17
Item#: HC500DW Item#: HC100DW Item#: HC50DW Unit Size: 8.38"x 8.38"x 8.75" Unit Size: 5.5"x 7"x 1.5" Unit Size: 5.5"x 7"x 1.5" Unit Weight: 6.31 Lbs Unit Weight: 1.09 lbs Unit Weight: .634 lbs Case Dims: 24"L x 17"W x 9"H Case Dims: 16.5"L x 13.78"W x 7.875"H Case Dims: 16.5"L x 13.78"W x 7.875"H MOQ: (Container) 5400 Units / 900 Cases MOQ: (Container) 47,520 MOQ: (Container) 47,520 Units Per Case 6 Units Per Case 48 Units Per Case 48 Cases per pallet: 45 Cases per pallet: 45 Cases per pallet: 45 Units per pallet: 270 Units per pallet: 2160 Units per pallet: 2160 Pallets per 53' Truckload: 20 Pallets per 53' Truckload: 22 Pallets per 53' Truckload: 22 Units per 53' Truckload: 5400 Units per 53' Truckload: 47520 Units per 53' Truckload: 47520 Pallet Dims: 48 x 40 x 88 Pallet Dims: 48 x 40 x 70 Pallet Dims: 48 x 40 x 70 Case UPC: 10860004463320 Case UPC: 10860004463399 Case UPC: 10860004463337 Unit UPC: 860004463306 Unit UPC: 860004463382 Unit UPC: 860004463313 DUNS #: 11-759-1021 TERMS: 50% Deposit with PO / Balance Due upon Customs Clearance at US Port COUNTRY OF ORIGIN: Israel DELIVERY LEAD TIME: 4 Weeks from Deposit 500-Count 100-Count DISINFECTING & CLEANING WIPES 50-Count

DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

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Page 1: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Item#: HC500DW Item#: HC100DW Item#: HC50DW

Unit Size: 8.38"x 8.38"x 8.75" Unit Size: 5.5"x 7"x 1.5" Unit Size: 5.5"x 7"x 1.5"

Unit Weight: 6.31 Lbs Unit Weight: 1.09 lbs Unit Weight: .634 lbs

Case Dims: 24"L x 17"W x 9"H Case Dims: 16.5"L x 13.78"W x 7.875"H Case Dims: 16.5"L x 13.78"W x 7.875"H

MOQ: (Container) 5400 Units / 900 Cases MOQ: (Container) 47,520 MOQ: (Container) 47,520

Units Per Case 6 Units Per Case 48 Units Per Case 48

Cases per pallet: 45 Cases per pallet: 45 Cases per pallet: 45

Units per pallet: 270 Units per pallet: 2160 Units per pallet: 2160

Pallets per 53' Truckload: 20 Pallets per 53' Truckload: 22 Pallets per 53' Truckload: 22

Units per 53' Truckload: 5400 Units per 53' Truckload: 47520 Units per 53' Truckload: 47520

Pallet Dims: 48 x 40 x 88 Pallet Dims: 48 x 40 x 70 Pallet Dims: 48 x 40 x 70

Case UPC: 10860004463320 Case UPC: 10860004463399 Case UPC: 10860004463337

Unit UPC: 860004463306 Unit UPC: 860004463382 Unit UPC: 860004463313

DUNS #: 11-759-1021 TERMS: 50% Deposit with PO / Balance Due upon Customs Clearance at US Port

COUNTRY OF ORIGIN: Israel

DELIVERY LEAD TIME: 4 Weeks from Deposit

500-Count 100-Count

DISINFECTING & CLEANING WIPES

50-Count

Page 2: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes

Safety Data Sheet Issue date: 6/23/2020

EN (English) 1/6

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

Product name : Multy Purpose Surface Cleaning Wipes

Product code : 23060111

Type of product : Detergent

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

1.2.1. Relevant identified uses

Use of the substance/mixture : Multy Purpose Surface Cleaning Wipes

1.2.2. Uses advised against

No additional information available

1.3. Details of the supplier of the safety data sheet Sasatech dalton

kibbutz sasa M.P MAROM HAGALIL 1387000 - ISRAEL

1.4. Emergency telephone number Emergency number :

SECTION 2: Hazards identification 2.1. Classification of the substance or mixture

Classification according to Regulation (EC) No. 1272/2008 [CLP]Mixtures/Substances: SDS EU 2015: According to Regulation

2015/830 (REACH Annex II)

Not classified

Adverse physicochemical, human health and environmental effects

To our knowledge, this product does not present any particular risk, provided it is handled in accordance with good occupational hygiene and safety

practice.

2.2. Label elements

Labelling according to Regulation (EC) No. 1272/2008 [CLP]Extra labelling to displayExtra classification(s) to display

EUH-statements : EUH210 - Safety data sheet available on request.

2.3. Other hazards No additional information available

SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable

3.2. Mixtures

Name Product identifier % Classification according to Regulation (EC) No. 1272/2008 [CLP]

ethanol; ethyl alcohol (CAS-No.) 64-17-5

(EC-No.) 200-578-6

(EC Index-No.) 603-002-00-5 (REACH-no) 01-2119457610-43

5 - 10 Flam. Liq. 2, H225

Eye Irrit. 2, H319

Full text of H-statements: see section 16

SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after eye contact : Rinse eyes with water as a precaution.

4.2. Most important symptoms and effects, both acute and delayed No additional information available

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

Page 3: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes Safety Data Sheet

6/23/2020 EN (English) 2/6

SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media : Water spray. Dry powder. Foam. Carbon dioxide.

5.2. Special hazards arising from the substance or mixture Hazardous decomposition products in case of fire : Toxic fumes may be released.

5.3. Advice for firefighters Protection during firefighting : Do not attempt to take action without suitable protective equipment. Self-contained

breathing apparatus. Complete protective clothing.

SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures

6.1.1. For non-emergency personnel

No additional information available

6.1.2. For emergency responders

No additional information available

6.2. Environmental precautions No additional information available

6.3. Methods and material for containment and cleaning up No additional information available

6.4. Reference to other sections For further information refer to section 13.

SECTION 7: Handling and storage 7.1. Precautions for safe handling Hygiene measures : Do not eat, drink or smoke when using this product. Always wash hands after handling the

product.

7.2. Conditions for safe storage, including any incompatibilities Storage conditions : Keep cool.

7.3. Specific end use(s) No additional information available

SECTION 8: Exposure controls/personal protection 8.1. Control parameters

ethanol; ethyl alcohol (64-17-5)

Netherlands Grenswaarde TGG 8H (mg/m³) 260 mg/m³

Netherlands Grenswaarde TGG 15MIN (mg/m³) 1900 mg/m³

8.2. Exposure controls No additional information available

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

Appearance : Clear.

Colour : No data available

Odour : No data available

Odour threshold : No data available

pH : 8 - 9.5

Relative evaporation rate (butylacetate=1) : No data available

Melting point : Not applicable

Freezing point : No data available

Boiling point : No data available

Flash point : No data available

Auto-ignition temperature : No data available

Decomposition temperature : No data available

Flammability (solid, gas) : Non flammable.

Vapour pressure : No data available

Relative vapour density at 20 °C : No data available

Relative density : No data available

Density : 0.98 - 0.99 g/cm³

Page 4: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes Safety Data Sheet

6/23/2020 EN (English) 3/6

Solubility : Water: soluble

Log Pow : No data available

Viscosity, kinematic : No data available

Viscosity, dynamic : 1 cP

Explosive properties : Non explosive

Oxidising properties : Non oxidizing

Explosive limits

Storage stability

Corrosion characteristics

: No data available

2 years

Not corrosive

9.2. Other information No additional information available

SECTION 10: Stability and reactivity 10.1. Reactivity The product is non-reactive under normal conditions of use, storage and transport.

10.2. Chemical stability Stable under normal conditions.

10.3. Possibility of hazardous reactions No dangerous reactions known under normal conditions of use.

10.4. Conditions to avoid None under recommended storage and handling conditions (see section 7).

10.5. Incompatible materials No additional information available

10.6. Hazardous decomposition products Under normal conditions of storage and use, hazardous decomposition products should not be produced.

SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity (oral) : Not classified

Acute toxicity (dermal) : Not classified

Acute toxicity (inhalation) : Not classified

ethanol; ethyl alcohol (64-17-5)

LD50 oral 10470 mg/kg bodyweight

LD50 dermal 15800 mg/kg bodyweight

LC50 inhalation rat (Dust/Mist - mg/l/4h) > 99999 mg/l/4h

Skin corrosion/irritation : Not classified

pH: 8 - 9.5

Serious eye damage/irritation : Not classified

pH: 8 - 9.5

Respiratory or skin sensitisation : Not classified

Germ cell mutagenicity : Not classified

Carcinogenicity : Not classified

Reproductive toxicity : Not classified

STOT-single exposure : Not classified

STOT-repeated exposure : Not classified

Aspiration hazard : Not classified

SECTION 12: Ecological information 12.1. Toxicity Ecology - general : The product is not considered harmful to aquatic organisms nor to cause long-term

adverse effects in the environment.

Hazardous to the aquatic environment, short-term (acute)

: Not classified.

Hazardous to the aquatic environment, long-term

(chronic)

: Not classified

Page 5: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes Safety Data Sheet

6/23/2020 EN (English) 4/6

ethanol; ethyl alcohol (64-17-5)

LC50 fish 1 14200 mg/l

EC50 other aquatic organisms 1 5012 mg/l EC50 waterflea (48 h)

EC50 other aquatic organisms 2 275 mg/l IC50 algea (72 h) mg/l

12.2. Persistence and degradability No additional information available

12.3. Bioaccumulative potential No additional information available

12.4. Mobility in soil No additional information available

12.5. Results of PBT and vPvB assessment No additional information available

12.6. Other adverse effects No additional information available

SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste treatment methods : Dispose of contents/container in accordance with licensed collector’s sorting instructions.

SECTION 14: Transport information In accordance with ADR / RID / IMDG / IATA / ADN

ADR IMDG IATA ADN RID

14.1. UN number

Not applicable Not applicable Not applicable Not applicable Not applicable

14.2. UN proper shipping name

Not applicable Not applicable Not applicable Not applicable Not applicable

14.3. Transport hazard class(es)

Not applicable Not applicable Not applicable Not applicable Not applicable

14.4. Packing group

Not applicable Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards

Not applicable Not applicable Not applicable Not applicable Not applicable

No supplementary information available

14.6. Special precautions for user

Overland transport

Not applicable

Transport by sea

Not applicable

Air transport

Not applicable

Inland waterway transport

Not applicable

Rail transport

Not applicable

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

15.1.1. Regulations

Contains no REACH substances with Annex XVII restrictions

Contains no substance on the REACH candidate list

Contains no REACH Annex XIV substances

Page 6: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes Safety Data Sheet

6/23/2020 EN (English) 5/6

Detergent Regulation : Ingredient data sheet:

Component CAS-No. %

ALCOHOL 64-17-5 1 - 10%

C12-16 PARETH-7 68439-50-9 1 - 10%

β-Alanine, N-C8-18-alkyl 90170-42-6 0.1 - 1%

tetrasodium ethylene diamine tetraacetate 64-02-8 0.1 - 1%

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides 68424-85-1 0.1 - 1%

didecyldimethylammonium chloride 7173-51-5 0.1 - 1%

AQUA 7732-18-5 0.1 - 1%

2-methylpropan-2-ol; tert-butyl alcohol 75-65-0 <0.1%

denatonium benzoate 3734-33-6 <0.1%

DIMETHYLOL GLYCOL 3586-55-8 <0.1%

METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE 55965-84-9 <0.1%

Detergent Regulation : Labelling of contents:

Component %

aliphatic hydrocarbons 5-15%

non-ionic surfactants <5%

Directive 2012/18/EU (SEVESO III)

15.1.2. National regulations

Germany

Reference to AwSV : Water hazard class (WGK) 2, Significantly hazardous to water (Classification according to AwSV, Annex 1)

12th Ordinance Implementing the Federal

Immission Control Act - 12.BImSchV

: Is not subject of the 12. BlmSchV (Hazardous Incident Ordinance)

Netherlands

SZW-lijst van kankerverwekkende stoffen : ethanol; ethyl alcohol is listed

SZW-lijst van mutagene stoffen : None of the components are listed

NIET-limitatieve lijst van voor de voortplanting giftige stoffen – Borstvoeding

: ethanol; ethyl alcohol is listed

NIET-limitatieve lijst van voor de voortplanting

giftige stoffen – Vruchtbaarheid

: ethanol; ethyl alcohol is listed

NIET-limitatieve lijst van voor de voortplanting giftige stoffen – Ontwikkeling

: ethanol; ethyl alcohol is listed

Denmark

Danish National Regulations : Pregnant/breastfeeding women working with the product must not be in direct contact with the product

15.2. Chemical safety assessment No chemical safety assessment has been carried out

SECTION 16: Other information

Full text of H- and EUH-statements:

Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4

Aquatic Chronic 3 Hazardous to the aquatic environment — Chronic Hazard, Category 3

Eye Dam. 1 Serious eye damage/eye irritation, Category 1

Eye Irrit. 2 Serious eye damage/eye irritation, Category 2

Flam. Liq. 2 Flammable liquids, Category 2

H225 Highly flammable liquid and vapour.

H302 Harmful if swallowed.

H318 Causes serious eye damage.

H319 Causes serious eye irritation.

H412 Harmful to aquatic life with long lasting effects.

Page 7: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Multy Purpose Surface Cleaning Wipes Safety Data Sheet

6/23/2020 EN (English) 6/6

EUH210 Safety data sheet available on request.

SDS EU (REACH Annex II)

This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental

requirements only. It should not therefore be construed as guaranteeing any specific property of the product.

Page 8: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

Wipe Material : Non-woven fabric, Spunlace 20% Viscosa , 80% Polyester, 40 grm.

- Section 15.1 is related to the raw material and the ingredients, - Raw material is water in 0.1-1 %. This i the water in the raw material not the water in the general formulation,Meaning that in section 15.1 shows the subtitle of the raw material.

CAS. Number Name % by weight Amount gr/l7173-51-5 Didecyl Dimethyl Amonium Chloride 0.2 268424-85-1 Benzalkonium chloride 0.3 364-17-5 ETHANOL 5 5090170-42-6 LAKELAND AMA LF 70 0.5 564-02-8 Tetrasodium EDTA 0.6 668551-12-2 Alcohols, C12-16, ethoxylated 2-15 EO 1.15 11.53586-55-855965-84-9

Determination of Cationic Active Matter content

ISO 2871-1:2010

Surface active agents — Detergents — Determination of cationic-active matter content — Part 1: High-molecular-mass cationic-active matter

THIS STANDARD WAS LAST REVIEWED AND CONFIRMED IN 2017. THEREFORE THIS VERSION REMAINS CURRENT.

Active

Non-active

0.01 0.1MERGAL K14

Page 9: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

2020-3788/20 23 00175 1/9

YEDA PHARM

STUDY REPORT

2020-3788/20 23 00175

Disinfectant and Antiseptic Sanitizer Code no. 21060710

SUSPENSION TEST ACCORDING TO EN 1276:2019

(Phase 2 step 1)

Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas – Test method and

requirements (phase 2, step 1)

MAY 2020

QACS LTD, 1 Antigonis str, 144-51 Metamorfossi, Greece. Tel: +30-210-2934745, fax: +30-210-2934606, email: [email protected] website: www.qacslab.com

Page 10: DISINFECTING & CLEANING WIPES · Multy Purpose Surface Cleaning Wipes Safety Data Sheet Issue date: 6/23/2020 EN (English) 1/6 SECTION 1: Identification of the substance/mixture and

2020-3788/20 23 00175 2/9

STUDY REPORT 2020-3788/20 23 00175

SUSPENSION TEST ACCORDING TO EN 1276:2019 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

TEST PRODUCT IDENTIFICATION

PRODUCT NAME : Disinfectant and Antiseptic Sanitizer Code No. 21060710

SUBSTANCES AND THEIR CONCENTRATIONS : Not Provided

APPEARANCE OF THE PRODUCT : Liquid

STORAGE CONDITIONS : Room Temperature, Darkness

LOT : 210607

METHOD : EN 1276:2019

CONTACT TIME : 60 seconds

CONCENTRATION : Undiluted (80%), 50%, 10%.

DILUENT RECOMENTED BY THE MANUFACTURER : Water

CONDITIONS OF TEST : 0.3g/L bovine albumin (Clean conditions)

STUDY SPONSOR : YEDA PHARM

PRODUCT SUPPLIER : YEDA PHARM

RECEIPT DATE : 21/04/2020

STUDY PERIOD : 06/05/2020-08/05/2020

LAB ID : 2020-3788/20 23 00175

SCOPE

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products that are used in food, industrial, domestic and institutional areas

excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas

PRINCIPLE

A sample of the product as delivered and/or diluted with hard water (or water for ready-to-use products with the exception of handwash products whose first dilution is done in hard water is added to a test suspension of bacteria in a solution of an interfering substance. The mixture is maintained at the chosen test temperature for the adopted contact time. At the end of this contact time, an aliquot is taken, and the bactericidal and/or the bacteriostatic activity in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neutralizer cannot be found, membrane filtration is used. The numbers of surviving bacteria in each sample are determined and the reduction is calculated.

The test is performed using Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Enterococcus hirae as test organisms. For temperatures ≥ 40 °C only Enterococcus faecium shall be used. For testing of hand hygiene products, Pseudomonas aeruginosa, Escherichia coli K12, Staphylococcus aureus and Enterococcus hirae are used as test organisms.

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2020-3788/20 23 00175 3/9

TEST CONDITIONS

1. The following procedure was performed in water bath at 20 °C

2. The test product was tested at 60 seconds contact time

3. A final concentration of 0.3g/L bovine albumin was used for testing (clean conditions)

4. Neutralization Method used: Dilution neutralization.

5. Neutralizer used: LPT Dilution Broth containing polysorbate 80.

6. According to EN 1276, products shall be tested at a minimum of three different

concentrations to include one concentration in the active range and one concentration in

the non-active range. In this case the product was tested: Undiluted, 50% 10%.

TEST ORGANISMS

Pseudomonas aeruginosa NCIMB 10421

Staphylococcus aureus ATCC 6538

Escherichia coli NCIMB 8879

Enterococcus hirae NCIMB 8192

BACTERICIDAL ACTIVITY FOR GENERAL PURPOSES

The product shall be deemed to have passed the EN 1276 standard if it demonstrates in a valid test at least a 5 lg reduction, under the suitable test conditions for general purpose defined by this standard when the test organisms are Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Enterococcus hirae (E. faecium when the test temperature is ≥ 40 °C).

ASSAY ACCEPTANCE CRITERIA

1. Test Suspension (N) is between 1.5 to 5.0 X 108 CFU per mL (8.17≤log N≤8.70)

2. No (N/10) is between 1.5 to 5.0 X 107 CFU per mL (7.17≤log No≤7.70)

3. Validation Suspension=Nν is between 3.0 x 102 and 1.6 x 103.

4. Nvo (Nv/10) is between 30 and 160

5. Na is the number of survivors (cells) per ml in the test mixture at the end of contact time.

6. R (log reduction) = No - Na

7. Average recovery values for the experimental conditions control (Α) were equal to or

greater than 0.5 times the Validation Suspension (Nνo)

8. Average recovery values for the Neutralizer control (Β) were equal to or greater than 0.5

times the Validation Suspension (Nνo)

9. Average recovery values for the Method Validation control (C) were equal to or greater than

0.5 times the Validation Suspension (Nνo)

10. Control of weighted mean counts. Quotient is not lower than 5 and not higher than 15

ARCHIVING

The laboratory book which contains all the information (raw data and results) regarding the study and the study reports are kept in the laboratory archives for 5 years.

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2020-3788/20 23 00175 4/9

TEST RESULTS FOR Pseudomonas aeruginosa (BACTERICIDAL SUSPENSION TEST)

Test suspensionTest - suspension(N and Nο)

N Vc1 Vc2 x mean

10-6

10-7

log N 8.30

No (N/10)

log No 7.30

7,17 < = logNo < = 7,70 Yes

Validation and controls

Validation suspension

(Nνο)

VC 1 52 VC 1 49 VC 1 49 x mean VC 1 55

VC 2 54 53 VC 2 51 VC 2 47 48 VC 2 52

30<x mean of Nνo < 160? x mean of A is > 0,5*x mean of Nνo? x mean of B is > 0,5*x mean of Nνo or NVB/1000? x mean of C is > 0,5*x mean of Nνo?

Yes Yes Yes Yes

Test Results

10 0 0 0 0 010 -1 0 0 0 0

100

0 0 0 0

10-1

0 0 0 0

100

> 330 > 330

10-1

> 330 > 330

Undiluted

(80%)

x mean x mean x mean

Experimental conditions (A)

53.5

2.02E+08

2.02E+07

Method validation (C)

Product conc.: Neutralizer control (B)

17 23

198 206

Criteria

≥ 5

≥ 5

≥ 5

Result

PASS TEST

PASS TEST

FAILS TEST

7.30

7.30

> 5.16

7.30

>

Product concentration (%)

Undiluted (80%)

50%

10%

Contact time Dilution step

60 sec

60 sec 14

log Na log No

log

Reduction

(No-Na)

> 3300 4.52

< 5.16

< 2.79

<

<140

> 33000

Vc 2Average of Vc1

and Vc2

50

>60 sec

Na= average x10

2.15140<14<

Vc 1

2.15<

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2020-3788/20 23 00175 5/9

TEST RESULTS FOR Staphylococcus aureus (BACTERICIDAL SUSPENSION TEST)

Test suspensionTest - suspension(N and Nο)

N Vc1 Vc2 x mean

10-6

10-7

log N 8.26

No (N/10)

log No 7.26

7,17 < = logNo < = 7,70 Yes

Validation and controls

Validation suspension

(Nνο)

VC 1 43 VC 1 47 VC 1 51 x mean VC 1 42

VC 2 46 44.5 VC 2 42 VC 2 48 49.5 VC 2 46

30<x mean of Nνo < 160? x mean of A is > 0,5*x mean of Nνo? x mean of B is > 0,5*x mean of Nνo or NVB/1000? x mean of C is > 0,5*x mean of Nνo?

Yes Yes Yes Yes

Test Results

10 0 0 0 0 010 -1 0 0 0 0

100

0 0 0 0

10-1

0 0 0 0

100

> 330 > 330

10-1

> 330 > 330≥ 5 FAILS TEST33000 > 4.52 7.26 < 2.74

> 5.11 ≥ 5 PASS TEST

10% 60 sec > 3300 >

50% 60 sec < 14 < 140 < 2.15 7.26

2.15 7.26 > 5.11 ≥ 5 PASS TEST

Result

Undiluted (80%) 60 sec < 14 < 140 <

Average of Vc1

and Vc2

Na= average

x10log Na log No

log

Reduction

(No-Na)

Criteria

x mean x mean x mean

44.5 44

Product concentration (%) Contact time Dilution step Vc 1 Vc 2

Experimental conditions (A) Neutralizer control (B)Method validation (C)

Product conc.:

Undiluted

(80%)

1.82E+07

16 19

1.82E+08

179 187

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TEST RESULTS FOR Escherichia Coli (BACTERICIDAL SUSPENSION TEST)

Test suspensionTest - suspension(N and Nο)

N Vc1 Vc2 x mean

10-7

10-8

log N 8.53

No (N/10)

log No 7.53

7,17 < = logNo < = 7,70 Yes

Validation and controls

Validation suspension

(Nνο)

VC 1 78 VC 1 82 VC 1 79 x mean VC 1 78

VC 2 81 79.5 VC 2 77 VC 2 84 81.5 VC 2 83

30<x mean of Nνo < 160? x mean of A is > 0,5*x mean of Nνo? x mean of B is > 0,5*x mean of Nνo or NVB/1000? x mean of C is > 0,5*x mean of Nνo?

Yes Yes Yes Yes

Test Results

10 0 0 0 0 010 -1 0 0 0 0

100

0 0 0 0

10-1

0 0 0 0

100

> 330 > 330

10-1

> 330 > 330≥ 5 FAILS TEST33000 > 4.52 7.53 < 3.01

> 5.39 ≥ 5 PASS TEST

10% 60 sec > 3300 >

50% 60 sec < 14 < 140 < 2.15 7.53

2.15 7.53 > 5.39 ≥ 5 PASS TEST

Result

Undiluted (80%) 60 sec < 14 < 140 <

Average of Vc1

and Vc2Na= average x10 log Na log No

log

Reduction

(No-Na)

Criteria

x mean x mean x mean

79.5 80.5

Product concentration (%) Contact time Dilution step Vc 1 Vc 2

Experimental conditions (A) Neutralizer control (B)Method validation (C)

Product conc.:

Undiluted

(80%)

3.41E+07

4 3

3.41E+08

35 33

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TEST RESULTS FOR Enterococcus hirae (BACTERICIDAL SUSPENSION TEST)

Test suspensionTest - suspension(N and Nο)

N Vc1 Vc2 x mean

10-6

10-7

log N 8.30

No (N/10)

log No 7.30

7,17 < = logNo < = 7,70 Yes

Validation and controls

Validation suspension

(Nνο)

VC 1 43 VC 1 46 VC 1 51 x mean VC 1 52

VC 2 45 44 VC 2 49 VC 2 47 49 VC 2 48

30<x mean of Nνo < 160? x mean of A is > 0,5*x mean of Nνo? x mean of B is > 0,5*x mean of Nνo or NVB/1000? x mean of C is > 0,5*x mean of Nνo?

Yes Yes Yes Yes

Test Results

10 0 0 0 0 010 -1 0 0 0 0

100

0 0 0 0

10-1

0 0 0 0

100

> 330 > 330

10-1

> 330 > 330≥ 5 FAILS TEST33000 > 4.52 7.30 < 2.78

> 5.15 ≥ 5 PASS TEST

10% 60 sec > 3300 >

50% 60 sec < 14 < 140 < 2.15 7.30

2.15 7.30 > 5.15 ≥ 5 PASS TEST

Result

Undiluted (80%) 60 sec < 14 < 140 <

Average of Vc1

and Vc2

Na= average

x10log Na log No

log

Reduction

(No-Na)

Criteria

x mean x mean x mean

47.5 50

Product concentration (%) Contact time Dilution step Vc 1 Vc 2

Experimental conditions (A) Neutralizer control (B)Method validation (C)

Product conc.:

Undiluted

(80%)

1.98E+07

21 19

1.98E+08

192 204

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CONCLUSION

TEST SUBSTANCE IDENTIFICATION

PRODUCT NAME : Disinfectant and Antiseptic Sanitizer Code No. 21060710

SUBSTANCES AND THEIR CONCENTRATIONS : Not Provided

APPEARANCE OF THE PRODUCT : Liquid

STORAGE CONDITIONS : Room Temperature, Darkness

LOT : 210607

METHOD : EN 1276:2019

CONTACT TIME : 60 seconds

CONCENTRATION : Undiluted (80%), 50%, 10%.

DILUENT RECOMENTED BY THE MANUFACTURER : Water

CONDITIONS OF TEST : 0.3g/L bovine albumin (clean conditions)

STUDY SPONSOR : YEDA PHARM

PRODUCT SUPPLIER : YEDA PHARM

RECEIPT DATE : 21/04/2020

STUDY PERIOD : 06/05/2020-08/05/2020

LAB ID : 2020-3788/20 23 00175

METHODOLOGY ABSTRACT

A test suspension of bacteria (P. aeruginosa, S. aureus, E. coli & E. hirae) is tested against a product test solution at three different concentrations with the presence of interfering substance. The mixture is maintained at 20°C ±1°C for 5 minutes. At the end of this contact time, an aliquot is taken, and the bactericidal activity in this portion is immediately neutralized or suppressed. The numbers of surviving flora are determined and the log reduction is calculated.

RESULT

The product under test: “Disinfectant and Antiseptic Sanitizer Code No. 21060710” demonstrated bactericidal activity according to EN 1276:2019 (≥ 5 log reduction), under clean conditions, for 60

seconds contact time, at 20 1 °C, when tested at product concentration: Undiluted (80%) using as test organisms the reference strains: P. aeruginosa, S. aureus, E. coli & E. hirae. For the QACS Ltd Laboratory,

Signature date: 14/05/2020 Lagiopoulos Giorgos Agronomist-Food Technologist M.Sc. Study Manager

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STUDY SUMMARY / ABSTRACT

SUSPENSION TEST ACCORDING TO EN 1276:2019 Chemical disinfectants and antiseptics – Basic Bactericidal activity Test methods and requirements (Phase 2 Step 1)

PRODUCT NAME : Disinfectant and Antiseptic Sanitizer Code

No. 21060710

SUBSTANCES AND THEIR CONCENTRATIONS : Not Provided

APPEARANCE OF THE PRODUCT : Liquid

STORAGE CONDITIONS : Room Temperature, Darkness

LOT : 210607

METHOD : EN 1276:2019

CONTACT TIME : 60 seconds

CONCENTRATION : Undiluted (80%), 50%, 10%.

DILUENT RECOMENTED BY THE MANUFACTURER : Water

CONDITIONS OF TEST : 0.3g/L bovine albumin (clean conditions)

STUDY SPONSOR : YEDA PHARM

PRODUCT SUPPLIER : YEDA PHARM

RECEIPT DATE : 21/04/2020

STUDY PERIOD : 06/05/2020-08/05/2020

LAB ID : 2020-3788/20 23 00175

TEST MICROORGANISMS

Pseudomonas aeruginosa NCIMB 10421

Staphylococcus aureus ATCC 6538

Escherichia coli NCIMB 8879

Enterococcus hirae NCIMB 8192

RESULT

The product under test: “Disinfectant and Antiseptic Sanitizer Code No. 21060710” demonstrated bactericidal activity according to EN 1276:2019 (≥ 5 log reduction), under clean conditions, for 60

seconds contact time, at 20 1 °C, when tested at product concentration:

Undiluted (80%) using as test organisms the reference strains: P. aeruginosa, S. aureus, E. coli & E. hirae

Results refer to the sample as received and analyzed on the period specified above.

The test report shall not be reproduced except in full, without written approval of the laboratory.

The samples will be stored by the laboratory during 1 month from the end test date.

The study report and raw data will be stored by the laboratory for 5 years.

End of Test Report