Safety Data Sheet according to Regulation (EC) No 1907/2006

B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
Hemodialysis Concentrate (SW xxx A)
1.2. Relevant identified uses of the substance or mixture and uses advised against
Use of the substance/mixture
Acidic bicarbonate haemodialysis concentrate (SW-A) for preparation of ready-to-use solutions
1.3. Details of the supplier of the safety data sheet
Company name: B. Braun Avitum AG
Street: Schwarzenberger Weg 73 - 79
Place: D-34212 Melsungen
Responsible Department: Zentrale Service-Bereiche / Logistik und Supply Chain
Telephone: +49 (0) 5661 / 71-4422
E-Mail: [email protected]
Responsible for the safety data sheet: [email protected]
1.4. Emergency telephone number: INTERNATIONAL: +49 - (0) 6132 - 84463, GBK GmbH (24h - 7d/w - 365d/a)
England and Wales: NHS Direct - 0845 4647; Scotland: NHS 24 - 08454 24 24 24

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture according to 1272/2008/EC
This mixture is not classified as hazardous according to Regulation (EC) No. 1272/2008.
2.2. Label elements
Special labelling of certain mixtures
EUH210 Safety data sheet available on request.
2.3. Other hazards
Not known.

SECTION 3: Composition/information on ingredients

3.2. Mixtures
Chemical characterization
Acidic concentrate
Hazardous components
CAS No Chemical name Quantity
EC No Index No REACH No
Classification according to Regulation (EC) No. 1272/2008 [CLP]
10043-52-4 Calcium chloride <3%
233-140-8 017-013-00-2 01-2119494219-28
Eye Irrit. 2; H319
Full text of H and EUH statements: see section 16.

SECTION 4: First aid measures

4.1. Description of first aid measures

General information
No hazards which require special first aid measures.
After contact with skin
Wash hands with water as a precaution.
After contact with eyes
Rinse immediately with plenty of water, also under the eyelids.
If eye irritation persists, consult a specialist.

GB - EN Page 1 of 6
Safety Data Sheet according to Regulation (EC) No 1907/2006
B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

After ingestion
Rinse out mouth and give plenty of water to drink.
If symptoms develop, seek medical attention.
4.2. Most important symptoms and effects, both acute and delayed
If appropriately handled and if in accordance with the general hygienic rules, no damages to health have
become known.
4.3. Indication of any immediate medical attention and special treatment needed
Treat symptoms.

SECTION 5: Firefighting measures

5.1. Extinguishing media

Suitable extinguishing media
Product does not burn, fire-extinguishing activities according to surrounding.
Any extinguishing means and measures are acceptable.
5.2. Special hazards arising from the substance or mixture
Not known.
5.3. Advice for firefighters
No special protective equipment required.
Additional information
Fire residues and contaminated firefighting water must be disposed of in accordance with the local
regulations.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

No special precautions required.
6.2. Environmental precautions
No special environmental precautions required.
6.3. Methods and material for containment and cleaning up
Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder).
Shovel into suitable container for disposal.
Flush away residues with water.
6.4. Reference to other sections
Observe protective instructions (see Sections 7 and 8).
Information for disposal see section 13.

SECTION 7: Handling and storage

7.1. Precautions for safe handling
Advice on safe handling
Avoid contact with eyes.
Advice on protection against fire and explosion
No special protective measures against fire required.
7.2. Conditions for safe storage, including any incompatibilities
Requirements for storage rooms and vessels
Keep container tightly closed.
Keep tightly closed.
7.3. Specific end use(s)
Acidic bicarbonate haemodialysis concentrate (SW-A) for preparation of ready-to-use solutions
SECTION 8: Exposure controls/personal protection

8.1. Control parameters

8.2. Exposure controls
Protective and hygiene measures
When using do not eat, drink or smoke.
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Safety Data Sheet according to Regulation (EC) No 1907/2006
B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

Avoid contact with eyes.

No special protective equipment required.
Eye/face protection
Not required under normal use.
Hand protection
Not required under normal use.
Skin protection
Not required under normal use.
Respiratory protection
Not required under normal use.

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

Physical state: Liquid
Colour: Colourless
Odour: Odourless

pH-Value (at 20 °C): 2-3

Changes in the physical state
Initial boiling point and boiling range: > 100 °C
Flash point: n.a.
Lower explosion limits: n.a.
Upper explosion limits:
Ignition temperature: n.a.
Vapour pressure: n.d.
Density (at 20 °C): 1,1 - 1,2 g/cm³
Water solubility: Completely miscible
(at 20 °C)
9.2. Other information
No data available.

SECTION 10: Stability and reactivity

10.1. Reactivity
No decomposition if stored and applied as directed.
10.2. Chemical stability
Stable under normal conditions.
10.3. Possibility of hazardous reactions
No hazardous reactions known.
10.4. Conditions to avoid
Not known.
10.5. Incompatible materials
No materials to be especially mentioned.
10.6. Hazardous decomposition products
No hazardous decomposition products known.

SECTION 11: Toxicological information

11.1. Information on toxicological effects
Acute toxicity
Based on available data, the classification criteria are not met.
No toxicological data available.

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Safety Data Sheet according to Regulation (EC) No 1907/2006
B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

Irritation and corrosivity

Based on available data, the classification criteria are not met.
Sensitising effects
Based on available data, the classification criteria are not met.
STOT-single exposure
Based on available data, the classification criteria are not met.
Severe effects after repeated or prolonged exposure
Based on available data, the classification criteria are not met.
Carcinogenic/mutagenic/toxic effects for reproduction
Based on available data, the classification criteria are not met.
Aspiration hazard
Based on available data, the classification criteria are not met.
Additional information on tests
Classification in compliance with the assessment procedure specified in the Regulation (EC) no 1272/2008.

Practical experience
Other observations
If appropriately handled and if in accordance with the general hygienic rules, no damages to health have
become known.

SECTION 12: Ecological information

12.1. Toxicity
Ecological data are not available.
12.2. Persistence and degradability
No data available.
12.3. Bioaccumulative potential
No data available.
12.4. Mobility in soil
No data available.
12.5. Results of PBT and vPvB assessment
According to Regulation (EC) No 1907/2006 (REACH) none of the substances, contained in this product are
a PBT / vPvB substance.
12.6. Other adverse effects
Low hazard to waters.
Further information
If handled and used properly, no adverse ecological effects are to be expected.

SECTION 13: Disposal considerations

13.1. Waste treatment methods

Advice on disposal
Can be landfilled or incinerated, when in compliance with local regulations.
Waste disposal number of waste from residues/unused products
180107 WASTES FROM HUMAN OR ANIMAL HEALTH CARE AND/OR RELATED RESEARCH (except kitchen
and restaurant wastes not arising from immediate health care); wastes from natal care, diagnosis, treatment
or prevention of disease in humans; chemicals other than those mentioned in 18 01 06

Contaminated packaging
Empty containers should be taken for local recycling, recovery or waste disposal.
Contaminated packaging should be emptied as far as possible and after appropriate cleansing may be
taken for reuse.
Packaging that cannot be cleaned should be disposed of like the product.

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Safety Data Sheet according to Regulation (EC) No 1907/2006
B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

SECTION 14: Transport information

Land transport (ADR/RID); Marine transport (IMDG); Air transport (ICAO); Inland waterways transport (ADN):

14.1. UN number:
No hazardous material as defined by the transport regulations.
14.2. UN proper shipping name:
No hazardous material as defined by the transport regulations.
14.3. Transport hazard class(es):
No hazardous material as defined by the transport regulations.
14.4. Packing group:
No hazardous material as defined by the transport regulations.
14.5. Environmental hazards
No hazardous material as defined by the transport regulations.
14.6. Special precautions for user
No hazardous material as defined by the transport regulations.
14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
No hazardous material as defined by the transport regulations.

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulatory information
2004/42/EC (VOC): 0%
National regulatory information
Water contaminating class (D): 1 - slightly water contaminating
15.2. Chemical safety assessment
For this substance a chemical safety assessment has not been carried out.

SECTION 16: Other information

Abbreviations and acronyms
ADR = Accord européen relatif au transport international des marchandises Dangereuses par Route
RID = Règlement concernant le transport international ferroviaire de marchandises dangereuses
ADN = Accord européen relatif au transport international des marchandises dangereuses par voie de navigation intérieure
IMDG = International Maritime Code for Dangerous Goods
IATA/ICAO = International Air Transport Association / International Civil Aviation Organization
MARPOL = International Convention for the Prevention of Pollution from Ships
IBC-Code = International Code for the Construction and Equipment of Ships Carrying Dangerous Chemicals in Bulk
GHS = Globally Harmonized System of Classification and Labelling of Chemicals
REACH = Registration, Evaluation, Authorization and Restriction of Chemicals
CAS = Chemical Abstract Service
EN = European norm
ISO = International Organization for Standardization
DIN = Deutsche Industrie Norm
PBT = Persistent Bioaccumulative and Toxic
vPvB = Very Persistent and very Bio-accumulative

LD = Lethal dose
LC = Lethal concentration
EC = Effect concentration
IC = Median immobilisation concentration or median inhibitory concentration
Relevant H and EUH statements (number and full text)
H319 Causes serious eye irritation.
EUH210 Safety data sheet available on request.
Further Information
Data of items 4 to 8, as well as 10 to 12, do partly not refer to the use and the regular employing of the
product (in this sense consult information on use and on product), but to liberation of major amounts in case
of accidents and irregularities.
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Safety Data Sheet according to Regulation (EC) No 1907/2006
B. Braun Avitum AG
Hemodialysis Concentrate (SW xxx A)
Revision date: 01.06.2015 Revision No: 1,1
Product code: 00056-0259

The information describes exclusively the safety requirements for the product(s) and is based on the
present level of our knowledge.
The delivery specifications are contained in the corresponding product sheet.
This data does not constitute a guarantee for the characteristics of the product(s) as defined by the legal
warranty regulations.
(n.a. = not applicable; n.d. = not determined)

(The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safety data
sheet.)

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