Number and Sex Dose Mortality of Animals mg/kg bw I 5 per sex 600 0 II (Control) 5 per sex 0 0 LD50 > 600 mg/kg bw Signs of Toxicity No clinical signs were noted up to 2 hours after the initial administration of the test substance. After 4 hours, hypocinesia was observed in all the animals treated with the test substance. The general behaviour and body weight of the animals were not influenced by the treatment after 24 hours and to day 15. Effects in Organs Macroscopic examination of the animals sacrificed at the end of the revealed no abnormalities. The notified biopolymer is of low toxicity via the oral route up to maximum practicable dose tested. Rhone-Poulenc (1988a) 7.1.2. Acute toxicity oral – Notified biopolymer OECD TG 401 Acute Oral Toxicity. Species/Strain Mice/Swiss Crl CD-1 Vehicle Water Remarks Method Statement of GLP. No significant deviations from standard protocol. – The dose 600 mg/kg, corresponded to the maximum dose level it was technically possible to administer. The dose was given over a period of 5 hours in 3 equal fractions, each in a volume of 20 ml/kg. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 per sex 600 0 Control 5 males and 5 females - 0 LD50 > 600 mg/kg bw Signs of Toxicity General behaviour and body weight of the animals were not influenced by the treatment. Effects in Organs Macroscopic examination of animals sacrificed at the end of the revealed no abnormalities. Remarks Results – The notified biopolymer is of low toxicity via the oral route. Rhone-Poulenc (1988b) 7.2. Acute toxicity dermal – Not determined. The biopolymer has a high molecular weight and is unlikely to pass biological membranes. Daily application of a 1% solution of xanthan gum for 15 days to rat skin produced no sign of irritation (JECFA (2006)). 7.3. Acute toxicity inhalation – Xanthan gum - analogue
Number and Sex of Animals Dose mg/kg bw Mortality I 5 per sex 600 0 II (Control) 5 per sex 0 0 LD50 > 600 mg/kg bw Signs of Toxicity No clinical signs were noted up to 2 hours after the initial administration of the test substance. After 4 hours, hypocinesia was observed in all the animals treated with the test substance. The general behaviour and body weight of the animals were not influenced by the treatment after 24 hours and to day 15. Effects in Organs Macroscopic examination of the animals sacrificed at the end of the revealed no abnormalities. The notified biopolymer is of low toxicity via the oral route up to maximum practicable dose tested. Rhone-Poulenc (1988a) 7.1.2. Acute toxicity – oral Notified biopolymer OECD TG 401 Acute Oral Toxicity. Species/Strain Mice/Swiss Crl CD-1 Vehicle Water Remarks – Method Statement of GLP. No significant deviations from standard protocol. The dose 600 mg/kg, corresponded to the maximum dose level it was technically possible to administer. The dose was given over a period of 5 hours in 3 equal fractions, each in a volume of 20 ml/kg. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 per sex 600 0 Control 5 males and 5 females - 0 LD50 > 600 mg/kg bw Signs of Toxicity General behaviour and body weight of the animals were not influenced by the treatment. Effects in Organs Macroscopic examination of animals sacrificed at the end of the revealed no abnormalities. Remarks – Results The notified biopolymer is of low toxicity via the oral route. Rhone-Poulenc (1988b) 7.2. Acute toxicity – dermal Not determined. The biopolymer has a high molecular weight and is unlikely to pass biological membranes. Daily application of a 1% solution of xanthan gum for 15 days to rat skin produced no sign of irritation (JECFA (2006)). 7.3. Acute toxicity – inhalation Xanthan gum - analogue
STD1194FR.docx