Repeat dose toxicity Not determined Genotoxicity - bacterial reverse mutation Non mutagenic Genotoxicity in vitro Not determined – Cytotoxicity study (ISO Elution Method) No evidence of cell lysis or toxicity 7.1. (a) Acute toxicity oral – Zonatac Alternate #1 (ASL 5263) Study 8219A 10/30/84 Stated as OECD method. Analogous to TG 401 Acute Oral Toxicity – Limit test Species/Strain Rat/Sprague-Dawley Vehicle Corn oil Remarks Method Gavage – Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 10.0 g/kg None LD50 > 10.0 g/kg bw of Toxicity Diarrhoea in 5/5 males and 2/5 females, which reversed by day 3. Salivation in 3/5 males and 1/5 females on day 1 only. Wet abdomen in 3/5 males and 3/5 females, which reversed by day 3. 1/5 males experience hair loss and a sore on a hind leg from day 6 onwards. Reduced activity and increased respiratory rate in 1/5 females was observed from day 4 to end of the observation period. Effects in Organs The female rat in persistent clinical signs were observed was found at necropsy to have abscessed lobes of the lung which adhered to the rib cage. Remarks Results Abscessed lung in 1/5 females and hair loss/sore on leg in 1/5 males are – likely to be unrelated to the test substance. The notified chemical is of low acute toxicity via the oral route. Food and Drug Research Laboratories (1984a) 7.1. (b) toxicity oral – Zonatac Alternate #1 Lite (ASL 5264) Study 8219B 10/30/84 Method analogous to OECD TG 401 Acute Oral Toxicity Limit test. – Species/Strain Rat/Sprague-Dawley Vehicle Corn oil 25% solution Remarks Method Gavage. Observations carried out to Day 15. – Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 10g/kg None
Repeat dose toxicity Not determined Genotoxicity - bacterial reverse mutation Non mutagenic Genotoxicity – in vitro Not determined Cytotoxicity study (ISO Elution Method) No evidence of cell lysis or toxicity 7.1. (a) Acute toxicity – oral Zonatac Alternate #1 (ASL 5263) Study 8219A 10/30/84 Stated as OECD method. Analogous to TG 401 Acute Oral Toxicity – Limit test Species/Strain Rat/Sprague-Dawley Vehicle Corn oil Remarks – Method Gavage Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 10.0 g/kg None LD50 > 10.0 g/kg bw of Toxicity Diarrhoea in 5/5 males and 2/5 females, which reversed by day 3. Salivation in 3/5 males and 1/5 females on day 1 only. Wet abdomen in 3/5 males and 3/5 females, which reversed by day 3. 1/5 males experience hair loss and a sore on a hind leg from day 6 onwards. Reduced activity and increased respiratory rate in 1/5 females was observed from day 4 to end of the observation period. Effects in Organs The female rat in persistent clinical signs were observed was found at necropsy to have abscessed lobes of the lung which adhered to the rib cage. Remarks – Results Abscessed lung in 1/5 females and hair loss/sore on leg in 1/5 males are likely to be unrelated to the test substance. The notified chemical is of low acute toxicity via the oral route. Food and Drug Research Laboratories (1984a) 7.1. (b) toxicity – oral Zonatac Alternate #1 Lite (ASL 5264) Study 8219B 10/30/84 Method analogous to OECD TG 401 Acute Oral Toxicity – Limit test. Species/Strain Rat/Sprague-Dawley Vehicle Corn oil 25% solution Remarks – Method Gavage. Observations carried out to Day 15. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 10g/kg None
STD-1065-FR-final-270404.docx