Concerning the safty of Inovex’s Colloidal Platinum.

Introduction

There are two methods used to create microscopic metal particles. The top-down method involves breaking up masses of the metal until it becomes a fine powder, whereas in the bottom-up method metal particles are created by turning the metal into gas or liquid. When metal particles are especially small, most are made using the bottom-up approach. Making metal particles from gas is called as the gaseous phase method and making them from liquid is called the solution method, Colloidal Platinum is primarily made using the solution method.

Manufacturing method of Colloidal Platinum

The general method for producing platinum colloids is to reduce platinum salts in a solution in which platinum is dissolved and generate platinum particles, or to irradiate a platinum plate in a solution with laser light and generate platinum particles.

However, even if platinum particles are the same size, the properties and applications are completely different depending on the conditions of particle formation, the type of material and solvent that protects the particles, and the purification method.

Colloidal Platinum has been primarily used in industry, and particle size uniformity, dispersion and solvent type are important factors in industrial use. On the other hand, because safety and stability are a top priority for colloidal platinum used in food and cosmetics, the production method differs. Therefore, it is required to productize it in accordance with each standards and regulations.

Recently, Colloidal Platinum has come to be formulated into a number of cosmetics and food products for its anti-oxidation properties, however, the capabilities may vary depending in the manufacturing company and its method, and some products have almost no antioxidant effect. Even if the stability of platinum particles is maintained, manufacturing may result in residual ionic material, such as platinum salt and reducing agents therefore safety cannot be completely guaranteed using this method.

Our Unique Manufacturing Method

When making Colloidal Platinum for food products, we carefully select raw materials recognized for food use. Likewise, when making Colloidal Platinum for cosmetics, we select raw materials recognized for cosmetics. To ensure the safety and stability of our Colloidal Platinum, we use an ultrafiltration membrane with a molecular weight threshold of thirty thousand wherein all ionic materials that pass through the membrane are removed. This ultrafiltration membrane along with the carefully selected raw materials is part of our patented process (patented in 12 countries), guaranteeing unrivaled safety and stability of Colloidal Platinum produced by Inovex.

Safety

Safety has been our highest priority since we began producing Colloidal Platinum in 1996. We have performed a variety of scientific tests on our Colloidal Platinum, and the results indicate no toxicity or danger or any indication that anything is absorbed into the skin and body. Upon the submission of data on the safety and physicochemical properties of our Colloidal Platinum for food to the relevant agencies, we received approval to use platinum as a food additive as well as a manufacturing license for soft drinks. In addition to the number of safety tests we have passed, we have a proven track record of 20 years in the soft drink business.

Our Colloidal Platinum was registered as a raw cosmetic material using Colloidal Platinum by the CTFA (Cosmetic, Toiletry and Fragrance Association, currently named Personal Care Products Council) for the first time in the word.

In addition, through a variety of safety tests, our Colloidal Platinum has been used by many cosmetics manufacturers both in and out of the country since 2002, and it has been formulated in many products such as skin care, hair care, and makeup products.

Safety Issues

 Test Item & Test MethodsTesting DateResult
1Single oral administration toxicity test (max. limit test)
Notification No. 24 of PAB1/ Notification No. 88 PAB-New Drug Approval (GLP Observance)
3/21, ’07No Toxicity
2Primary irritancy skin test
based on the Handbook of production for cosmetic & quasi-drug 2006 (GLP Observance)
3/13, ’07No irritancy
3Two weeks consecutive irritancy skin test
based on the Handbook of production for cosmetic & quasi-drug 2006 (GLP Observance)
3/21, ’07No consecutive
skin irritancy
4Skin sensitivity test
Notification No. 24 of PAB1& based on the guideline of drug toxicity test
4/5, ’07Negative
5Eye irritation test
based on the Handbook of production for cosmetic & quasi-drug 2006 (GLP Observance)
3/13, ’07No Irritancy
6Reverse mutation test / Guideline on geno-toxicity test of drugs
based on PAB Notification No. 1604 (Nov. 1, ’99) (GLP Observance)
3/13, ’07Negative
724 Hours blockage human patch test (40 examples)10/26, ’07Safety product
equivalent
8Acute oral toxicity test (maximum limit test)
based on OECD Guideline of Chemical Substance Toxicity Testing 1987
10/8, ’96No Toxicity
928 days repetition dose toxicity test
Guideline on toxicity test of drugs
based on PAB1 Notification No. 24, Notification No. 88 of PAB-New Drug Approval, PAB Notification No. 655
1/18, ’08No toxicity
10Oral administration test9/12, ’05No residual
11Cytotoxicity test using HT29 cells
Intestinal permeability test using Caco-2 cells
10/11, ’18No Toxicity
No permeation
12Skin penetrability test8/8, ’05No absorbance
13Skin permeability test using human skin5/24, ’15No permeation
14Intravenous dose12/26, ’05Quick excretion from body, No influence
15Toxicity test using Bacteria8/8, ’05No Toxicity