EC Safety Data Sheet - Lysoform.ch

EC Safety Data Sheet
In accordance with EC Guideline 2001/58/EEC
Revised on: 01.06.2006 Page 1 of 4
1. Identification of the substance/preparation and the company
Information on the product LYSOFORMIN 2000
Trade name
Disinfection of medical devices by wiping or
immersion/insertion (Surface and instrument disinfection in
accordance with DGHM)
Manufacturer
Department providing information
Lysoform Dr. Hans Rosemann GmbH
Kaiser-Wilhelm-Strasse 133
D-12247 Berlin
Tel: +49 (30) 77992-0 Fax: +49 (30) 77992-219
www.lysoform.de
Scientific-technical department
Telephone +49 (30) 77992-215
Emergency information
Germany
Switzerland
Poison emergency telephone number, Munich Swiss Toxicological Centre of Information
Toxicology Department,
Freiestrasse 16
Clinical centre on the right of the Isar
8030 Zurich
Ismaninger Str. 22, 81675 Munich
Phone: + 49 (89) 19 24 0
Phone: 01 / 25 15 151 Fax: 01 / 25 28 833
Fax: + 49 (89) 4140-24 67
2. Composition / information on ingredients
Chemical characterization
Description
Solution of aldehydes and surfactants in water
Active ingredients and components contributing to the hazard:
CAS No. EINECS Designation Content Hazard R-phrases
No.
symbol
50-00-0 200-001-8 Formaldehyde 13.0 % T, C 23/24/25-34-40-43
Carc.Cat.3
107-22-2 203-474-9 Glyoxal 3.6 % Xn, Xi 20-36/38-43-68
Muta.Car.3
111-30-8 203-856-5 Glutaraldehyde 3.2 % T, C, N 23/25-34-42/43-50
69011-36-5 Isotridecanol, ethoxylated ≤ 5.0 % Xn, Xi 22-41
68585-34-2 500-223-8 Sodium lauryl ether
≤ 5.0 % Xi 36/38
sulphate
Other ingredients according to the Detergent Bill (EEC) Nr. 648/2004, Annex VII:
Perfumes BENZYL SALICYLATE, COUMARIN, LINALOOL
The packaging materials contain (optional: our packaging materials contain) no substances included on the candidate li
(11/28/2008) according to article 59 (1, 10) of Regulation (EC) No 1907/2006 („REACH“) (see the website of the
European Chemicals Agency (EChA) http://echa.europa.eu/) in a concentration above 0.1 % weight by weight.
3. Hazards identification
Hazard symbol: Xn - Harmful to health
The concentrate is harmful: possible risk of irreversible effects through inhalation, in contact with
skin and if swallowed. Limited evidence of a carcinogenic effect. Risk of serious damage to eyes.
May cause sensitisation by inhalation and skin contact.

EC Safety Data Sheet
In accordance with EC Guideline 2001/58/EEC
Revised on: 01.06.2006 Page 2 of 4
Trade name: LYSOFORMIN 2000
4. First-aid measures
General information: Immediately remove contaminated, soaked clothing
Inhalation:
Get ample amounts of fresh air
Skin contact:
Flush with ample amounts of water
Eye contact:
Flush with ample amounts of water, immediately consult a
physician
Ingestion:
Drink ample amounts of water to dilute the concentrate,
immediately consult a physician
5. Fire-fighting measures
Suitable extinguishing media:
Water, foam, powder, carbon dioxide
6. Accidental release measures
Personal precautions:
Suitable protective gloves
Environmental precautions:
Do not let the concentrate get into the ground, the sewer system or watercourses
Methods for cleaning up:
Absorb with liquid-binding material
7. Handling and storage
Safe handling advice:
Keep containers closed
Information on fire and explosion protection:
None
Requirement for storage rooms and containers:
Store in a cool and dry place in the original container (5-30ºC)
Joint-storage information:
Keep separate from any kind of food in accordance with the VCI concept for joint storage of
chemicals
Further information on the storage conditions: None
Storage class:
LGK 8 (in accordance with VCI)
8. Exposure controls / personal protection
Ingredients with exposure limits to be monitored with regard to the work place:
CAS No. Designation of the substance Type Value Unit
-------------------------------------------------------------------------------------------------------------------
50-00-0 Formaldehyde Max. workplace con. 0.5 ppm
111-30-8 Glutaraldehyde Max. workplace con. 0.1 ppm
Max.conc. at the working place acc.to TRGS 900 from August 2004
General protection / hygiene measures:
Wash hands before a break and at the end of the work
Hand protection:
Protective gloves (e.g. chemical-protection gloves made of butyl rubber or nitrile rubber in Category
III in accordance with EN 374).

EC Safety Data Sheet
In accordance with EC Guideline 2001/58/EEC
Revised on: 01.06.2006 Page 3 of 4
Trade name: LYSOFORMIN 2000
9. Physical and chemical properties
Form: Liquid
Colour: Blue
Odour: Scented
Value/range Unit Method
Auto-ignition properties:
Product is not spontaneously flammable.
Explosion hazard:
The product is not explosive.
Density: at 20º C approx. 1.1 g/cm³
Solubility in water:
no limit
Viscosity: at 20º C > 10 mPa · s DIN 51562
pH value (50 g/l): at 20º C approx. 7
Solvent contained: water approx. 65%
10. Stability and reactivity
No decomposition when properly used
Hazardous decomposition products: None
11. Toxicological information
Acute toxicity:
LD/LC50 values relevant for classification:
Component Type Value Species
---------------------------------------------------------------------------------------------------
Lysoformin 2000 100% oral 2.13 ml/kg rat
Lysoformin 2000 2% inhalation no effect rat
12. Ecological information
General information:
Lysoformin 2000 is biodegradable
13. Disposal considerations
Product: Do not empty large amounts into sewer drains. Consult state, local or national regulations
for proper waste disposal.
Discard empty bottles/cans in the recycling containers after closing with original caps.

EC Safety Data Sheet
In accordance with EC Guideline 2001/58/EEC
Revised on: 01.06.2006 Page 4 of 4
Trade name: LYSOFORMIN 2000
15. Regulatory information
Labelling in accordance with the EEC directives:
Xn - Harmful to health
Components contributing to the hazard for labelling:
Formaldehyde, glyoxal, glutaraldehyde
R-phrases:
R 68/20/21/22 Harmful: possible risk of irreversible effects through inhalation, in contact
with skin and if swallowed.
R 40
Limited evidence of a carcinogenic effect.
R 41
Risk of serious damage to eyes.
R 37/38 Irritating to respiratory system and skin.
R 42/43 May cause sensitization by inhalation and skin contact.
S-phrases:
S 26
In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice.
S 28
After contact with skin, wash immediately with plenty of water.
S 36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
S 51
S 45
Use only in well-ventilated areas.
In case of accident or if you feel unwell, seek medical advice immediately
(show the label where possible).
Other National Regulations:
Water pollution class (self classification): WGK 3 – severely hazardous to waters
Medical device Class IIa CE 0482 in accordance with MPG
In case of non-medical indication: biocide according to the EU Biocidal Products Directive
(98/8/EC)
Keep out of reach of children.
16. Other information
This data sheet replaces all earlier issues. The following sections have changed from the last
version of August 30, 2004: § 2.
R-phrases of the ingredients:
R 20
R 22
R 23/25
R 23/24/25
R 34
R 36/38
R 40
R 41
R 42/43
R 43
R 50
R 68
Harmful by inhalation
Harmful if swallowed
Toxic by inhalation and if swallowed
Toxic by inhalation, in contact with skin and if swallowed
Causes burns.
Irritating to eyes and skin
Limited evidence of a carcinogenic effect.
Risk of serious damage to eyes
May cause sensitization by inhalation and skin contact
May cause sensitization by skin contact
Very toxic to aquatic organisms
Possible risk of irreversible effects
The information is based on the present status of our knowledge, but it does constitute assurance
of product characteristics and does not form the basis for a contractual legal relationship.
Department issuing the data sheet:
Contact person for scientific questions:
Scientific-technical department
Dr. Cielusek