CleanBioTM-Zinc

CleanBioTM-Zinc

CleanBioTM-Zinc, the trade name of KOLON biocide, is 48% aqueous

dispersion type which is widely used in cosmetics or personal-care

products.

CleanBioTM-Zinc bactericide-fungicide is the most effective anti-dandruff

agent especially used in shampoos.

CleanBioTM-Zinc

CleanBioTM-Zinc

Zinc pyrithione 48% Aqueous Dispersion

KOLON biocide, CleanBioTM-Zinc is effective inhibitor of growth of fungi and bacteria

and also inhibit the growth of fungi, molds and yeast in cosmetic preparations. In addition

to this, they exhibit high growth inhibiting activity against a broad spectrum of

gram-positive and gram-negative bacteria in cosmetic preparations.

CleanBioTM-Zinc is 48% aqueous dispersion of Zinc Pyrithione as an active ingredient that

have ultra-fine particles of zinc pyrithione, a dispersant and a stabilizing agent.

CleanBioTM-Zinc is mainly used for an antidandruff agent for shampoos and generally

stable at the temperatures and pH required for the formulation of shampoos and can be

combined with most commonly used shampoo ingredients.

General Information

General Name(INCI name): Zinc Pyrithione(CTFA name), ZPT

Chemical Name: Zinc bis(2-pyridinethiol-1-oxide)

Zinc salt of 2-mercaptopyridine-N-oxide

Zinc bis[1-hydroxy-2(1H)-pyridinethionato-O,S]-(T-4)

Structural Formula N

S

O

ZnN

S

O

Molecular Formula: C10H8N2O2S2Zn

Molecular Weight: 317.7

CAS Number: 13463-41-7

CleanBioTM-Zinc

Physical-Chemical Properties and Specifications

Specification

Appearance Off-white Aq. dispersion

Odor Mild

Zinc Pyrithione, Assay(%) 48~50%

Zinc(%) 9.3~11.3%

pH(average)-5% in pH 7 water 6.5~9.0

Bulk Density(gr/ml) 1.2~1.25

Particle Size(%) D(90 ) < 1㎛

D(100) <5㎛

Solubility(wt/wt% at 25℃)

Solvent CleanBioTM-Zinc

Water, pH 7 0.002

Ethyl Alcohol 0.01

Isopropyl Alcohol 0.008

Acetone 0.07

Polyethylene glycol 0.2

Dimethylformamide(DMF) 8.0

Dimethylsulfoxide(DMSO) 4.0

Chloroform 0.3

Mineral Oil <0.0001

Olive Oil <0.0003

Caster Oil <0.0001

Isopropyl Myristate <0.0001

Isopropyl Palmitate <0.0001

CleanBioTM-Zinc

Stability

Heat Stability CleanBioTM-Zinc is stable at 100℃ for least 120 hours and therefore

stable at the temperature used in formulation procedure.

pH Stability CleanBioTM-Zinc, antidandruff agent, is stable pH 4.5~9.5

-below pH 4.5 : the complex dissociates and forms free pyrithione.

-above pH 9.5 : the complex hydrolyzes to zinc hydroxide and salt of

Pyrithione.

Light Stability May be darkened and decomposed on exposure to light.

Chemical

Reactivity

Pyrithione is an excellent chelating agent for heavy metal ions.

In the presence of iron, copper, mercury and silver ion, Zinc pyrithione

may be transchelated and specific colors may be formed.

Storage

Stability

Temp. Time Appearance Assay(%) Dispersion

40℃ Initial White 49.0 Good

“ 1 week White 49.1 Good

“ 3 months White 48.9 Good

25℃ Initia White 48.7 Good

“ 1 week White 48.6 Good

“ 3 months White 48.7 Good

“ 12months White 48 4 Good

Stability of CleanBioTM-Zinc dispersion by Analytical Instrument

-Turbiscan instrument measure the backscattering and transmission intensities versus the

sample height in order to detect particle size change and phase separation.

-Stability index is degree of backscattering intensity change.

-Lower stability index of dispersion means that dispersion is more stable.

Figure 1. Delta Backscattering Changes over time of Competitor’s ZPT 48% dispersion.←A

CleanBioTM-Zinc

Figure 2. Delta Backscattering Changes over time of Competitor’s ZPT 48% dispersion.←B

Figure 3. Delta Backscattering Changes over time of KLS’s CleanBio

TM-Zinc.←10ZDS1-SP1029

CleanBioTM-Zinc

Figure 4.Stability kinetics and Stability Index of ZPT dispersion in DeltaBST(different degrees of backscattering intensity

between starting point of the test and measuring point as time passes ) at 60℃ for 14days.

∴ Regarding stability index stability of Zinc Pyrithione dispersion of Kolon is superior than

Zinc Pyrithione dispersion of Competitor.

Applications

CleanBioTM-Zinc, CleanBio

TM-ZP are widely used in cosmetics and industrials.

- effective agent for antidandruff shampoos and hair treatments.

- adhesives for wall paper, tile, flooring and carpeting.

- sealants, caulks for bathrooms, pools, doors and windows.

- anti-fouling agent for under-water painting.

- preservative in aluminium coating.

- antimicrobial agent in plastics.

Packing Unit

- CleanBioTM-Zinc 25kgs, 250kgs in polyethylene container.

1200kgs in IBC tank.

CleanBioTM-Zinc

Antimicrobial Activity

The Minimum Inhibitory Concentration (MIC) of CleanBioTM-Zinc was determined by agar

dilution method in DIN 58 940. The results, in vitro, show very low concentrations of

CleanBioTM-Zinc inhibits many microorganisms with broad spectrum of activity.

[MIC in ppm(㎍/㎖)]

Test Bacteria(Organism) ATCC No. MIC in ppm

Gram Positive Bacteria ;

Bacillus cereus 11778 12.2

Micrococcus luteus 9341 12.2

Staphylococcus aureus 6538P 12.2

Streptococcus faecalis 29212 12.2

Gram Negative Bacteria ;

Escherichia coli 25922 12.2

Proteus vulgaris 13315 24.4

Pseudomonas aeruginosa 9027 12.2

Salmonella typhimurium DSM 554 12.2

Molds ;

Aspergillus niger 16404 12.2

Trichophyton mentagrophytesCBS 26379 12.2

Yeasts ;

Malassezia furfur DSM 6170 12.2

Candida albicans 10231 12.2

Saccharomyces cerevisiae 9763 12.2

Anti-dandruff Efficacy of shampoo containing CleanBioTM-Zinc

Antidandruff effects of shampoo samples were evaluated by determining antimicrobial activity

against Malassezia furfur, Malassezia globasa, Malassezia restricta, known as dandruff causing

organism. We conducted antimicrobial activity test using Disc agar diffusion method (DDT). The

larger zone of inhibition, the test sample has higher antidandruff efficacy.

This study was carried out to confirm the antidandruff efficacy of the shampoo containing 1% of

CleanBioTM-Zinc (Shampoo A) by contrast with the shampoo containing competitor’s ZPT dispersion

(Shampoo B ~ D ).

CleanBioTM-Zinc

1. M. restricta

Shampoo A Shampoo B

Shampoo C Shampoo D

2. M. globosa

Shampoo A Shampoo B

Shampoo C Shampoo D

3. M. furfur

Shampoo A Shampoo B

Shampoo C Shampoo D

CleanBioTM-Zinc

- The shampoo containing CleanBioTM-Zinc has better anti-dandruff efficacy, especially

against M. restricta and M. globosa which are known as more closely related to dandruff.

Toxicological Test

Acute Oral Toxicity ▶

- LD50(male rats) : >200㎎/kg

- LD50(female rats) : >200㎎/㎏ and <2,000㎎/㎏ body weight

Primary Skin Irritation ▶

- New Zealand White Rabbits(1male and 2 female) were used.

- CleanBioTM-Zinc is considered to be "Not Irritating" to rabbit skin.

Primary Eye Irritation ▶

- New Zealand White Rabbits(1male and 2 female) were used.

- Based upon EEC Commission Directive 93/21/EEC, April 27(1993),

CleanBioTM-Zinc is considered to be "Cause Severe Eye Irritation" to rabbit skin.

Hair Deposition Result

CleanBio▶ TM-Zinc Deposition in Hair (㎍/g)

: 1,645±742㎍/g (immediately after treatment, Day 0)

: 1,189±764㎍/g (two day after without washing, Day +2)

: 849±704㎍/g (four day after without washing, Day +4)

CleanBio▶ TM-Zinc in Washing Water (㎍/㎖)

: 8±9㎍/㎖ (rinsing off from hair after the first 1,000㎖ washing water)

: 2±1㎍/㎖ (after second 1,000㎖ washing water)

: 2±1㎍/㎖ (after third sufficient amount of washing water)

< Test Condition >

- Volunteers 11 (10 female, 1 male) aged between 16 and 60 years.

- Hair samples (≧250㎎) were cut off before and immediately (day 0) and

two(day +2) and four(day +4) days after treatment and zinc pyrithione

content analyzed.

- In addition, the zinc pyrithione content of the tap water used for rinsing off

the test article was also analyzed.

CleanBioTM-Zinc

< Recommendations and Guidelines >

- EEC/CPMP Working Party on Efficacy of Drugs, July 3. 1987.

- Durchfuhrung von klinischen Arzneimittelprufungen in der Bundesrepublik

Deutschland, Merkblatt des BPI. Pharmazeut. Ind. 50, 1223-1240 (1986)

- 18th World Medical Assembly. Helsinki, Finland, June 1964.

- 29th World Assembly, Tokyo, Japan, October 1975.

- 35th World Medical Assembly, Venice, Italy, October 1983.

- 41st World Medical Assembly, Hong Kong, September 1989.

- 48th General Assembly, Somerset West Republic of South Africa October 1996.

CleanBioTM-Zinc

Suggested Formulations

Antidandruff Shampoo▶

Ingredient INCI name Supplier %

A TEGIN G1100 Glycol Distearate (1) 3.0

Texapon N28 Sodium Laurylsulfate (2) 40.0

B Perfume 0.3

CleanBioTM-Zinc Zinc pyrithione(48%) 2.0

ABIL B88183 Dimethicone Copolyol (1) 0.5

C Water 40.3

TEGO Carbomer 141 Carbomer (1) 0.2

NaOH(25%) ad pH 5≒ Sodium Hydroxide 0.1

D TEGO Betain F50 Cocamidopropyl Betain (1) 10.0

ANTIL HS60

Cocamidopropyl Betain

and Glyceryl Laurate

(1)

3.7

cf) (1) Th. Goldschmidt AG

(2) Henkel

<Procedure>

A The ingredients are heated up to app. 65 until the TEGIN G1100 is melted. ℃

Cool down while stirring until app. 45 . ℃

B Add the ingredients in the given order to phase A.

C The TEGO Carbomer is soluted in the water. Then the solution is neutralized

with the NaOH. Add to phase A+B.

D Add the ingredients in the given order.

Premium Antidandruff Shampoo▶

Ingredient INCI name Supplier %

A Deionized Water 76.0

STEPANOL AM-V Ammonium Laurylsulfate (1) 15.0

NINOL 40-CO Cocamide DEA (1) 2.0

B

TAB-2

Di(hydrogenated) tallow

phthalic acid amide

(1)

5.0

CleanBioTM-Zinc Zinc pyrithione(48%) 2.0

C Preservative q.s.

D Citric acid(50% solution) q.s.

or NaOH(50% solution) Sodium Hydroxide

E Ammonium Chloride q.s.

cf) (1) Stepan Chemicals

CleanBioTM-Zinc

<Procedure>

- In separate containers, mix well A and B components.

- Heat solution A to 165～175 , add dispersion B, and mix for 30minutes. ℉

- Cool the mixture to 120 and add C. ℉

- Adjust pH to 5.0～6.2 with D.

- Adjust viscosity of the solution with E.

Antidandruff Shampoo with Conditioner▶

Ingredient INCI name Supplier %

A Deionized Water 23.85

JAGUAR C-14S

Guar hydroxypropyltrimmonium

chloride

(1)

0.3

VEEGUM Regular Magnesium Aluminium Silicate (2) 0.7

CleanBioTM-Zinc Zinc pyrithione(48%) 2.1

B SIPON(R) ESY Sodium Laurylsulfate (1) 30.0

ELTESOL AX40 Ammonium xylenesulfonate, 40% aq. (3) 2.0

C VARISOFT TC-90 Tricetylammonium chloride (4) 0.5

Cetyl alcohol NF 0.4

Stearyl alcohol 0.4

CYCLOCHEM(R) EGDS Glycol distearate (1) 0.4

D CYCLOMIDE(R) C-212 Cocamide MEA (1) 1.7

SIPON L-22HNC Ammonium Laurylsulfate (1) 36.0

E KATHON CG Preservative (5) 0.05

Fragrance and dye q.s.

F Citric acid(25% aq.) q.s.

cf) (1) Rhone Poulenc (2) R.T. Vanderbilt

(3) Albright & Wilson St. Mihiel (4) Sherex

(5) Rohm & Haas

<Procedure>

- Prepare A by heating water to 50 and dispersing the JAGUAR C℃ -14S and

the VEEGUM with rapid agitation.

- Add CleanBio-Zinc dispersion and mix well

- Adjust pH of A to 4.5～5.0 with F.

- Slowly blend both components of B into A, mixing well.

- Adjust the pH of the mixture to 5.7～6.3 with F.

- In a separate container, combine all components in C, and heat mixture to 70～75 . ℃

- Heat the A/B mixture to 70～75 and blend with C, mixing well. ℃

- Blend both components of D into the hot mixture, and stirr well.

- Adjust the pH to 5.7～6.3 with F.

- Cool the mixture to 40～45 , add E, and mix well. ℃

- If desired, the viscosity of the product can be increased b adding 0.05～1% sodium chloride.

CleanBioTM-Zinc

Antidandruff Shampoo with Mixing Prescription▶

(=Piroctone Olamine+Zinc Pyrithione)

Ingredient INCI Name %

A Deionized Water 30.0

Ammonium

Lauryl Sulfate 15.0

Sodium Lauryl Sulfate 20.0

Cocamide DEA 4.0

B Deionized Water 20.0

PQ-10 Polyquaternium-10 0.4

CleanBio-Zinc Zinc Pyrithione(48%) 2.0

Piroctone Olamine 0.5

EDTA-2Na 0.1

C Propylene Glycol 1.0

Cocamido Propyl Betain 5.0

Hydrolyzed Soy Protein 0.3

D Coloring agent q.s.

Preservation q.s.

Perfume q.s.

E Citric Acid q.s.

NaCl q.s.

<Procedure>

-Put the A in Main Vessel and stir to dissolve.

-Put the B in Side Vessel and heat 70~75 to dissolve.℃

-Blend both mixture of B in Side Vessel into mixture of A Main Vessel.

-Cool the mixture to 50~60 , add C, and mix well.℃

-Cool the mixture to 35~45 , add D, and mix well.℃

-Adjust the pH to 5.7~6.3 with E

-If desired, the viscosity of the product can be increased adding 0.05~1%

Handling & Storage

In case of handling CleanBioTM-Zinc, avoid contact with skin, eyes and inhalation. And

wear protective goggles, rubber gloves and a mask.

CleanBioTM-Zinc should be stored in a dry place at temperature range 10～55℃. Keep

containers tightly closed when not in use.

CleanBioTM-Zinc

Safety Data Sheet

Safety Data Sheets for CleanBioTM-Zinc is available.

Other Information

The information contained herein is to the best of KOLON's knowledge and belief accurate.

However, since the condition of handling and use are beyond our control, we make no

guarantee for result obtained, and assure no responsibility for damages incurred by use of this

product. It is responsibility of the user to comply with all federal, state and local laws and

regulations.

Before using or handling CleanBioTM-Zinc the MSDS should be thoroughly reviewed. MSDS

informs you toxicological properties, personal protection, first aid, spill and disposal

procedure.

Technical service : If you need further information, please contact us Kolon Life Science

Institute below written address or telephone and fax.

- Address : Kolon Life Science Institute, Eco-friendly chemicals Research team,

207-2, Mabuk-dong, Giheung-gu, Yongin-si, Gyeonggi-do,

Korea, ZIP 446-797 - Telephon : +82 31 280 8732

- Telefax : +82 31 280 8760

- e-mail : smjo88@kolon.com, heejung@kolon.com

Sales Office

- Address : Kolon Life Science, Inc., Eco-friendly chemicals Business Team,

Fl 9. Kolon Tower, 1-23, Byeoryang-dong, Gwacheon-si, Gyeonggi-do,

Korea, ZIP 429-709

- Telephone : +82 2 3677 3632,3642

- Telefax : +82 2 3677 3557

- e-mail : hokim@kolon.com, alpacino11@kolon.com