INFORMATION SHEET:

T H O M A S

S W A N

PARA CHLORO META XYLENOL (PCMX)

Description

Thomas Swan & Co. Ltd, Crookhall, Consett, County Durham, DH8 7ND, England. Telephone: +44 1207 505131 Facsimile: +44 1207 590467 email: enquiries@thomas-swan.co.uk

PARA CHLORO META XYLENOL (PCMX) is an exceptionally broad spectrum bactericide and preservative with a long established and proven use in controlling bacteria, mildew and fungal growth in a wide range of applications (medical, domestic and industrial).

Physical and Chemical Properties

Synonyms: Para Chloro Meta Xylenol, PCMX 4 chloro 3,5-dimethyl phenol, 4 chloro 3,5 xylenol, 4 chloro meta xylenol "Chloroxylenol" (British Pharmacopoeia).

CAS number: 88-04-0

Typical Properties
Form Colour Odour Melting Point C crystals or crystalline powder white or cream characteristic 114 - 116

Antimicrobial Activity
PCMX is a bactericidal active which, in a large number of differing formulations, has been proved over many years to be highly efficient against a wide range of microorganisms. PCMX is bactericidal, not merely bacteriostatic and control is afforded versus fungi, gram positive, gram negative bacteria and some viruses. Many virus types are resistant to chemical germicides including PCMX but can be controlled by the use of easily formulated mixtures of PCMX and other bactericides. Other general advantages of PCMX preparations when compared with other bactericidal agents are: PCMX is compatible with a wide range of anionic and amphoteric surfactants and soaps and formulation is easy. Pine oil is a useful carrier and adjunct for PCMX and bactericidal activity can be enhanced by its use. For various applications PCMX may be formulated with other chlorinated phenols, sulphur and quaternary ammonium compounds. It is compatible with a wide variety of pharmaceuticals including hydrocortisones, pramoximes, propylparaban and sulphathiazoles. Dirt and particulate soil can inactivate all bactericides to a greater or lesser extent. PCMX based formulations are more tolerant than most in this respect. PCMX is bactericidally active over a pH range of at least 4 - 9. PCMX exhibits low metal corrosivity; an important factor where instrument sterilization is involved.
PCMX/01/95/Rev 0 (side 1 of 5)
The information contained herein is to the best of our knowledge accurate and reliable. However, as use conditions are not within our control, no guarantees are given or are to be inferred, nor is freedom from any patent to be inferred.

Registered in U.K. No 210794

Certified to all relevant quality & environmental standards, including EMAS

Solubility and Formulation

PCMX is only very slightly soluble in water even at high temperatures and only marginally more soluble in alkaline solution. It is soluble to a greater extent in alcohols such as ethanol and isopropanol (50-87 g/100ml solvent) and in glycols and glycol ethers. The alcohol and glycol solutions are themselves highly soluble in sodium, potassium or triethanolamine soaps of oleic, ricinoleic, coconut or myristic fatty acids. The most popular soap is the sodium or potassium salt of castor oil (ricinoleic predominant). For antiseptic skin/wound cleansers, disinfectants and detergent disinfectants, formulation is based on dissolving the PCMX in soap solution in the presence of alcohol. Soap quantity is critical (lower bactericidal action can result due to envelopment of PCMX in soap micelles). The most popular perfume addition is pine; pine oil, terpinolene, terpineol or blends. Such strong perfumes are sometimes deemed necessary to counter the strong 'phenolic' odour of PCMX but a distinctive note can be achieved by the further addition of small quantities of citronella, ionone, phenyl ether alcohol or similar aroma chemicals. Pine oil at certain levels can enhance bactericidal activity (eg versus salmonella typhi) but excessive concentrations can decrease activity towards staphylococcus type organisms.

Toxicity
There is a considerable wealth of published data relating to the toxicity of PCMX. general the product exhibits a very low order of toxicity. In summary:LD50 Acute Oral albino rats - 3830 mg/kg body weight LD50 Acute Dermal albino rabbits - average in excess of 1,000 mg/kg. Subacute and Dermal Toxicity (versus albino rabbits). Dosage rate 1.5 ml/kg of body weight/day for 20 days. No gross or systemic toxicity or pharmacological indication of percutaneous absorbtion. Low level of irritation. Acute Ocular Toxicity albino rabbits draize test. Mild conjunctivitis results but with no indication of corneal or iritis damage. There is no suggestion of any carcinogenic activity with PCMX. In

Applications
1. Hospital and General Medical Use PCMX based formulations can be used as antiseptics in hospitals and medical practice generally in: Surgical hand scrub operations The pre operative skin preparation of patients The sterilization of instruments The general cleaning of equipment and all hard surfaces to reduce the incidence of cross infection

Hospital sanitizing soaps, athletes foot and general first aid products can be formulated using PCMX. It may be formulated in liquid, waterless hand cleanser, powder, cream or lotion form. PCMX also acts as a preservative in other pharmaceutical products.

PCMX/01/95/Rev 0 (side 2 of 5)
The information contained herein is to the best of our knowledge accurate and reliable. However, as use conditions are not within our control, no guarantees are given or are to be inferred, nor is freedom from any patent to be inferred.

Registered in U.K. No 210794

Certified to all relevant quality & environmental standards, including EMAS

2. Household and General Germicidal Use The low toxicity of PCMX has led to its wide use in the home, office and factory in: Antiseptic skin wound cleaning and protectant formulations (liquids, creams, lotions) General disinfectants and combined detergent/disinfectants Antimicrobial soaps and health-care personal handwash formulations Shampoo (especially anti-dandruff) formulations.

3. Industrial Use PCMX has found use in the following applications: Surface Coatings:- in-can preservation of aqueous coating products and as a fungicidal additive to paints used in humid rooms Glues and Adhesives - prevention of microbial decomposition and mould infestation (especially protein based glues) Cutting Oils (Lubricants) - prevention of microbial decomposition which can cause objectionable odours, clogging of filters, corrosion and indeed cutting fluid becoming unserviceable Leather Processing - prevention of mould formation and bacterial and fungal attack (especially in pickled pelts, vegetable tanned leathers, salted and dried raw hides) Paper Processing - preservation of filler suspensions, coating mixes, resin sizes, size dispersion and especially preservation of highly susceptible coating mixes and sizes. Textile Processing and Finishing - fabric impregnation, (car roof linings, tarpaulins, rot proofing generally, cordage belts for fire hoses etc). Preservation (lubricants, finishes, sizes, yarn humidifiers, spinning bath solutions and durable print thickeners). Concrete - prevention of microbial decomposition of concrete additives used to slow down the setting and control the viscosity of concrete mixes. Fire Prevention - as a preservative for protein containing fire extinguishing products. Photographical - prevention of microbial attack in gelatins Polishes & other Wax Emulsions - prevention of microbial attack

General Notes on PCMX Formulations

Normal PCMX based antiseptic and disinfectant fluids consist of the germicide dissolved in soap solution together with a perfume base and possibly ethyl or isopropyl alcohol. The soap is made by saponification of castor oil with caustic soda (caustic potash may be used where no facilities exist for the heating needed in the manufacture of the sodium soap). Saponified castor oil is more satisfactory than sodium ricinoleate due to the solubilising properties of glycerol and the difficulty of preparing ricinoleic acid free from polymer. Soaps made from other fatty acids have their limitations. The soap has optimum bactericidal properties when made from saturated fatty acids of about C12 chain length such as lauric acid. Unfortunately the sodium salts of lauric acid are not as soluble as sodium ricinoleate. Synthetic anionic surface active agents, such as sulphated fatty alcohols, may be used instead of the soap, but the wetting properties can give rise to skin irritation and corrosion of surgical instruments sterilised in the diluted fluid. The nonionic surface active agents should not be used as they depress the bactericidal action of PCMX.

PCMX/01/95/Rev 0 (side 3 of 5)
The information contained herein is to the best of our knowledge accurate and reliable. However, as use conditions are not within our control, no guarantees are given or are to be inferred, nor is freedom from any patent to be inferred.

Registered in U.K. No 210794

Certified to all relevant quality & environmental standards, including EMAS

The quantity of soap used is critical, an excess resulting in a loss of killing power probably due to the envelopment of the active agent in soap micelles. The soap concentration should therefore be kept to the minimum compatible with the production of a stable fluid. The castor oil soap may be prepared by heating and preferably boiling, 147 parts of castor oil with 20 parts of caustic soda in 323 parts water until a clear solution is obtained. The soap should dilute with water to give a clear solution and be only slightly alkaline. Experience has shown that there is a slight saving if the bactericide and the perfume base are mixed in the freshly made warm soap before the addition of water. Isopropyl or ethyl alcohol may be added to assist solubility and in some cases to enhance the RW co-efficient of the fluid. The usual formulating procedure is to dissolve the bactericide in the perfume base or the perfume base/alcohol mixture and add with stirring to the freshly made soap to make a homogenous mixture. Water is then added slowly with stirring until the correct volume is attained. Colouring may be added to suit the manufacturers own requirements, but care must be taken to select a non fading, non toxic compound.

TYPICAL ANTISEPTIC/DISINFECTANT FORMULATION

Pts Wt 5.00 10.00 20.00 6.30 1.36 0.75 100

(Chloroxylenol solution BP 1973 from British Pharmacopoeia) PCMX Terpineol Alcohol (IPA 95%) Castor Oil Potassium Hydroxide Oleic Acid Water, deionised

to

Method of Manufacture Dissolve the potassium hydroxide in 1.5 parts by weight of deionised water. Add a solution of the castor oil in 6.3 parts by weight of the alcohol. Mix and allow to stand for an hour or until a small portion remains clear when diluted with nineteen times its volume of water. Then add the oleic acid, dissolve the PCMX in the remainder of the alcohol, mix with the terpineol and add to the soap solution, finally adding sufficient deionised water to produce 100 parts by weight.

CHEAPER PINE OIL TYPE DISINFECTANT

Pts Wt 2.00 4.00 12.00 82.00

PCMX Pine Oil Castor Oil, Soap 30% Water deionised

ANTISEPTIC LIQUID AND SOAP

Pts Wt 25.00 2.00 As required 100
PCMX/01/95/Rev 0 (side 4 of 5)

Potassium coconut oil soap (anhyd) PCMX Odorant Water to Make

The information contained herein is to the best of our knowledge accurate and reliable. However, as use conditions are not within our control, no guarantees are given or are to be inferred, nor is freedom from any patent to be inferred.

Registered in U.K. No 210794

Certified to all relevant quality & environmental standards, including EMAS

D
i

WATERLESS HAND CLEANER OIL/WATER EMULSION

Mix and heat to 60-70C 345g 75g 27g 288g qs

Colourless mineral spirit Oleic acid White mineral oil Water Odorant ii

In separate container agitate and heat to dissolve: 40g 36g 4g

Water Triethanolamine PCMX iii

Add ii slowly to i while agitating to produce gel.

Notes 1. To decrease viscosity of finished gel add more water to ii. 2. To increase viscosity decrease the water in ii. 3. The above formulation is a wipe-off type. To change to wipe-off and wash-off add 32 grams of Lipal 9N (EF Drew). Add 4.5% propylene glycol to the above waterless hand cleaner formulation. The resulting antiseptic lotion is ideal for squeeze bottle or regular lotion type dispensers.

AEROSOL SPRAY CONCENTRATE

587 gm 214 gm 128 gm 14 gm 57 gm

Alcohol, SDA #40 Triethylene glycol Propylene glycol PCMX Perfume allowance

Excellent mildew proofing aerosols, athlete's foot sprays and deodorant sprays employ similar formulations utilising PCMX as a broad spectrum fungicide and bactericide.

PCMX/01/95/Rev 0 (side 5 of 5)
The information contained herein is to the best of our knowledge accurate and reliable. However, as use conditions are not within our control, no guarantees are given or are to be inferred, nor is freedom from any patent to be inferred.

Registered in U.K. No 210794

Certified to all relevant quality & environmental standards, including EMAS