Page 1/5
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 10.10.2007 Revision: 10.10.2007
1 Identification of the substance/preparation and of the company/undertaking
?Product details
?Trade name: EdelZyme
?Article number: 80120
?Application of the substance / the preparation Preparation
?Manufacturer/Supplier:
Produits Dentaires SA
Rue des Bosquets 18
CH-1800 Vevey - Switzerland
Tel.: 0041 21 921 26 31
Fax: 0041 21 921 39 79
?Further information obtainable from: Laboratory
?Information in case of emergency: NHS Direct: 0845 46 47 / Textphone: 0845 606 46 47
2 Hazards identification
?Hazard description:
C Corrosive
?Information concerning particular hazards for human and environment:
The product has to be labelled due to the calculation procedure of the "General Classification guideline for
preparations of the EU" in the latest valid version.
R 22 Harmful if swallowed.
R 34 Causes burns.
R 42 May cause sensitisation by inhalation.
?Classification system:
The classification is according to the latest editions of the EU-lists, and extended by company and literature
data.
3 Composition/information on ingredients
?Chemical characterization
?Description: Mixture: consisting of the following components.
?Dangerous components:
CAS: 110-63-4 butane-1,4-diol 25-50%
EINECS: 203-786-5 Xn; R 22
CAS: 112-34-5 2-(2-butoxyethoxy)ethanol 10-25%
EINECS: 203-961-6 Xi; R 36
CAS: 2372-82-9 N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine 2.5-10%
EINECS: 219-145-8 C, Xn, N; R 22-34-50
?Additional information: For the wording of the listed risk phrases refer to section 16.
4 First aid measures
?General information:
Immediately remove any clothing soiled by the product.
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48
hours after the accident.
?After inhalation: In case of unconsciousness place patient stably in side position for transportation.
?After skin contact: Immediately wash with water and soap and rinse thoroughly.
?After eye contact: Rinse opened eye for several minutes under running water. Then consult a doctor.
?After swallowing:
Call for a doctor immediately.
(Contd. on page 2)
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Page 2/5
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 10.10.2007 Revision: 10.10.2007
Trade name: EdelZyme
(Contd. of page 1)
Drink plenty of water and provide fresh air. Call for a doctor immediately.
5 Fire-fighting measures
?Suitable extinguishing agents:
CO2, 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: Wear protective equipment. Keep unprotected persons away.
?Measures for environmental protection:
Dilute with plenty of water.
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).
Use neutralizing agent.
Dispose contaminated material as waste according to item 13.
Ensure adequate ventilation.
7 Handling and storage
?Handling:
?Information for safe handling:
Ensure good ventilation/exhaustion at the workplace.
Prevent formation of aerosols.
?Information about fire - and explosion protection: 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: Keep container tightly sealed.
8 Exposure controls/personal protection
?Additional information about design of technical facilities: No further data; see item 7.
?Ingredients with limit values that require monitoring at the workplace:
112-34-5 2-(2-butoxyethoxy)ethanol
IOELV (EU) Short-term value: 101.2 mg/m? 15 ppm
Long-term value: 67.5 mg/m? 10 ppm
?Additional information: The lists valid during the making were used as basis.
?Personal protective equipment:
?General protective and hygienic measures:
Keep away from foodstuffs, beverages and feed.
Immediately remove all soiled and contaminated clothing
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
?Respiratory protection:
In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure
use self-contained respiratory protective device.
?Protection of hands:
Protective gloves
(Contd. on page 3)
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Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 10.10.2007 Revision: 10.10.2007
Trade name: EdelZyme
(Contd. of page 2)
?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.
?Eye protection:
Tightly sealed goggles
9 Physical and chemical properties
?General Information
Fluid
Form:
Blue
Colour:
Characteristic
Odour:
?Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
>100癈
?Flash point:
Not applicable.
?Ignition temperature:
Product is not selfigniting.
?Self-igniting:
Product does not present an explosion hazard.
?Danger of explosion:
1.02 g/cm?br>
?Density at 20癈:
?Solubility in / Miscibility with
Fully miscible.
water:
9.9
?pH-value at 20癈:
10 Stability and reactivity
?Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
?Dangerous reactions No dangerous reactions known.
?Dangerous decomposition products: No dangerous decomposition products known.
11 Toxicological information
?Acute toxicity:
?LD/LC50 values relevant for classification:
110-63-4 butane-1,4-diol
Oral LD50 1525 mg/kg (rat)
?Primary irritant effect:
?on the skin: Caustic effect on skin and mucous membranes.
?on the eye: Strong caustic effect.
?Sensitization: No sensitizing effects known.
?Additional toxicological information:
The product shows the following dangers according to the calculation method of the General EU
Classification Guidelines for Preparations as issued in the latest version:
Harmful
(Contd. on page 4)
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Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 10.10.2007 Revision: 10.10.2007
Trade name: EdelZyme
(Contd. of page 3)
Corrosive
Swallowing will lead to a strong caustic effect on mouth and throat and to the danger of perforation of
esophagus and stomach.
?Sensitisation May cause sensitisation by inhalation.
12 Ecological information
?General notes:
Must not reach sewage water or drainage ditch undiluted or unneutralized.
Water hazard class 2 (German Regulation) (Self-assessment): hazardous for water
Do not allow product to reach ground water, water course or sewage system.
Danger to drinking water if even small quantities leak into the ground.
13 Disposal considerations
?Product:
?Recommendation
Must not be disposed together with household garbage. Do not allow product to reach sewage system.
?Waste disposal key:
CED 070000
CED 070600
?Uncleaned packaging:
?Recommendation: Disposal must be made according to official regulations.
?Recommended cleansing agents: Water, if necessary together with cleansing agents.
14 Transport information
?Land transport ADR/RID (cross-border)
8 (C7) Corrosive substances.
?ADR/RID class:
56B
?Danger code (Kemler):
3267
?UN-Number:
II
?Packaging group:
8
?Hazard label:
3267 CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S. (N-(3-aminopropyl)-N-
?Description of goods:
dodecylpropane-1,3-diamine)
?Limited quantities (LQ) LQ7
3
?Transport category
?Tunnel restriction code E
?Maritime transport IMDG:
8
?IMDG Class:
3267
?UN Number:
8
?Label
II
?Packaging group:
F-A,S-B
?EMS Number:
Yes
?Marine pollutant:
(Contd. on page 5)
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Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 10.10.2007 Revision: 10.10.2007
Trade name: EdelZyme
(Contd. of page 4)
?Proper shipping name: CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S. (N-(3-aminopropyl)-N-
dodecylpropane-1,3-diamine)
?Air transport ICAO-TI and IATA-DGR:
8
?ICAO/IATA Class:
3267
?UN/ID Number:
8
?Label
II
?Packaging group:
CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S. (N-(3-aminopropyl)-N-
?Proper shipping name:
dodecylpropane-1,3-diamine)
15 Regulatory information
?Labelling according to EU guidelines:
The product has been marked in accordance with EU Directives / respective national laws.
2004/73/CE ; 2006/8/CE
?Code letter and hazard designation of product:
C Corrosive
?Hazard-determining components of labelling:
butane-1,4-diol
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
?Risk phrases:
22 Harmful if swallowed.
34 Causes burns.
42 May cause sensitisation by inhalation.
?Safety phrases:
1/2 Keep locked up and out of the reach of children.
23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).
28 After contact with skin, wash immediately with plenty of soap and water.
36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where
possible).
60 This material and its container must be disposed of as hazardous waste.
16 Other information
This information is based on our present knowledge. However, this shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
?Relevant R-phrases
22 Harmful if swallowed.
34 Causes burns.
36 Irritating to eyes.
50 Very toxic to aquatic organisms.
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