datasheet - staxs · premier-wfi klercide 70/30 sterile alcohol sterile spore free 70% alcohol,...

15
DATASHEET STAXS ART.NO. SUPPLIER ART.NO. DESCRIPTION SALES UNIT TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, sterile, spray 500 ml 12 bottles of 500 ml per box TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, sterile, spray 1 liter 6 bottles of 1 liter per box TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, sterile, spray can 4 liters 4 cans of 4 liters per box TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, sterile, capped can 5 liters 4 cans of 5 liters per box STAXS ART.NR. LEVERANCIERS ART.NR. OMSCHRIJVING VERKOOPEENHEID TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, steriel, spray 500 ml 12 flacons à 500 ml per doos TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, steriel, spray 1 liter 6 flacons à 1 liter per doos TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, steriel, spray can 4 liter 4 cans à 4 liter per doos TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, steriel, capped can 5 liter 4 cans à 5 liter per doos STAXS NO. D’ARTICLE VENDEURS NO. D’ARTICLE DESCRIPTION UNITE DE VENTE TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, stérile, spray de 500 ml 12 flacons de 500 ml par carton TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, stérile, spray de 1 litre 6 flacons de 1 litre par carton TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, stérile, bidon avec pulverization de 4 litres 4 bidons de 4 litres par carton TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, stérile, ‘capped can’ de 5 litres 4 bidons de 5 litres par carton UNCONTROLLED COPY LAST REVIEW 10/12/2013 NO. OF PAGES 15 E NL F WWW.STAXS.EU STAXS BELGIUM NV · HELSTSTRAAT 51-10 · 2630 AARTSELAAR · BELGIUM · T +32 (0)3 877 6030 · F +32 (0)3 877 5744 · [email protected] STAXS THE NETHERLANDS BV · BUSINESSPARK FRIESLAND-WEST 1 · 8466 SL HEERENVEEN · P.O. BOX 576 · 8440 AN HEERENVEEN · THE NETHERLANDS T +31 (0)513 677 076 · F +31 (0)513 677 957 · [email protected]

Upload: ngokhue

Post on 02-Feb-2019

214 views

Category:

Documents


0 download

TRANSCRIPT

DATASHEET

STAXS

ART.NO.

SUPPLIER ART.NO.

DESCRIPTION

SALES UNIT

TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, sterile, spray 500 ml 12 bottles of 500 ml per box

TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, sterile, spray 1 liter 6 bottles of 1 liter per box

TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, sterile, spray can 4 liters 4 cans of 4 liters per box

TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, sterile, capped can 5 liters 4 cans of 5 liters per box

STAXS

ART.NR.

LEVERANCIERS ART.NR.

OMSCHRIJVING

VERKOOPEENHEID

TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, steriel, spray 500 ml 12 flacons à 500 ml per doos

TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, steriel, spray 1 liter 6 flacons à 1 liter per doos

TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, steriel, spray can 4 liter 4 cans à 4 liter per doos

TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, steriel, capped can 5 liter 4 cans à 5 liter per doos

STAXS

NO. D’ARTICLE

VENDEURS NO. D’ARTICLE

DESCRIPTION

UNITE DE VENTE

TS-0001-500 3035380 Premier-WFI Klercide 70/30 IPA, stérile, spray de 500 ml 12 flacons de 500 ml par carton

TS-0001-1 3035400 Premier-WFI Klercide 70/30 IPA, stérile, spray de 1 litre 6 flacons de 1 litre par carton

TS-0001-4 3035420 Premier-WFI Klercide 70/30 IPA, stérile, bidon avec pulverization de 4 litres

4 bidons de 4 litres par carton

TS-0001-5 3035440 Premier-WFI Klercide 70/30 IPA, stérile, ‘capped can’ de 5 litres

4 bidons de 5 litres par carton

UNCONTROLLED COPY LAST REVIEW 10/12/2013 NO. OF PAGES 15

E

NL

F

WWW.STAXS.EU STAXS BELGIUM NV · HELSTSTRAAT 51-10 · 2630 AARTSELAAR · BELGIUM · T +32 (0)3 877 6030 · F +32 (0)3 877 5744 · [email protected] STAXS THE NETHERLANDS BV · BUSINESSPARK FRIESLAND-WEST 1 · 8466 SL HEERENVEEN · P.O. BOX 576 · 8440 AN HEERENVEEN · THE NETHERLANDS T +31 (0)513 677 076 · F +31 (0)513 677 957 · [email protected]

Premier-WFI Klercide 70/30 Sterile Alcohol

Sterile spore free 70% alcohol, either IPA, denatured ethanol (IMS) or Pharma Ethanol, blended with highest grade (EP) Water for Injection.

Advantages

High quality product

All three types of alcohol are blended with highest grade (EP) Water for Injection, with guaranteed endotoxin levels below 0.25 EU/ml. They are triple bagged for easy transfer into Grade A and B cleanrooms and gamma irradiated to ensure a sterile, spore free product.

Range of formats

There is a choice of formats from easy to use trigger sprays of 500 ml, 1.0 litre and 4.0 litre, spray aerosol, stream aerosol and capped ready-to-use. The large droplet size of the trigger sprays reduces the risk of inhalation. The stream aerosol format minimises particulates during use, so is ideal for critical areas where there is continuous monitoring to meet new GMP guidelines.

Guaranteed sterility during use

The SteriShield Delivery System on the trigger spray formats has been validated to give an in-use shelf life of three months, so there is no need to discard unused product. The aerosols have also been validated to maintain sterility for three months during use.

Optimum surface coverage

The choice of formats allows the user to select the most appropriate method of application, from the fine mist of an aerosol, to a fully adjustable trigger spray which allows the liquid to be dispensed as either a jet or spray, or application via a wipe to minimise inhalation.

Description

Premier-WFI Klercide 70/30 sterile IPA is a blend of 70% isopropyl alcohol with Water for Injection.

Premier-WFI Klercide 70/30 sterile denatured ethanol (IMS) is 70% denatured ethanol blended with Water for Injection. Premier-WFI Klercide 70/30 sterile Pharma Ethanol is 70% ethanol denatured with IPA for a very low residue product. Endotoxin levels for all formats are guaranteed to be below 0.25 EU/ml.

The alcohol blend is 0.2 micron filtered, filled and triple bagged under Grade A Laminar Air Flow in a Grade C (ISO Class 7) cleanroom, before irradiation using a validated process at no less than 25 kGy. All trigger spray bottles incorporate the patented SteriShield Delivery System and an adjustable trigger spray. The way in which the SteriShield Delivery System works as a closed system ensures that the sterility of the contents is preserved throughout use. Premier-WFI Klercide 70/30 Sterile IPA Stream Aerosol can also be wall mounted using the Klercide Wall Mounted Spray Adaptor.

Protocol for use

Ready to use so can be sprayed directly onto the surface to be sanitised. Always ensure the whole surface is in contact with the liquid. For optimum results wipe the surface to physically remove any contaminants.

Use biocides safely. Always read the label and product information before use.

Validation

Supplied by an EN ISO 9001:2008, EN ISO 13485:2003 and European Medical Device Directive 93/42/EEC accredited company.

CEN Test Data available on request.

Certificates of analysis, irradiation, quantitative endotoxin levels < 0.25EU/ml and sterility with every batch.

Sterility and endotoxin tested to an approved pharmacopoeial method.

2 year shelf life (aerosols 3 years).

In use sterility guaranteed by the SteriShield Delivery System, validated for three months.

Product Codes

Code Description Size Unit of Sale

3050930 Premier-WFI Klercide 70/30 Sterile IPA Stream Aerosol

360 ml 24 cans x 360 ml

3057910 Klercide Wall Mounted Spray Adaptor Each

3033660 (KW2002)

Premier-WFI Klercide 70/30 Sterile IPA Aerosol 360 ml 24 cans x 360 ml

3035380 (KW2004)

Premier-WFI Klercide 70/30 Sterile IPA Spray 500 ml 12 bottles x 500 ml

3035400 (KW2006)

Premier-WFI Klercide 70/30 Sterile IPA Spray 1.0 litre 6 bottles x 1.0L

3035420 (KW2008)

Premier-WFI Klercide 70/30 Sterile IPA Spray 4.0 litre 4 bottles x 4.0L

3035440 (KW2012)

Premier-WFI Klercide 70/30 Sterile IPA Capped 5.0 litre 4 bottles x 5.0L

3035450 (KW2205)

Premier-WFI Klercide 70/30 Sterile Pharma Ethanol Spray

1.0 litre 6 bottles x 1.0L

3035460 (KW2207)

Premier-WFI Klercide 70/30 Sterile Pharma Ethanol Spray

4.0 litre 4 bottles x 4.0L

3035470

(KW2211)

Premier-WFI Klercide 70/30 Sterile Pharma

Ethanol Capped

5.0 litre 4 bottles x 5.0L

3033650 (KW2001)

Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Aerosol

360 ml 24 cans x 360 ml

3035370 (KW2003)

Premier-WFI Klercide 70/30 Sterile Denatured Ethanol (IMS) Spray

500 ml 12 bottles x 500 ml

3035390 (KW2005)

Premier-WFI Klercide 70/30 Sterile Denatured Ethanol (IMS) Spray

1.0 litre 6 bottles x 1.0L

3035410 (KW2007)

Premier-WFI Klercide 70/30 Sterile Denatured Ethanol (IMS) Spray

4.0 litre 4 bottles x 4.0L

3035430 (KW2011)

Premier-WFI Klercide 70/30 Sterile Denatured Ethanol (IMS) Capped

5.0 litre 4 bottles x 5.0L

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SAFETY DATA SHEET

Product name

PREMIER-WFI KLERCIDE 70/30 STERILE IPAConforms to Regulation (EC) No. 1907/2006 (REACH), Annex II (453/2010) - Europe

:

1.1 Product identifier

1.3 Details of the supplier of the safety data sheet

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

Identified uses

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

Product code :

Uses advised against

1.4 Emergency telephone number

National advisory body/Poison Centre

Surface disinfectant. Manual processSurface disinfectant. Spray and rinse manual process

None known.

:Manufacturer/ Distributor/Importer

Ecolab Ltd.David Murray John BuildingUK-SN1 1NH Swindon, WiltshireEnglandTel +44 (0)1793 511221Fax +44 (0)1793 [email protected]

112865E

Product use : Surface Disinfectant

Product is for professional use only

Manufacturer/ Distributor/ Importer:Telephone number 0870 600 6266 (This service is only available to health professionals)

:Telephone number 01793 511221Food & Beverage, Institutional, Agri - 01793 548888Healthcare Leeds - 0113 2322480Healthcare Swansea - 01252 717616

Version : 1.1

Classification F; R11Xi; R36R67

:

Physical/chemicalhazards

: Highly flammable.

:Human health hazards Irritating to eyes. Vapours may cause drowsiness and dizziness.

See Section 11 for more detailed information on health effects and symptoms.

SECTION 2: Hazards identification2.1 Classification of the substance or mixture

Product definition : Mixture

See Section 16 for the full text of the R phrases or H statements declared above.

Classification according to Directive 1999/45/EC [DPD]

The product is classified as dangerous according to Directive 1999/45/EC and its amendments.

2.2 Label elements

Date of issue/Date of revision : 1/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 2: Hazards identification

:Other hazards which donot result in classification

Hazard symbol or symbols

Safety phrases S2- Keep out of the reach of children.S16- Keep away from sources of ignition - No smoking.S23- Do not breathe vapour or spray.S26- In case of contact with eyes, rinse immediately with plenty of water and seekmedical advice.S51- Use only in well-ventilated areas.

R11- Highly flammable.R36- Irritating to eyes.R67- Vapours may cause drowsiness and dizziness.

Risk phrases

Contains

:

:

:

:

Highly flammable, Irritant

Propan-2-ol

Indication of danger :

2.3 Other hazards

Not applicable.

There are no additional ingredients present which, within the current knowledge of the supplier and in theconcentrations applicable, are classified as hazardous to health or the environment and hence require reporting in thissection.

SECTION 3: Composition/information on ingredients

[1] Substance classified with a health or environmental hazard[2] Substance with a workplace exposure limit[3] Substance meets the criteria for PBT according to Regulation (EC) No. 1907/2006, Annex XIII[4] Substance meets the criteria for vPvB according to Regulation (EC) No. 1907/2006, Annex XIII

Type

Identifiers 67/548/EECProduct/ingredientname

See section 16 forthe full text of the R-phrases declaredabove

% TypeRegulation (EC) No.1272/2008 [CLP]

Classification

See Section 16 for thefull text of the Hstatements declaredabove.

Propan-2-ol REACH #: 01-2119457558-25EC: 200-661-7CAS: 67-63-0Index: 603-117-00-0

50-75 F; R11

Xi; R36R67

Flam. Liq. 2, H225

Eye Irrit. 2, H319STOT SE 3, H336

[1] [2]

Mixtures3.2

Date of issue/Date of revision : 2/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

Wash out mouth with water. Remove dentures if any. Remove victim to fresh airand keep at rest in a position comfortable for breathing. Do not induce vomitingunless directed to do so by medical personnel. If vomiting occurs, the head shouldbe kept low so that vomit does not enter the lungs. Get medical attention if adversehealth effects persist or are severe. Never give anything by mouth to anunconscious person. If unconscious, place in recovery position and get medicalattention immediately. Maintain an open airway. Loosen tight clothing such as acollar, tie, belt or waistband.

Skin contact

Immediately flush eyes with plenty of water, occasionally lifting the upper and lowereyelids. Check for and remove any contact lenses. Continue to rinse for at least 15minutes. Get medical attention if adverse health effects persist or are severe.

Flush contaminated skin with plenty of water. Remove contaminated clothing andshoes. Get medical attention if symptoms occur. Wash clothing before reuse.Clean shoes thoroughly before reuse.

4.1 Description of first aid measures

Remove victim to fresh air and keep at rest in a position comfortable for breathing. Ifit is suspected that fumes are still present, the rescuer should wear an appropriatemask or self-contained breathing apparatus. If not breathing, if breathing is irregularor if respiratory arrest occurs, provide artificial respiration or oxygen by trainedpersonnel. It may be dangerous to the person providing aid to give mouth-to-mouthresuscitation. Get medical attention. If unconscious, place in recovery position andget medical attention immediately. Maintain an open airway. Loosen tight clothingsuch as a collar, tie, belt or waistband.

Notes to physician Treat symptomatically. Contact poison treatment specialist immediately if largequantities have been ingested or inhaled.

Ingestion

Inhalation

Eye contact

:

:

:

:

:

Specific treatments

Protection of first-aiders :

SECTION 4: First aid measures

4.2 Most important symptoms and effects, both acute and delayed

Potential acute health effects

Inhalation : Vapours may cause drowsiness and dizziness.

No known significant effects or critical hazards.:Ingestion

Skin contact : No known significant effects or critical hazards.

Irritating to eyes.:Eye contact

Over-exposure signs/symptoms

Skin contact

Ingestion

Inhalation Adverse symptoms may include the following:nausea or vomitingheadachedrowsiness/fatiguedizziness/vertigo

No specific data.

No specific data.

:

:

:

Eye contact : Adverse symptoms may include the following:irritationwateringredness

4.3 Indication of any immediate medical attention and special treatment needed

No specific treatment.:

No action shall be taken involving any personal risk or without suitable training. Itmay be dangerous to the person providing aid to give mouth-to-mouth resuscitation.

Date of issue/Date of revision : 3/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

Promptly isolate the scene by removing all persons from the vicinity of the incident ifthere is a fire. No action shall be taken involving any personal risk or without suitabletraining. Move containers from fire area if this can be done without risk. Use waterspray to keep fire-exposed containers cool.

Hazardous combustionproducts

Hazards from thesubstance or mixture

Decomposition products may include the following materials:carbon dioxidecarbon monoxide

Highly flammable liquid. In a fire or if heated, a pressure increase will occur and thecontainer may burst, with the risk of a subsequent explosion. Runoff to sewer maycreate fire or explosion hazard.

Fire-fighters should wear proper protective equipment.Special protectiveequipment for fire-fighters

Use dry chemical, CO2, water spray (fog) or foam.

5.1 Extinguishing media

:

:

:

Do not use water jet.

Suitable extinguishingmedia

:

Unsuitable extinguishingmedia

:

SECTION 5: Firefighting measures

5.2 Special hazards arising from the substance or mixture

5.3 Advice for firefighters

Special precautions forfire-fighters

:

6.2 Environmentalprecautions

Prevent entry into sewers, water courses, basements or confined areas. Containand collect spillage with non-combustible, absorbent material e.g. sand, earth,vermiculite or diatomaceous earth and place in container for disposal according tolocal regulations (see section 13). Use spark-proof tools and explosion-proofequipment.

Avoid dispersal of spilt material and runoff and contact with soil, waterways, drainsand sewers. Inform the relevant authorities if the product has caused environmentalpollution (sewers, waterways, soil or air).

Large spill :

Dilute with plenty of water. Absorb with an inert material and place in an appropriatewaste disposal container. Use spark-proof tools and explosion-proof equipment.

Small spill: :

6.3 Methods and materials for containment and cleaning up

SECTION 6: Accidental release measures6.1 Personal precautions, protective equipment and emergency procedures

For non-emergencypersonnel

:

For emergency responders :

6.4 Reference to othersections

See Section 1 for emergency contact information.See Section 8 for information on appropriate personal protective equipment.See Section 13 for additional waste treatment information.

No action shall be taken involving any personal risk or without suitable training.Evacuate surrounding areas. Keep unnecessary and unprotected personnel fromentering. Do not touch or walk through spilt material. Shut off all ignition sources.No flares, smoking or flames in hazard area. Avoid breathing vapour or mist.Provide adequate ventilation. Wear appropriate respirator when ventilation isinadequate. Put on appropriate personal protective equipment.

If specialised clothing is required to deal with the spillage, take note of anyinformation in Section 8 on suitable and unsuitable materials. See also Section 8 foradditional information on hygiene measures.

:

:

Date of issue/Date of revision : 4/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

Store between the following temperatures: 0 to 25°C (32 to 77°F). Store inaccordance with local regulations. Store in a segregated and approved area. Storein original container protected from direct sunlight in a dry, cool and well-ventilatedarea, away from incompatible materials (see section 10) and food and drink.Eliminate all ignition sources. Separate from oxidizing materials. Keep containertightly closed and sealed until ready for use. Containers that have been openedmust be carefully resealed and kept upright to prevent leakage. Do not store inunlabelled containers. Use appropriate containment to avoid environmentalcontamination.

SECTION 7: Handling and storageThe information in this section contains generic advice and guidance. The list of Identified Uses in Section 1 should beconsulted for any available use-specific information provided in the Exposure Scenario(s).

7.1 Precautions for safe handling

Protective measures :

Advice on generaloccupational hygiene

:

7.2 Conditions for safestorage, including anyincompatibilities

7.3 Specific end use(s)

Put on appropriate personal protective equipment (see Section 8). Do not ingest.Avoid contact with eyes, skin and clothing. Avoid breathing vapour or mist. Use onlywith adequate ventilation. Wear appropriate respirator when ventilation isinadequate. Do not enter storage areas and confined spaces unless adequatelyventilated. Keep in the original container or an approved alternative made from acompatible material, kept tightly closed when not in use. Store and use away fromheat, sparks, open flame or any other ignition source. Use explosion-proof electrical(ventilating, lighting and material handling) equipment. Use non-sparking tools.Take precautionary measures against electrostatic discharges. To avoid fire orexplosion, dissipate static electricity during transfer by earthing and bondingcontainers and equipment before transferring material. Empty containers retainproduct residue and can be hazardous. Do not reuse container.

Eating, drinking and smoking should be prohibited in areas where this material ishandled, stored and processed. Workers should wash hands and face beforeeating, drinking and smoking. Remove contaminated clothing and protectiveequipment before entering eating areas. See also Section 8 for additionalinformation on hygiene measures.

:

Recommendations :Industrial sector specificsolutions

:Not applicable.Not applicable.

No DNELs available.

Predicted effect concentrations

No PNECs available.

SECTION 8: Exposure controls/personal protectionThe information in this section contains generic advice and guidance. The list of Identified Uses in Section 1 should beconsulted for any available use-specific information provided in the Exposure Scenario(s).

8.1 Control parameters

Derived effect levels

Product/ingredient name Exposure limit values

Occupational exposure limits

Propan-2-ol EH40/2005 WELs (United Kingdom (UK), 8/2007).STEL: 1250 mg/m³ 15 minute(s).

STEL: 500 ppm 15 minute(s). TWA: 999 mg/m³ 8 hour(s). TWA: 400 ppm 8 hour(s).

Date of issue/Date of revision : 5/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 8: Exposure controls/personal protection

Hand protection(EN 374)

A respirator is not needed under normal and intended conditions of product use.

No special recommendations.

Safety glasses.Eye/face protection(EN 166)

Respiratory protection(EN 143, 14387)

:

:

:

Skin protection

Personal protective equipment for the body should be selected based on the taskbeing performed and the risks involved and should be approved by a specialistbefore handling this product.

:

Environmental exposurecontrols

: Emissions from ventilation or work process equipment should be checked to ensurethey comply with the requirements of environmental protection legislation. In somecases, fume scrubbers, filters or engineering modifications to the processequipment will be necessary to reduce emissions to acceptable levels.

Appropriate engineeringcontrols

: Use only with adequate ventilation. Use process enclosures, local exhaustventilation or other engineering controls to keep worker exposure to airbornecontaminants below any recommended or statutory limits. The engineering controlsalso need to keep gas, vapour or dust concentrations below any lower explosivelimits. Use explosion-proof ventilation equipment.

Wash hands, forearms and face thoroughly after handling chemical products, beforeeating, smoking and using the lavatory and at the end of the working period.Appropriate techniques should be used to remove potentially contaminated clothing.Wash contaminated clothing before reusing. Ensure that eyewash stations andsafety showers are close to the workstation location.

8.2 Exposure controls

Hygiene measures :

Individual protection measures

Body protection(EN 14605)

:

Other skin protection

Thermal hazards :

Appropriate footwear and any additional skin protection measures should beselected based on the task being performed and the risks involved and should beapproved by a specialist before handling this product.

Not applicable.

SECTION 9: Physical and chemical properties

Physical state

Melting point/freezing point

Initial boiling point and boilingrange

Vapour pressure

Liquid.

Alcohol-likeOdour

pH

Colourless.Colour

Evaporation rate

Flash point 21 °C (Closed cup)

Lower: 2%

6 to 8 [Conc. (% w/w): 100%]

Odour threshold

Upper/lower flammability orexplosive limits

:

:

:

:

:

:

:

:

:

:

:

9.1 Information on basic physical and chemical propertiesAppearance

Burning time

Burning rate

:

:

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Flammability (solid, gas) : Not applicable and/or not determined for the mixture.

Date of issue/Date of revision : 6/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 9: Physical and chemical properties

Relative density

Vapour density

Solubility(ies)

0.872 to 0.883

Easily soluble in the following materials: cold water.

Auto-ignition temperature

Partition coefficient: n-octanol/water

Explosive properties

:

:

::

:

:

None.Oxidising properties :

9.2 Other information

Decomposition temperature :

No additional information.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable and/or not determined for the mixture.

Not applicable.

Not applicable and/or not determined for the mixture.Viscosity :

10.6 Hazardousdecomposition products

10.4 Conditions to avoid Avoid all possible sources of ignition (spark or flame). Do not pressurise, cut, weld,braze, solder, drill, grind or expose containers to heat or sources of ignition.

Under normal conditions of storage and use, hazardous decomposition productsshould not be produced.

The product is stable.10.2 Chemical stability :

:

:

10.3 Possibility ofhazardous reactions

: Under normal conditions of storage and use, hazardous reactions will not occur.

SECTION 10: Stability and reactivity10.1 Reactivity : No specific test data related to reactivity available for this product or its ingredients.

10.5 Incompatible materials : No specific data.

Acute toxicity

Propan-2-ol LD50 Oral Rat 5000 mg/kg -

Product/ingredient name Result Species Dose Exposure

Irritation/Corrosion

Propan-2-ol Eyes - Moderate irritant Rabbit - 24 hours 100milligrams

-

Eyes - Moderate irritant Rabbit - 10 milligrams -Eyes - Severe irritant Rabbit - 100

milligrams-

Skin - Mild irritant Rabbit - 500milligrams

-

Product/ingredient name Result Score Exposure Observation

Conclusion/Summary : No known significant effects or critical hazards.

Sensitiser

Conclusion/Summary : No known significant effects or critical hazards.

Species

SECTION 11: Toxicological information11.1 Information on toxicological effects

Conclusion/Summary : No known significant effects or critical hazards.

Date of issue/Date of revision : 7/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 11: Toxicological information

Potential chronic health effects

Potential acute health effects

Inhalation : Vapours may cause drowsiness and dizziness.

No known significant effects or critical hazards.:Ingestion

Skin contact : No known significant effects or critical hazards.

Irritating to eyes.:Eye contact

No known significant effects or critical hazards.General :

No known significant effects or critical hazards.Carcinogenicity :

No known significant effects or critical hazards.Mutagenicity :

No known significant effects or critical hazards.Teratogenicity :

Carcinogenicity

Mutagenicity

Teratogenicity

Reproductive toxicity

Developmental effects : No known significant effects or critical hazards.

Fertility effects : No known significant effects or critical hazards.

Symptoms related to the physical, chemical and toxicological characteristics

Skin contact

Ingestion

Inhalation Adverse symptoms may include the following:nausea or vomitingheadachedrowsiness/fatiguedizziness/vertigo

No specific data.

No specific data.

:

:

:

Eye contact : Adverse symptoms may include the following:irritationwateringredness

Delayed and immediate effects and also chronic effects from short and long term exposure

Short term exposure

Long term exposure

Conclusion/Summary : No known significant effects or critical hazards.

Conclusion/Summary : No known significant effects or critical hazards.

Conclusion/Summary : No known significant effects or critical hazards.

Conclusion/Summary : No known significant effects or critical hazards.

Information on the likelyroutes of exposure

: No known significant effects or critical hazards.

Potential immediateeffects

:

Potential delayed effects :

Potential immediateeffects

:

Potential delayed effects :

No known significant effects or critical hazards.

No known significant effects or critical hazards.

No known significant effects or critical hazards.

No known significant effects or critical hazards.

Conclusion/Summary : No known significant effects or critical hazards.

Other information : No known significant effects or critical hazards.

Date of issue/Date of revision : 8/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 12: Ecological information

LogPow BCF Potential

12.3 Bioaccumulative potential

12.6 Other adverse effects No known significant effects or critical hazards.

Product/ingredient name

Propan-2-ol 0.05 - low

12.1 Toxicity

Propan-2-ol Acute LC50 >1400 mg/L Fish 96 hours

Product/ingredient name SpeciesResult Exposure

12.2 Persistence and degradability

Conclusion/Summary : The ecological evaluation of the product is based on data from the raw materialand/or comparable substances. Readily and rapidly degradable. All organicsubstances contained in the product achieve > 60% BOD/COD or CO2 liberation, or> 70% DOC reduction in tests for ease of degradability. Threshold values for 'readilydegradable' (e.g. to OECD method 301) are reached.

PBT : Not applicable.

vPvB : Not applicable.

12.4 Mobility in soil

12.5 Results of PBT and vPvB assessment

:

Conclusion/Summary : No known significant effects or critical hazards.

Soil/water partitioncoefficient (KOC)

: Not determined for the mixture.

Mobility : Not determined for the mixture.

European waste catalogue (EWC)

Yes.Hazardous waste :

The generation of waste should be avoided or minimised wherever possible. Emptycontainers or liners may retain some product residues. This material and itscontainer must be disposed of in a safe way. Significant quantities of waste productresidues should not be disposed of via the foul sewer but processed in a suitableeffluent treatment plant. Dispose of surplus and non-recyclable products via alicensed waste disposal contractor. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmentalprotection and waste disposal legislation and any regional local authorityrequirements. Avoid dispersal of spilt material and runoff and contact with soil,waterways, drains and sewers.

:Methods of disposal

SECTION 13: Disposal considerationsThe information in this section contains generic advice and guidance. The list of Identified Uses in Section 1 should beconsulted for any available use-specific information provided in the Exposure Scenario(s).

13.1 Waste treatment methods

Product

Packaging

Waste code Waste designation

20 01 13* solvents

Date of issue/Date of revision : 9/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 13: Disposal considerationsMethods of disposal :

Special precautions :

The generation of waste should be avoided or minimised wherever possible. Wastepackaging should be recycled.

This material and its container must be disposed of in a safe way. Care should betaken when handling emptied containers that have not been cleaned or rinsed out.Empty containers or liners may retain some product residues. Vapor from productresidues may create a highly flammable or explosive atmosphere inside thecontainer. Do not cut, weld or grind used containers unless they have been cleanedthoroughly internally. Avoid dispersal of spilt material and runoff and contact withsoil, waterways, drains and sewers.

ISOPROPANOL

3

II

ISOPROPANOL

3

II

Isopropanol

UN1219

33

ISOPROPANOL

II

UN1219

II

UN1219 UN1219

SECTION 14: Transport information

ADR/RID IMDG IATA

14.1 UN number

14.2 UN propershipping name

14.3 Transporthazard class(es)

14.4 Packinggroup

ADN/ADNR

14.5Environmentalhazards

14.6 Specialprecautions foruser

14.7 Transport in bulkaccording to Annex II ofMARPOL 73/78 and the IBCCode

No. No. No. No.

: Not applicable.

None. None. None. None.

Other EU regulations

Not applicable.Annex XVII - Restrictionson the manufacture,placing on the market anduse of certain dangeroussubstances, mixtures andarticles

:

SECTION 15: Regulatory information15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

EU Regulation (EC) No. 1907/2006 (REACH)

Annex XIV - List of substances subject to authorisation

Substances of very high concern

None of the components are listed.

Date of issue/Date of revision : 10/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 15: Regulatory information

National regulations

United Kingdom (UK)

15.2 Chemical SafetyAssessment

This product contains substances for which Chemical Safety Assessments are stillrequired.

:

The Chemicals (Hazard Information and Packaging for Supply) Regulations.The Control of Substances Hazardous to Health Regulations.Health and Safety at Work Act.

1/9/2012.Date of printing :

R11- Highly flammable.R36- Irritating to eyes.R67- Vapours may cause drowsiness and dizziness.

:Full text of abbreviated Rphrases

F - Highly flammableXi - Irritant

:Full text of classifications[DSD/DPD]

Indicates information that has changed from previously issued version.

SECTION 16: Other information

Full text of abbreviated Hstatements

:

Abbreviations andacronyms

: ADN/ADNR = European Provisions concerning the International Carriage ofDangerous Goods by Inland WaterwayADR = The European Agreement concerning the International Carriage ofDangerous Goods by RoadATE = Acute Toxicity EstimateBCF = Bioconcentration FactorCLP = Classification, Labelling and Packaging Regulation [Regulation (EC) No.1272/2008]DNEL = Derived No Effect LevelDPD = Dangerous Preparations Directive [1999/45/EC]EC = European CommissionEUH statement = CLP-specific Hazard statementIATA = International Air Transport AssociationIBC = Intermediate Bulk ContainerIMDG = International Maritime Dangerous GoodsLogPow = logarithm of the octanol/water partition coefficientMARPOL 73/78 = International Convention for the Prevention of Pollution FromShips, 1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution)OEL = Occupational Exposure LimitPBT = Persistent, Bioaccumulative and ToxicPNEC = Predicted No Effect ConcentrationREACH = Registration, Evaluation, Authorisation and Restriction of ChemicalsRegulation [Regulation (EC) No. 1907/2006]RID = The Regulations concerning the International Carriage of Dangerous Goodsby RailREACH # = REACH Registration NumbervPvB = Very Persistent and Very Bioaccumulative

Full text of classifications[CLP/GHS]

:

H224 Extremely flammable liquid and vapour.H225 Highly flammable liquid and vapour.H319 Causes serious eye irritation.H336 May cause drowsiness or dizziness.

Eye Irrit. 2, H319 SERIOUS EYE DAMAGE/ EYE IRRITATION - Category 2Flam. Liq. 1, H224 FLAMMABLE LIQUIDS - Category 1Flam. Liq. 2, H225 FLAMMABLE LIQUIDS - Category 2STOT SE 3, H336 SPECIFIC TARGET ORGAN TOXICITY (SINGLE

EXPOSURE) [Narcotic effects] - Category 3

Date of issue/Date of revision : 11/129 January 2012

PREMIER-WFI KLERCIDE 70/30 STERILE IPA

SECTION 16: Other informationDate of issue/ Date ofrevision

Version

The above information is believed to be correct with respect to the formula used to manufacture the product inthe country of origin. As data, standards, and regulations change, and conditions of use and handling arebeyond our control, NO WARRANTY, EXPRESS OR IMPLIED, IS MADE AS TO THE COMPLETENESS ORCONTINUING ACCURACY OF THIS INFORMATION.

Notice to reader

Date of previous issue

:

:

:

1/9/2012.

No previous validation.

1.1

Date of issue/Date of revision : 12/129 January 2012