Appendix B: Toxicological Investigations Acute toxicity oral – Notified polymer (approximately 19 wt% aqueous solution) OECD TG 425 Acute Oral Toxicity: Up-and-Down Procedure Species/Strain Rat/Crl:CD(SD) Vehicle None administered as supplied – Remarks - Method No significant protocol deviations. Group Number and Sex Dose of test substance Mortality of Animals mg/kg bw 1 1F 175 0/1 2 1F 550 0/1 3 1F 1,750 0/1 4 1F 5,000 0/1 5 1F 5,000 0/1 6 1F 5,000 0/1 LD50 >5,000 mg test substance/kg bw (> 1,000 mg notified polymer/kg bw) Signs of Toxicity None Effects in Organs None The test substance containing the notified polymer at approximately 19 wt% concentration is of low toxicity via the oral route. DuPont (2008a) Acute toxicity inhalation – Notified polymer (approximately at 20 % concentration) Similar to OECD TG 403 Acute Inhalation Toxicity Species/Strain Rat/Crl:CD(SD) Vehicle None administered as supplied – Method of Exposure Nose-only exposure Exposure Period 4 hours Physical Form Liquid aerosol Particle Size MMAD±GSD = 4.0±3.2 and 3.8±3.9 µm for groups 2 and 3, respectively. Remarks - Method A control group was exposed to air. Two control animals were sacrificed 1 day post-exposure with the remaining two sacrificed 14 days The dosed groups were maintained until death or until 14 days post-exposure. All surviving rats were sacrificed on day 14 by carbon dioxide asphyxiation. Microscopic examination of the lungs was conducted on the control and Group 3 animals. Group Number and Sex Concentration Mortality of Animals mg/m3 Total Dry aerosol aerosol1 1 4 M 0 0 0/4 2 5 M 2,200* 1,200 0/5 3 10 M 4,700** 1,700 8/10 *MMAD±GSD: 4.0 ± 3.2m (78% particles by mass <
Appendix B: Toxicological Investigations Acute toxicity – oral Notified polymer (approximately 19 wt% aqueous solution) OECD TG 425 Acute Oral Toxicity: Up-and-Down Procedure Species/Strain Rat/Crl:CD(SD) Vehicle None – administered as supplied Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose of test substance mg/kg bw Mortality 1 1F 175 0/1 2 1F 550 0/1 3 1F 1,750 0/1 4 1F 5,000 0/1 5 1F 5,000 0/1 6 1F 5,000 0/1 LD50 >5,000 mg test substance/kg bw (> 1,000 mg notified polymer/kg bw) Signs of Toxicity None Effects in Organs None The test substance containing the notified polymer at approximately 19 wt% concentration is of low toxicity via the oral route. DuPont (2008a) Acute toxicity – inhalation Notified polymer (approximately at 20 % concentration) Similar to OECD TG 403 Acute Inhalation Toxicity Species/Strain Rat/Crl:CD(SD) Vehicle None – administered as supplied Method of Exposure Nose-only exposure Exposure Period 4 hours Physical Form Liquid aerosol Particle Size MMAD±GSD = 4.0±3.2 and 3.8±3.9 µm for groups 2 and 3, respectively. Remarks - Method A control group was exposed to air. Two control animals were sacrificed 1 day post-exposure with the remaining two sacrificed 14 days The dosed groups were maintained until death or until 14 days post-exposure. All surviving rats were sacrificed on day 14 by carbon dioxide asphyxiation. Microscopic examination of the lungs was conducted on the control and Group 3 animals. Group Number and Sex of Animals Concentration mg/m3 Mortality Total aerosol Dry aerosol1 1 4 M 0 0 0/4 2 5 M 2,200* 1,200 0/5 3 10 M 4,700** 1,700 8/10 *MMAD±GSD: 4.0 ± 3.2m (78% particles by mass <
EX190-LTD1498-FR-Final.DOCX