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 Results (mg/kg bw) Reference Physical form Study Species and purity Polihexanideequivalent Vantocil P (20% 2747 (M), Jackson Acute oral Rat LD50=549 (M), 501 (F) solution) 2504 (F) (1979) Pale yellow solid LD50 > 5000 mg/kg bw Driscoll Rat – powder 96.0% (no deaths) (2003a) Vantocil P (20% >2000 (no Jackson Rabbit >400 (no deaths) Acute dermal solution) deaths) (1979) Baquacil SB® >5000 (no Trueman & (20% + dye + Rat >1000 (no deaths) deaths) Eaton (1977) fragrance)* Pale yellow solid Driscoll Rabbit Severe powder 96.0% (2003c) Vantocil IB Jackson & Eye irritation Rabbit Severe (20%) Nixon (1981) 25% Rabbit Corrosive Anon (1966) formulation* Pale yellow solid Rabbit Driscoll Slight powder 96.0% (4 h) (2003b) Baquacil SB® Rat Trueman & Dermal (20% + dye + Severe Eaton (1977) irritation (24 h) fragrance)* 25% Rat Corrosive Anon (1966) formulation* (24 h) 20% solution 20% moderate, Guinea Duerden Sensitisation pig (1993) 6% mild * 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.
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.
28861-human_health_risk_assessment_of_polihexanide_1_1_updated_2200118-final_0.docx