neodisher OXIVARIO

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Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 1(10)

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

1.1. Product identifier

neodisher OXIVARIO

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

Use of the substance/preparation

Washing and cleaning products (including solvent based products)

1.3. Details of the supplier of the safety data sheet

Address:

Chemische Fabrik Dr. Weigert GmbH & Co. KG

Mühlenhagen 85

D-20539 Hamburg

Telephone no.

+49 40 789 60 0

Fax no.

+49 40 789 60 120

www.drweigert.com

E-mail address of person responsible for this SDS:

sida@drweigert.de

1.4. Emergency telephone number

GBK/ Infotrac: (USA domestic) 1 800 535 5053 or international +1 352 323 3500

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture

Classification (Regulation (EC) No. 1272/2008)

Classification (Regulation (EC) No. 1272/2008)

Acute Tox. 4

H302

Eye Dam. 1

H318

2.2. Label elements

Labelling according to regulation (EC) No 1272/2008

Hazard pictograms

Signal word

Danger

Hazard statements

H302

Harmful if swallowed.

H318

Causes serious eye damage.

Precautionary statements

P280

Wear protective gloves/protective clothing/eye protection/face protection.

P305+P351+P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact

lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER or doctor.

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 2(10)

Dispose only when container is empty and closed. For disposal of product

residues, refer to Safety Data Sheet.

Hazardous component(s) to be indicated on label (Regulation (EC) No. 1272/2008)

contains

hydrogen peroxide solution

2.3. Other hazards

No special hazards have to be mentioned.

SECTION 3: Composition/information on ingredients

3.2. Mixtures

Hazardous ingredients

hydrogen peroxide solution

CAS No.

7722-84-1

EINECS no.

231-765-0

Registration no.

01-2119485845-22

Concentration

>=

<

Classification (Regulation (EC) No. 1272/2008)

Ox. Liq. 1

H271

Acute Tox. 4

H332

Route of exposure: inhalative

Acute Tox. 4

H302

Route of exposure: oral

Skin Corr. 1A

H314

Eye Dam. 1

H318

STOT SE 3

H335

Aquatic Chronic 3

H412

Concentration limits (Regulation (EC) No. 1272/2008)

Ox. Liq. 1

H271

>= 70

Skin Corr. 1B

H314

>= 50 < 70

Eye Irrit. 2

H319

>= 5 < 8

Eye Dam. 1

H318

>= 8 < 50

Skin Corr. 1A

H314

>= 70

Ox. Liq. 2

H272

>= 50 < 70

Skin Irrit. 2

H315

>= 35 < 50

STOT SE 3

H335

>= 35

Aquatic Chronic

H412

>= 63

SECTION 4: First aid measures

4.1. Description of first aid measures

General information

Remove contaminated, soaked clothing immediately and dispose of safely. Clean body thoroughly (bath,

shower). In any case show the physician the Safety Data Sheet.

After inhalation

Ensure supply of fresh air. When spray fog inhaled, seek medical aid.

After skin contact

After contact with skin, wash immediately with plenty of water.

After eye contact

In case of contact with the eyes, rinse immediately for at least 15 minutes with plenty of water. Summon

a doctor immediately.

After ingestion

Rinse mouth thoroughly with water. Let plenty of water be drunk in small gulps. Do not induce vomiting.

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 3(10)

Take medical treatment.

Adhere to personal protective measures when giving first aid

First aider: Pay attention to self-protection!

4.2. Most important symptoms and effects, both acute and delayed

Until now no symptoms known so far.

4.3. Indication of any immediate medical attention and special treatment needed

Hints for the physician / treatment

Treat symptomatically

SECTION 5: Firefighting measures

5.1. Extinguishing media

Suitable extinguishing media

Product itself is non-combustible; adapt fire extinguishing measures to surrounding areas.

Non suitable extinguishing media

Full water jet

5.2. Special hazards arising from the substance or mixture

If a fire breaks out nearby, pressure build-up and danger of bursting are possible.

5.3. Advice for firefighters

Special protective equipment for fire-fighting

Do not inhale explosion and/or combustion gases. In case of combustion use a suitable breathing

apparatus.

Other information

Collect contaminated fire-fighting water separately, must not be discharged into the drains. Fire residues

and contaminated fire-fighting 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

Avoid contact with skin, eyes and clothing. Refer to protective measures listed in Sections 7 and 8.

6.2. Environmental precautions

Do not discharge into the drains/surface waters/groundwater.

6.3. Methods and material for containment and cleaning up

Take up with absorbent material (eg sand, kieselguhr, universal binder). Do not pick up with the help of

saw-dust or other combustible substances. Dispose of absorbed material in accordance with the

regulations. Flush away residues with water.

6.4. Reference to other sections

Refer to protective measures listed in Sections 7 and 8.

SECTION 7: Handling and storage

7.1. Precautions for safe handling

Advice on safe handling

Avoid formation of aerosols. Keep container tightly closed. Observe the usual precautions for handling

chemicals.

Advice on protection against fire and explosion

The product is not combustible. Keep away from combustible material.

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 4(10)

7.2. Conditions for safe storage, including any incompatibilities

Recommended storage temperature

Value

>=

<

Requirements for storage rooms and vessels

Keep in original packaging, tightly closed. Storage rooms must be properly ventilated.

Hints on storage assembly

Do not store with combustible materials.

Storage class according to TRGS 510

Storage class according to

TRGS 510

5.1B

Oxidising hazardous substances

Further information on storage conditions

Protect from heat/overheating. Protect from contamination. Do not keep the container sealed.

7.3. Specific end use(s)

no data

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

Exposure limit values

hydrogen peroxide solution

List

EH40

Type

Value

mg/m³

ppm(V)

Short term exposure limit

mg/m³

ppm(V)

Status: 2011

Other information

There are not known any further control parameters.

8.2. Exposure controls

General protective and hygiene measures

Hold eye wash fountain available. Do not inhale gases/vapours/aerosols. Avoid contact with skin and

eyes. Do not eat, drink or smoke during work time. Wash hands before breaks and after work.

Respiratory protection

If workplace limits are exceeded, a respiratory protection approved for this particular job must be worn.

Hand protection

Chemical resistant gloves (EN 374)

Permanent hand contact

Appropriate Material

neoprene

Material thickness

>=

0,65

Breakthrough time

>

Appropriate Material

nitrile

Material thickness

>=

Breakthrough time

>

Appropriate Material

butyl

Material thickness

>=

Breakthrough time

>

Short-term hand contact

Appropriate Material

nitrile

Material thickness

>=

0,11

Eye protection

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 5(10)

Safety glasses with side protection shield (EN 166)

Body protection

Clothing as usual in the chemical industry.

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

Form

liquid

Colour

colourless

Odour

characteristic

Odour threshold

Remarks

not determined

pH value

Value

appr.

Melting point

Remarks

not determined

Freezing point

Remarks

not determined

Initial boiling point and boiling range

Remarks

not determined

Flash point

Remarks

Not applicable

Evaporation rate (ether = 1) :

Remarks

not determined

Flammability (solid, gas)

evaluation

not determined

Upper/lower flammability or explosive limits

Remarks

not determined

Vapour pressure

Remarks

not determined

Vapour density

Remarks

not determined

Density

Value

1,11

g/cm³

Temperature

Solubility in water

Remarks

miscible in all proportions

Solubility(ies)

Remarks

not determined

Partition coefficient: n-octanol/water

Remarks

not determined

Ignition temperature

Remarks

Not applicable

Decomposition temperature

Remarks

not determined

Viscosity

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 6(10)

dynamic

Value

<

mPa.s

Temperature

Explosive properties

evaluation

not determined

Oxidising properties

evaluation

oxidizing

9.2. Other information

Other information

None known

SECTION 10: Stability and reactivity

10.1. Reactivity

No hazardous reactions when stored and handled according to prescribed instructions.

10.2. Chemical stability

Protect from contamination.

10.3. Possibility of hazardous reactions

Do not keep the container sealed.

10.4. Conditions to avoid

Protect from heat and direct sunlight.

Decomposition temperature

Remarks

not determined

10.5. Incompatible materials

Reactions with combustible substances. Reactions with strong acids and alkalies. Reactions with alkali

metals. Reactions with earth alkali metals. Reactions with metals in powder form.

10.6. Hazardous decomposition products

Oxygen

SECTION 11: Toxicological information

11.1. Information on toxicological effects

Acute oral toxicity

Reference substance

hydrogen peroxide solution

LD50

appr.

1200

mg/kg

Remarks

Test conducted with a similar formulation.

Acute dermal toxicity

Remarks

Based on available data, the classification criteria are not met.

Acute inhalational toxicity

Remarks

Based on available data, the classification criteria are not met.

Skin corrosion/irritation

evaluation

slight irritant effect - does not require labelling

Serious eye damage/irritation

Remarks

Risk of serious damage to eyes.

Sensitization

Remarks

Based on available data, the classification criteria are not met.

Subacute, subchronic, chronic toxicity

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 7(10)

Remarks

Based on available data, the classification criteria are not met.

Mutagenicity

Remarks

Based on available data, the classification criteria are not met.

Reproductive toxicity

Remarks

Based on available data, the classification criteria are not met.

Carcinogenicity

Remarks

Based on available data, the classification criteria are not met.

Specific Target Organ Toxicity (STOT)

Remarks

not determined

Aspiration hazard

No special hazards have to be mentioned.

Experience in practice

Inhalation may lead to irritation of the respiratory tract.

Other information

There is no data available on the product apart from the information given in this subsection.

SECTION 12: Ecological information

12.1. Toxicity

General information

not determined

Fish toxicity (Components)

hydrogen peroxide solution

Species

Fathead minnow (Pimephales promelas)

LC50

16,4

mg/l

Duration of exposure

Daphnia toxicity (Components)

hydrogen peroxide solution

Species

Daphnia pulex

EC50

mg/l

Duration of exposure

Algae toxicity (Components)

hydrogen peroxide solution

Species

Chlorella vulgaris

IC50

mg/l

Duration of exposure

Bacteria toxicity (Components)

hydrogen peroxide solution

Species

activated sludge

EC50

mg/l

Duration of exposure

Method

OECD 209

hydrogen peroxide solution

Species

activated sludge

EC50

>

1000

mg/l

Duration of exposure

Method

OECD 209

12.2. Persistence and degradability

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 8(10)

General information

not determined

12.3. Bioaccumulative potential

General information

not determined

Partition coefficient: n-octanol/water

Remarks

not determined

12.4. Mobility in soil

General information

not determined

12.5. Results of PBT and vPvB assessment

General information

not determined

Evaluation of persistance and bioaccumulation potential

The product contains no PBT or vPvB substances.

12.6. Other adverse effects

General information

not determined

General information / ecology

Do not allow to enter soil, waterways or waste water canal.

SECTION 13: Disposal considerations

13.1. Waste treatment methods

Disposal recommendations for the product

Allocation of a waste code number, according to the European Waste Catalogue (EWC), should be

carried out in agreement with the regional waste disposal company.

Disposal recommendations for packaging

Completely emptied packagings can be given for recycling.

SECTION 14: Transport information

Land transport ADR/RID

Marine transport

IMDG/GGVSee

Air transport ICAO/IATA

14.1. UN number

2014

2014

2014

14.2. UN proper shipping name

HYDROGEN PEROXIDE,

AQUEOUS SOLUTION

HYDROGEN PEROXIDE,

AQUEOUS SOLUTION

HYDROGEN PEROXIDE,

AQUEOUS SOLUTION

14.3. Transport hazard

class(es)

Subsidiary risk

Label

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 9(10)

14.4. Packing group

Limited Quantity

Transport category

14.5. Environmental hazards

Tunnel restriction code

IMDG-Code segregation group

16 Peroxides

Information for all modes of transport

14.6. Special precautions for user

See Sections 6 to 8

Other information

14.7. Transport in bulk according to Annex II of Marpol and the IBC Code

Not applicable

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance

or mixture

Ingredients (Regulation (EC) No 648/2004)

30 % and more:

oxygen-based bleaching agents

Water Hazard Class (Germany)

Water Hazard Class

(Germany)

WGK 1

Remarks

Classification according to Annex 4 VwVwS

VOC

VOC (EU)

Other information

The product does not contain substances of very high concern (SVHC).

15.2. Chemical safety assessment

For this preparation a chemical safety assessment has not been carried out.

SECTION 16: Other information

Hazard statements listed in Chapter 3

H271

May cause fire or explosion; strong oxidiser.

H302

Harmful if swallowed.

H314

Causes severe skin burns and eye damage.

H318

Causes serious eye damage.

H332

Harmful if inhaled.

H335

May cause respiratory irritation.

H412

Harmful to aquatic life with long lasting effects.

CLP categories listed in Chapter 3

Acute Tox. 4

Acute toxicity, Category 4

Aquatic Chronic 3

Hazardous to the aquatic environment, chronic, Category 3

Eye Dam. 1

Serious eye damage, Category 1

Date revised: 28.11.2016

Print date: 28.06.17

2 / GB- 800851-001-02

Version: 2 / GB

Replaces Version: 1 /

Safety data sheet in accordance with regulation (EC) No

1907/2006

neodisher OXIVARIO

Page 10(10)

Ox. Liq. 1

Oxidising liquid, Category 1

Skin Corr. 1A

Skin corrosion, Category 1A

STOT SE 3

Specific target organ toxicity - single exposure, Category 3

Supplemental information

Relevant changes compared with the previous version of the safety data sheet are marked with: ***

This information is based on our present state of knowledge. However, it should not constitute a

guarantee for any specific product properties and shall not establish a legally valid relationship.

Read the complete document

neodisher

®

Liquid, active oxygen-based cleaning enhancer

for the automated cleaning of instruments using the Miele OXIVARIO process

Chemische Fabrik Dr. Weigert GmbH & Co. KG

Telefon: (040) 789 60 - 0

E-Mail: info @drweigert.de

Mühlenhagen 85, D – 20539 Hamburg

Telefax: (040) 789 60 - 120

Internet: www. drweigert.de

Die Angaben dieses Merkblattes beruhen auf unseren derzeitigen Kenntnissen und Erfahrungen. Sie befreien den

Verwender nicht von eigenen Prüfungen und Versuchen. Eine rechtlich verbindliche Zusicherung bestimmter

Eigenschaften kann hieraus nicht abgeleitet werden.

With the above information, which is appropriate to our current knowledge we describe

our product regarding possible safety necessities, but we do not involve any quality description

or promise certain properties.

Reg. Warenzeichen der

Miele & Cie. KG, Gütersloh

Main fields of application:

neodisher OXIVARIO is a component for the Miele-Oxivario-process as well as for the

Miele-ORTHOVARIO-process.

Characteristics:

neodisher Oxivario is an oxidant based on hydrogen peroxide.

Application and dosage:

neodisher Oxivario is exclusively used as a component in combination with alkaline

detergents in the "Oxivario" and "Orthovario" processes developed and recommended by

Miele. Please observe the instructions of the company Miele concerning use and dosage

as well as material tolerance.

Subsequently the cleaning-solution with neodisher OXIVARIO has to be rinsed out

completely by sufficient rinsing. Do not mix with other product concentrates.

Rinse out dosing system including hose with water before changing product.

After the whole Miele OXIVARIO-process it is recommended that hinge instruments be

treated with neodisher IP Spray.

Only for professional use.

Technical data:

Density (20 °C): 1.1 g/cm

pH range (determined in deionised water at 20 °C): 5.7 – 5.5 (0.3 – 0.7%)

Viscosity (Concentrate, 20 °C): < 50 mPas

Ingredients:

Ingredients according to Regulation (EC) No 648/2004 on detergents:

> 30 % oxygen-based bleaching agents

CE-marks:

neodisher OXIVARIO conforms to the requirements of the legislation for medical

devices according to the European directive 93/42/EC.

Storage information:

The product is sensitive to frost below -20 °C. Protect from frost and from direct

sunlight. Usable for 1 year when stored as recommended.

Hazard and precautionary

statements:

For safety information see EC safety data sheets. These are available at

www.drweigert.com under the category “Download”.

Dispose only when container is empty and closed. For disposal of product residues, refer

to the Material Safety Data Sheet.

MB 4004/2-5 GB

10/14

______________________________________________________________________

1) The Chemische Fabrik Dr. Weigert GmbH & Co. KG is not responsible for any legal obligations (guarantees) concerning

possible changes of medical devices reprocessed with these Miele processes.

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