Specifications and Certificate of Analysis

ISOPROPYL METHYLPHENOL

Date: November, 2004

Product Data

Isopropyl Methylphenol (IPMP) is an isomer of thymol (primary component of volatile oil from labiate plants), which has been used for centuries as folk medicine.

In 1953, a method for industrial manufacturing of Isopropyl Methylphenol was developed, and its properties including bactericidal and antioxidant actions have been studies. As its favorable physicochemical properties, excellent efficacy and mild action characteristics have been recognized, it has come to be used widely today in drugs (for general use), quasi-drugs, cosmetics and other industrial fields.

Characteristics:
· It is almost tasteless and odorless. It has mild astringency which is a characteristic suitable for cosmetics
· It has almost no irritant action and does not induce skin allergy at 2% concentration
· It acts uniformly on various bacterial, yeast, mold and some viral species
· It absorbs ultraviolet rays with wavelengths of 250-300 nm (peak absorption wavelength 279 nm) and shows antioxidant action
· It is highly stable against air, light, temperature and humidity and retains its actions over a long period of time
· It is a highly safe compound used in drugs (for general use), non-medical products and cosmetics

Antibacterial Potency:
Isopropyl Methylphenol has been confirmed by pharmacological and clinical studies to show strong bactericidal or antibacterial activities against parasitic microorganisms such as the Trichophyton. Actions on influenza virus have been confirmed (200 ppm).

Antioxidant Activity:
Isopropyl Methylphenol suppresses oxidation and prevents degradation of co-existing materials. This property, along with the bactericidal activity, is advantageous for preservation of the quality of preparations including cosmetics in which large amounts of materials that are likely to degrade by oxidation such as oils and fats, perfumes, vitamins and hormones are contained.
An experiment on antioxidant activity was conducted where Isopropyl Methylphenol was added to 50 g of paraffin wax at 0.01% and 0.04%, bubbled with air at 160°C at a rate of 2 1/hr, and the time until the peroxide level reached 50 (induction time: an index of qualitative deterioration) was measured. It was found that Isopropyl Methylphenol delayed the oxidation induction time by 3 hours at 0.01% and by 9 hours at 0.04%.

Environmental Effects:
Isopropyl Methylphenol is an isomer of thymol which is contained in plant components. It is a compound with a relatively low molecular weight not containing a metal, halogen or sulfur atom. It exerts no adverse effect on microorganisms when diluted below their minimum inhibitory concentrations. It is composed of Carbon, Hydrogen and Oxygen and does not generate dioxins under ordinary conditions.

Safety:
The safety of Isopropyl Methylphenol has been confirmed by various tests.
· Single dose toxicity

· Mutagenicity
The results of Ames Test performed according to the standards of the Labor Safety and Hygiene Law were confirmed to be negative.

· Others
1. Isopropyl Methylphenol has been confirmed to have a mild irritant activity and no sensitizing activity by cutaneous primary irritation, ocular mucosal irritation, other cutaneous sensitization and cutaneous photosensitization (including phototoxicity) tests in rabbits
2. The safety of Isopropyl Methylphenol has been confirmed by a 30-day and 90-day repeated dose toxicity studies (oral) in rats
3. The safety of Isopropyl Methylphenol has been confirmed by negative results of endocrine tests using human breast cancer cells and yeast. (Responses to nonylphenol and benzoate ester, which were examined as controls, were positive)

Uses:
· Cosmetics
Preservative for creams, lipsticks and hairdressings
(Standard for use by the Ministry of Heath an Welfare: 0.1% or less in rinse-on preparations)
· Drugs
Drugs for bacterial or fungal skin disorders, oral disinfectants and anal preparations (3% or less)
· Quasi-Drugs
External sterilizers or disinfectants (including hand disinfectants), oral disinfectants, hair tonics, anti-acne drugs, toothpaste, etc. (0.05 - 1%)
· Industrial Uses
The disinfection of air-conditioneers and rooms, antibacterial and deodorization processing of fabrics, various antibacterial and antifungal processing and others
1. Interior Disinfectants:
The interior can be disinfected effectively by spraying a 0.1 - 1% solution (prepared by diluting an emulsion or alcohol solution of Isopropyl Methylphenol to a concentration appropriate for the target microorganism) over the floor and the wall at about 25-100 ml/m2.
2. Sanitizer for clothes, interior items and furniture:
Excellent antibacterial, deodorant and antifungal effects can be obtained by attaching appropriate preparations to clothes, beddings, carpets or curtains by spraying or immersing or treating the materials of fabric by a special fixation procedure

Incompatibility:
· When Isopropyl Methylphenol is used concomitantly with non-ionic surfactants or macromolecular compounds such as CMC, its bactericidal activity may be reduced as it is contained in or absorbed on micelles of the surfactant. Enhancement of the effect by agents such as EDTA2Na or substitution for anionic surfactants is needed
· Isopropyl Methylphenol forms an eutectic mixture and liquefies when mixed with camphor or menthol by intense pestling. Prevent liquefaction by using oil absorbents such as porous silica gel.
· Isopropyl Methylphenol may be inactivated or made less efficacious by salt-forming compounds in an intensely alkaline environment