Conalor plv. - SpofaDental

SAFETY DATA SHEET
as per 1907/2006/ES
Conalor plv.
Date of Issue: 07/05/2013
Page 1 of 5
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE
AND OF THE COMPANY/UNDERTAKING
1.1 Product identifiers:
Conalor plv.
1.2 Relevant identified uses of the substance or mixture and uses advised against:
Colouring of resin facets on metallic constructions of fixed dentures. Colouring of base resin
in applications such as saddles of removable skeleton dentures. Shading and final colouring
of crown resins, imitation of cosmetic defects in tooth enamel.
1.3 Manufacturer Identification:
Business Name:
Company Headquarters:
Company Identification Nr.:
Telephone:
Fax:
E-mail:
SpofaDental a.s.
Markova 238, 506 46 Jičín, The Czech Republic
63999447
+420 - 493 583 111
+420 - 493 583 333
[email protected]
1.4 Telephone number for urgent situations:
+420 - 224 919 293
(National Toxicological Centre, Na bojišti 1, 120 00 Praha 2, CR)
2. INFORMATION REGARDING THE DANGERS OF THE SUBSTANCE
OR PRODUCT
2.1 Classification of the substance or mixture:
N - Dangerous for the environment
R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects
in the aquatic environment.
Xi - Irritant
R36: Irritating to eyes
R43: May cause sensitisation by skin contact
2.2 Label elements:
Hazard symbols:
Hazard statements:
R50/53-36-43: Very toxic to aquatic organisms, may cause long-term adverse effects
in the aquatic environment. Irritating to eyes. May cause sensitisation by skin contact.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor plv.
Date of Issue: 07/05/2013
Page 2 of 5
Safety phrases:
S 28: After contact with skin, wash immediately with plenty of water
S 37/39: Wear suitable gloves and eye/face protection
S 61: Avoid release to the environment
2.3 Other hazards: Not known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical name
Zinc oxide
Dibenzoyl
peroxide
Contents
(%)
60-95
INECS
CAS
215-222-5
1314-13-2
‹1
202-327-6
94-36-0
DSD-classific.
N
R: 50/53
E
Xi
R2
R36-43
CLP-classific.
Aquatic Acute 1,
Aquatic Chronic 1
H410
Org. Perox. C H242
Eye Irrit. 2
H319
Skin. Sens. 1
H317
Aquatic Acute 1 H400
For R-phrases, see sect. 2. For H-phrases, see sect. 16.
4. FIRST AID MEASURES
4.1 Description of first aid measures:
Ensure the safety of all persons present. Provide mental rest and calm to anyone
affected. Avoid further exposure. Provide a sufficient supply of fresh air.
With apparent health problems, seek medical assistance. Upon contact with skin wash
with water and soap, use regenerating ointment afterwards. If the skin is affected to
a greater extent, seek medical assistance. Affected eyes wash out with plenty
of lukewarm water, seek medical assistance. Upon ingestion wash the mouth out
thoroughly. With apparent health problems, seek medical assistance.
4.2 Most important acute and delayed symptoms and effects:
See safety phrases.
4.3 Indication of any immediate medical attention and special treatment needed:
In case of damage to the eyes seek medical assistance.
5. MEASURES FOR FIRE EXTINCTION
5.1 Suitable extinguishing agents: powder, heavy or medium foam, CO2
5.2 Special danger arising from the substance or mixture:
At high temperatures of fire, may produce hazardous decomposition products.
5.3 Instructions for fire workers:
Use the fire protective suit and respiratory protection.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor plv.
Date of Issue: 07/05/2013
Page 3 of 5
6. MEASURES TO BE TAKEN IN CASE OF RANDOM LEAK
6.1 Regulations for the protection of persons, protective equipment and emergency
procedures:
Provide a sufficient supply of fresh air, avoid direct contact with the product.
6.2 Regulations for the protection of the environment:
Avoid leakage to the aquatic system, soil or vegetation.
6.3 Methods and material for containment and cleaning:
The product must be thoroughly removed using an absorbent and move into a solid
package.
6.4 Reference to other sections: 7. HANDLING AND STORAGE
7.1 Precautions for safe handling:
The product must be stored in a tightly-sealed container in a well-ventilated place.
When handling, suitable protective garments and gloves must be used; direct contact
with the skin must be avoided. Personal sanitary measures must be adopted.
After work, the hands must be thoroughly washed in lukewarm water and soap.
7.2 Conditions for safe storage of substances and mixtures, including any incompatibilities:
To be stored in a well sealed package.
7.3 Specific use:
See 1.2 herein. The product is classified as a medical device as per directive
93/42/EHS (in the Czech Republic: Government Decree 336/2004 Coll.).
The product is intended for professional use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Control parameters:
No information is available for the product.
Zinc oxide:
Permissible exposure limit PEL (mg/m3):
Maximum permissible concentration NPK-P (mg/m3):
2
5
8.2 Reduction of exposition: The product must be handled in a well-ventilated area.
8.3 Personal protective aids:
Air passage protection:
Sufficient aeration
Eye protection:
Goggles or shield
Hand protection:
Rubber gloves
Skin protection:
Working garment
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor plv.
Date of Issue: 07/05/2013
Page 4 of 5
9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties:
Appearance
State: (at 20°C):
solid - powder
Colour:
as required
9.2 Other informations:
not available
10. STABILITY AND REACTIVITY
10.1 Reactivity: In contact with the liquid component of the powder occurs polymerization
and a solid mass.
10.2 Chemical stability: Stable under normal conditions.
10.3 Possibility of hazardous reactions: No data available.
10.4 Conditions to avoid: Don´t store near heat sources.
10.5 Incompatible materials: Strong oxidizers.
10.6 Dangerous decomposition products: No data available.
11. TOXICOLOGICAL INFORMATION
No information available for the product.
Zinc oxide:
Acute toxicity
LD50 per os, brown rat (mg/kg):
LD50 inhaled, brown rat, 4 hrs:
7950 mg/kg
2500 mg/m3
12. ENVIRONMENTAL INFORMATION
No information available for the product.
Zinc oxide:
Acute toxicity to aquatic organisms:
EC50 , 72 hrs:
170 µg/l
13. DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods:
Unusable waste and contaminated packages must be burnt in an incineration plant or handled
by a company authorised for dangerous waste disposal.
14. TRANSPORT INFORMATION
Not classified as hazardous for transport.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor plv.
Date of Issue: 07/05/2013
Page 5 of 5
15. INFORMATION CONCERNING LEGAL REGULATIONS
15.1 Regulations applicable to safety, health and environment / specific regulations
regarding the substance or mixture:
European Parliament and Council Directive (ES) 1907/2006
Act No. 350/2012 Coll. (applicable in the Czech Republic)
Act No. 201/2012 Coll., On air protection
Act No. 258/2000 Coll., On protection of public health, as amended
15.2
Chemical Safety Assessment: No information available.
16. OTHER INFORMATION
H-phrases used:
H 242 Heating may cause a fire or explosion
H 317 May cause an allergic skin reaction
H 319 Causes serious eye irritation
H 400 Very toxic to aquatic life
H 410 Very toxic to aquatic life with long lasting effects
Updates in the safety data sheet: most passages have been changes made by COMMISSION
REGULATION (EU) Nr. 453/2010 (REACH).
The above information applies to customer packages unless stated otherwise, and fully
expresses our current knowledge and experience. The product is assumed for use at worksites
corresponding to its designation, and the instructions on the enclosed instruction sheet as well
as the standard labour safety regulations for the handling of chemical products are assumed to
be adhered to.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 1 of 6
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE
AND OF THE COMPANY/UNDERTAKING
1.1 Product identifiers:
Conalor liq.
1.2 Relevant identified uses of the substance or mixture and uses advised against:
Along with the powder part for colouring of resin facets on metallic constructions of fixed
dentures. Colouring of base resin in applications such as saddles of removable skeleton
dentures. Shading and final colouring of crown resins, imitation of cosmetic defects in tooth
enamel.
1.3 Manufacturer Identification:
Business Name:
Company Headquarters:
Company Identification Nr.:
Telephone:
Fax:
E-mail:
SpofaDental a.s.
Markova 238, 506 46 Jičín, The Czech Republic
63999447
+420 - 493 583 111
+420 - 493 583 333
[email protected]
1.4 Telephone number for urgent situations:
+420 - 224 919 293
(National Toxicological Centre, Na bojišti 1, 120 00 Praha 2, CR)
2. INFORMATION REGARDING THE DANGERS OF THE SUBSTANCE
OR PRODUCT
2.1 Classification of the substance or mixture:
Xi - Irritant
R36/37/38: Irritating to eyes, respiratory system and skin
R43: May cause sensitisation by skin contact
2.2 Label elements:
Hazard symbols:
Hazard statements:
R36/37/38-43: Irritating to eyes, respiratory system and skin. May cause sensitisation
by skin contact.
Safety phrases:
S 28: After contact with skin, wash immediately with plenty of water
S 37/39: Wear suitable gloves and eye/face protection
S 61: Avoid release to the environment
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 2 of 6
2.3 Other hazards: Not known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical name
Triethylenedioxydiethyl
dimethacrylate
Contents
(%)
100
INECS
CAS
203-652-6
109-16-0
DSDclassific.
Xi
R36/37/38
R43
CLP-classific.
Skin Irrit. 2 H315
Eye Irrit. 2 H319
STOT SE 3 H335
For R-phrases, see sect. 2. For H-phrases, see sect. 16.
4. FIRST AID MEASURES
4.1 Description of first aid measures:
Ensure the safety of all persons present. Provide mental rest and calm to anyone
affected. Avoid further exposure. Provide a sufficient supply of fresh air.
With apparent health problems, seek medical assistance. Upon contact with skin wash
with water and soap, use regenerating ointment afterwards. If the skin is affected to
a greater extent, seek medical assistance. Affected eyes wash out with plenty
of lukewarm water, seek medical assistance. Upon ingestion wash the mouth out
thoroughly. With apparent health problems, seek medical assistance.
4.2 Most important acute and delayed symptoms and effects:
See safety phrases.
4.3 Indication of any immediate medical attention and special treatment needed:
In case of damage to the eyes seek medical assistance.
5. MEASURES FOR FIRE EXTINCTION
5.1 Suitable extinguishing agents: powder, heavy or medium foam, CO2
5.2 Special danger arising from the substance or mixture: oxides of carbon
5.3 Instructions for fire workers: For fire fighting if necessary use the respiratory protection.
5.4 Other informations: No information available.
6. MEASURES TO BE TAKEN IN CASE OF RANDOM LEAK
6.1 Regulations for the protection of persons, protective equipment and emergency
procedures:
Provide a sufficient supply of fresh air, avoid direct contact with the product.
6.2 Regulations for the protection of the environment:
Avoid leakage to the aquatic system, soil or vegetation.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 3 of 6
6.3 Methods and material for containment and cleaning:
Soak up with inert absorbent and dispose of as hazardous waste. Keep in suitable,
closed container.
6.4 Reference to other sections: Dispose of in accordance with sect. 13.
7. HANDLING AND STORAGE
7.1 Precautions for safe handling:
Avoid contact with skin and eyes. Do not breathe vapor or mist.
7.2 Conditions for safe storage of substances and mixtures, including any incompatibilities:
Store in a cool place. Keep container tightly closed in a dry, well-ventilated place.
Sensitive to light.
7.3 Specific use:
See 1.2 herein. The product is classified as a medical device as per directive
93/42/EHS (in the Czech Republic: Government Decree 336/2004 Coll.).
The product is intended for professional use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Control parameters:
Components with workplace control parameters.
Contains no substances with occupational exposure limit values in the workplace.
8.2 Reduction of exposition:
Appropriate engineering controls:
Observe safety precautions for handling chemicals. Wash your hands before working
breaks and after work.
Personal protective aids:
Eye and face protection: Safety goggles with side-shields conforming to EN 166.
Use equipment for eye protection tested and approved under appropriate government
standards such as NIOSH (U.S.) or EN 166 (EU).
Skin protection: Wear protective gloves. Gloves must be inspected prior to use.
Use proper glove removal technique without touching glove's outer surface to avoid
skin contact with this product. After use, dispose of contaminated gloves
in accordance with applicable laws and good laboratory practices. Wash your hands.
The selected protective gloves have to satisfy the specifications of EU Directive
89/686/EEC and the standard EN 374 derived.
Body protection: Impervious clothing.
Air passage protection: Sufficient aeration, local exhaustion.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 4 of 6
9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties:
a) Appearance, form:
liquid
b) Odour
no data available
c) Odour threshold
no data available
d) pH
no data available
e) Melting point/freezing point
no data available
f) Initial boiling point and boiling range
170 - 172 °C at 7 hPa - lit.
g) Flash point
167 °C - closed cup
h) Evaporation rate
no data available
i) Flammability (solid, gas)
no data available
j) Upper/lower flammability or explosive limits
no data available
k) Vapour pressure
no data available
l) Vapour density
no data available
m) Relative density
no data available
n) Water solubility
no data available
o) Partition coefficient
n-octanol/water log POW: 1.88
p) Auto-ignition temperature
no data available
q) Decomposition temperature
no data available
r) Viscosity
no data available
s) Explosive properties
no data available
t) Oxidizing properties
no data available
9.2 Other informations:
not available
10. STABILITY AND REACTIVITY
10.1 Reactivity: No data available.
10.2 Chemical stability: No data available.
It contains the stabilizer: Mequinol (> = 80 - <= 120 ppm).
10.3 Possibility of hazardous reactions: No data available.
10.4 Conditions to avoid: The light can polymerize.
10.5 Incompatible materials: Strong bases, strong oxidizers.
10.6 Dangerous decomposition products: No data available.
11. TOXICOLOGICAL INFORMATION
a) Acute toxicity
10837 mg/kg
LD50 per os, brown rat (mg/kg):
The lowest toxic dose (TDLo)50 per os, brown rat 7889 mg/kg
b) Caustic / skin irritation - no data available.
c) Serious eye damage / eye irritation
The product causes irritation of eyes, skin and mucous membranes.
d) Respiratory / skin sensitization - no data available.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 5 of 6
e) Germ cell mutagenicity - no data available.
f) Carcinogenicity
IARC: No component of this product present at levels identified greater than or equal
to 0.1% as probable, possible or confirmed carcinogen.
g) Reproductive toxicity - no data available.
h) Toxicity to specific target organs - single exposure
Inhalation - may cause irritation of the respiratory tract.
i) Toxicity and specific target organ - repeated exposure - no data available.
j) Inhalation hazard - no data available.
k) Potential health effects
Inhalation: May be harmful if inhaled. Causes respiratory tract irritation.
Ingestion: May be harmful if swallowed.
Skin: May be harmful if absorbed through skin. May cause skin irritation.
Eyes: Causes severe eye irritation.
l) Signs and symptoms of exposure
Symptoms of exposure may include burning sensations, coughing, wheezing,
laryngitis, shortness of breath, headache, nausea and vomiting. The best of our
knowledge, the chemical, physical and toxicological properties have not been
thoroughly investigated.
m) Additional information - RTECS: OZ4100000
12. ENVIRONMENTAL INFORMATION
12.1 Toxicity
No information available.
12.2 Persistency and degradability
No information available.
12.3 Bioaccumulation potential
No information available.
12.4 Soil mobility
No information available.
12.5 PBT and vPvB assessment
No information available.
12.6 Other adverse effects 13. DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods:
Unusable waste must be handled by a company authorised for dangerous waste disposal.
SAFETY DATA SHEET
as per 1907/2006/ES
Conalor liq.
Date of Issue: 07/05/2013
Page 6 of 6
14. TRANSPORT INFORMATION
Not classified as hazardous for transport - less than limit amount.
15. INFORMATION CONCERNING LEGAL REGULATIONS
15.1 Regulations applicable to safety, health and environment / specific regulations
regarding the substance or mixture:
European Parliament and Council Directive (ES) 1907/2006
Act No. 350/2012 Coll. (applicable in the Czech Republic)
Act No. 201/2012 Coll., On air protection
Act No. 258/2000 Coll., On protection of public health, as amended
15.2
Chemical Safety Assessment: No information available
16. OTHER INFORMATION
H-phrases used:
H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation
Updates in the safety data sheet: most passages have been changes made by COMMISSION
REGULATION (EU) Nr. 453/2010 (REACH).
The above information applies to customer packages unless stated otherwise, and fully
expresses our current knowledge and experience. The product is assumed for use at worksites
corresponding to its designation, and the instructions on the enclosed instruction sheet as well
as the standard labour safety regulations for the handling of chemical products are assumed to
be adhered to.