Appendix B: Toxicological Investigations Acute toxicity oral – SUBSTANCE Notified polymer (>90%) OECD TG 420 Acute Oral Toxicity - Fixed Dose Method. EC Directive2004/73/EC B.1 bis Acute Toxicity (Oral) Fixed Dose Method. Species/Strain Rat/Wistar, female Vehicle Corn oil Remarks - Method No significant protocol deviations. All animals were dosed by gavage. The sighting study was conducted using 1 animal dosed at 300 mg/kg bw and 1 animal dosed at 2000 mg/kg. As there were no mortalities an additional four animals were dosed at 2000 mg/kg bw. RESULTS Discriminating Dose >2000 mg/kg bw Signs of Toxicity There were no deaths. No signs of systemic toxicity were noted. Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified polymer is of low toxicity via the oral route. JRF (2009a) Acute toxicity dermal – Notified polymer (>90%) OECD TG 402 Acute Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rat/Wistar Vehicle Test substance moistened with distilled water Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 per sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local There were no clinical signs and no cutaneous lesions Signs of Toxicity - Systemic There were no deaths and no clinical signs of systemic toxicity Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified polymer is of low toxicity via the dermal route. JRF (2009b) Irritation skin – Mexomere PAS (<60% notified polymer) 2 Batches diluted to give a – final concentration of <33% notified polymer.
Appendix B: Toxicological Investigations Acute toxicity – oral Notified polymer (>90%) OECD TG 420 Acute Oral Toxicity - Fixed Dose Method. EC Directive2004/73/EC B.1 bis Acute Toxicity (Oral) Fixed Dose Method. Species/Strain Rat/Wistar, female Vehicle Corn oil Remarks - Method No significant protocol deviations. All animals were dosed by gavage. The sighting study was conducted using 1 animal dosed at 300 mg/kg bw and 1 animal dosed at 2000 mg/kg. As there were no mortalities an additional four animals were dosed at 2000 mg/kg bw. Discriminating Dose >2000 mg/kg bw Signs of Toxicity There were no deaths. No signs of systemic toxicity were noted. Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified polymer is of low toxicity via the oral route. JRF (2009a) Acute toxicity – dermal Notified polymer (>90%) OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rat/Wistar Vehicle Test substance moistened with distilled water Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 per sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity - Local There were no clinical signs and no cutaneous lesions Signs of Toxicity - Systemic There were no deaths and no clinical signs of systemic toxicity Effects in Organs No abnormalities were noted at necroscopy Remarks - Results Body weight gains were as expected. The notified polymer is of low toxicity via the dermal route. JRF (2009b) Irritation – skin Mexomere PAS (<60% notified polymer) – 2 Batches diluted to give a final concentration of <33% notified polymer. SUBSTANCE RESULTS