LYSOFORMIN SPEZIAL E 15.07.10.10
LYSOFORMIN SPEZIAL E 15.07.10.10
LYSOFORMIN SPEZIAL E 15.07.10.10
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Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 1/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
1. Product and company identification<br />
Information on the product<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
Application: Submersion, dip and wipe disinfection of medical devices<br />
Manufacturer Lysoform Dr. Hans Rosemann GmbH<br />
Kaiser-Wilhelm-Straße 133<br />
D-12247 Berlin<br />
Telephone: +49 (0) 30/77992-0 Fax: +49 (0) 30/77992-219<br />
www.lysoform.de<br />
Department providing<br />
information<br />
Contact email:<br />
Emergency information<br />
Germany<br />
Toxic emergency number Munich<br />
Toxicological department,<br />
Klinikum rechts der Isar<br />
Ismaninger Str. 22, 81675 München<br />
Telephone: +49 (0) 89/19240<br />
Fax: +49 (0) 89/4140-2467<br />
2. Hazard identification<br />
Special indications of danger for humans and the environment:<br />
The product must be labelled on the basis of the calculation procedure of the "General<br />
classification guideline for preparations of the EU" in the latest valid version.<br />
R 10 Flammable.<br />
R36/38 Irritating to eyes and skin<br />
R43 May cause sensitisation by skin contact<br />
R 51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment<br />
3. Composition/details about the components<br />
Chemical characterisation<br />
Description: Mixture of the following substances with non-hazardous constituents.<br />
Hazardous ingredients:<br />
Scientific-technical department<br />
Telephone: +49 (0) 30/77992-285<br />
kontakt@lysoform.de<br />
Xi Irritant<br />
N Harmful for the environment<br />
CAS: 69011-36-5 Isotridecanol, ethoxylated<br />
Xn, Xi; R 22-41<br />
CAS: 7173-51-5 Didecyldimethyl ammonium chloride<br />
EINECS: 230-525-2 C, Xn; R 22-34<br />
CAS: 27083-27-8<br />
Polymer<br />
Poly(hexamethylendiguanid)-hydrochloride<br />
Xn, Xi, N; R 22-37/38-41-43-50/53<br />
Switzerland<br />
Swiss toxic information centre<br />
Freiestrasse 16<br />
8030 Zürich<br />
Telephone: 0041 44 2515151<br />
Fax: 0041 44 2528833<br />
≤ 15%<br />
(continued on page 2)<br />
9,8%<br />
2,9%<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 2/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
Regulation (EC) No. 648/2004 on detergent/information on the ingredients<br />
Nonionic surfactants 5 – 15%<br />
Perfumes (2-(4-tert-butylbenzyl)propionaldehyde, alpha- < 5%<br />
Hexylcinnamonaldehyde, LINALOOL), Methyl-IH-benzotriazol<br />
Additional information: Please refer to Chapter 16 for the texts of the listed danger indications<br />
4. First aid measures<br />
After inhalation:<br />
Plenty of fresh air, if unwell seek medical advice.<br />
If unconscious, move and transport in the recovery position.<br />
After skin contact: wash immediately with water and soap and rinse thoroughly.<br />
After eye contact:<br />
Rinse out with plenty of running water with the eyelid held wide open for several minutes.<br />
Seek medical advice immediately.<br />
After swallowing:<br />
Drink plenty of water to dilute the product, immediately consult a physician.<br />
5. Fire-fighting measures<br />
Suitable extinguishing media:<br />
CO2, extinguishing powder or water jet. Fight larger fires with water jets or alcohol-resistant<br />
foam.<br />
Protective equipment: No special measures required.<br />
6. Procedure in case of accidental release<br />
Personal safety precautions:<br />
Wear protective equipment. Keep unprotected people away.<br />
Measures for environmental protection:<br />
If the product enters used waters or sewer system inform responsible administration immediately.<br />
Dilute with plenty of water.<br />
Do not allow to enter the sewer system/surface waters/groundwater.<br />
Cleaning/Collecting procedure:<br />
Absorb using liquid-binding material (sand, kieselguhr, acid binder, universal binder, sawdust).<br />
Ensure adequate ventilation.<br />
7. Handling and storage<br />
Handling:<br />
Information about safe handling:<br />
Ensure good ventilation/extraction at the workplace.<br />
Avoid the formation of aerosol.<br />
Information about fire and explosion prevention:<br />
Keep away from ignition sources – Do not smoke.<br />
Take precautions against electrostatic charging.<br />
Storage:<br />
Requirements made of storage rooms and containers: Store in the original container only.<br />
Joint storage information: Keep away from foodstuff.<br />
Other information about storage conditions:<br />
Keep container tightly closed.<br />
Storage class: LGK 3 A (acc. to VCI) (continued on page 3)<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 3/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
8. Exposure limitation and control / personal protectionn<br />
(continued from page 2)<br />
Additional information about the design of technical systems: No further data, see item 7<br />
Components with critical values that require monitoring at the workplace:<br />
This product contains no amounts of substances relevant for the monitoring of maximum amounts at the<br />
workplace.<br />
Additional information : This information is based on the lists that were valid when this data sheet was<br />
generated.<br />
Personal protective equipment<br />
General precautions and hygienic measures:<br />
Keep away from food, drinks and animal feed.<br />
Immediately remove any soiled, saturated clothing.<br />
Wash hand before breaks and at the end of work.<br />
Avoid contact with skin.<br />
Avoid contact with eyes and skin.<br />
Respiration protection:<br />
For short-term or low exposure respiration filter device; for intensive or longer exposure<br />
use a respiration filter device that operates independently of the circulating air.<br />
Hand protection:<br />
Protective gloves<br />
The material of the gloves must be impermeable and resistant to the product.<br />
As compatibility tests are not available no recommendation can be made for the gloves suitable for the product.<br />
The choice of gloves has to be made under consideration of perforation time, permeation rate and degradation<br />
of the material .<br />
Glove material:<br />
Butyl rubber<br />
Nitrile rubber<br />
The choice of suitable gloves is not only depending on the material, but on a few further quality features. And<br />
this differs from one producer to the other. As the product is a preparation containing different chemicals, the<br />
resistance of the glove material is not predictable and must therefore be checked before use.<br />
Penetration time of the glove material:<br />
Ask the manufacturer about the exact penetration time and comply with this.<br />
Eye protection: (continued on page 4)<br />
Tight-fitting goggles<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 4/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
9. Physical and chemical properties<br />
General information<br />
Form:<br />
Colour:<br />
Smell:<br />
Change of state<br />
Melting point/melting range:<br />
Boiling point/boiling range:<br />
Flash point:<br />
Self -ignition:<br />
Risk of explosion:<br />
Vapour pressure at 20°C:<br />
Density at 20°C:<br />
Solubility in / mixability with<br />
water:<br />
pH-value (50 g/l) at 20°C:<br />
Contents of solvent:<br />
Organic solvents:<br />
Water:<br />
10. Stability and reactivity<br />
Thermal decomposition / conditions to be avoided:<br />
No decomposition if used properly<br />
Dangerous reactions: No dangerous reactions known.<br />
Dangerous products of decomposition: No dangerous decomposition products known.<br />
11. Toxicological information<br />
Acute toxicity:<br />
Classification relevant LD/LC50 values:<br />
Liquid<br />
No colour<br />
Characteristic<br />
Not determined<br />
Not determined<br />
> 49°C (DIN 51755)<br />
7173-51-5 Didecyl dimethl ammonium chloride<br />
Oral LD50 84 mg/kg (rat)<br />
Lysoformin spezial:<br />
oral: 4.0 ml/kg (rat)<br />
dermal: 8.0 ml/kg (rat)<br />
The product is not self-igniting.<br />
The product is not explosive, however formation of<br />
explosive vapours/air mixtures may be formed.<br />
Not determined<br />
approx. 1 g/cm³<br />
Completely mixable.<br />
approx. 7<br />
approx. 5,0 %<br />
approx. 70 %<br />
(continued from page 3)<br />
Primary irritation:<br />
on skin: Has a caustic effect on skin and mucus membranes. (continued from page 5)<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 5/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
(continued from page 4)<br />
in eyes: Severe burns and risk of severe damage to the eyes..<br />
Sensitisation: May cause sensitisation by skin contact.<br />
Further toxicological information:<br />
Due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the<br />
latest valid version, the product has the following risks:<br />
Irritating<br />
Sensitisation: May cause sensitisation by skin contact.<br />
12. Ecological information<br />
Information about elimination (persistence and degradability): Biodegradable<br />
The surfactant in this preparation satisfies the conditions of the biological degradability as defined<br />
in the regulations (EU) No. 648/2004 resp. CH in the ChemRRV on detergents.<br />
Ecotoxicological effects:<br />
Aquatic toxicity:<br />
7173-51-5 Didecyl dimethyl ammonium chloride<br />
Oral EC10 (16 h) 0,13 (Pseudomonas putida)<br />
EC50 (72 h) 0,33 (Scendesmus subspicatus)<br />
NOEC 21 d (OECD 203) 0,041 mg/l (daphnia magna)<br />
NOEL 21 d (OECD 2) 0,22 mg/l (daphnia magna)<br />
LC50 (96 h) 1 mg/l (rainbow trout)<br />
NOTE toxic for fish<br />
General information:<br />
Water pollutant class (German legislation) 2 (self-classification): Dangerous for the waters<br />
Do not allow to enter the groundwater, waste waters or the sewer system. Dangerous for drinking water by<br />
leakage of even small quantities in watercourses. Toxic also for fish and plankton in watercourses. Toxic for<br />
aquatic organisms.<br />
13. Disposal consideration<br />
Product:<br />
Recommendation:<br />
Handover to special waste collector or bring to a special waste collection point.<br />
May not be disposed of together with the household waste. Do not allow to enter the sewer system.<br />
European Waste Code<br />
07 04 01 aqueous washing liquids and mother lye.<br />
Soiled packaging:<br />
Recommendation: Dispose of in accordance with the official regulations.<br />
Recommended cleaning agent: Water, possibly with detergent additives.<br />
(continued on page 6)<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 6/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
14. Transport information<br />
Land transport ADR/RID and GGVS/GGVE (cross-border/Germany):<br />
ADR/RID-GGVS/E class: 3 flammable liquid<br />
Kemler-Number: 30<br />
UN-Number: 1993<br />
Packaging group: III<br />
Danger markings and labels: 3<br />
Name of goods: 1993 FLAMMABLE LIQUID, N.O.S.<br />
(mixture containing ETHANOL (ETHYL ALCOHOL)<br />
Limited quantities (LQ): LQ7<br />
Tunnel restriction code: D/E<br />
Sea transport IMDG/GGVSee:<br />
IMDG/GGVSea class: 3<br />
UN-Number: 1993<br />
Label: 3<br />
Packaging group: III<br />
EMS-Number: F-E,S-C<br />
Marine pollutant: No<br />
Correct technical name: FLAMMABLE LIQUID, N.O.S.<br />
(mixture containing ETHANOL (ETHYL ALCOHOL))<br />
Air transport ICAO-TI and IATA-DGR:<br />
(continued from page 5)<br />
ICAO/IATA-class: 3<br />
UN/ID-number: 1993<br />
Label: 3<br />
Packaging group: III<br />
Correct technical name: FLAMMABLE LIQUID, N.O.S.<br />
(mixture containing ETHANOL (ETHYL ALCOHOL)) (continued on page 7)<br />
EN
Safety data sheet<br />
according to 1907/2006/EG<br />
Page: 7/7<br />
Printed on:15 th July 2010 Version :6 Revised on: 15 th July 2010<br />
Trade name: <strong>LYSOFORMIN</strong> <strong>SPEZIAL</strong><br />
15. Regulatory information<br />
(continued from page 6)<br />
Labelled according to the EEC Directives:<br />
The product has been classified and identified according to the EC Directives/Hazardous Goods Ordinance.<br />
Code letter and danger indication of the product:<br />
Xi Irritant<br />
N Harmful for the environment<br />
Hazardous components for labelling:<br />
Poly(hexamethylendiguanid)-hydrochloride<br />
R-phrases:<br />
10 Flammable.<br />
R36/38 Irritating to eyes and skin<br />
43 May cause sensitisation by skin contact.<br />
51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.<br />
S-phrases:<br />
23 Do not breathe gas/fumes/vapour/spray.<br />
24 Avoid contact with skin.<br />
26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.<br />
37/39 Wear suitable gloves and eye/face protection.<br />
45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).<br />
57 Use appropriate container to avoid environmental contamination.<br />
National regulations:<br />
Other regulations, restrictions and prohibitions<br />
Medical device Cl. IIa CE 0482 acc. to German MPG<br />
acc. to EU-RL 93/42/EEC<br />
16. Other information<br />
The information contained herein is based on the present state of our knowledge. It does not represent a<br />
guarantee of the properties of the product or form the basis for a legal position.<br />
Relevant R-phrases<br />
22 Harmful if swallowed.<br />
34 Causes burns.<br />
R36/37/38 Irritating to eyes, respiratory system and skin<br />
41 Risk of serious damage to eyes.<br />
43 May cause sensitisation by skin contact.<br />
50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic<br />
environment.<br />
Area issuing the data sheet: Department Product Safety<br />
Contact partner: Dr. G. Cielusek<br />
* Data changed compared to previous version<br />
EN