Description
Pathol Antiseptic Spray has one of the most widely used and trusted antiseptic germicide preparations in the world. It is effective against bacteria, germs and viruses, yet non-poisonous and non-staining. Its active ingredient, Chloroxylenol, is recognized by the US Environmental Protection Agency (EPA) No. 49403-1 as safe and effective against the spread of viruses like influenza virus. It is ideal for use as an antiseptic spray in hospitals, dental and medical clinics, offices, hotels, schools, land transport, cruise ships and homes.
The spray will provide protection in the prevention of disease. It is convenient and consumer-friendly for use. It also provides the pleasant fragrance in refreshening your working environments
This antiseptic spary has a broad spectrum of anti-bacterial activity against both gram-positive (Streptococcus pyogenes, Streptococcus aureus, etc) and the gram-negative (S. choleraesuis, S. typhosa, E. coli, Pseudomonas aeruginosa, etc) and lipophilic anti-viral activity.
Pathol Antiseptic Spray has the following features:
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Complied with HALAL requirements according to Islamic Law Reg. No. JAKIM (22.00) 492/2/P2435.
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It is safe, hypoallergenic and contains no respiratory or ophthalmic irritants.
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It can be absorbed through the skin, inhaled without harmful effects.
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Produced under Good Manufacturing Practices (GMP) Standards.
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Kills bacteria, germs and viruses without causing any adverse effects to surfaces, humans or the environment.
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Non-corrosive. Safe on metals, alloys, synthetics, rubber, glass, painted surfaces and plastics.
EFFICACY
Chloroxylenol, the active ingredient in Pathol Antiseptic Spray has a broad spectrum of microbiocidal activity against every vegetative micro-organism tested to date. Fungi, gram-positive bacteria, and gram-negative bacteria are all controlled.
Inhibiting Effects of Chloroxylenol
ORGAHISM
Candida albicans
Pseudomonas aeruginosa
Proteus vulgaris
E.coli
B. subtilis
Penicillium chrysogenum
Altenaria solani
Aspergillus niger
Rhizopus nigricans
Aerobac ter/aerogenus
Staphylococcus aureus
B. cereus
Streptococcus faecalis
Mucor recemosa
Oidium lactis
Saccharomyces pastorianus
Torula roseus
The bacteriostatic activity of Chloroxylenol
ORGANISM
Staphylococcus Group I
Staphylococcus Group I
Staphylococcus Group II
Staphylococcus Group IV
Staphylococcus Group V
Micrococcus spp. (aerobic)
StreptococcuS faecalis Type C
Streptococcus faecalis Type D
Streptococcus faecalis Type D
Streptococcus faecalis Type D
Streptococcus faecalis Type A
Neisseria catarrhalis
Acinetobacter anitratum
Escherichia coli AA 9395
Escherichia coli AA 9721
Escherichia coli AA 9803
Escherichia coli 10245
Escherichia coli
Citrobacter sp.
Klebsiella aerogenes CA 22852
Klebsiella aerogenes AC 23535
Klebsiella aerogenes
Proteus mirabilis BA 23919
Proteus mirabilis BA 25702
Proteus mirabilis BA 25945
Proteus mirabilis (1)
Proteus mirabilis (2)
Proteus mirabilis
Providence (A)
Providence (B)
Pseudomonas aeruginosa 12211
Pseudomonas aeruginosa
Pseudomonas aeruginosa 65376
Pseudomonas aeruginosa Thornham
Enterobacter spp.
Serratia marcencens
Mycobacterium smegmatis
Diphtheroid( lipolytic)
Diphtheroid(non- lipohilic)
Diphtheroid(anaerobic)
SAFETY
Toxic effects of the active ingredient
Chloroxylenol : An antiseptic/disinfectant of low toxicity.
Toxic effects of finished product
Pathol Antiseptic Spray has the same active ingredient, Chloroxylenol, as another known product which has been marketed worldwide for the last 80 years. The latter product has been well-accepted by the consumers to be safe and effective.
TOXICITY OF CHLOROXYLENOL
The safety of Chloroxylenol has been proven by a wealth of available toxicity data. In particular, a large number of acute and chronic animal studies have shown the toxicity potential of Chloroxylenol to be almost non-existent.
ACUTE ORAL LD.
The acute oral LD (lethal dose for 50% of the animals of Chloroxylenol for 50 male albino rats was found to be 3.83 gm/kg of body weight. According to one widely used toxicity classification system (Hodge, H.D. and J.H. Sterner, Am. Ind. Hyg. Assoc. Quart.
10:4, 93, 1943) the above listed LD
50 classifies Chloroxylenol as slightly toxic by ingestion.
ACUTE DERMAL LD50
Chloroxylenol was applied at graded dosage levels as an aqueous paste to one series of albino rabbits. A second series of rabbits received a 30% weight/volume solution of Chloroxylenol in propylene glycol. The test materials remained in contact with the skin for 24 hours under an impervious cover.
No mortalities occurred in either test series. The acute dermal LD
50 of Chloroxylenol for albino rabbits is, therefore, in excess of 10.0gm/kg or 3.00gm/kg respectively, when applied as an aqueous paste or as a solution in propylene glycol.
Skin irritation was mild and transient following application of the aqueous paste and more marked following application of the propylene glycol solution. On the basis of these results, Chloroxylenol is classified as non-toxic following skin application.
SUBACUTE AND CHRONIC DERMAL TOXICITY
The irritative potential and systemic toxicity by percutaneous absorption of propylene glycol (Group 1 - Control) a 1.8% solution of Chloroxylenol in propylene glycol (Group 2), and an 18% solution of Chloroxylenol in propylene glycol (Group 3) were evaluated in albino rabbits. Fifteen daily applications to rabbits with abraded skin and 65 applications to rabbits with intact skin were made. The dosage rate was l.0ml/kg of body weight/day for each group.
No significant differences among the three groups were noted with respect to body weight gains, gross appearance and behaviour, hematological findings, urine values, or gross pathological findings at autopsy. Survival in the groups receiving Chloroxylenol was 100%. No gross signs of systemic toxicity or pharmacological effect indicative of percutaneous absorption of the applied materials were noted. Minimal gross skin irritation was noted among the control rabbits and those receiving 1.8% Chloroxylenol. Moderate to extreme skin irritation occurred among the animals receiving 18% Chloroxylenol. No significant differences in irritative response were noted among animals with intact skin compared with those with abraded skin in any group.
TOXICITY
Gross and microscopic examination of tissues from control and test animals showed no changes which could be associated with dermal application of Chloroxylenol.
ACUTE OCULAR TOXICITY
One hundred milligrams of the sample was applied to the left eye of each of six albino rabbits. The right eye was untreated and served as a control. The treated eyes of three rabbits were irrigated with 20 ml of lukewarm tap water, approximately four seconds after. The remaining three rabbits were not irrigated. Scoring of irritative effect was according to the method of Draize. In three of three rabbits whose eyes were not irrigated following sample applications. Chloroxylenol produced mild to moderate conjunctivitis, mild iritis, and mild to severe corneal opacity. In addition, pannas was noted in two rabbits, one of which showed a corneal lesion.
The degree and duration of irritative effects were markedly reduced in those rabbits whose eyes were irrigated with water following application of Chloroxylenol. Irritation was generally limited to mild conjunctivitis. There was no evidence of iritis or corneal damage.
REPEATED INSULT PATCH TEST OF CHLOROXYLENOL
Using an adaptation of the Draize test procedure, a repeated insult patch test was conducted on 25 male and female panelists with Chloroxylenol at concentrations of 0.01%, 0.1% and 1.0% in corn oil. All solutions were non-irritating throughout the study. There were no reactions of any panelist at any time which were suggestions of sensitization.
SALMONELLA MUTAGENESIS ASSAY (CHLOROXYLENOL)
Chloroxylenol was tested via Salmonella mutagenesis assay over a dose range of 0.2 to 1.0 microgram/plate. Six test strains of Salmonella with and without a liver preparation were tested. Chloroxylenol is concluded to be non-mutagenic to tested strains, either in the presence or absence of a liver metabolic system.
ENVIRONMENTAL ACCEPTABILITY
The active ingredient, Chloroxylenol, readily degrades in rivers, sewage and activated sludge. It has a biodegradability of 70% after 7 days with the degradation products of xylenols and unchanged toxicity.
DIRECTIONS FOR USE
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Spray from 6” onto affected area.
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Clean or leave to dry.
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Apply 3 times daily.
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May be covered with a sterile bandage.
CAN CONTENT
Active Ingredient : Chloroxylenol
Inert Ingredients : Solvent, Hydrocarbon Propellant, Fragrance and Compressed Air
CAUTION
Pressurized container. Keep away from heat and naked flame. Do not puncture or incinerate container. Do not expose to heat or store at temperature above 50°C.
FOR EXTERNAL USE ONLY. If contact with eyes, wash thoroughly with water for at least 5 – 15 minutes with eyelids held open. Keep out of reach of children.
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