Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Dentsply (Australia) Pty Ltd
Chemwatch Hazard Alert Code: 3
Chemwatch: 4993-53
Version No: 4.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 02/02/2015
Print Date: 09/01/2017
S.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY / UNDERTAKING
Product Identifier
Product name
Synonyms
Proper shipping name
Other means of
identification
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Part Number 607058 - 607080
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (contains frits chemicals, lead containing)
Not Available
Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses
Use according to manufacturer's directions.
Requires that the two parts be mixed by hand or mixer before use, in accordance with manufacturers directions. Mix only as much as is required. Do
not return the mixed material to the original containers
UV/ EB-curing is a drying technology for coatings, inks and adhesives. It uses light of a certain wavelength or high speed electrons to give almost
instantaneous dry films. It allows formulators to develop products for a wide variety of applications and substrates without using volatile organic compounds as
solvents. It represents therefore a major technological advance compared to other technologies, which may require abatement installations to take care of these
compounds, as many of these compounds are able to cause either environmental or health risks if present in a too large concentration.
Dual curing dental crown and bridge cement.
Details of the supplier of the safety data sheet
Registered company name
Address
Telephone
Fax
Website
Email
Dentsply (Australia) Pty Ltd
11-21 Gilby Road Mount Waverley VIC 3149 Australia
1300 55 29 29
+61 3 9538 8260
www.dentsply.com.au
[email protected]
Emergency telephone number
Association / Organisation
Emergency telephone
numbers
Other emergency telephone
numbers
Poisons Information Centre (AUSTRALIA)
13 11 26 - AUSTRALIA (24 hour service)
Not Available
SECTION 2 HAZARDS IDENTIFICATION
Classification of the substance or mixture
HAZARDOUS CHEMICAL. DANGEROUS GOODS. According to the WHS Regulations and the ADG Code.
CHEMWATCH HAZARD RATINGS
Min
Flammability
Toxicity
Body Contact
Reactivity
Chronic
0
2
2
1
3
Poisons Schedule
Classification [1]
Legend:
Max
0 = Minimum
1 = Low
2 = Moderate
3 = High
4 = Extreme
Not Applicable
Acute Toxicity (Oral) Category 4, Acute Toxicity (Inhalation) Category 4, Skin Corrosion/Irritation Category 2, Eye Irritation Category 2A, Skin Sensitizer
Category 1, Reproductive Toxicity Category 1A, Specific target organ toxicity - single exposure Category 3 (respiratory tract irritation), Specific target organ
toxicity - repeated exposure Category 2, Acute Aquatic Hazard Category 1, Chronic Aquatic Hazard Category 1
1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3. Classification drawn from EC Directive 1272/2008 - Annex VI
Label elements
GHS label elements
Continued...
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Version No: 4.1.1.1
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
SIGNAL WORD
Issue Date: 02/02/2015
Print Date: 09/01/2017
DANGER
Hazard statement(s)
H302
Harmful if swallowed.
H332
Harmful if inhaled.
H315
Causes skin irritation.
H319
Causes serious eye irritation.
H317
May cause an allergic skin reaction.
H360
May damage fertility or the unborn child.
H335
May cause respiratory irritation.
H373
May cause damage to organs through prolonged or repeated exposure.
H410
Very toxic to aquatic life with long lasting effects.
Precautionary statement(s) Prevention
P201
Obtain special instructions before use.
P260
Do not breathe dust/fume/gas/mist/vapours/spray.
P271
Use only outdoors or in a well-ventilated area.
P280
Wear protective gloves/protective clothing/eye protection/face protection.
Precautionary statement(s) Response
P308+P313
IF exposed or concerned: Get medical advice/attention.
P362
Take off contaminated clothing and wash before reuse.
P302+P352
P305+P351+P338
IF ON SKIN: Wash with plenty of soap and water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Precautionary statement(s) Storage
P405
P403+P233
Store locked up.
Store in a well-ventilated place. Keep container tightly closed.
Precautionary statement(s) Disposal
P501
Dispose of contents/container in accordance with local regulations.
SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS
Substances
See section below for composition of Mixtures
Mixtures
CAS No
%[weight]
Name
65997-18-4
<70
frits chemicals, lead containing
1565-94-2
<20
bisphenol A glycidylmethacrylate
24448-20-2
}<15
2,2-bis[4-(2-methacryloxy)ethoxy)phenyl]propane
109-16-0
}
triethylene glycol dimethacrylate
67762-90-7
<5
silica, dimethylsiloxane treated
94-36-0
<2
dibenzoyl peroxide
SECTION 4 FIRST AID MEASURES
Description of first aid measures
Eye Contact
Skin Contact
Inhalation
If this product comes in contact with the eyes:
Wash out immediately with fresh running water.
Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the upper and lower lids.
Seek medical attention without delay; if pain persists or recurs seek medical attention.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
If skin contact occurs:
Immediately remove all contaminated clothing, including footwear.
Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.
If fumes or combustion products are inhaled remove from contaminated area.
Lay patient down. Keep warm and rested.
Prostheses such as false teeth, which may block airway, should be removed, where possible, prior to initiating first aid procedures.
Apply artificial respiration if not breathing, preferably with a demand valve resuscitator, bag-valve mask device, or pocket mask as trained. Perform CPR if
necessary.
Transport to hospital, or doctor, without delay.
Continued...
Chemwatch: 4993-53
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Version No: 4.1.1.1
Issue Date: 02/02/2015
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Print Date: 09/01/2017
If swallowed do NOT induce vomiting.
If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain open airway and prevent aspiration.
Observe the patient carefully.
Never give liquid to a person showing signs of being sleepy or with reduced awareness; i.e. becoming unconscious.
Give water to rinse out mouth, then provide liquid slowly and as much as casualty can comfortably drink.
Seek medical advice.
Ingestion
Indication of any immediate medical attention and special treatment needed
Treat symptomatically.
Gastric acids solubilise lead and its salts and lead absorption occurs in the small bowel.
Particles of less than 1 um diameter are substantially absorbed by the alveoli following inhalation.
Lead is distributed to the red blood cells and has a half-life of 35 days. It is subsequently redistributed to soft tissue & bone-stores or eliminated. The kidney accounts for 75% of daily lead loss;
integumentary and alimentary losses account for the remainder.
Neurasthenic symptoms are the most common symptoms of intoxication. Lead toxicity produces a classic motor neuropathy. Acute encephalopathy appears infrequently in adults. Diazepam is
the best drug for seizures.
Whole-blood lead is the best measure of recent exposure; free erythrocyte protoporphyrin (FEP) provides the best screening for chronic exposure. Obvious clinical symptoms occur in adults
when whole-blood lead exceeds 80 ug/dL.
British Anti-Lewisite is an effective antidote and enhances faecal and urinary excretion of lead. The onset of action of BAL is about 30 minutes and most of the chelated metal complex is excreted
in 4-6 hours, primarily in the bile. Adverse reaction appears in up to 50% of patients given BAL in doses exceeding 5 mg/kg. CaNa2EDTA has also been used alone or in concert with BAL as
an antidote. D-penicillamine is the usual oral agent for mobilisation of bone lead; its use in the treatment of lead poisoning remains investigational. 2,3-dimercapto-1-propanesulfonic acid
(DMPS) and dimercaptosuccinic acid (DMSA) are water soluble analogues of BAL and their effectiveness is undergoing review. As a rule, stop BAL if lead decreases below 50 ug/dL; stop
CaNa2EDTA if blood lead decreases below 40 ug/dL or urinary lead drops below 2 mg/24hrs.
[Ellenhorn & Barceloux: Medical Toxicology]
BIOLOGICAL EXPOSURE INDEX - BEI
These represent the determinants observed in specimens collected from a healthy worker who has been exposed at the Exposure Standard (ES or TLV):
Determinant
1. Lead in blood
2. Lead in urine
3. Zinc protoporphyrin in blood
Index
30 ug/100 ml
150 ug/gm creatinine
250 ug/100 ml erythrocytes OR 100 ug/100 ml blood
Sampling Time
Not Critical
Not Critical
After 1 month exposure
Comments
B
B
B: Background levels occur in specimens collected from subjects NOT exposed.
SECTION 5 FIREFIGHTING MEASURES
Extinguishing media
Water spray or fog.
Alcohol stable foam.
Dry chemical powder.
Carbon dioxide.
Special hazards arising from the substrate or mixture
Fire Incompatibility
Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result
|amines
Advice for firefighters
Alert Fire Brigade and tell them location and nature of hazard.
May be violently or explosively reactive.
Wear full body protective clothing with breathing apparatus.
Prevent, by any means available, spillage from entering drains or water course.
Fire Fighting
Fire/Explosion Hazard
HAZCHEM
The material is not readily combustible under normal conditions.
However, it will break down under fire conditions and the organic component may burn.
Not considered to be a significant fire risk.
Heat may cause expansion or decomposition with violent rupture of containers.
Combustion products include:
carbon dioxide (CO2)
hydrogen fluoride
,
sulfur oxides (SOx)
,
silicon dioxide (SiO2)
,
metal oxides
,
other pyrolysis products typical of burning organic material.
•3Z
SECTION 6 ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment and emergency procedures
See section 8
Environmental precautions
See section 12
Methods and material for containment and cleaning up
Continued...
Chemwatch: 4993-53
Page 4 of 11
Version No: 4.1.1.1
Issue Date: 02/02/2015
Print Date: 09/01/2017
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Minor Spills
Clean up all spills immediately.
Avoid breathing vapours/ aerosols/ or dusts and avoid contact with skin and eyes.
Control personal contact with the substance, by using protective equipment.
Contain and absorb spill with sand, earth, inert material or vermiculite.
Environmental hazard - contain spillage.
Major Spills
Clear area of personnel and move upwind.
Alert Fire Brigade and tell them location and nature of hazard.
Wear breathing apparatus plus protective gloves.
Prevent, by any means available, spillage from entering drains or water course.
Environmental hazard - contain spillage.
Personal Protective Equipment advice is contained in Section 8 of the SDS.
SECTION 7 HANDLING AND STORAGE
Precautions for safe handling
Safe handling
Other information
Most acrylic monomers have low viscosity therefore pouring, material transfer and processing of these materials do not necessitate heating.
Viscous monomers may require heating to facilitate handling. To facilitate product transfer from original containers, product must be heated to no more than
60 deg. C. (140 F.), for not more than 24 hours.
Avoid all personal contact, including inhalation.
Wear protective clothing when risk of exposure occurs.
Use in a well-ventilated area.
Prevent concentration in hollows and sumps.
Store in original containers.
Keep containers securely sealed.
Store in a cool, dry, well-ventilated area.
Store away from incompatible materials and foodstuff containers.
Conditions for safe storage, including any incompatibilities
Suitable container
Storage incompatibility
Polyethylene or polypropylene container.
Packing as recommended by manufacturer.
Check all containers are clearly labelled and free from leaks.
Avoid reaction with oxidising agents
SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION
Control parameters
OCCUPATIONAL EXPOSURE LIMITS (OEL)
INGREDIENT DATA
Source
Ingredient
Material name
TWA
STEL
Peak
Notes
Australia Exposure Standards
dibenzoyl peroxide
Benzoyl peroxide
5 mg/m3
Not Available
Not Available
Not Available
EMERGENCY LIMITS
Ingredient
Material name
TEEL-1
TEEL-2
TEEL-3
triethylene glycol
dimethacrylate
Methacrylic acid, diester with triethylene glycol; (Polyester TGM3)
33 mg/m3
360 mg/m3
2,100 mg/m3
silica, dimethylsiloxane treated
Siloxanes and silicones, dimethyl, reaction products with silica; (Hydrophobic silicon dioxide, amorphous)
120 mg/m3
1,300 mg/m3
7,900 mg/m3
dibenzoyl peroxide
Benzoyl peroxide
15 mg/m3
1,200 mg/m3
7,000 mg/m3
Ingredient
Original IDLH
Revised IDLH
frits chemicals, lead containing
700 mg/m3
100 mg/m3
bisphenol A glycidylmethacrylate
Not Available
Not Available
2,2-bis[4-(2methacryloxy)ethoxy)phenyl]propane
Not Available
Not Available
triethylene glycol dimethacrylate
Not Available
Not Available
silica, dimethylsiloxane treated
Not Available
Not Available
dibenzoyl peroxide
7,000 mg/m3
1,500 mg/m3
Exposure controls
Appropriate engineering
controls
Engineering controls are used to remove a hazard or place a barrier between the worker and the hazard. Well-designed engineering controls can be highly
effective in protecting workers and will typically be independent of worker interactions to provide this high level of protection.
The basic types of engineering controls are:
Process controls which involve changing the way a job activity or process is done to reduce the risk.
Enclosure and/or isolation of emission source which keeps a selected hazard "physically" away from the worker and ventilation that strategically "adds" and
"removes" air in the work environment.
Personal protection
Continued...
Chemwatch: 4993-53
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Version No: 4.1.1.1
Issue Date: 02/02/2015
Print Date: 09/01/2017
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Eye and face protection
Skin protection
Safety glasses with side shields.
Chemical goggles.
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document, describing the wearing of
lenses or restrictions on use, should be created for each workplace or task.
See Hand protection below
NOTE:
The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and other protective equipment, to avoid
all possible skin contact.
Contaminated leather items, such as shoes, belts and watch-bands should be removed and destroyed.
General warning: Do NOT use latex gloves! Use only recommended gloves - using the wrong gloves may increase the risk:
Hands/feet protection
Exposure condition
Short time use; (few minutes less than 0.5 hour)
Little physical stress
Use of thin nitrile rubber gloves:
Nitrile rubber (0.1 mm)
Excellent tactibility ("feel"), powder-free
Disposable
Inexpensive
Give adequate protection to low molecular weigh acrylic monomers
Exposure condition
Medium time use;
less than 4 hours
Physical stress (opening drums, using tools, etc.)
Use of medium thick nitrile rubber gloves
Nitrile rubber, NRL (latex) free; <0.45 mm
Moderate tactibility ("feel"), powder-free
Disposable
Moderate price
Gives adequate protection for most acrylates up to 4 hours
Do NOT give adequate protection to low molecular weight monomers at exposures longer than 1 hour
Exposure condition
Long time
Cleaning operations
Nitrile rubber, NRL (latex) free; >0.56 mm
low tactibility ("feel"), powder free
High price
Gives adequate protection for most acrylates in combination with commonly used solvents up to 8 hours
Do NOT give adequate protection to low molecular weight monomers at exposures longer than 1 hour
Avoid use of ketones and acetates in wash-up solutions.
Where none of this gloves ensure safe handling (for example in long term handling of acrylates containing high levels of acetates and/ or ketones, use
laminated multilayer gloves.
Guide to the Classification and Labelling of UV/EB Acrylates Third edition, 231 October 2007 - Cefic
Body protection
Other protection
Thermal hazards
See Other protection below
Overalls.
P.V.C. apron.
Barrier cream.
Not Available
Respiratory protection
Type A-P Filter of sufficient capacity. (AS/NZS 1716 & 1715, EN 143:2000 & 149:2001, ANSI Z88 or national equivalent)
Where the concentration of gas/particulates in the breathing zone, approaches or exceeds the "Exposure Standard" (or ES), respiratory protection is required.
Degree of protection varies with both face-piece and Class of filter; the nature of protection varies with Type of filter.
Required Minimum Protection Factor
Half-Face Respirator
Full-Face Respirator
Powered Air Respirator
up to 10 x ES
A-AUS P2
-
A-PAPR-AUS / Class 1 P2
up to 50 x ES
-
A-AUS / Class 1 P2
-
up to 100 x ES
-
A-2 P2
A-PAPR-2 P2 ^
^ - Full-face
A(All classes) = Organic vapours, B AUS or B1 = Acid gasses, B2 = Acid gas or hydrogen cyanide(HCN), B3 = Acid gas or hydrogen cyanide(HCN), E = Sulfur dioxide(SO2), G = Agricultural
chemicals, K = Ammonia(NH3), Hg = Mercury, NO = Oxides of nitrogen, MB = Methyl bromide, AX = Low boiling point organic compounds(below 65 degC)
SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES
Information on basic physical and chemical properties
Appearance
Physical state
28frits Creamy off white paste with sweet acrylic ester odour; not miscible with water
Free-flowing Paste
Relative density (Water = 1)
1.8 approx.
Odour
Not Available
Partition coefficient
n-octanol / water
Odour threshold
Not Available
Auto-ignition temperature
(°C)
Not Available
pH (as supplied)
Not Available
Decomposition
temperature
Not Available
Melting point / freezing
point (°C)
Not Available
Viscosity (cSt)
Not Available
Initial boiling point and
boiling range (°C)
Not Applicable
Molecular weight (g/mol)
Not Available
Not Applicable
Flash point (°C)
Not Applicable
Taste
Not Available
Evaporation rate
Not Applicable
Explosive properties
Not Available
Flammability
Not Applicable
Oxidising properties
Not Available
Continued...
Chemwatch: 4993-53
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Version No: 4.1.1.1
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Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Upper Explosive Limit (%)
Not Applicable
Surface Tension (dyn/cm or
mN/m)
Not Available
Lower Explosive Limit (%)
Not Applicable
Volatile Component (%vol)
Not Available
Vapour pressure (kPa)
Not Applicable
Solubility in water (g/L)
Immiscible
Vapour density (Air = 1)
Not Applicable
Gas group
Not Available
pH as a solution (1%)
Not Available
VOC g/L
Not Available
SECTION 10 STABILITY AND REACTIVITY
Reactivity
Chemical stability
See section 7
Unstable in the presence of incompatible materials.
Product is considered stable.
Hazardous polymerisation will not occur.
Possibility of hazardous
reactions
See section 7
Conditions to avoid
See section 7
Incompatible materials
See section 7
Hazardous decomposition
products
See section 5
SECTION 11 TOXICOLOGICAL INFORMATION
Information on toxicological effects
Inhaled
The material can cause respiratory irritation in some persons. The body's response to such irritation can cause further lung damage.
No report of respiratory illness in humans as a result of exposure to multifunctional acrylates has been found.
Inhalation of vapours or aerosols (mists, fumes), generated by the material during the course of normal handling, may be harmful.
Ingestion
Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious
damage to the health of the individual.
Not normally a hazard due to physical form of product.
Considered an unlikely route of entry in commercial/industrial environments
Skin Contact
This material can cause inflammation of the skin on contact in some persons.
The material may accentuate any pre-existing dermatitis condition
All multifunctional acrylates (MFA) produce skin disorders and sensitise the skin and inflammation. Vapours generated by the heat of milling may occur in
sufficient concentration to produce inflammation.
Open cuts, abraded or irritated skin should not be exposed to this material
Eye
This material can cause eye irritation and damage in some persons.
Substance accumulation, in the human body, is likely and may cause some concern following repeated or long-term occupational exposure.
Long-term exposure to respiratory irritants may result in disease of the airways involving difficult breathing and related systemic problems.
Skin contact with the material is more likely to cause a sensitisation reaction in some persons compared to the general population.
Chronic
Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.
This material can cause serious damage if one is exposed to it for long periods. It can be assumed that it contains a substance which can produce severe
defects.
Ample evidence exists that developmental disorders are directly caused by human exposure to the material.
Ample evidence from experiments exists that there is a suspicion this material directly reduces fertility.
There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.
There is some evidence that inhaling this product is more likely to cause a sensitisation reaction in some persons compared to the general population.
Prolonged or repeated skin contact with benzoyl peroxide may result in allergic skin reactions even at diluted concentrations. Ingestion results in abdominal
pain, low body oxygen and severe depression. Chronic effects of exposure include allergic reactions characterised by redness, itching, oozing, crusting, and
scaling of the skin and asthmatic wheezing. Although it does not exhibit complete carcinogenic or tumour-initiating activity, it has been associated with certain
tumours of like papillomas and squamous cell carcinomas.
Lead, in large amounts, can affect the blood, nervous system, heart, glands, immune system and digestive system. Anaemia may occur.
Lead can cross the placenta, and cause miscarriage, stillbirths and birth defects. Exposure before birth can cause mental retardation, behavioural disorders
and infant death.
Dentsply Calibra Esthetic Resin
Cement - Catalyst Paste
TOXICITY
IRRITATION
Not Available
Not Available
TOXICITY
dermal (rat) LD50: >2000 mg/kg
IRRITATION
[1]
Not Available
[1]
Inhalation (monkey) LC50: 0.03 mg/L15 min
Inhalation (monkey) LC50: 0.0467 mg/L15 min[1]
Inhalation (monkey) LC50: 0.204 mg/L15 min[1]
frits chemicals, lead containing
Inhalation (monkey) LC50: 0.23 mg/L15 min[1]
Inhalation (monkey) LC50: 0.94 mg/L15 min[1]
Inhalation (mouse) LC50: >0.00902 mg/L15 min[1]
Inhalation (rabbit) LC50: >0.0224 mg/L15 min[1]
Inhalation (rat) LC50: >1.864 mg/l/4hr[1]
Inhalation (rat) LC50: >1.895 mg/l/4hr[1]
Continued...
Chemwatch: 4993-53
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Version No: 4.1.1.1
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Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Print Date: 09/01/2017
Inhalation (rat) LC50: >3.227 mg/l/4hr[1]
Inhalation (rat) LC50: >3.407 mg/l/4hr[1]
Inhalation (rat) LC50: >5.05 mg/l/4hr[1]
Inhalation (rat) LC50: >5.273 mg/l/4hr[1]
Inhalation (rat) LC50: 0.025 mg/L30 min[1]
Oral (rat) LD50: >63-<259 mg/kg>[1]
bisphenol A glycidylmethacrylate
2,2-bis[4-(2methacryloxy)ethoxy)phenyl]propane
TOXICITY
IRRITATION
Not Available
Not Available
TOXICITY
IRRITATION
Not Available
Not Available
TOXICITY
IRRITATION
triethylene glycol dimethacrylate
Oral (rat) LD50: 10837 mg/kg
[2]
Not Available
TOXICITY
silica, dimethylsiloxane treated
IRRITATION
Oral (rat) LD50: >5000 mg/kg
[2]
Eyes: 0.7/110 24hr Draize
non-irritating
Skin: 0/8 non-irritating
TOXICITY
dibenzoyl peroxide
dermal (mammal) LD50: >1000 mg/kg
Oral (rat) LD50: >950 mg/kg
Legend:
IRRITATION
[1]
[2]
Eye (rabbit): 500 mg/24h - mild
Skin effects (MAK): very weak
1. Value obtained from Europe ECHA Registered Substances - Acute toxicity 2.* Value obtained from manufacturer's SDS. Unless otherwise specified data
extracted from RTECS - Register of Toxic Effect of chemical Substances
SILICA, DIMETHYLSILOXANE TREATED
For silica amorphous:
When experimental animals inhale synthetic amorphous silica (SAS) dust, it dissolves in the lung fluid and is rapidly eliminated. If
swallowed, the vast majority of SAS is excreted in the faeces and there is little accumulation in the body. Following absorption across the
gut, SAS is eliminated via urine without modification in animals and humans. SAS is not expected to be broken down (metabolised) in
mammals.
DIBENZOYL PEROXIDE
The material may be irritating to the eye, with prolonged contact causing inflammation. Repeated or prolonged exposure to irritants may
produce conjunctivitis.
The material may cause skin irritation after prolonged or repeated exposure and may produce on contact skin redness, swelling, the
production of vesicles, scaling and thickening of the skin.
Benzoyl peroxide may cause double vision, breathing problems, excess saliva and tear formation, redness of the skin and changes in
motor activity. It did not produce blood or biochemical adverse effects, gene mutation or evidence of cancer. Repeated oral administration
may result in decreased weights of testes and the newborn.
The substance is classified by IARC as Group 3:
NOT classifiable as to its carcinogenicity to humans.
Evidence of carcinogenicity may be inadequate or limited in animal testing.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & TRIETHYLENE GLYCOL
DIMETHACRYLATE & DIBENZOYL PEROXIDE
The following information refers to contact allergens as a group and may not be specific to this product.
Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of
contact eczema involves a cell-mediated (T lymphocytes) immune reaction of the delayed type. Other allergic skin reactions, e.g. contact
urticaria, involve antibody-mediated immune reactions.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & BISPHENOL A
GLYCIDYLMETHACRYLATE & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
& TRIETHYLENE GLYCOL DIMETHACRYLATE
Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a non-allergenic
condition known as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high levels of highly irritating
compound. Key criteria for the diagnosis of RADS include the absence of preceding respiratory disease, in a non-atopic individual, with
abrupt onset of persistent asthma-like symptoms within minutes to hours of a documented exposure to the irritant. A reversible airflow
pattern, on spirometry, with the presence of moderate to severe bronchial hyperreactivity on methacholine challenge testing and the lack of
minimal lymphocytic inflammation, without eosinophilia, have also been included in the criteria for diagnosis of RADS.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & BISPHENOL A
GLYCIDYLMETHACRYLATE & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
UV (ultraviolet)/ EB (electron beam) acrylates are generally of low toxicity
UV/EB acrylates are divided into two groups; "stenomeric" and "eurymeric" acrylates.
The first group consists of well-defined acrylates which can be described by a simple idealised chemical;they are low molecular weight
species with a very narrow weight distribution profile.
The eurymeric acrylates cannot be described by an idealised structure and may differ fundamentally between various suppliers; they are of
relatively high molecular weigh and possess a wide weight distribution.
Stenomeric acrylates are usually more hazardous than the eurymeric substances.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & FRITS CHEMICALS, LEAD
CONTAINING & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
No significant acute toxicological data identified in literature search.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
The chemical structure of hydroxylated diphenylalkanes or bisphenols consists of two phenolic rings joined together through a bridging
carbon. This class of endocrine disruptors that mimic oestrogens is widely used in industry, particularly in plastics
Bisphenol A (BPA) and some related compounds exhibit oestrogenic activity in human breast cancer cell line MCF-7, but there were
remarkable differences in activity. Several derivatives of BPA exhibited significant thyroid hormonal activity towards rat pituitary cell line
GH3, which releases growth hormone in a thyroid hormone-dependent manner. However, BPA and several other derivatives did not show
such activity.
Continued...
Chemwatch: 4993-53
Page 8 of 11
Version No: 4.1.1.1
Issue Date: 02/02/2015
Print Date: 09/01/2017
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
Based on the available oncogenicity data and without a better understanding of the carcinogenic mechanism the Health and
Environmental Review Division (HERD), Office of Toxic Substances (OTS), of the US EPA previously concluded that all chemicals that
contain the acrylate or methacrylate moiety (CH2=CHCOO or CH2=C(CH3)COO) should be considered to be a carcinogenic hazard
unless shown otherwise by adequate testing.
This position has now been revised and acrylates and methacrylates are no longer de facto carcinogens.
Dentsply Calibra Esthetic Resin Cement Catalyst Paste & BISPHENOL A
GLYCIDYLMETHACRYLATE & 2,2-BIS[4-(2METHACRYLOXY)ETHOXY)PHENYL]PROPANE
Where no "official" classification for acrylates and methacrylates exists, there has been cautious attempts to create classifications in the
absence of contrary evidence. For example
Monalkyl or monoarylesters of acrylic acids should be classified as R36/37/38 and R51/53
Monoalkyl or monoaryl esters of methacrylic acid should be classified as R36/37/38
Acute Toxicity
Carcinogenicity
Skin Irritation/Corrosion
Reproductivity
Serious Eye
Damage/Irritation
STOT - Single Exposure
Respiratory or Skin
sensitisation
STOT - Repeated Exposure
Mutagenicity
Aspiration Hazard
Legend:
– Data available but does not fill the criteria for classification
– Data required to make classification available
– Data Not Available to make classification
SECTION 12 ECOLOGICAL INFORMATION
Toxicity
Ingredient
Endpoint
Test Duration (hr)
Species
Value
Source
frits chemicals, lead
containing
LC50
96
Fish
0.0079mg/L
2
frits chemicals, lead
containing
EC50
48
Crustacea
0.1455mg/L
2
frits chemicals, lead
containing
EC50
72
Algae or other aquatic plants
0.018mg/L
2
frits chemicals, lead
containing
EC50
2400
Fish
0.0081mg/L
2
frits chemicals, lead
containing
NOEC
504
Crustacea
0.00016mg/L
2
triethylene glycol
dimethacrylate
LC50
96
Fish
66.369mg/L
3
dibenzoyl peroxide
LC50
96
Fish
0.0602mg/L
2
dibenzoyl peroxide
EC50
48
Crustacea
0.11mg/L
2
dibenzoyl peroxide
EC50
72
Algae or other aquatic plants
0.0422mg/L
2
dibenzoyl peroxide
EC50
72
Algae or other aquatic plants
0.0613mg/L
2
dibenzoyl peroxide
NOEC
72
Algae or other aquatic plants
0.02mg/L
2
Legend:
Extracted from 1. IUCLID Toxicity Data 2. Europe ECHA Registered Substances - Ecotoxicological Information - Aquatic Toxicity 3. EPIWIN Suite V3.12 Aquatic Toxicity Data (Estimated) 4. US EPA, Ecotox database - Aquatic Toxicity Data 5. ECETOC Aquatic Hazard Assessment Data 6. NITE (Japan) Bioconcentration Data 7. METI (Japan) - Bioconcentration Data 8. Vendor Data
Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Do NOT allow product to come in contact with surface waters or to intertidal areas below the mean high water mark. Do not contaminate water when cleaning equipment or disposing of equipment
wash-waters.
Wastes resulting from use of the product must be disposed of on site or at approved waste sites.
For bisphenol A and related bisphenols:
Environmental fate:
Biodegradability (28 d) 89% - Easily biodegradable
Bioconcentration factor (BCF) 7.8 mg/l
Bisphenol A, its derivatives and analogues, can be released from polymers, resins and certain substances by metabolic products
Substance does not meet the criteria for PBT or vPvB according to Regulation (EC) No 1907/2006, Annex XIII
As an environmental contaminant, bisphenol A interferes with nitrogen fixation at the roots of leguminous plants associated with the bacterial symbiont Sinorhizobium meliloti. Despite a half-life in
the soil of only 1-10 days, its ubiquity makes it an important pollutant. According to Environment Canada, "initial assessment shows that at low levels, bisphenol A can harm fish and organisms over
time. Studies also indicate that it can currently be found in municipal wastewater." However, a study conducted in the United States found that 91-98% of bisphenol A may be removed from water
during treatment at municipal water treatment plants.
Substances containing unsaturated carbons are ubiquitous in indoor environments. They result from many sources (see below). Most are reactive with environmental ozone and many produce
stable products which are thought to adversely affect human health.The potential for surfaces in an enclosed space to facilitate reactions should be considered.
Source of unsaturated substances
Unsaturated substances (Reactive Emissions)
Major Stable Products produced following reaction with ozone.
For Lead:
Environmental Fate: Lead is assessed as low hazard if it remains in its solid, massive, metallic form. Lead, in the form of alkyls, has been introduced to the environment primarily from leaded
gasoline/petrol. These are converted to water-soluble lead compounds of high toxicity and availability to plants.
Atmospheric Fate: Lead is primarily an atmospheric pollutant that enters soil and water as fallout, a process determined by the physical form involved and particle size.
For Acrylates
Ecotoxicity - Compounds with a log Pow >5 cause drowsiness or stupor, but at lower log Pow the toxicity of acrylates is greater than predicted for simple narcotics.
Atmospheric Fate: Volatilized acrylic acid and acrylic esters are predicted to degrade rapidly by atmospheric photo-oxidation with estimated half-lives of 2 to 24 h.
Terrestrial Fate: Acrylic acid biodegrades aerobically in soil. The mobility in soil of acrylic acid and its esters ranged from ‘medium' to ‘very high'.
For Nickel: Transport and distribution of nickel particulates between different environmental compartments, is strongly influenced by particle size. Fine particulate matter has a longer residence
time in the environment and is carried a long distance from its source; larger particles are deposited near the emission source.
Atmospheric Fate: Atmospheric residence time for nickel particulates is estimated to be 5.4-7.9 days.
Aquatic Fate: Drinking Water Standards: Nickel 50 ug/l (UK max.) 20 ug/l (WHO guideline).
DO NOT discharge into sewer or waterways.
Continued...
Chemwatch: 4993-53
Page 9 of 11
Version No: 4.1.1.1
Issue Date: 02/02/2015
Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Print Date: 09/01/2017
Persistence and degradability
Ingredient
Persistence: Water/Soil
Persistence: Air
triethylene glycol
dimethacrylate
LOW
LOW
dibenzoyl peroxide
LOW (Half-life = 14 days)
LOW (Half-life = 21.25 days)
Bioaccumulative potential
Ingredient
Bioaccumulation
triethylene glycol
dimethacrylate
LOW (LogKOW = 1.88)
dibenzoyl peroxide
LOW (LogKOW = 3.46)
Mobility in soil
Ingredient
Mobility
triethylene glycol
dimethacrylate
LOW (KOC = 10)
dibenzoyl peroxide
LOW (KOC = 771)
SECTION 13 DISPOSAL CONSIDERATIONS
Waste treatment methods
Product / Packaging
disposal
Containers may still present a chemical hazard/ danger when empty.
Return to supplier for reuse/ recycling if possible.
Otherwise:
If container can not be cleaned sufficiently well to ensure that residuals do not remain or if the container cannot be used to store the same product, then
puncture containers, to prevent re-use, and bury at an authorised landfill.
Where possible retain label warnings and SDS and observe all notices pertaining to the product.
DO NOT allow wash water from cleaning or process equipment to enter drains.
It may be necessary to collect all wash water for treatment before disposal.
In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first.
Where in doubt contact the responsible authority.
Recycle wherever possible or consult manufacturer for recycling options.
Consult State Land Waste Authority for disposal.
Bury or incinerate residue at an approved site.
Recycle containers if possible, or dispose of in an authorised landfill.
SECTION 14 TRANSPORT INFORMATION
Labels Required
Marine Pollutant
HAZCHEM
•3Z
Land transport (ADG)
UN number
UN proper shipping name
3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (contains frits chemicals, lead containing)
Class
9
Subrisk
Not Applicable
Transport hazard class(es)
Packing group
Environmental hazard
III
Not Applicable
Special provisions
274 331 335 375 AU01
Limited quantity
5L
Special precautions for user
Environmentally Hazardous Substances meeting the descriptions of UN 3077 or UN 3082
are not subject to this Code when transported by road or rail in;
(a) packagings;
(b) IBCs; or
(c) any other receptacle not exceeding 500 kg(L).
- Australian Special Provisions (SP AU01) - ADG Code 7th Ed.
Continued...
Chemwatch: 4993-53
Page 10 of 11
Version No: 4.1.1.1
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Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Print Date: 09/01/2017
Air transport (ICAO-IATA / DGR)
UN number
UN proper shipping name
3082
Environmentally hazardous substance, liquid, n.o.s. * (contains frits chemicals, lead containing)
ICAO/IATA Class
Transport hazard class(es)
Packing group
Environmental hazard
9
ICAO / IATA Subrisk
Not Applicable
ERG Code
9L
III
Not Applicable
Special precautions for user
Special provisions
A97 A158 A197
Cargo Only Packing Instructions
964
Cargo Only Maximum Qty / Pack
450 L
Passenger and Cargo Packing Instructions
964
Passenger and Cargo Maximum Qty / Pack
450 L
Passenger and Cargo Limited Quantity Packing Instructions
Y964
Passenger and Cargo Limited Maximum Qty / Pack
30 kg G
Sea transport (IMDG-Code / GGVSee)
UN number
UN proper shipping name
3082
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (contains frits chemicals, lead containing)
IMDG Class
9
IMDG Subrisk
Not Applicable
Transport hazard class(es)
Packing group
Environmental hazard
III
Marine Pollutant
Special precautions for user
EMS Number
F-A, S-F
Special provisions
274 335 969
Limited Quantities
5L
Transport in bulk according to Annex II of MARPOL and the IBC code
Not Applicable
SECTION 15 REGULATORY INFORMATION
Safety, health and environmental regulations / legislation specific for the substance or mixture
FRITS CHEMICALS, LEAD CONTAINING(65997-18-4) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Hazardous Substances Information System - Consolidated Lists
Australia Inventory of Chemical Substances (AICS)
BISPHENOL A GLYCIDYLMETHACRYLATE(1565-94-2) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Inventory of Chemical Substances (AICS)
2,2-BIS[4-(2-METHACRYLOXY)ETHOXY)PHENYL]PROPANE(24448-20-2) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Inventory of Chemical Substances (AICS)
TRIETHYLENE GLYCOL DIMETHACRYLATE(109-16-0) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Inventory of Chemical Substances (AICS)
SILICA, DIMETHYLSILOXANE TREATED(67762-90-7) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Inventory of Chemical Substances (AICS)
DIBENZOYL PEROXIDE(94-36-0) IS FOUND ON THE FOLLOWING REGULATORY LISTS
Australia Exposure Standards
Australia Hazardous Substances Information System - Consolidated Lists
Australia Inventory of Chemical Substances (AICS)
International Agency for Research on Cancer (IARC) - Agents Classified by the IARC
Monographs
International Air Transport Association (IATA) Dangerous Goods Regulations - Prohibited List
Passenger and Cargo Aircraft
National Inventory
Status
Australia - AICS
Y
Canada - DSL
Y
Canada - NDSL
N (2,2-bis[4-(2-methacryloxy)ethoxy)phenyl]propane; silica, dimethylsiloxane treated; dibenzoyl peroxide; triethylene glycol dimethacrylate; bisphenol A
glycidylmethacrylate; frits chemicals, lead containing)
China - IECSC
Y
Europe - EINEC / ELINCS /
NLP
N (silica, dimethylsiloxane treated)
Continued...
Chemwatch: 4993-53
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Dentsply Calibra Esthetic Resin Cement - Catalyst Paste
Japan - ENCS
N (silica, dimethylsiloxane treated; frits chemicals, lead containing)
Korea - KECI
Y
New Zealand - NZIoC
Y
Philippines - PICCS
Y
USA - TSCA
Y
Legend:
Y = All ingredients are on the inventory
N = Not determined or one or more ingredients are not on the inventory and are not exempt from listing(see specific ingredients in brackets)
Issue Date: 02/02/2015
Print Date: 09/01/2017
SECTION 16 OTHER INFORMATION
Other information
Classification of the preparation and its individual components has drawn on official and authoritative sources as well as independent review by the Chemwatch Classification committee using
available literature references.
A list of reference resources used to assist the committee may be found at:
www.chemwatch.net
The SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards are Risks in the workplace or other
settings. Risks may be determined by reference to Exposures Scenarios. Scale of use, frequency of use and current or available engineering controls must be considered.
Definitions and abbreviations
PC－TWA: Permissible Concentration-Time Weighted Average
PC－STEL: Permissible Concentration-Short Term Exposure Limit
IARC: International Agency for Research on Cancer
ACGIH: American Conference of Governmental Industrial Hygienists
STEL: Short Term Exposure Limit
TEEL: Temporary Emergency Exposure Limit。
IDLH: Immediately Dangerous to Life or Health Concentrations
OSF: Odour Safety Factor
NOAEL :No Observed Adverse Effect Level
LOAEL: Lowest Observed Adverse Effect Level
TLV: Threshold Limit Value
LOD: Limit Of Detection
OTV: Odour Threshold Value
BCF: BioConcentration Factors
BEI: Biological Exposure Index
This document is copyright.
Apart from any fair dealing for the purposes of private study, research, review or criticism, as permitted under the Copyright Act, no part may be reproduced by any process without written
permission from CHEMWATCH.
TEL (+61 3) 9572 4700.
end of SDS