Product registration Currently there are 19 products containing polihexanide registered in Australia and are included in the APVMA review. Details of these registrations are presented in Table 1 below. Table 1: Polihexanide products registered in Australia APVMA Product registration number Product name Registration holder Associated label approval numbers Pool and spa products 48356 HTL Bio-Blu Swimming Pool and Spa Water Treatment and Sanitiser HTL Pty Ltd 48356/107402 48356/01 49284 King Neptune’s Ozone Clear Pool Sanitiser Isaac Technologies Pty Ltd 49284/1098 57606 Aquafresh by Lo-Chlor Pool Sanitiser M I International Pty Ltd T/A Chemicals 57606/56365 57606/0603 59949 Aquaspa By Lo-Chlor Spa Sanitiser M I International Pty Ltd T/A Chemicals 59949/0509 59949/0408 61106 Clark Rubber Filtrite for Family Pools Eezy Sanitiser Clark Rubber Franchising Pty Ltd 61106/59508 61106/0606 64278 Nature Spa Spa Water Treatment & Sanitiser Enviro Spa & Pool Pty Ltd 64278/0909 64823 Clark Rubber Filtrite Eezy Sanitiser Clark Rubber Franchising Pty Ltd 64823/50208 66624 Crystal Waters Spa Sanitiser M I International Pty Ltd T/A Chemicals 66624/56198 66624/54048 66943 Crystal Waters Pool Sanitiser M I International Pty Ltd T/A Chemicals 66943/57122 66943/54752 68964 Filtrite Sanit-Eezy Eezy Sanitiser for Spas Spa Sanitiser Clark Rubber Franchising pty Ltd 68964/59507 82162 Spa Soft Spa Sanitiser M I International Pty Ltd T/A Chemicals 82162/105117
APPENDIX II: STANDARD TEST PARAMETERS Haematology Clinical chemistry Urinalysis Activated Partial Thromboplastin Time Erythrocyte Count Haematocrit Haemoglobin MCV MCH MCHC Leucocyte Count (total and differential) Platelet Count Prothrombin Time Alanine Aminotransferase Albumin Alkaline Phosphatase Aspartate Aminotransferase Bilirubin (total) Blood/Serum Urea Nitrogen Calcium Chloride Cholesterol Creatinine Globulin Glucose Potassium Phosphorous Protein (total) Sodium Triglycerides Lactate dehydrogenase Bilirubin Colour Glucose Ketones Microscopic Sediment Occult Blood PH Protein Specific Gravity Turbidity Urine chemistry Organs weighed Tissues examined histopathologically Calcium Chloride Creatinine Creatinine Ratio (protein: urinary) Fractional Clearance of: Calcium Chloride Phosphorous Potassium Sodium Phosphorous Potassium Adrenals Brain Kidneys Liver Pituitary Thyroid and parathyroid Lungs Heart Thymus Spleen Testes/ovaries Epididymides Prostate Adrenal Gland(s) Aorta Brain Caecum Cervix Colon Duodenum Epididymis (ides) Eye (s) Fallopian Tubes Femur (and marrow) Gall Bladder Heart Ovary (ies) Pancreas Parathyroid Gland Pituitary Gland Prostate Gland Rectum Salivary Gland Sciatic Nerve Seminal Vesicle(s) Skeletal Muscle Skin Spinal Cord Spleen
Protein Sodium Uterus Salivary gland Ileum Jejunum Kidney (s) Liver Lung (s) Lymph Node (s) Mammary Gland (s) Oesophagus Optic Nerve (s) Sternum (and marrow) Stomach Testis (es) Thymus Gland Thyroid Gland (s) Trachea Urinary Bladder Uterus Vagina
Veterinary products—surface, equipment, air space and animal housing disinfectants 54149 F10SC Veterinary Disinfectant Health & Hygiene Pty Ltd 4 g/L (1 L, 5 L, 25 L) Benzalkonium chloride 54 g/L 54149/0502 59720 F10SCXD Veterinary Disinfectant Cleanser Health & Hygiene Pty Ltd 4 g/L (100 mL, 200 mL, 1 L, 5 L 25 L) Benzalkonium chloride 54 g/L 59720/1105 59998 Trigene II Virucidal Disinfectant Concentrate Ceva Animal Health Pty Ltd (formerly Delvet Pty Ltd) 1.0 g/L (1 L, 5 L, 20 L) Didecyl dimethyl ammonium chloride (DDAC) 75 g/L, benzalkonium chloride 50 g/L 59998/0906 62103 Microtech 7000 General Purpose Disinfectant Chemetall (Australasia) Pty Ltd 4 g/L (5 L, 20 L) Benzalkonium chloride 54 g/L 62103/0508 70073 Safe4 Disinfectant Cleaner Concentrate Safe4 All (Aust) Pty Ltd 4 g/L Benzalkonium chloride 54 g/L 70073/106951 70073/62442 Veterinary products—germicidal products for topical application 58543 F10 Germicidal Treatment Shampoo Health & Hygiene Pty Ltd 0.3 g/L (250 mL, 500 mL, 5 L) Benzalkonium chloride 4.05 g/L 58543/0207 58543/0904 58544 F10 Germicidal Barrier Ointment Health & Hygiene Pty Ltd 0.3 g/L (25 g, 100 g, 500 g) Benzalkonium chloride 4.05 g/L 58544/1105 58544/0904 60080 Dermcare Otoflush Dermcare-Vet Pty Ltd 2 g/L (75 mL, 125 mL, 250 mL) Disodium edetate 1.2 g/L 60080/0407
IIA 5.2—Acute toxicity A summary of the results of acute toxicity studies conducted on polihexanide is provided in the table below. There were no studies available for acute oral or acute inhalational toxicity or dermal sensitisation. Table 3: Summary of acute toxicity of polihexanide Study Physical form and purity Species Results (mg/kg bw) Reference Polihexanideequivalent Acute oral Vantocil P (20% solution) Rat 2747 (M), 2504 (F) LD50=549 (M), 501 (F) Jackson (1979) Acute dermal Pale yellow solid powder 96.0% Rat – LD50 > 5000 mg/kg bw (no deaths) Driscoll (2003a) Vantocil P (20% solution) Rabbit >2000 (no deaths) >400 (no deaths) Jackson (1979) Baquacil SB® (20% + dye + fragrance)* Rat >5000 (no deaths) >1000 (no deaths) Trueman & Eaton (1977) Eye irritation Pale yellow solid powder 96.0% Rabbit Severe Driscoll (2003c) Vantocil IB (20%) Rabbit Severe Jackson & Nixon (1981) 25% formulation* Rabbit Corrosive Anon (1966) Dermal irritation Pale yellow solid powder 96.0% Rabbit (4 h) Slight Driscoll (2003b) Baquacil SB® (20% + dye + fragrance)* Rat (24 h) Severe Trueman & Eaton (1977) 25% formulation* Rat (24 h) Corrosive Anon (1966) Sensitisation 20% solution Guinea pig 20% moderate, 6% mild Duerden (1993) * These may in fact be a product with other constituents, but are included here for comparison. Formulation details not provided to the review. None of these tradenames are registered for use in Australia. Shaded studies are those of highest regulatory value, due to test guideline compliance.
Scars 2.5 4 M3 F1 9 M6 F3 5.0 1 F1 5 M3 F2 13 M5 F8 Desquamation 2.5 3 M2 F1 8 M2 F6 12 M6 F6 17 M8 F9 17 M9 F8 5.0 6 M3 F3 5 M2 F3 6 M1 F5 Other clinical signs Subdued (slight) 2.5 1 M1* 3 M1 F2 1 M1 1 M1 1 M1 5.0 1 M1 3 M3 3 M2 F1 2 M2 Hunched (slight) 2.5 20 M10 F10 16 M8 F 8 5 M3 F2 5 M3 F2 1 M1 1 M1 5.0 1 M1 7 M2 F5 15 M7 F8 8 M4 F4 8 M4 F4 1 M1 1 M1 1 M1 Salivating 2.5 5.0 3 M3 Piloerection 2.5 10M6 F4 7M3 F4 5.0 3 F3 2 F2 Red stain (mouth) 2.5 5.0 1 F1 Incontinence 2.5 1 M1* 1 M1 1 M1 1 M1 5.0 4 2 2