LYSOFORMIN SPEZIAL E 15.07.10.10

Safety data sheet
according to 1907/2006/EG
Page: 1/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
1. Product and company identification
Information on the product
Trade name: LYSOFORMIN SPEZIAL
Application: Submersion, dip and wipe disinfection of medical devices
Manufacturer Lysoform Dr. Hans Rosemann GmbH
Kaiser-Wilhelm-Straße 133
D-12247 Berlin
Telephone: +49 (0) 30/77992-0 Fax: +49 (0) 30/77992-219
www.lysoform.de
Department providing
information
Contact email:
Emergency information
Germany
Toxic emergency number Munich
Toxicological department,
Klinikum rechts der Isar
Ismaninger Str. 22, 81675 München
Telephone: +49 (0) 89/19240
Fax: +49 (0) 89/4140-2467
2. Hazard identification
Special indications of danger for humans and the environment:
The product must be labelled on the basis of the calculation procedure of the "General
classification guideline for preparations of the EU" in the latest valid version.
R 10 Flammable.
R36/38 Irritating to eyes and skin
R43 May cause sensitisation by skin contact
R 51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
3. Composition/details about the components
Chemical characterisation
Description: Mixture of the following substances with non-hazardous constituents.
Hazardous ingredients:
Scientific-technical department
Telephone: +49 (0) 30/77992-285
kontakt@lysoform.de
Xi Irritant
N Harmful for the environment
CAS: 69011-36-5 Isotridecanol, ethoxylated
Xn, Xi; R 22-41
CAS: 7173-51-5 Didecyldimethyl ammonium chloride
EINECS: 230-525-2 C, Xn; R 22-34
CAS: 27083-27-8
Polymer
Poly(hexamethylendiguanid)-hydrochloride
Xn, Xi, N; R 22-37/38-41-43-50/53
Switzerland
Swiss toxic information centre
Freiestrasse 16
8030 Zürich
Telephone: 0041 44 2515151
Fax: 0041 44 2528833
≤ 15%
(continued on page 2)
9,8%
2,9%
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Safety data sheet
according to 1907/2006/EG
Page: 2/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
Regulation (EC) No. 648/2004 on detergent/information on the ingredients
Nonionic surfactants 5 – 15%
Perfumes (2-(4-tert-butylbenzyl)propionaldehyde, alpha- < 5%
Hexylcinnamonaldehyde, LINALOOL), Methyl-IH-benzotriazol
Additional information: Please refer to Chapter 16 for the texts of the listed danger indications
4. First aid measures
After inhalation:
Plenty of fresh air, if unwell seek medical advice.
If unconscious, move and transport in the recovery position.
After skin contact: wash immediately with water and soap and rinse thoroughly.
After eye contact:
Rinse out with plenty of running water with the eyelid held wide open for several minutes.
Seek medical advice immediately.
After swallowing:
Drink plenty of water to dilute the product, immediately consult a physician.
5. Fire-fighting measures
Suitable extinguishing media:
CO2, extinguishing powder or water jet. Fight larger fires with water jets or alcohol-resistant
foam.
Protective equipment: No special measures required.
6. Procedure in case of accidental release
Personal safety precautions:
Wear protective equipment. Keep unprotected people away.
Measures for environmental protection:
If the product enters used waters or sewer system inform responsible administration immediately.
Dilute with plenty of water.
Do not allow to enter the sewer system/surface waters/groundwater.
Cleaning/Collecting procedure:
Absorb using liquid-binding material (sand, kieselguhr, acid binder, universal binder, sawdust).
Ensure adequate ventilation.
7. Handling and storage
Handling:
Information about safe handling:
Ensure good ventilation/extraction at the workplace.
Avoid the formation of aerosol.
Information about fire and explosion prevention:
Keep away from ignition sources – Do not smoke.
Take precautions against electrostatic charging.
Storage:
Requirements made of storage rooms and containers: Store in the original container only.
Joint storage information: Keep away from foodstuff.
Other information about storage conditions:
Keep container tightly closed.
Storage class: LGK 3 A (acc. to VCI) (continued on page 3)
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Safety data sheet
according to 1907/2006/EG
Page: 3/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
8. Exposure limitation and control / personal protectionn
(continued from page 2)
Additional information about the design of technical systems: No further data, see item 7
Components with critical values that require monitoring at the workplace:
This product contains no amounts of substances relevant for the monitoring of maximum amounts at the
workplace.
Additional information : This information is based on the lists that were valid when this data sheet was
generated.
Personal protective equipment
General precautions and hygienic measures:
Keep away from food, drinks and animal feed.
Immediately remove any soiled, saturated clothing.
Wash hand before breaks and at the end of work.
Avoid contact with skin.
Avoid contact with eyes and skin.
Respiration protection:
For short-term or low exposure respiration filter device; for intensive or longer exposure
use a respiration filter device that operates independently of the circulating air.
Hand protection:
Protective gloves
The material of the gloves must be impermeable and resistant to the product.
As compatibility tests are not available no recommendation can be made for the gloves suitable for the product.
The choice of gloves has to be made under consideration of perforation time, permeation rate and degradation
of the material .
Glove material:
Butyl rubber
Nitrile rubber
The choice of suitable gloves is not only depending on the material, but on a few further quality features. And
this differs from one producer to the other. As the product is a preparation containing different chemicals, the
resistance of the glove material is not predictable and must therefore be checked before use.
Penetration time of the glove material:
Ask the manufacturer about the exact penetration time and comply with this.
Eye protection: (continued on page 4)
Tight-fitting goggles
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Safety data sheet
according to 1907/2006/EG
Page: 4/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
9. Physical and chemical properties
General information
Form:
Colour:
Smell:
Change of state
Melting point/melting range:
Boiling point/boiling range:
Flash point:
Self -ignition:
Risk of explosion:
Vapour pressure at 20°C:
Density at 20°C:
Solubility in / mixability with
water:
pH-value (50 g/l) at 20°C:
Contents of solvent:
Organic solvents:
Water:
10. Stability and reactivity
Thermal decomposition / conditions to be avoided:
No decomposition if used properly
Dangerous reactions: No dangerous reactions known.
Dangerous products of decomposition: No dangerous decomposition products known.
11. Toxicological information
Acute toxicity:
Classification relevant LD/LC50 values:
Liquid
No colour
Characteristic
Not determined
Not determined
> 49°C (DIN 51755)
7173-51-5 Didecyl dimethl ammonium chloride
Oral LD50 84 mg/kg (rat)
Lysoformin spezial:
oral: 4.0 ml/kg (rat)
dermal: 8.0 ml/kg (rat)
The product is not self-igniting.
The product is not explosive, however formation of
explosive vapours/air mixtures may be formed.
Not determined
approx. 1 g/cm³
Completely mixable.
approx. 7
approx. 5,0 %
approx. 70 %
(continued from page 3)
Primary irritation:
on skin: Has a caustic effect on skin and mucus membranes. (continued from page 5)
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Safety data sheet
according to 1907/2006/EG
Page: 5/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
(continued from page 4)
in eyes: Severe burns and risk of severe damage to the eyes..
Sensitisation: May cause sensitisation by skin contact.
Further toxicological information:
Due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the
latest valid version, the product has the following risks:
Irritating
Sensitisation: May cause sensitisation by skin contact.
12. Ecological information
Information about elimination (persistence and degradability): Biodegradable
The surfactant in this preparation satisfies the conditions of the biological degradability as defined
in the regulations (EU) No. 648/2004 resp. CH in the ChemRRV on detergents.
Ecotoxicological effects:
Aquatic toxicity:
7173-51-5 Didecyl dimethyl ammonium chloride
Oral EC10 (16 h) 0,13 (Pseudomonas putida)
EC50 (72 h) 0,33 (Scendesmus subspicatus)
NOEC 21 d (OECD 203) 0,041 mg/l (daphnia magna)
NOEL 21 d (OECD 2) 0,22 mg/l (daphnia magna)
LC50 (96 h) 1 mg/l (rainbow trout)
NOTE toxic for fish
General information:
Water pollutant class (German legislation) 2 (self-classification): Dangerous for the waters
Do not allow to enter the groundwater, waste waters or the sewer system. Dangerous for drinking water by
leakage of even small quantities in watercourses. Toxic also for fish and plankton in watercourses. Toxic for
aquatic organisms.
13. Disposal consideration
Product:
Recommendation:
Handover to special waste collector or bring to a special waste collection point.
May not be disposed of together with the household waste. Do not allow to enter the sewer system.
European Waste Code
07 04 01 aqueous washing liquids and mother lye.
Soiled packaging:
Recommendation: Dispose of in accordance with the official regulations.
Recommended cleaning agent: Water, possibly with detergent additives.
(continued on page 6)
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Safety data sheet
according to 1907/2006/EG
Page: 6/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
14. Transport information
Land transport ADR/RID and GGVS/GGVE (cross-border/Germany):
ADR/RID-GGVS/E class: 3 flammable liquid
Kemler-Number: 30
UN-Number: 1993
Packaging group: III
Danger markings and labels: 3
Name of goods: 1993 FLAMMABLE LIQUID, N.O.S.
(mixture containing ETHANOL (ETHYL ALCOHOL)
Limited quantities (LQ): LQ7
Tunnel restriction code: D/E
Sea transport IMDG/GGVSee:
IMDG/GGVSea class: 3
UN-Number: 1993
Label: 3
Packaging group: III
EMS-Number: F-E,S-C
Marine pollutant: No
Correct technical name: FLAMMABLE LIQUID, N.O.S.
(mixture containing ETHANOL (ETHYL ALCOHOL))
Air transport ICAO-TI and IATA-DGR:
(continued from page 5)
ICAO/IATA-class: 3
UN/ID-number: 1993
Label: 3
Packaging group: III
Correct technical name: FLAMMABLE LIQUID, N.O.S.
(mixture containing ETHANOL (ETHYL ALCOHOL)) (continued on page 7)
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Safety data sheet
according to 1907/2006/EG
Page: 7/7
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010
Trade name: LYSOFORMIN SPEZIAL
15. Regulatory information
(continued from page 6)
Labelled according to the EEC Directives:
The product has been classified and identified according to the EC Directives/Hazardous Goods Ordinance.
Code letter and danger indication of the product:
Xi Irritant
N Harmful for the environment
Hazardous components for labelling:
Poly(hexamethylendiguanid)-hydrochloride
R-phrases:
10 Flammable.
R36/38 Irritating to eyes and skin
43 May cause sensitisation by skin contact.
51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
S-phrases:
23 Do not breathe gas/fumes/vapour/spray.
24 Avoid contact with skin.
26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
37/39 Wear suitable gloves and eye/face protection.
45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).
57 Use appropriate container to avoid environmental contamination.
National regulations:
Other regulations, restrictions and prohibitions
Medical device Cl. IIa CE 0482 acc. to German MPG
acc. to EU-RL 93/42/EEC
16. Other information
The information contained herein is based on the present state of our knowledge. It does not represent a
guarantee of the properties of the product or form the basis for a legal position.
Relevant R-phrases
22 Harmful if swallowed.
34 Causes burns.
R36/37/38 Irritating to eyes, respiratory system and skin
41 Risk of serious damage to eyes.
43 May cause sensitisation by skin contact.
50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment.
Area issuing the data sheet: Department Product Safety
Contact partner: Dr. G. Cielusek
* Data changed compared to previous version
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