SYNIMED SAFETY DATA SHEET
DATE: 06/08/2019 SURGICAL CEMENT
Section 1 PRODUCT IDENTIFICATION
Product: Surgical Cement (Acrylic resin with a powder component and a liquid component)
The mixture of both components is used for the repair of cranial and facial bone defects
Product use: of traumatic, surgical or tumor origin. Their reaction gives rise to a solid and rigid piece
(cured cement).
Laboratorios SL SA, Estados Unidos 4503 (B1667JHA), Area Promoción el Triangulo,
Maker: Malvinas Argentinas, Buenos Aires, Argentina. (+54 11) 5272 4060
e-mail: [email protected]
Authorized representative to the
Synimed Synergie Ingénierie Médicale SARLZA de l´Angle, 19370 Chamberet, France
EU:
Emergency telephone number: Tel. +5411 52724060
Section 2 HAZARDS IDENTIFICATION
2.1 Classification of the mixture
Component Description Classes and categories of danger Warnings
Methyl
Non-hazardous -
Solid polymethacrylate
Barium sulfate Non-hazardous -
Flammable liquid (Category 2) Skin irritation (Category 2) H225
Methyl Skin sensitization (Category 1) H315
methacrylate Specific toxicity for target organs - single exposure H317
(Category 3) H335
Liquid Specific toxicity for target organs - repeated exposure H373
(Category 2) H412
N, N-dimethyl p-
Toxicity for the aquatic environment (Category 3) Acute H311
toluidine
toxicity, inhalation (Category 3) Acute toxicity, Dermal H331
(Category 3) Acute toxicity, oral (Category 3) H301
2.1.2 Classification according to Directives 67/548 / CEE or CEE or 1999/45 / CE
R and S
Component Description
phrases
Methyl polymethacrylate Non-hazardous -
Solid
Barium sulfate Non-hazardous -
R11 / R37 /
Methyl methacrylate Flammable, irritant
R38 / R43
Toxic by inhalation, skin
Liquid R23/24/25
contact and ingestion. Danger
N, N-dimethyl-p-toluidine R33
of cumulative effects. Harmful
R52/53
to aquatic organisms.
Notes: Carcinogenicity, teratogenicity, mutagenicity, chronic toxicity on the reproductive system and synergistic
properties are not known
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THIS SAFETY DATA SHEET HAS BEEN PREPARED IN ACCORDANCE WITH DIRECTIVES 91/155 / CEE, 93/112 / CE, 2001/5 / CE AND SGA / GHS AND RES.SRT Nº 801/15 PAGE 1 OF 7
SYNIMED SAFETY DATA SHEET
Section 3 COMPOSITION / INFORMATION ON INGREDIENTS
Component overview: powder mainly composed of methyl methacrylate polymers and liquid mainly composed of
methyl methacrylate
Chemical name CAS No. Concentration (%)
Solid component
Methyl polymethacrylate 9011-14-7 85-90
Barium sulfate 7727-43-7 8-10
Liquid component
Methyl methacrylate 80-62-6 97-99
N, N-dimethyl-p-toluidine 99-97-8 0.5-1.5
Section 4. FIRST AID MEASURES
In case of Inhalation
Remove the affected person to fresh air, get medical help if the discomfort persists.
In case of skin contact
Take off contaminated clothing and wash skin with plenty of soap and water. In case of skin reactions seek medical
assistance.
In case of eye contact
Rinse with plenty of water for 15 minutes, even under the eyelids.
In case of ingestion
Rinse the mouth with water if the affected person is conscious. Do not induce vomiting and do not give the affected
person anything to eat or drink.
Section 5. FIRE FIGHTING MEASURES
5.1 Suitable extinguishing media
Use Class B fire extinguishing media: Carbon Dioxide, Dry Powder, Fog, or Foam.
5.2 Fire extinguishing media that must not be used for safety reasons
High volume water jet.
5.3 Special risks of exposure derived from the substance, the products of combustion or the gases produced.
Avoid breathing combustion gases as they can be toxic after the fire
Solid component:combustible but not easily flammable at high temperatures. The minimum ignition temperature of a
dust cloud is approximately 480ºC.
Liquid component:Flammable..
5.4 Special protective devices for fire-fighting staff
Advice for firefighters in case of fire, cool the containers or take them to a safe place. Use water spray to cool
unopened containers. In the event of a fire wear respiratory protective equipment regardless of the surrounding air
and protective clothing.
Section 6. MEASURES IN CASE OF ACCIDENTAL SPILLAGE (see also sections 8 and 13)
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SYNIMED SAFETY DATA SHEET
6.1 Personal precautions, protection devices and emergency procedures
Do not breathe dust. Provide ventilation. Eliminate any source of ignition: avoid sources of sparks and ignition. Avoid
contact with skin, eyes and clothes.
6.2 Environmental precautions
Avoid spilling the product in the sewerage and aquifers.
6.3 Methods and material for containment and decontamination
Powder component: Minimize airborne particle suspension (eg, use industrial vacuum cleaner) or wet sweep.
Liquid component: Dry with inert adsorbent material, collect in containers and dispose of in an authorized company.
Whash the contaminated place after having collected all the material.
Section 7. HANDLING AND STORAGE
7.1 Precautions for safe handling
Avoid inhalation of vapours. Avoid contact with eyes, skin and clothes. Avoid prolonged exposure. Get adequate
ventilation.
7.2 Conditions for safe storage, including any incompatibilities
Keep tightly sealed. Store in a cool, ventilated place, away from any sources of heat, sparks, and open flames.
Section 8. PERSONAL PROTECTION / EXPOSURE CONTROLS
8.1 Control parameters (values)
Exposure limit values
Solid component: Does not contain substances with an occupational exposure limit value
Liquid component: TLV-STEL: 100 ppm
TLV- TWA: 50 ppm
8.2 Exposure control: In case of handling: use gloves, safety glasses and mask.
Solid component: If operating procedures to limit exposure are not adequate, use P1 type filter masks)
Liquid component: Avoid inhaling liquid vapours, if necessary using full masks with combined filters.
Section 9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties.
Solid Component (polymer)
Appearance: Volatile Fine Powder Self-ignition temperature: 304 ºC
Colour: White Explosive properties: Not applicable
Odour: Odourless Oxidizing properties Not applicable
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SYNIMED SAFETY DATA SHEET
Olfatory threshold: Not applicable Vapor pressure: Not applicable
pH: not applicable Relative density: 1.2 g /cm3
Boiling point: Not applicable Solubility in water at 20ºC: Insoluble
Melting Point/ freezing point: Not applicable Solubility in flax oil at 20ºC: Insoluble
Flash point: : 250ºC Partition coefficient:: Not applicable
Flammability limit (lower): Not applicable Viscosity: not applicable
Flammability limit (upper): Not applicable Vapor density: Not applicable
Liquid Component (methyl methacrylate)
Appearance: Liquid Vapor pressure: 51.3 hPa at 25ºC
Colour: Transparent colourless Vapor density: 3.46
Odor: Characteristic: strong and pungent Relative density: 0.936 g / cm3 at 25ºC
Odor Threshold: No data available. Solubility in water: 15 g / l
pH: not applicable Partition coefficient: Log pow 1.38
Melting Point/freezing point: –48 ºC Auto-ignition temperature: 430ºC *
Initial boiling point: 100 ºC Decomposition temperature: No data available
Flash Point: 9ºC (closed cup) Viscosity: No data available
Evaporation rate: No data available Explosive properties: Does not apply
Flammability (solids, gases): No data available Oxidative properties: Does not apply
Flammability limit (upper): 12.5% Surface tension: 28 mN / m at 20ºC
Flammability limit (lower): 2.12% Relative vapor density: 3.46- (Air = 1.0)
9.2 Other safety information
Liquid component:
• Ignition temperature 430 °C Method: DIN 51 794 tested substance:, methyl methacrylate
• Autoinflammability Not capable of spontaneous combustion or heating.
• Self accelerating polymerization temp (ºC) > 60ºC
Section 10. STABILITY AND REACTIVITY
10.1 Reactivity
N/A
10.2 Chemical stability
The liquid component is stable under recommended storage conditions. Avoid contact with incompatible materials.
10.3 Possibility of hazardous reactions
N/A
10.4 Conditions to avoid
The liquid component can polymerize if exposed to: heat, flames and sparks, extreme temperatures and direct
sunlight, humidity and strong light, in particular fluorescent or UV.
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SYNIMED SAFETY DATA SHEET
10.5 Incompatible materials
Oxidizing agents, peroxides, bases, strong acids, reducing agents and halogens.
10.6 Hazardous decomposition products
N/A
10.7 Materials to avoid
The liquid component can polymerize: avoid organic peroxides, catalysts, free radical generators and multivalent
metal oxides.
10.8 Decomposition products
Carbon monoxide, carbon dioxide. In case of fire see section 5
Section 11. TOXICOLOGICAL INFORMATION
Solid Component
Possible health consequences:
Inhalation: can be harmful if inhaled, causing irritation of the respiratory tract.
Ingestion: May be dangerous if swallowed.
Skin: can cause irritation
Eyes: can cause irritation
Additional Information
RTECS: Methyl Polymethacrylate TR0400000
RTECS: Barium Sulfate: No Data Available
Liquid Component
Inhalation
Irritating to respiratory system. High concentrations in the atmosphere can lead to irritation of the respiratory tract,
vertigo, headache and anesthetic effects.
Skin contact:
May cause sensitization by skin contact. Irritating to skin. Repeated or prolonged contact can cause dermatitis.
Eye contact:
Irritating to eyes. A high concentration of steam will produce irritation.
Ingestion.
Low oral toxicity, but ingestion can irritate the gastrointestinal tract.
Long-term exposure
Repeated exposure to high concentrations produces adverse effects on the heart, lungs, liver and kidneys.
Repeated exposure by inhalation of animals at concentrations equal to or greater than the occupational exposure
limit produces adverse effects on the nasal epithelium (concentrations of 100 and 400 ppm)
Based on animal studies, appropriate mutagenicity studies and adequate epidemiology studies in representative
cohorts, there is no reason to believe that methyl methacrylate represents a carcinogenic or mutagenic risk to man.
Studies have revealed that high exposures do not produce toxic effects for the embryo or fetus, nor teratogenic
effects in the presence of maternal toxicity.
None of these effects are likely to occur in humans, provided that the exposure is maintained at or below the
Occupational Exposure Limit level.
Section 12. ECOLOGICAL INFORMATION
Component Powder and Cured Cement:
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SYNIMED SAFETY DATA SHEET
Ecotoxicity: Non-toxic
Mobility: The product is insoluble in water. It is foreseeable that it has low mobility on the ground.
Persistence and Degradability: Not easily biodegradable. Persistent.
Bioaccumulative Potential: The product has a low bioaccumulation potential.
Other Harmful Effects:They don't know each other.
Liquid Component
Ecotoxicity
Low toxicity to fish. LC50 (fish) Typically:> 100mg / L
Harmful to aquatic invertebrates: EC50 (Daphnia magna) (48 hours) 69 mg / L
Low toxicity to algae. EC50 (selenastrum capricornutum) 170 mg / L
Mobility: The product is limitedly soluble in water. It is expected that it will have high mobility on the ground.
Persistence and Degradability: Not easily biodegradable. Chemical Oxygen Demand (COD) 88% (28 days) Inherent
biodegradation: Elimination of dissolved organic carbon (Elimination of COD)> 95% (28 days)
Bioaccumulative Potential: The product has a low bioaccumulation potential.
Other Harmful Effects They don't know each other.
Section 13. DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Mix the powder with the liquid from a plane to obtain a non-hazardous product and / or dispose of the product in
accordance with current local or national legislation.
Dispose of as contaminated container.
Section 14. TRANSPORT CONSIDERATIONS
14. 1 UN number:
Solid component: Non-hazardous
Liquid component: ADR / RID: 1247, IMDG: 1247, IATA: 1247
14.2 UN regulations
Solid component: Non-hazardous
Liquid component: ADR / RID: Methyl Methacrylate Monomer Stabilized, IMDG: Methyl
Methacrylate Monomer Stabilized, IATA: Methyl Methacrylate Monomer Stabilized
14.3 Hazard classes for transport materials
Solid component: Non-hazardous
Liquid component: ADR / RID: 3, IMDG: 3, IATA: 3
14.4 Packaging unit
Solid component: Non-hazardous
Liquid component: ADR / RID: II (Liquid Component), IMDG II: (Liquid Component), IATA II (Liquid
Component)
14.5 Environmental hazards
Solid component: ADR / RID: No IMDG Marine Pollutant: No IATA: No
Liquid component: ADR / RID: No IMDG Marine Pollutant: No IATA: No
Section 15. REGULATORY INFORMATION
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SYNIMED SAFETY DATA SHEET
Cementos Ortopédicos de Laboratorios SL SA are approved and CE marked, under European regulations, as a
class llb medical device (medical device).
This safety sheet meets the requirements of the regulation (CE) No. 1907/2006
Section 16. OTHER INFORMATION
Laboratorios SL SA hereby authorize the printing of an unlimited number of copies exclusively for internal use.
The information contained in this safety data sheet is considered correct; however, it may not be exhaustive and
should therefore be considered for information only. Laboratorios SL SA is not responsible for any damage derived
from the use or contact with the product described in this safety data sheet.
ISSUE DATE AUGUST 6, 2019 REVIEW: -----
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