FE-1022/EN rev.A

Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier
NIGHT CLEANER

Trade name:1.2. Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses:

Cleaning and disinfecting agent

Intended purpose:

NIGHT CLEANER ensures the decontamination andprevents biofilm formation in water lines of all EMS
AIRFLOW® units and extends their life when used daily.

Uses advised against:

None at intended use.

Note:

The product is intended for professional users.

1.3. Details of the supplier of the safety data sheet
Supplier:

E.M.S. Electro Medical Systems S.A.
Ch. de la Vuarpillière 311260 Nyon - Switzerland
Telephone: +41 (0) 22 99 44 700Internet: www.ems-dental.com

E-mail address for the competent person
responsible for the safety data sheet:

doku@alpro-medical.de

1.4. Emergency telephone number
In-house emergency telephone number:+49 7725 9392-0 (ALPRO MEDICAL GMBH)
Monday – Friday from 08:00 am to 04:30 pm (UTC+1);
for chemical information and legal information on
hazardous substances only

Poison centre:+49 761 19240
Poisoning information centre, Freiburg, Germany(24 h / 7 d), English is spoken

SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
Classification in accordance with Regulation (EC) No 1272/2008 [CLP]
The mixture is not classified as hazardous in the sense of Regulation (EC) No 1272/2008 [CLP].

2.2. Label elements
Label elements in accordance with Regulation (EC) No 1272/2008 [CLP]
The mixture does not require labelling in the sense of Regulation (EC) No 1272/2008 [CLP].
Hazard pictograms:-

Signal word:-

Hazard components
for labelling:-

H-phrases:-

P-phrases:-

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

2.3. Other hazards
The substances in the mixture do not meet the PBT/vPvB criteria according to Regulation (EC) No
1907/2006, Annex XIII.
No further hazards known.

SECTION 3: Composition/information on ingredients3.2. Mixtures
Chemical characterisation:

Mixture of propylene glycol, parabens, biguanides and complexing
agents in aqueous solution.

Hazardous ingredients
Does not contain hazardous ingredients above concentration limit values fixed in Regulation (EC) No
1907/2006.

SECTION 4: First aid measures
4.1. Description of first aid measures
General information:

First aider: Pay attention to self-protection!

Following inhalation:

Supply fresh air. In case of complaints consult a physician.

Following skin contact:

No special measures necessary.

Following eye contact:

Flush eyes with flowing water for several minutes holding eyelids apart.
Remove contact lenses, if present and easy to do.

Following ingestion:

Rinse mouth with water. Let drink water.

4.2. Most important symptoms and effects, both acute and delayed
None known.
4.3. Indication of any immediate medical attention and special treatment needed
The product contains a source of phenylalanine.

SECTION 5: Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media:

Water spray jet, alcohol resistant foam, extinguishing powder,carbon dioxide (CO2)

Unsuitable extinguishing media:

Full water jet

5.2. Special hazards arising from the substance or mixture
Hazardous combustion products:

Carbon monoxide (CO), carbon dioxide (CO2)5.3. Advice for firefighters
Special protective equipment:

Not necessary

Further information:

Cool endangered containers with water spray jet.

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
Use personal protective equipment. See SECTION 8.2.
Special danger of slipping by leaked/spilled product.
For emergency responders
Use personal protective equipment. See SECTION 8.2.
6.2. Environmental precautions
Not necessary
6.3. Methods and material for containment and cleaning up
Containment
Not necessary
Cleaning up
Wipe up small amounts with absorbent material (e.g. cloth, fleece). Absorb large amounts with liquidbinding material (sand, diatomaceous earth, universal binder, sawdust).
Other information
Inappropriate containment and cleaning methods are not known.
6.4. Reference to other sections
Information on safe handling see SECTION 7.1.
Information on personal protective equipment see SECTION 8.2.
Information on disposal see SECTION 13.

SECTION 7: Handling and storage
7.1. Precautions for safe handling
Precautions
Not necessary
Advice on general occupational hygiene
When using do not eat, drink or smoke. Wash hands before breaks and at end of work. Keep awayfrom food and drink.
7.2. Conditions for safe storage, including any incompatibilities
Requirements for storage rooms and vessels: Keep only in the original container.
Advice on common storage:

Not necessary

Further information on storage conditions:

Recommended storage temperature: -10 °C – 30 °C

Storage class ([DE] TRGS 510):

LGK 12 Non-combustible liquids that are not assigned toany of the aforementioned LGK

7.3. Specific end use(s)Apart from the uses mentioned in section 1.2 no other specific end uses are stipulated.

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

Industry and sector specific guidance[DE]

TRGS 525 – Hazardous substances in medical care facilities (Section 7 Activities withdisinfectants); Issue: September 2014;
Source: GMBl 2014 page 1294-1307 of 13.10.2014 [No 63]; www.baua.de[DE]

DGUV rules 107-002 (former BGR 206) - Disinfection works in health service
Issue: July 1999; Source: www.dguv.de/publikationen

SECTION 8: Exposure controls/personal protection
8.1. Control parameters
Occupational exposure limits
Does not contain substances above concentration limits fixing an occupational exposure limit.
Biological limit values
Does not contain substances above concentration limits fixing a biological limit value.
Information on monitoring procedures
BS EN 482:2012-04-30; Title: Workplace exposure - General requirements for the performance ofprocedures for the measurement of chemical agents;
British version of EN 482:2012
BS EN 689:1996-04-15; Title: Workplace atmospheres - Guidance for the assessment of exposure byinhalation to chemical agents for comparison with limit values and measurement strategy;
British version of EN 689:1995
BS EN 14042:2003-04-24; Title: Workplace atmospheres - Guide for the application and use ofprocedures for the assessment of exposure to chemical and biological agents;
British version of EN 14042:2003
8.2. Exposure controls
Appropriate engineering controls
Technical and organisational protective measures
No special protective measures necessary.
Personal protective equipment
Eye/face protection:

Not necessary when used as intended.

Skin protection:
Hand protection:

Not necessary when used as intended.

Other skin protection:

Not necessary when used as intended.

Respiratory protection:

Not necessary when used as intended.

Thermal hazards:

No special protective measures necessary.

Environmental exposure controls
Not necessary

SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Appearance:

clear, blue liquid

Odour:

characteristic
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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

Odour threshold:no data available

pH (undiluted):

5.5 – 6.5

Melting point/freezing point:

no data available(20 °C)

Initial boiling point and boiling range: no data available
Flash point:

not applicable

Evaporation rate:

no data available

Flammability (solid, gas):

not applicable

Lower explosive limit:

not applicable

Upper explosive limit:

not applicable

Vapour pressure:no data available

Vapour density:

no data available

Relative density:

0.995 – 1.005

Solubility in water:completely soluble

Partition coefficient:
n-octanol/water

not applicableAuto-ignition temperature:

not applicable

Decomposition temperature:

no data available

Viscosity:

no data available

Explosive properties:

none

Oxidising properties:

none(… °C)(20 °C)9.2. Other information
Refractive index nD:

1.3355-1.3370(20 °C)Electrical conductivity (undiluted):

920-1020 µS/cm(20 °C)SECTION 10: Stability and reactivity
10.1. Reactivity
No hazardous reactions when handled and stored as intended.
10.2. Chemical stability
The product is stable when handled and stored as intended.
10.3. Possibility of hazardous reactions
None known
10.4. Conditions to avoid
None known
10.5. Incompatible materials
None known
10.6. Hazardous decomposition products
Does not decompose when used as intended.

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

SECTION 11: Toxicological information
11.1. Information on toxicological effects
Acute toxicity
Product
Acute toxicity - oral:

Acute Toxicity Estimate ATEmix > 2000 mg/kg=> no classification

Acute toxicity - dermal:

Acute Toxicity Estimate ATEmix > 2000 mg/kg=> no classification

Acute toxicity - inhalation:

Acute Toxicity Estimate ATEmix > 20 mg/l=> no classification

Skin corrosion/irritation
Product
No classification. [calculation method]
Serious eye damage/irritation
Product
No classification. [calculation method]
Respiratory or skin sensitisation
Product
No classification. [calculation method]
Germ cell mutagenicity
Product
No data available.
Carcinogenicity
Product
No data available.
Reproductive toxicity
Product
No data available.
STOT-single exposure
Product
No classification. [calculation method]
STOT-repeated exposure
Product
No data available.
Aspiration hazard
Product
No data available.

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

SECTION 12: Ecological information
12.1. Toxicity
No classification. [calculation method]
12.2. Persistence and degradability
Biodegradability:
The product is biodegradable according to OECD criteria. The statement has been derived from theproperties of the ingredients.
12.3. Bioaccumulative potential
No data available.
12.4. Mobility in soil
No data available.
12.5. Results of PBT and vPvB assessment
The substances in the mixture do not meet the PBT/vPvB criteria according to Regulation (EC) No
1907/2006, Annex XIII.
12.6. Other adverse effects
No data available.

SECTION 13: Disposal considerations
13.1. Waste treatment methods
Disposal of the productProduct residues must be disposed of as non-hazardous waste in compliance with the Directive
2008/98/EC on waste as well as national and regional regulations. Do not mix with other wastematerials.
Waste codes / waste designations according to EWC
Product residues:

16 10 02 aqueous liquid wastes other than those mentioned
in 16 10 01

Disposal of the packaging
Waste codes / waste designations according to EWC
Contaminated packaging:

15 01 02 plastic packaging

Recommendation
Contaminated packaging must be emptied optimally and can be recycled.

SECTION 14: Transport information
14.0. Transport classification
No dangerous good in sense of the transport regulations in road traffic (ADR), railway traffic (RID), inland
waterway traffic (ADN), maritime traffic (IMDG-Code) and air traffic (ICAO-TI/IATA-DGR).
14.1. UN number-

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

14.2. UN proper shipping name14.3. Transport hazard class(es)14.4. Packing group
14.5. Environmental hazards
14.6. Special precautions for user
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code14.8. Further information-

SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU-Regulations
REGULATION (EC) No 1005/2009 on substances that deplete the ozone layer
not applicable
REGULATION (EC) No 850/2004 on persistent organic pollutants and amending Directive 79/117/EEC
not applicable
REGULATION (EU) No 649/2012 concerning the export and import of hazardous chemicals
not applicable
DIRECTIVE 2012/18/EU (Seveso III Directive) on the control of major-accident hazards involving
dangerous substances, amending and subsequently repealing Council Directive 96/82/EC
not applicable
DIRECTIVE 2010/75/EU on industrial emissions (integrated pollution prevention and control)
not applicable
REACH – List of substances subject to authorisation (Annex XIV)
not applicable
REACH – Restrictions on the manufacture, placing on the market and use of certain dangerous
substances, mixtures and articles (Annex XVII)
not applicable
COUNCIL DIRECTIVE 94/33/EC on the protection of young people at work
not applicable

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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019

Version: 2.0
Replaces version: 1.0

COUNCIL DIRECTIVE 92/85/EEC on the introduction of measures to encourage improvements in thesafety and health at work of pregnant workers and workers who have recently given birth or arebreastfeeding
not applicable
15.2. Chemical safety assessment
For this mixture no chemical safety assessment has been carried out.

SECTION 16: Other information

16.1. Full text of hazard classes and H-phrases

Hazard classes-

H-phrases (Hazard statements)
16.2. Abbreviations and acronyms
ADN

Accord européen relatif au transport international des marchandises dangereuses par voie denavigation intérieure (European Agreement concerning the International Carriage ofDangerous Goods by Inland Waterways)
ADR
Accord européen relatif au transport international des marchandises dangereuses par route(European Agreement concerning the International Carriage of Dangerous Goods by Road)
BGR
Berufsgenossenschaftliche Regeln (English: Employers' liability insurance association rules)
BS
British Standards
CLP
Regulation on Classification, Labelling and Packaging of Substances and Mixtures[DE]
National German regulations
DGUV
Deutsche Gesetzliche Unfallversicherung (English: German statutory accident insurance)
EC
European Community
EEC
European Economic Community
EN
European Standard
EU
European Union
EWC
European Waste Catalogue
GHS
Globally Harmonized System of Classification, Labelling and Packaging of Chemicals
GMBl
Gemeinsames Ministerialblatt (English: Joint Ministerial Gazette)
IATA-DGR International Air Transport Association - Dangerous Goods Regulations
IBC-Code International Code for the Construction and Equipment of Ships carrying Dangerous
Chemicals in Bulk
ICAO-TI
Technical Instructions For The Safe Transport of Dangerous Goods by Air
IMDG-Code International Maritime Code for Dangerous Goods
LGK
Lagerklasse (English: Storage class)
MARPOL International Convention for the Prevention of Marine Pollution from Ships
OECD
Organization for Economic Co-operation and Development
PBT
Persistent, bioaccumulative and toxic
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
RID
Règlement concernant le transport International ferroviaire de marchandises Dangereuses(Regulations Concerning the International Carriage of Dangerous Goods by Rail)TRGSTechnische Regeln für Gefahrstoffe (English: Technical Rules for Hazardous Substances)
UN
United Nations
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Safety data sheet
according to Regulation (EC) No 1907/2006
Trade name: NIGHT CLEANER
Issue/Revision: 05.07.2019
Print date: 05.07.2019
UTC
vPvB

Version: 2.0
Replaces version: 1.0

Coordinated Universal Time (French: Temps Universel Coordonné)
Very persistent and very bioaccumulative

16.3. Key literature references and sources for data---

Regulation (EC) No 1907/2006 (REACH), Annex II
European Chemicals Agency (ECHA) – Guidance on the compilation of safety data sheets; Version 2.1(February 2014); http://echa.europa.eu/documents/10162/13643/sds_en.pdf
GISBAU (Hazardous substances information system of the BG BAU) – course „safety data sheet“;
http://www.bgbau.de/gisbau/SDB/lehrgang/lehrgang.htm
Regulation (EC) No 1272/2008 (CLP regulation)
European Chemicals Agency (ECHA) – Guidance on Labelling and Packaging in accordance with
Regulation (EC) No 1272/2008 (04/2011);
http://echa.europa.eu/documents/10162/13562/clp_labelling_en.pdf
European Chemicals Agency (ECHA), Registered substances;
http://echa.europa.eu/information-on-chemicals/registered-substances
European Chemicals Agency (ECHA), C&L Classification and Labelling Inventory;
http://echa.europa.eu/information-on-chemicals/cl-inventory-database
Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA):GESTIS database on hazardous substances and GESTIS - International limit values for chemical agents;
http://www.dguv.de/dguv/ifa/index.jsp
German Environmental Agency (Umweltbundesamt), Section IV 2.4: Office of Documentation andInformation on Substances Hazardous to Waters RIGOLETTO (catalogue of Substances Hazardous to
Waters); http://webrigoletto.uba.de/rigoletto

16.4. Training advice
Provide adequate information, instructions and training for users.
16.5. Indication of changes
A backslash in the left hand margin indicates an amendment from the previous version.
___________________________________________________________________________________________The information given in the safety data sheet only applies to the described product in connection with its
intended use. This information is based on the latest state of our knowledge at the time of revision. In
particular, it describes our product under the aspect of its hazards and safety measures to be taken. It does notconstitute any guarantee of product properties and quality features.
___________________________________________________________________________________________

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