposed
containers cool.
Extinguishing media to avoid
Do not use direct water stream
Special exposure hazards in a fire
Heat may cause polymerization with rapid release of energy.
Special protective equipment
A self-contained breathing apparatus should be worn by fire fighting personnel. Cool exposed
for fire-fighters containers with water spray to prevent polymerization under fire conditions.
6.0Accidental Release Measures
6.1
Personal precautions
Ventilate area. Wear safety glasses, gloves, and lab coat.
6.2
Environmental precautions
Contain spilled material. Follow all government regulations.
6.3
Method for clean upAbsorb or wipe up spill with suitable material (paper towels or cloths). Collect for disposal in a covered container.
Wash area of spill with alcohol or soap and water.
7.0
7.1
7.2
7.3
Handling and Storage
HandlingFor use only by dental professionals. Follow good hygiene practices. Do not smoke, eat or drink while using.
Remove applicator tip from syringe and cap container immediately after use. Keep light-cured materials shaded
from intense light sources.
StorageKeep containers tightly closed. Store product in original container at cool room temperature (<25°C) and in a
dry, well ventilated area. Avoid direct, strong light, sources of ignition and extremes of temperature (>27°C/80°F,
<5°C/40°F). Shelf life for unopened product is two years from date of manufacture, provided that the material
has been stored properly.
Specific uses
Dental material
8.0
8.1
8.2
8.2.1
8.2.1.1
8.2.1.2
8.2.1.3
8.2.1.4
Exposure Controls / Personal Protection
Exposure limit values
PEL: Not established. TLV: Not established.
Exposure controls
Occupational exposure controlsNo special equipment required under normal conditions of use of this product in the quantity provided.
Respiratory protectionNone required. Good general ventilation is sufficient to control any airborne vapors from uncured material.
Hand protection
No special requirements other than the usual surgical gloves.
Eye protection
No special requirements other than the usual safety glasses.
Skin protectionNo special requirements. Good personal hygiene and safety practices and wearing a lab coat should protect
dental staff from unnecessary exposure to uncured material.
8.2.1.5 Other controls
Emergency eye wash fountain should be available. Wash hands after use.
8.2.2
Environmental exposure controls
Follow all government regulations. Cure material before disposing.
9.0
9.1
9.1.1
9.1.2
9.2
9.2.1
9.2.2
9.2.3
9.2.4
9.2.5
9.2.6
9.2.7
9.2.8
9.2.9
9.2.10
9.2.11
9.2.12
9.2.13
Physical and Chemical Properties
Appearance / Color
Color / Physical state
Light blue gel
Odor
Faint, characteristic
Important health, safety and environmental information
pH
Not determined
Boiling point
Not determined
Flash point
Not determined
Flammability (solid, gas)
Not applicable
Explosive properties
Not applicable
Oxidizing properties
Not determined
Vapor pressure
< 1 mm Hg / 133 Pa / Id: B
Specific gravity
1.290
Solubility in water
Nil
Partition coefficient
Not determined
Viscosity
Not determined
Vapor density
Not determined
Evaporation rate
Not determined
10.0
10.1
10.2
10.3
Stability and reactivity
Conditions to avoid
Avoid temperature extremes (>80°F / 27°C, <40°F/ 5°C), intense light, contamination.
Materials to avoid
Reducing and oxidizing agents, peroxides, amines.
Hazardous decomposition productsUnder fire conditions and with amounts far greater than that supplied in this product, hazardous polymerization
may occur with heat build- up, release of carbon monoxide, carbon dioxide, oxides of nitrogen.
Further information
Polymerization will occur when exposed to direct light.
10.4
11.0Toxicological information
11.1
Acute toxicityNot toxic. Minimal health hazard in the quantities present in this product and under normal conditions of use.
11.2
Irritation and corrosiveness
May be irritating to eyes, mucous membranes or skin on contact or with prolonged exposure.
11.3
SensitizationMay be sensitizing. Prolonged or frequent skin contact may cause allergic skin reactions in some susceptible
individuals.
11.4
Sub-acute, sub-chronic and
Prolonged and/or frequent skin contact may cause allergic skin reactions in susceptible
prolonged toxicity individuals. Prolonged exposure to large amounts (more than in this product) of this material may cause eye and
respiratory irritation.
11.5
Carcinogenicity, Mutagenicity, None known
Reproductive Toxicity
11.6
Empirical data
Not available
11.7
Clinical experienceKool-Dam has been sold on the domestic and international market for about 10 years. During that time there
have been no reports of adverse events.
12.0
12.1
Ecological Information
EcotoxicityTo the best of our knowledge, polymerized material is inert. No other information is available. Follow all
government regulations.
13.0
13.1
Disposal Considerations
RegulationsFollow all local and national government regulations in disposing material or contaminated packaging.
14.0Transport Information
14.1
Restrictions
None. Not regulated.
15.0
15.1
15.2
15.3
Class I medical devices under MDD 93/42/EEC.
Class I medical device
Class III medical device
Regulatory Information
EU US FDA
Health Canada
16.0Other information
16.1
List of relevant R phrases
R36/37/38: Irritating to eyes, respiratory system and skin.
R43: Sensitizing by skin contact
16.2
Hazard Statements
H319: Eye irritation. Hazard category 2.
H335: Specific Target Organ Toxicity - Single exposure; hazard category. 3. Respiratory tract irritation.
H315: Skin irritation. Hazard category 2.
H317: Skin Sensitization. Hazard category 1.
16.3
Precautionary Statements
P261: Avoid breathing vapor.
P280: Wear protective gloves and eye protection
P305 + P351: If in eyes, rinse cautiously with water for several minutes.
P337 + P313: If eye irritation persists, get medical advice/attention.
P302 + P352: If on skin, wash with plenty of soap and water.
P333 + P313: If irritation or rash occurs, get medical advice / attention.
P410 + P411: Protect from sunlight. Store at temperature not exceeding 27°C / 80°F.
16.4
Restrictions on use
Pulpdent products are to be sold to and used by dental professionals only.
16.5
Further informationThe information presented herein is believed to be factual as it has been derived from the works of persons
believed to be qualified experts. However, nothing contained in this information is to be taken as a warranty
or representation for which Pulpdent Corporation bears legal responsibility. The user should review any
recommendations in the specific context of the intended use to determine whether they are appropriate.
16.6
Sources of key data
National Institute for Occupational Safety (NIOSH)
US Occupational Safety and Health Administration (OSHA)
Eur-Lex European Union Law: Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006
(REACH).
Guidance on the compilation of safety data sheets. Version 1.1; December 2011. European Chemicals Agency
16.7
Information which has been
This Safety Data Sheet has been revised to meet the requirements of the GHS SDS format,
added, deleted or revised. Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006 (REACH). Specifically, Sections 2.1,
2.2, 3.2, 16.2, 16.3 have been modified.
The PULPDENT PORCELAIN PREP KIT contains the necessary ingredients for preparing porcelain veneers and inlays and fractured porcelain
teeth for bonding.
the dangers of hydrofluoric acid, provided it is used in accordance with
these instructions.
For safe intra-oral use, carefully follow the Directions for Use.
Caution:
Porcelain Etch Gel contains 9.6% hydro-fluoric acid, a powerful and
aggressive chemical that produces irritating fumes and must be handled
with extreme care. Ingestion, contact with skin and eyes, and chronic
inhalation of fumes are dangerous.
Care must be taken to protect practitioner, assistant and patient. Pulpdent
Porcelain Etch Gel has been buffered, gelled and packaged to minimize
NOTE: Multi-dose syringes should either be encased in a fresh protective
barrier for each patient or cleaned and disinfected between patients, as
appropriate
WARNING:
If Porcelain Etch Gel comes in contact with skin or soft tissue, rinse
exposed area with copious amounts of water for at least two minutes. Use
high-speed evacuation system to remove water.
INSTRUCTIONS FOR USE
1. Protective eyewear must be worn by practitioner, assistant and patient.
Protective gloves must be worn by practitioner and assistant.
2. Place rubber dam to isolate operative site and protect soft tissue.
3. Securely attach a green 18-gauge applicator tip to the Kool-Dam and
apply a coat of Kool-Dam 1-2 mm thick on the gingiva or tooth surfaces requiring protection, if needed.
4. Light cure for 10 seconds. Cures with all lights.
5. Assistant must stand ready at chairside and hold vacuum tip 2-3
inches from porcelain surface during the etching process to evacuate
acid fumes.
6. Securely attach a 25-gauge applicator tip to the Porcelain Etch Gel
syringe. Carefully start the flow of Porcelain Etch Gel on a pad and
immediately dispose of this sample. Do not start flow in patient’s mouth.
For maximum control of flow, do not push on plunger with thumb. It is
recommended instead to hold syringe barrel between thumb and forefinger while resting plunger in palm of hand. Gently pull back with thumb
and forefinger to start flow. Never force plunger. Use a new applicator
tip for each patient.
7. Carefully apply Porcelain Etch Gel to porcelain surface and leave for
one minute while evacuating fumes with vacuum. Cap syringe immediately after use.
8. Remove etch gel with vacuum. Rinse treated surface with copious
amounts of water and dry with clean, uncontaminated, oil-free and
moisture-free compressed air.
9. Securely attach red dropper tip to the Dry-Rite syringe and apply
Pulpdent Dry-Rite drying agent to treated surface. To promote rapid
drying, use a gentle flow of clean, oil-free air if desired. Cap Dry-Rite
immediately after use.
10. Securely attach red dropper tip to Silane syringe and apply Pulpdent
Silane Bond Enhancer to the etched ceramic surface and allow to
dry. Apply a gentle flow of clean, oil-free and moisture-free air, if
desired. Cap syringe immediately after use.
11. Proceed with repair or cementation of porcelain teeth, inlays or
veneers using your preferred unfilled resin bonding agent and
restorative resin or resin cement.
Français
KIT DE PREPARATION DE LA PORCELAINE
ATTENTION : Le Gel de mordançage pour porcelaine contenant 9,6%
d’acide hydrofluorique, un produit chimique puissant et agressif produit des
émanations irritantes, doit être utilisé avec grand soin. L’ingestion, le contact avec la peau et les yeux et une inhalation chronique des émanations
d’acide sont dangereux.
PREVENTION : Si le gel de mordançage pour porcelaine est au contact de
la peau, ou des tissus mous, rincer copieusement avec de l’eau au moins
pendant deux minutes. Utiliser une aspiration accélérée pour évacuer l’eau.
Mode d’emploi
1. L e praticien, son assistante et le patient doivent porter des lunettes de
protection. Le praticien et son assistante doivent porter des gants.
2. Isoler la dent à traiter et les tissus mous environnants avec une digue.
3. A
u besoin, appliquez une couche de Kool-Dam de 1 à 2 mm d’épaisseur
sur la gencive ou sur les dents nécessitants une protection.
4. P
olymérisez pendant 10 secondes. Kool-Dam est polymérisables avec
toutes les lumières.
5. L ’assistante doit tenir l’aspiration chirurgicale à 5-6cm de la céramique
en train d’être mordancée, pour aspirer les émanations d’acide.
6. Pour un contrôle maximum du flux de “Porcelain Etch Gel”, il est recommandé de ne pas pousser le piston de la seringue avec le pouce, mais
plutôt de bloquer la seringue entre le pouce et l’index avec le piston
libre, dans la paume de la main. Repousser doucement la seringue
vers la paume avec le pouce et l’index. Utiliser un nouvel embout pour
chaque patient.
7. Appliquer le “Porcelain Etch Gel” sur la surface de céramique à mordancer et laisser agir 1 minute en évacuant les émanations d’acide avec
l’aspiration du fauteuil.
8. Rincer abondamment la surface mordancée pendant 2 minutes et
sécher avec un air décontaminé, sans huile ni humidité résiduelle.
9. En utilisant un embout rouge, appliquer Dry-Rite sur la surface traitée.
Pour accélérer le séchage, aidez-vous de la seringue à air. Refermer la
seringue de Dry-Rite immédiatement après usage.
10.Appliquer le Silane avec un embout rouge et laisser sécher. Accélérer
le séchage avec la seringue à air, si nécessaire. Refermer la seringue
Silane immédiatement après usage.
11. R
éparer votre éclat de porcelaine avec votre adhésif et composite de
restauration préféré, ou, sceller l’inlay ou facette céramique avec votre
ciment résine préféré.
Deutsch
Porcelain Prep Kit
9,6 % Fluorhydratsäure
Dry-Rite Drying Agent
Silane Bond Enhancer
enthält die notwendigen Bestandteile um Keramik-Facetten und
-Inlays zu befestigen und Keramikkronen zu reparieren
VORSICHTSMASSNAHME:
Porcelain-Etch Gel enthält 9,6 % Fluorhydratsäure, eine kraftvolle
aggressive Substanz, welche gefährliche Dämpfe erzeugt und mit
besonderer Vorsicht verarbeitet werden muß.
Vermeiden Sie den Kontakt mit Haut und Augen und das dauernde
Einatmen der Dämpfe.
Zum Schutz des Zahnarztes, der Zahnarzthelferin und des Patienten
sind sämtliche Vorsichts-maßnahmen zu treffen. Porcelain-Etch
ist verstöpselt und entsprechend verpackt, um die Gefahren der
Fluorhydratsäure so weit wie möglich zu verringern.
Gebrauchsanweisung:
1. Zahnarzt, Zahnarzthelferin und Patient haben Schutzbrillen und
Schutzhandschuhe zu tragen
2. Platzieren Sie einen Kofferdam, um das Arbeitsgebiet zu isolieren
und die Weichteile zu schützen.
3. Um Gingiva oder Zahnoberflächen zu schützen, applizieren Sie einen
ca. 1-2mm dicken Film von Kool-Dam.
4. 10 Sek. lichthärten (mit allen Lichthärtegeräten möglich).
5. Die Zahnarzthelferin muß bereit sein, die Säuredämpfe mit
Hilfe einer Kanüle aus einer Entfernung von ca. 6 cm vom
Behandlungsbereich abzusaugen.
6. Den Stöpsel der Spritze entfernen und eine Kanüle aufset-zen.
Keine Anwendung im Mund des Patienten vornehmen, bevor
nicht ein Versuch auf einem Wachspapier gemacht wurde, das
dann sofort wegge-worfen wird. Um den Fluß des Präparates besser
zu kontrollieren, sollte die Spritze zwischen Daumen und Zeigefinger
gehalten werden und der Kolben in der Handfläche liegen. Daumen
und Zeigefinger vorsichtig gegen die Handfläche ziehen, um den
Fluß auszulösen.
7. Applizieren Sie Porcelain-Etch vorsichtig auf die
Porzellanoberfläche, lassen Sie dieses 1 Minute einwirken und saugen Sie gleichzeitig mit einer Absaugkanüle die Dämpfe ab.
8. Die behandelte Oberfläche während 2 Minuten mit viel Wasser
abspülen und trocknen.
9. Verwenden Sie Pulpdent Dry-Rite Drying Agent mit den roten
Ansätzen um die bearbeiteten Oberflächen zu reinigen. Um die
Trocknungszeit zu verkürzen können Sie diese mit sauberer, ölfreier
Luft beschleunigen.
10. A
pplizieren Sie Pulpdent Silane Haftvermittler mit den roten
Ansätzen und lassen Sie ihn 1 Minute trocknen. Wenn der Silane
nach 1 Minute nicht trocken ist verwenden Sie saubere ölfreie Luft.
Verschließen Sie die Spritze sofort nach Gebrauch!
11. S
etzen Sie mit der Reparatur der gebrochenen Porzellankrone
fort. Verwenden Sie Ihr bevorzugtes licht- härtendes Composite
für die Reparatur der Porzellankrone oder einen geeigneten
Befestigungszement zum Zementieren von Porzellan-Facetten und
-Inlays.
Español
PORCELAIN PREP KIT - Kit para adhesión a porcelana
Contenido: Gel de grabado de porcelana, Agente Secante Dry Rite, KoolDam y Silano - mejorador de la adhesión
El kit de Preparación de Porcelana de Pulpdent contiene los ingredientes
necesarios para Preparar veneers de Porcelana, inlays y dientes de
porcelana fracturados para bonding.
PRECAUCIÓN: El gel de grabado de porcelana contiene ácido hidrofluorídrico al 9,6 %, un poderoso y agresivo agente químico que produce
vapores irritantes y debe ser manejado con extremo cuidado. Su
ingestión, contacto con la piel y con los ojos, o la inhalación continua de
los vapores es peligrosa.
El odontólogo, su asistente y el paciente deben ser protegidos.
El Gel de grabado de Porcelana ha sido procesado para minimizar los
peligros del ácido hidrofluorídrico, siempre y cuando sea utilizado de
acuerdo con las instrucciones adjuntas.
Para un uso intra-oral seguro, siga cuidadosamente las instrucciones
de empleo.
ADVERTENCIA
Si el gel de grabado de Porcelana entra en contacto con la piel o la
mucosa, lave el área expuesta con grandes cantidades de agua durante
por lo menos 2 minutos. Utilice un sistema de evacuación de gran velocidad para retirar el agua. Recomendamos fehacientemente el uso de Etch
Arrest para neutralizar el grabador antes de su remoción.
Instrucciones De Uso
1. Odontólogo, asistente y paciente deben usar lentes de protección. El
odontólogo y su asistente deben usar guantes protectores.
2. Coloque dique de goma para aislar el campo operativo y proteger
las mucosas.
3. Aplique una capa de Kool-Dam con 1-2 mm de grosor en la gingiva o
superficie del diente si es necesario.
4. Fotocura durante 10 segundos. Se cura con todo tipo de luz.
5. La asistente debe encontrarse lista y sostener la punta aspiradora
a 2-3 pulgadas de la superficie de porcelana durante el proceso de
grabado para evacuar los vapores del ácido.
6. Remueva la tapa del Gel de grabado de Porcelana y coloque una
aguja predoblada en la jeringa. Cuidadosamente comience a dejar
fluír el gel sobre una loseta e inmediatamente tire esta muestra.
NO comience el flujo en boca. Para un máximo control del flujo del
gel, no empuje el émbolo con el pulgar. Se recomienda en cambio
sostener la jeringa entre el pulgar y el índice mientras descansa la
jeringa en la palma de la mano. Tire suavemente con el índice y el
pulgar para comenzar el flujo de producto. Use una aguja nueva con
cada paciente.
7. Aplique cuidadosamente el Gel de grabado de Porcelana a la superficie de porcelana y déjela por uno minuto, mientras evacúa los vapores
con el aspirador.
8. Lave la superficie tratada con gran cantidad de agua durante dos
minutos y seque con aire comprimido limpio, no contaminado, que no
contenga residuos de aceite ni humedad.
9. Utilizando una punta aplicadora roja, coloque el agente secante Dry
Rite sobre la superficie tratada. Aplique aire no contaminado (limpio,
sin residuos de aceite) en forma suave - si lo desea. Tape la jeringa
inmediatamente después del uso.
10. Aplique el agente mejorador de la adhesión - Silano - con una punta
roja y permita que seque. Puede secarse suavemente con aire no
contaminado. Tape la jeringa inmediatamente después de su uso.
11. Proceda con la reparación o cementado del diente de porcelana,
inlay o veneer utilizando bonding de resina fluída y resina restaurativa o cemento de resina.
Italiano
PORCELAIN PREP KIT
Modalità d’uso
1. Operatore, assistente e paziente devono indossare occhiali protettivi.
Per operatore e assistente sono previsti anche i guanti.
2. Posizionare la diga di gomma per isolare il campo di lavoro e proteggere i tessuti.
3. Applicare uno strato di Kool Dam dello spessore di 1-2mm sulle superfici gengivali o del dente da proteggere, se necessario.
4. Fotopolimerizzare per 10 secondi. Polimerizza con qualsiasi tipo di
lampada.
5. Durante la mordenzatura l’assistente deve restare accanto alla
poltrona e tenere l’aspiratore vicino alla superficie in porcellana, per
eliminare i vapori acidi.
6. Rimuovere il tappo della siringa di Porcelain Etch Gel e montare sulla
stessa un ago ricurvo. Versare il prodotto su un tampone. Non versare
direttamente nella bocca del paziente. Per controllare al massimo il
flusso, non premere lo stantuffo con il pollice; è consigliato, invece,
tenere il corpo della siringa con pollice e indice, mentre il pistone
rimane nel palmo della mano. Per avviare il flusso, tirare indietro
delicatamente con pollice e indice. Utilizzare un ago nuovo per ogni
paziente.
7. Applicare accuratamente il Porcelain Etch Gel sulla superficie in porcellana e lasciare in posa per 1 minuti, mentre vengono eliminati i vapori
con l’aspiratore.
8. R
isciacquare abbondantemente con acqua la superficie trattata per
1 minuti, quindi asciugare con aria compressa pulita, incontaminata,
senza olii e umidità.
9. A
pplicare l’agente essiccante Dry-Rite sulla superficie trattata utilizzando il contagocce rosso. Per accelerare l’essiccazione è possibile
dirigere sulla parte trattata un leggero getto d’aria. Tappare la siringa
di Dry-Rite subito dopo l’uso.
10. Applicare il Silane Bond Enhancer con il contagocce rosso e lasciare
asciugare per 1 minuto. Se, entro questo tempo, il prodotto non si
asciuga, è possibile utilizzare un leggero getto d’aria. Tappare la
siringa subito dopo l’uso.
11. Procedere alla riparazione dei denti in porcellana fratturati, utilizzando
la propria tecnica per veneers e inlays.
Nederlands
Porselein Prep Kit
Gebruiksaanwijzing
1. Een beschermbril dient gedragen te worden door zowel de tandarts,de
assistente en de patiënt. De tandarts en assistente dienen tevens
handschoenen te dragen.
2. Leg cofferdamvellen aan om het werkgebied te isoleren en zacht
weefsel te beschermen.
3. Breng een laag van Kool Dam met een dikte van 1-2mm aan op de
Gingiva of ander tanddeel voor bescherming indien noodzakelijk.
4. Lichtuitharding 10 seconden. Uitharding met alle mogelijke lampen.
5. De assistente dient klaar te staan naast de stoel en de afzuigtip 5 tot
8cm van het porselein oppervlak te houden tijdens het etsen om de
zuurdampen af te zuigen.
6. Verwijder het dopje van de Porselein Ets Gel spuit en bevestig een
voorgebogen applicatietip op de spuit. Druk voorzichtig wat Porselein
Ets Gel uit de spuit op een mengblok en gooi dit blaadje weg. Begin
niet met spuiten in de mond van de patiënt. Voor een optimale controle
over de spuitmassa, druk niet op de plunger met de duim. Aanbevolen
wordt de spuit te klemmen tussen duim en wijsvinger, terwijl de
plunger op de palm van de hand rust. Trek met duim en wijsvinger
de spuit voorzichtig terug om te beginnen met spuiten. Gebruik een
nieuwe applicatietip voor iedere patiënt.
7. Voorzichtig Porselein Ets Gel op het porselein oppervlak aanbrengen
en 1 minuut laten inwerken terwiji de dampen worden afgezogen.
8. Het behandelde oppervlak met overvloedig water spoelen gedurende 1
minuten. Daarna drogen met schone, olievrije ongecontamineerde en
vochtvrije perslucht.
9. Bevestig een red dropper tip op het spuitje Dry-Rite en appliceer dit
op het behandelde oppervlak. Om het drogen te bevorderen Om het
drogen te bevorderen, kan schone, olievrije lucht worden toegevoegd.
Na gebruik het dopje weer op de Dry-Rite bevestigen.
10. Bevestig een red dropper tip op het spuitje Pulpdent Silane Bond
Enhancer en appliceer dit op het behandelde oppervlak. Laat dit drogen. Indien gewenst kan schone, olievrije en vochtvrije lucht worden
toegevoegd. Na gebruik het dopje weer op de Silane bevestigen.
11. Vervolg met het repareren of cementeren van porseleinen tanden,
inlays of veneers met het door U gewenste adhesief of composiet.
Pulpdent Corporation
VORSICHT: Wenn Porcelain-Etch Gel in Kontakt mit Haut oder
Weichgewebe kommt, spülen Sie während
mindestens 2 Minuten mit reichlich Wasser. Porcelain Etch Gel
greift Inox an.
Revision Date: July 1, 2013
Safety Data Sheet
1.0 Commercial Product Name and Supplier
1.1 Commercial product name/designation
1.2 Application / Use
1.2.2
SIC
1.3
Producer
1.4
Emergency Telephone Number
1.5
Authorized European Representative Pulpdent Porcelain Etch Gel, 9.6% Hydrofluoric Acid Gel
Dental material used to etch porcelain.
851 Human health activity
Pulpdent Corporation 80 Oakland Street, PO Box 780
Watertown, MA 02472 USA
1-800-535-5053 (24 Hour / USA)
International Business Solutions Ltd.
54 Mayfield Ridge
Hatch Warren, Basingstoke, RG22 4RS UK
Tel: 1 617 926-6666
Fax: 1 617 926-6262
Email: Pulpdent@pulpdent. com Tel: 07989 407479/Fax: 01256 350330
Email: [email protected]
2.0
Hazards Identification
2.1Classification
2.1.1
Classification according to Regulation Hazard Class
Hazard Category
(EC) No. 1272/2008 [CLP]
Acute Toxicity
2
Skin Corrosion
1A
Serious eye damage
1
2.1.2
Classification according to Directive 67/548/EEC T; R26/27/28 C; R35
(See SECTION 16 for full text of risk phrases)
2.2
GHS Label Elements
Hazard Pictograms
Signal Word: DANGER
Restricted to use by dental professional only.
Hazard Statements
H300: Fatal if swallowed
H330: Fatal if inhaled.
H310: Fatal in contact with skin.
H314: Causes severe skin burns and eye damage.
H318: Causes serious eye damage.
Precautionary Statements
P261: Avoid breathing vapors.
P262: Do not get in eyes, on skin or on clothing.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves, lab coat and eye/face protection.
P301: If swallowed, immediately call a Poison Center or doctor/physician.
P302+P350: If on skin, gently wash with soap and water.
P304+340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing.
XK-PPK-IN-12
REV: 09/2013
Hazard Statement
H300, H330, H310
H314
H318
3.0Composition
3.1
Chemical Characterization
9.6% Hydrofluoric Acid in a proprietary gel base
3.2
Hazardous Ingredients
CAS Number
Name of the ingredient
Concentration
Classification per 67/548/EEC
7664-39-3
Hydrofluoric acid
9.6%
T; R 26 / 27 / 28
C; R 35
64-17-5
Ethyl alcohol
5.3 %
Xi: R 36 / 37 / 38
4.0
4.1
4.2
4.3
4.4
4.5
4.6
4.7 Classification per Regulation
(EC) No.1278/2008 (CLP).
Acute Toxicity; 2; Skin Corrosion; 1A
Serious eye damage; 1
Eye irritation, 2, STOT SE 3,
Skin irritation, 2,
First Aid Measures
General InformationVERY CORROSIVE! Toxic! Although Porcelain Etch Gel is buffered, diluted (9.6%) hydrofluoric acid that has
been incorporated into a gel, this product is still very corrosive. AVOID ALL CONTACT WITH PRODUCT. May
be fatal if inhaled, swallowed or absorbed through skin. Causes severe burns. Acute effects may be delayed.
Eye ContactCall for emergency medical care. Immediately (within 1 minute) flush eyes and surrounding skin with running
water for 30-60 minutes, holding lids apart to ensure flushing of the entire surface. Get emergency medical
attention only after the flushing is complete unless it can be continued during transport.
Skin ContactCall for emergency medical care. Immediately flush skin with running water for 30-60 minutes while removing
contaminated clothing and shoes. Get emergency medical attention only after the flushing is complete unless
it can be continued during transport. Apply 2.5% calcium gluconate gel to the exposed area (rubbing it in well)
every 15 minutes; if calcium gluconate is not available, apply benzethonium chloride or benzalkonium chloride
to the exposed area.
IngestionCall for emergency medical care. Do not induce vomiting. If conscious, have patient rinse mouth and drink a
large amount of water to dilute. Never give anything by mouth to an unconscious person
InhalationRemove patient to fresh air. Administer oxygen, artificial respiration and/or CPR as necessary. Seek immediate
medical care. Have patient lie down; keep quiet, warm.
Precautions for first respondersAvoid all contact with material. Wear face shield, gloves, lab coat. Awareness of burns may be delayed. Begin
first aid as soon as possible. Have someone else call for emergency medical care and ventilate area.
Information for physicians
Symptoms
Pain and redness at site of contact. Victim may not initially be aware of burn.
Hazards
May be fatal if inhaled, swallowed, absorbed through skin. Causes severe burns.
TreatmentSame as above (4.1 to 4.4). Also, skin burns may be treated by immersing the area in iced magnesium sulfate
solution (25 to 50%) or iced water, taking care to prevent frostbite by moving from iced solution every 10 to 15
minutes.
5.0
Fire Fighting Measures
5.1
Suitable extinguishing media
Carbon dioxide. Dry chemical.
5.2
Extinguishing media to avoid
Water.
5.3
Special exposure hazards in a fire
Porcelain Etch Gel: None likely in this product.
Bulk Hydrofluoric acid in closed containers: Pressure will build to dangerous levels when exposed to high
temperatures. Flammable when heated.
5.4
Special protective equipmentFirefighters should wear self-contained breathing apparatus with full
for firefighters facepiece operated in pressure demand or other positive pressure mode. Use extinguishing media appropriate
to surrounding fire conditions, but no water.
6.0Accidental Release Measures
6.1
Personal precautionsWear face shield or goggles, chemically resistant gloves, and buttoned up lab coat. Avoid all contact with
material. Ventilate the area.
6.2
Environmental precautionsNot indicated for the quantity of HF in this product and under normal conditions of use in a dental practice.
Large amounts should not be flushed into sewer.
6.3
Method for clean upFor a small spill (this product): Absorb or wipe up spill with inert material, such as paper towels, and transfer to
container for disposal. Wash spill site.
7.0
7.1
7.2
7.3
Handling and Storage
HandlingFor use by dental professionals only. Keep tightly capped in original container. Do not add any other material to
container. Empty container may contain explosive or flammable residue.
Industrial HygieneDo not allow food or drink consumption or smoking while handling. Wear protective gloves and goggles. Do not
get in eyes, on skin, or on clothing. Wash hands well after use.
StorageKeep containers tightly closed. Recap immediately after use. Store product in original container at cool room
temperature (<25°C) and in a dry, well-ventilated area. Avoid water, heat, sparks, flame, organic substances,
direct sunlight.
8.0
8.1
8.2
8.2.1
Exposure Controls / Personal Protection
Exposure limit values
PEL/TLV (HF): 3 ppm; TWA (Alcohol): 1000 ppm
Exposure controls
Occupational exposure controlsEye protection and chemically impervious gloves are recommended for dental personnel under anticipated
conditions of normal use.
8.2.1.1 Respiratory protectionFor the small quantity provided in this product, no special respiratory protection is required. Local mechanical
exhaust ventilation should be used to maintain exposure below 3 ppm.
For large amounts of hydrofluoric acid, when threshold limits are exceeded (greater than 3 ppm), use
self-contained breathing apparatus. Guard against aspiration into lungs.
8.2.1.2 Hand protection
Neoprene or polyethylene gloves are recommended.
8.2.1.3 Eye protectionSafety glasses or face shield worn by dental staff is adequate under normal conditions of use. For large
quantities, safety goggles are required.
8.2.1.4 Skin ProtectionWear buttoned lab coat, long sleeves and/or apron over clothing to protect skin.
8.2.1.5 Other ControlsIf used in vivo, use rubber dam around tooth to be etched and high speed evacuator tip or other protective
devices for patient. Mask all surrounding tissue. Patient should wear safety glasses. Emergency eye wash
fountain should be close by. Wash hands thoroughly after handling. Clean protective equipment before reuse
8.2.2
Environmental exposure controls
Do not wash large amounts of any acid into sewer system.
9.0
Physical and Chemical Properties
9.1
Appearance / Color
9.1.1
Color / Physical state
Transparent yellow gel
9.1.2Odor
Characteristic
9.2
Important health, safety and environmental information
9.2.1
pH value
pH <1.5
9.2.2
Boiling Point (Hydrofluoric acid)
108.33°C
9.2.3
Flash point
Not determined
9.2.4
Flammability
Not applicable for Porcelain Etch Gel.
9.2.5
Explosive propertiesNot applicable for Porcelain Etch Gel. For bulk hydrofluoric acid in closed containers: Pressure will build to
dangerous levels when exposed to high temperatures. Flammable when heated.
9.2.6
Oxidizing properties
Not determined
9.2.7
Vapor Pressure
10.00 mm Hg / 13.33 mbar / Id: E
9.2.8
Specific Gravity
1.18
9.2.9
Solubility in water
100%
9.2.10 Partition coefficient
Not determined
9.2.11 Viscosity
Not determined
9.2.12 Vapor density
0.7
9.2.13 Evaporation rate
Not determined
9.2.14 Ignition temperature
Not applicable
9.2.15 Further information
Odor Threshold: 0.04 ppm
10.0
10.1
10.2
10.3
10.4
Stability and reactivity
Conditions to avoidExtremes of temperature (>27°C/80°F, <5°C/40°F), sparks, open flame, all other sources of ignition,
contamination
Materials to avoidWater, glass, concrete, materials containing silicon, carbonates, sulfides, cyanides, alkalis, bases, reducing
agents, nitric acid, organic materials, metals.
Hazardous decomposition products
Not available
Hazardous reactionsStrong exothermic reaction when exposed to incompatible substances. Pressure will build to dangerous levels
when closed containers of Hydrofluoric acid are exposed to high temperatures. Flammable when heated.
11.0Toxicological information
11.1
Acute toxicity of Hydrofluoric acid PEL/TLV: 3 ppm. Dermal LD50 mouse: 500 mg/kg. Vapor LC50 human: 50 ppm, 30 min.
(as F)Causes severe burns. Destructive to tissue. Sensation may be delayed.
11.2
Irritation and corrosiveness
Causes severe burns. Destructive to tissue. Sensation of burn may be delayed.
11.3
Sensitization
Not a sensitizer
11.4
Sub-acute, sub-chronic and
Not likely in the quantity and concentration available in this product.
prolonged toxicity
11.5
Carcinogenicity, Mutagenicity, None known.
Reproductive Toxicity
11.6
Empirical data
None available.
11.7
Clinical experiencePulpdent Porcelain Etch Gel has been used for almost twenty years to successfully prepare porcelain surfaces
for bonding. There have been no reports of serious injury during that time. Many of these preparations have
taken place in a dental lab where there is less danger. Sometimes, however, it is necessary to use Porcelain
Etch Gel intraorally. For these cases, it is most important to have a well-trained, experienced dentist perform the
procedure and to use adequate shielding of soft tissue.
12.0
12.1 13.0
13.1
Ecological Information
EcotoxicityStrong acid. Large amounts of HF may damage wildlife or aquatic ecosystems. Do not flush large amounts to
sewer; do not allow large amounts to flow into bodies of water.
Disposal Considerations
RegulationsFollow all local and national government regulations in disposing material or contaminated packaging.
14.0Transport Information
14.1
UN Number
UN 1790
14.2
Technical name
Hydrofluoric Acid Preparation
14.3
IATA Class / Packing group
Class 8, 6.1, Packing Group II
14.4
Transport over land
US DOT/ IATA: Excepted Small Quantities. Maximum unit quantity: 0.5L
14.4.1 Transport Class
Class 8, 6.1, Packing Group II
14.4.2 Label
Hydrofluoric Acid Preparation. Corrosive! Toxic!
14.5
Transport at seaUS DOT/IATA: Excepted Small Quantities. On deck, under deck, passenger and cargo vessels Maximum unit
quantity: 0.5L
14.5.1 Transport Class
Class 8, 6.1, Packing Group II
14.5.2 Label
Hydrofluoric Acid Preparation; Corrosive! Toxic!
14.6
Air transport
US DOT/ IATA: Excepted Small Quantities. Maximum unit quantity: 30 ml
14.6.1 Transport Class
Class 8, 6.1, Packing Group II
14.6.2 Label
Hydrofluoric Acid Preparation. Corrosive! Toxic!
14.7
Further informationNo aluminum or glass containers. Packaging must be very secure to prevent leaks and breakage.
15.0
15.1
15.2
15.3
Regulatory Information
EU US FDA
Health Canada
Class I medical device under the MDD 93/42/EEC.
Class II medical device
Class III medical device
16.0Other information
16.1
List of the relevant R phrases
R 35: Causes severe burns
R 26 / 27 / 28: Very toxic by inhalation, in contact with skin and if swallowed.
16.2
Hazard Statements
H300: Fatal if swallowed
H330: Fatal if inhaled.
H310: Fatal in contact with skin.
H314: Causes severe skin burns and eye damage.
H318: Causes serious eye damage.
16.3
Precautionary Statements
P261: Avoid breathing vapors.
P262: Do not get in eyes, on skin or on clothing.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves, lab coat and eye/face protection.
P301: If swallowed, immediately call Poison Center or doctor/physician.
P302 + P350: If on skin, gently wash with soap and water.
P304 + 340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing.
16.4
Restrictions on use
Porcelain Etch Gel is to be sold to and used by dental professionals only.
16.5 Further informationThe information presented herein is believed to be factual as it has been derived from the works of persons
believed to be qualified experts. However, nothing contained in this information is to be taken as a warranty
or representation for which Pulpdent Corporation bears legal responsibility. The user should review any
recommendations in the specific context of the intended use to determine whether they are appropriate.
16.6
Sources of key data
National Institute for Occupational Safety (NIOSH)
Occupational Safety and Health Administration (OSHA)
Eur-Lex European Union Law: Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006
(REACH).
Guidance on the compilation of safety data sheets. Version 1.1; December 2011. European Chemicals Agency
16.7
Information which has been
This Safety Data Sheet has been revised to meet the requirements of the
added, deleted or revised. GHS SDS format, Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006 (REACH).
Specifically, Sections 2.1, 2.2, 3.2, 16.2, 16.3 have been modified.
Pulpdent Corporation
Revision Date: July 1, 2013
Safety Data Sheet
1.0
Commercial Product Name and Supplier
1.1
Commercial product name/designation
1.2
Application / Use
1.2.2
SIC
1.2.3
Use Category
1.3
Manufacturer, Importer
1.3.1
Manufacturer
1.4
Emergency Telephone Number
1.5
Authorized European Representative
Dry-Rite Drying Agent
Silane Bond Enhancer
Dental material for use by dental professionals.
851 Human health activity
55
Pulpdent Corporation
80 Oakland Street
P.O. Box 780
Watertown, MA 02472 USA
1-800-535-5053 (24 Hour / USA)
International Business Solutions Ltd.
54 Mayfield Ridge, Hatch Warren
Basingstoke, RG22 4RS UK
2.0
Hazards Identification
2.1Classification
2.1.1
Classification according to Regulation Hazard Class
(EC) No. 1272/2008 [CLP] Flammable liquid
2
Eye irritation
STOT SE
Skin irritation
2.1.2
Classification according to Directive 67/548/EEC Flammable (F) R11
(See SECTION 16 for full text of risk phrases) Irritant (Xi) R36 / 37 / 38 – 66
2.2
GHS Label Elements
Hazard Pictograms
Signal Word: DANGER
Restricted to use by dental professional only
Hazard Statements:
H225: Highly flammable liquid and vapor. Category 2.
H319: Causes serious eye irritation. Category 2.
Hazard Category
H225
2
3
2
Tel: 1 617 926-6666
Fax: 1 617 926-6262
Email: [email protected]
Tel: 07989 407479
Fax: 01256 350330
Email: [email protected]
Hazard Statement
H319
H335
H315; EUH066
H335: Specific Target Organ Toxicity (STOT), single exposure, respiratory tract, Category 3: May cause respiratory irritation.
H315: Causes skin irritation. Category 2.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary Statements:
P210: Keep away from heat, sparks, open flame, hot surfaces. No smoking.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing fumes.
P280: Wear protective gloves/ clothing and eye protection.
P304+P340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: If in eyes, rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P303+P361+P353: If on skin or hair, remove contaminated clothing. Rinse skin with water.
P370+P378: In case of fire, use dry chemical, alcohol foam, or carbon dioxide for extinction.
3.0Composition
3.1
Chemical characterization of the preparation: Denatured ethyl alcohol preparation.
3.2
Hazardous ingredients
CAS Number
Name of the Ingredient
Concentration
Classification per 67/548/EEC 64-17-5
Ethyl alcohol 92%
Flammable (F); Irritant (Xi).
R11- 36/ 37/38-66
67-64-1
Acetone (denaturant)
7%
Flammable (F);
Irritant (Xi).
R11- 36/ 37/38-66
4.0
4.1
4.2
4.3
4.4
4.5
4.6
4.7
5.0
5.1
5.2
5.3
5.4
Classification per Regulation
(EC) No.1278/2008 (CLP).
Flammable liquid, Category 2
Eye irritation, Category 2
STOT SE, Category 3
Skin irritation Category 2.
Flammable liquid, Category 2
Eye irritation, Category 2
STOT SE, Category 3
Skin irritation Category 2.
First Aid Measures
General InformationMay cause irritation of eyes or skin on contact. May cause irritation of respiratory tract if inhaled. Exposure to
ethanol >1000 ppm may cause headache, drowsiness, lassitude, appetite loss. Show this safety data sheet to
medical personnel. Get medical attention in case of uncertainty.
Eye Contact
Keep eyelids apart, flush with running water for 15+ minutes. Get medical attention.
Skin ContactRemove contaminated clothing. Immediately wash with soap, running water. Use hand cream. Get medical
attention if irritation persists.
IngestionRinse mouth with water. Do not induce vomiting. Get immediate medical attention. Never give anything by
mouth to an unconscious person.
InhalationMove to fresh air. If necessary, administer oxygen and/or artificial respiration; seek medical attention.
Precautions for first responders
Ventilate the area. Wear safety glasses and gloves.
Information for physicians
SymptomsContact with material may cause irritation or redness in eyes or on skin. Inhalation may cause irritation of
respiratory tract.
HazardsExposure to ethanol >1000 ppm may cause headache, drowsiness, lassitude, appetite loss. Persons with
chronic respiratory or skin disease are at increased risk with prolonged and/or repeated contact.
Treatment
Same as above under First Aid
Fire Fighting Measures
Suitable extinguishing mediaUse dry chemical, alcohol foam, or carbon dioxide. Water may be ineffective, but should be used to keep
fire-exposed containers cool.
Extinguishing media to avoid
Water may be ineffective, but will keep fire-exposed containers cool.
Special exposure hazards in a fire
Carbon monoxide, carbon dioxide from incomplete combustion
Special protective equipment
Self-contained breathing apparatus.
for fire-fighters
6.0Accidental Release Measures
6.1
Personal precautions.
Wear chemical splash goggles and gloves.
6.2
Environmental precautions
Avoid releasing large quantities into environment.
6.3
Method for clean upFor small quantities: Ventilate area. Wear safety glasses, lab coat, gloves. Wipe up with absorbent material
(paper or cloth towels). Rinse area of spill with water. Place all material in closed container away from heat,
sparks, sun and oxidizers.
7.0
7.1
Handling and Storage
HandlingFor use by dental professionals only. Remove applicator tip and recap immediately after use. Keep material
tightly capped in original container. Do not use in presence of ignition sources. Take same precautions when
container is emptied, as residual product is hazardous.
7.2
StorageRemove applicator tip after use. Keep tightly capped in original container. Store at cool room temperature in a
well-ventilated area. Avoid extreme temperatures (>27°C/80°F, <5°C/40°F), sparks, direct sunlight, oxidizing
agents. Vapor may form flammable mixtures with air.
7.3
Specific uses
Dry-Rite: Dental drying agent
Silane: Material used to enhance bonding of porcelain to resin composites and luting agents.
8.0
8.1
8.2
8.2.1
8.2.1.1
8.2.1.2
8.2.1.3
8.2.1.4
8.2.1.5
8.2.2
Exposure Controls / Personal Protection
Exposure limit values
Ethanol: 1000 ppm; Acetone: 750 ppm
Exposure controls
Occupational exposure controlsNo special equipment or ventilation required under normal conditions of use in dental practice. For large
quantities/prolonged exposure, use enclosure, local ventilation, dilution to reduce concentration below TLV.
Respiratory protectionNo special requirements under normal conditions of use. Good general ventilation is sufficient to control any
airborne vapors.
Hand protection
No special requirements other than surgical gloves.
Eye protection
No special requirements other than safety glasses.
Skin protection
No special requirements other than good hygiene and safety practices.
Other controlsEmergency eye wash fountain should be close by and maintained. Wash hands after use. Do not eat, drink or
smoke.
Environmental exposure controls
Follow all government regulations.
9.0
Physical and Chemical Properties
9.1
Appearance / Color
9.1.1
Color
Dry-Rite: Pink liquid
Silane: Clear liquid
9.1.2
Odor
Characteristic, sweet, ethanol odor
9.2
Important health, safety and environmental information
9.2.1
pH
Not applicable
9.2.2
Boiling point
Boiling Point: 173°F / 78.3°C
9.2.3
Flash point
43°F / 6°C (Tag closed cup)
9.2.4
Ignition temperature
423°C
9.2.5
Explosive properties
LEL: 3.3; UEL: 19
9.2.6
Odor threshold
159 ppm
9.2.7
Vapor pressure
44.6 mm Hg / 59 mbar / Id: E
9.2.8
Specific gravity
0.795
9.2.9
Solubility in water
Dry-Rite: Complete
Silane: Slight
9.2.10 Partition coefficient
Not determined
9.2.11 Viscosity
Not determined
9.2.12 Vapor density
1.59
9.2.13 Evaporation rate
Not determined
10.0
10.1
10.2
10.3
10.4
Stability and reactivity
Conditions to avoid
Materials to avoid
Hazardous decomposition products
Further information
Heat, sparks, open flame, any ignition source.
Acetyl chloride and a wide range of oxidizing agents.
Carbon monoxide, carbon dioxide from incomplete combustion.
Stable if stored and used as directed.
11.0Toxicological information
11.1
Acute toxicity
Minimal health hazard under normal conditions of use in dental practice
Ethanol: LD50 in young rats: 10.6 g/kg orally; LD50 in old rats: 7.06 g/kg orally.
Acetone: LD50 in rats : 10.7 ml/kg orally
11.2
Irritation and corrosivenessMay cause irritation/redness of eyes or skin on contact. May cause irritation of respiratory tract if inhaled.
11.3
Sensitization
Not applicable.
11.4
Sub-acute, sub-chronic and
No chronic health hazard under normal conditions of use.
prolonged toxicity
11.5
Carcinogenicity, Mutagenicity, Not a carcinogen under normal conditions of use. Large quantities of ethanol, ingested over
Reproductive Toxicity time, may be carcinogenic or a cause of Fetal Alcohol Syndrome. IARC has reported a relationship between
habitual drinking of significant quantities of alcoholic beverages and cancer of oral cavity, pharynx, esophagus,
liver.
11.6
Empirical data
None available
11.7
Clinical experienceDry-Rite, Silane and similar products have been used in dentistry for decades with no reported problems.
12.0
12.1
Ecological Information
Ecotoxicity
13.0
13.1
Disposal Considerations
RegulationsFollow all local and national government regulations in disposing material or contaminated packaging.
Follow good work practices and government regulations. Avoid release into environment.
14.0Transport Information
14.1
UN Number
14.2
Technical name
14.3
Packing group
14.4
IATA class
1170
Ethyl alcohol
II
3
15.0
15.1
15.2
15.3
Dry-Rite (Class I) and Silane (Class IIA) are medical devices under MDD 93/42/EEC.
Dry-Rite and Silane are Class II medical devices
Dry-Rite (Class I) and Silane (Class III) medical devices
Regulatory Information
EU
US FDA
Health Canada
16.0Other information
16.1
List of relevant R phrases
R11: Highly flammable
R36/37/38: Irritating to eyes, respiratory system and skin.
R66: Repeated exposure may cause skin dryness or cracking.
16.2
Hazard Statements
H225: Highly flammable liquid and vapor. Category 2.
H319: Causes serious eye irritation. Category 2.
H335: Specific Target Organ Toxicity (STOT), single exposure, respiratory tract, Category 3: May cause
respiratory irritation.
H315: Causes skin irritation. Category 2.
EUH066: Repeated exposure may cause skin dryness or cracking.
16.3
Precautionary Statements
P210: Keep away from heat, sparks, open flame, hot surfaces. No smoking.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing fumes.
P280: Wear protective gloves/ clothing and eye protection.
P304+P340: If inhaled, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: If in eyes, rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
P303+P361+P353: If on skin or hair, remove contaminated clothing. Rinse skin with water.
P370+P378: In case of fire, use dry chemical, alcohol foam, or carbon dioxide for extinction.
16.4
Restrictions on usePulpdent dental materials, such as Dry-Rite and Silane, are to be sold to and used by dental professionals only.
16.5
Further informationThe information presented herein is believed to be factual as it has been derived from the works of persons
believed to be qualified experts. However, nothing contained in this information is to be taken as a warranty
or representation for which Pulpdent Corporation bears legal responsibility. The user should review any
recommendations in the specific context of the intended use to determine whether they are appropriate.
16.6
Sources of key data
National Institute for Occupational Safety (NIOSH)
US Occupational Safety and Health Administration (OSHA)
Eur-Lex European Union Law: Regulation (EC) No. 1272/2008 (CLP) and Regulation (EC) No. 1907/2006
(REACH).
Guidance on the compilation of safety data sheets. Version 1.1; December 2011. European Chemicals Agency
16.7
Information which has been added,
This Safety Data Sheet has been revised to meet the requirements of the GHS SDS format,
deleted or revised. Regulation (EC) No. 1272/2008 (CLP) andRegulation (EC) No. 1907/2006 (REACH). Specifically, Sections 2.1,
2.2, 3.2, 16.2, 16.3 have been modified.
Pulpdent Corporation
Revision Date: July 1, 2013
Safety Data Sheet
1.0
Commercial Product Name and Supplier
1.1
Commercial product name/designation
1.2
Application / Use
1.2.2
SIC
1.2.3
Use Category
1.3
Manufacturer, Importer
1.3.1
Manufacturer
1.4
Emergency Telephone Number
1.5
Authorized European Representative Kool-Dam Heatless Liquid Dam & Block Out Resin
Dental material for use by dental professional only.
851 Human health activity
55
Pulpdent Corporation
80 Oakland Street
P.O. Box 780
Watertown, MA 02472 USA
1-800-535-5053 (24 Hour / USA)
International Business Solutions Ltd.
54 Mayfield Ridge
Hatch Warren, Basingstoke, RG22 4RS UK
2.0
Hazards Identification
2.1
Classification Irritant.
2.1.1
Classification according to
Hazard Class Regulation (EC) No 1272/2008 [CLP]
Eye irritation STOT SE Skin irritation Skin sensitization
2.1.2
Classification according to Directive 67/548/EEC
Irritant; Xi; R 36/37/38 - 43
(See SECTION 16 for full text of risk phrases)
2.2
GHS Label Elements
Hazard Pictograms
Signal Word: WARNING
Restricted to use by dental professional only.
Hazard Statements
H319: Eye irritation. 2. May cause eye irritation.
H335: STOT SE. 3. May cause respiratory irritation.
H315: Skin irritation. 2. May cause skin irritation.
H317: Sensitization. 1. May cause an allergic skin reaction.
Precautionary Statements
P261: Avoid breathing vapor.
P280: Wear protective gloves and eye protection
P305+P351: If in eyes, rinse cautiously with water for several minutes.
P337+P313: If eye irritation persists, get medical advice/attention.
P302+P352: If on skin, wash with plenty of soap and water.
Tel: 1 617 926-6666
Fax: 1 617 926-6262
Email: [email protected]
Tel: 07989 407479 / Fax: 01256 350330
Email: [email protected]
Hazard Category
2
3
2
1
Hazard Statement
H319
H335
H315
H317

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