Material Safety Data Sheet
acc. to ISO/DIS 11014

* 1 Identification of substance
?? Product details
?? Trade name: GC Gradia Direct
GC Gradia Direct X
?? Application of the substance / the preparation Auxiliary for dental technology
?? Manufacturer/Supplier:
GC EUROPE N.V.
Interleuvenlaan 13
B-3001 Leuven
Tel. +32/(0)16/39.80.50
Fax +32/(0)16/40.26.84
quality@gceurope.com
?? Information department: Technical Operations


* 2 Composition/Data on components
?? Chemical characterization
?? Description:
Mixture of the substances listed below with nonhazardous additions.
Mixture: consisting of the following components.
?? Dangerous components:
CAS: 72869-86-4 Urethane Dimethacrylate (UDMA) 15-30%
EINECS: 276-957-5
Fluoro Alumino-silicate glass 30-40%
CAS: 60842-32-2 Silica powder 10-20%
Prepolymerized filler 20-30%
Dimethacrylate 0-5%
CAS: 465-29-2 Camphorquinone TRACE%
EINECS: 207-363-6
?? Additional information: For the wording of the listed risk phrases refer to section 16.


3 Hazards identification
?? Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of international guidelines.
?? Classification system:
The classification was made according to the latest editions of international substances lists, and expanded
upon from company and literature data.
?? NFPA ratings (scale 0 - 4)
Health = 0
0 Fire = 0
0 0 Reactivity = 0




D  Material Safety Data Sheet
acc. to ISO/DIS 11014

Trade name: GC Gradia Direct
GC Gradia Direct X

?? HMIS-ratings (scale 0 - 4)
HEALTH 0 Health = 0
Fire = 0
FIRE 0
Reactivity = 0
REACTIVITY 0




4 First aid measures
?? General information: No special measures required.
?? After inhalation: Supply fresh air; consult doctor in case of complaints.
?? After skin contact: Generally the product does not irritate the skin.
?? After eye contact: Rinse opened eye for several minutes under running water.
?? After swallowing: If symptoms persist consult doctor.


5 Fire fighting measures
?? Suitable extinguishing agents:
CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.
?? Protective equipment: No special measures required.


6 Accidental release measures
?? Person-related safety precautions: Not required.
?? Measures for environmental protection: Do not allow to enter sewers/ surface or ground water.
?? Measures for cleaning/collecting:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
?? Additional information: No dangerous substances are released.


7 Handling and storage
?? Handling:
?? Information for safe handling: No special measures required.
?? Information about protection against explosions and fires: No special measures required.
?? Storage:
?? Requirements to be met by storerooms and receptacles: No special requirements.
?? Information about storage in one common storage facility: Not required.
?? Further information about storage conditions: None.


8 Exposure controls and personal protection
?? Additional information about design of technical systems: No further data; see item 7.
?? Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
?? Additional information: The lists that were valid during the creation were used as basis.
?? Personal protective equipment:
?? General protective and hygienic measures:
The usual precautionary measures for handling chemicals should be followed.
?? Breathing equipment: Not required.




D  Material Safety Data Sheet
acc. to ISO/DIS 11014

Trade name: GC Gradia Direct
GC Gradia Direct X

?? Protection of hands:
The glove material has to be impermeable and resistant to the product/ the substance/ the preparation.
Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/
the chemical mixture.
Selection of the glove material on consideration of the penetration times, rates of diffusion and the
degradation
?? Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of quality
and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the
resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the
application.
?? Penetration time of glove material
The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be
observed.
?? Eye protection: Goggles recommended during refilling.


9 Physical and chemical properties
?? General Information
Liquid
Form:
According to product specification
Color:
Characteristic
Odor:
?? Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
Not applicable.
?? Flash point:
Product is not selfigniting.
?? Auto igniting:
Product does not present an explosion hazard.
?? Danger of explosion:
Not determined.
?? Density:
?? Solubility in / Miscibility with
Insoluble.
Water:
?? Solvent content:
0.0 %
Organic solvents:
99.9 %
?? Solids content:



10 Stability and reactivity
?? Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
?? Dangerous reactions No dangerous reactions known.
?? Dangerous products of decomposition: No dangerous decomposition products known.


11 Toxicological information
?? Acute toxicity:
?? Primary irritant effect:
?? on the skin: No irritant effect.
?? on the eye: No irritating effect.
?? Sensitization: No sensitizing effects known.




D  Material Safety Data Sheet
acc. to ISO/DIS 11014

Trade name: GC Gradia Direct
GC Gradia Direct X

?? Additional toxicological information:
The product is not subject to classification according to internally approved calculation methods for
preparations:


12 Ecological information
?? General notes:
Water hazard class 1 (Self-assessment): slightly hazardous for water
Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage
system.


13 Disposal considerations
?? Product:
?? Recommendation: Smaller quantities can be disposed of with household waste.
?? Uncleaned packagings:
?? Recommendation: Disposal must be made according to official regulations.


14 Transport information
?? DOT regulations:
-
?? Hazard class:
?? Land transport ADR/RID (cross-border):
?? ADR/RID class: -
?? Maritime transport IMDG:
-
?? IMDG Class:
?? Marine pollutant: No
?? Air transport ICAO-TI and IATA-DGR:
?? ICAO/IATA Class: -


* 15 Regulations
?? Sara
?? Section 355 (extremely hazardous substances):
None of the ingredient is listed.
?? Section 313 (Specific toxic chemical listings):
None of the ingredients is listed.
?? TSCA (Toxic Substances Control Act):
126-30-7 Neopentylglycol dimethacrylate
?? Proposition 65
?? Chemicals known to cause cancer:
None of the ingredients is listed.
?? Chemicals known to cause reproductive toxicity for females:
None of the ingredients is listed.
?? Chemicals known to cause reproductive toxicity for males:
None of the ingredients is listed.




D  Material Safety Data Sheet
acc. to ISO/DIS 11014

Trade name: GC Gradia Direct
GC Gradia Direct X

?? Chemicals known to cause developmental toxicity:
None of the ingredients is listed.
?? Cancerogenity categories
?? EPA (Environmental Protection Agency)
None of the ingredients is listed.
?? IARC (International Agency for Research on Cancer)
128-37-0 Dibutylhydroxytoluene 3
13463-67-7 titanium dioxide 3
1309-37-1 Red iron oxide 3
?? NTP (National Toxicology Program)
None of the ingredients is listed.
?? TLV (Threshold Limit Value established by ACGIH)
128-37-0 Dibutylhydroxytoluene A4
13463-67-7 titanium dioxide A4
1309-37-1 Red iron oxide A4
?? MAK (German Maximum Workplace Concentration)
None of the ingredients is listed.
?? NIOSH-Ca (National Institute for Occupational Safety and Health)
13463-67-7 titanium dioxide
?? OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.
?? Product related hazard informations:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations according to directives on hazardous materials.
?? National regulations:
?? Water hazard class: Water hazard class 1 (Self-assessment): slightly hazardous for water.


16 Other information
?? Department issuing MSDS: Technical Operations
?? Contact: Dr. P. Manouvriez
?? * Data compared to the previous version altered.




D 

DL-CAMPHORQUINONE