adjuvant method Non sensitising; non-adjuvant method Mildly sensitising. Repeat Dose Oral, gavage 28 day Rat NOAEL 100 mg/kg/day Oral, drinking water 14 day Rat NOAEL 500 mg/kg/day palatability study Oral, drinking water 28 day Rat 500 mg/kg/day Inhalation, 2 week Rat NOAEL 70 ppm Inhalation, 13 week Rat NOAEL 50 ppm Developmental Probe study, oral, gavage Rat maternal toxicity 100 mg/kg/day; NOAEL, developmental effects,500 mg/kg/day. Oral, gavage Rabbit NOAEL, maternal toxicity, 100 mg/kg/day. NOAEL, developmental effects, 250 mg/kg/day Inhalation Rat NOAEL, maternal toxicity & developmental effects, 225 ppm. Reproduction Oral, drinking water, Rat Parental NOAEL, systemic effects, 2-generation 50 mg/kg/day; NOAEL, reproductive effects, 1000 mg/kg/day; NOAEL, neonatal toxicity 250 mg/kg/day. Genotoxicity Reverse mutation Non-mutagenic S. typhimurium Forward mutation CHO cells Non-mutagenic Chromosomal aberration, Lymphocytes Non-clastogenic in vitro Induction of micronuclei, Mouse Non-clastogenic in vivo 9.1 Acute Toxicity 9.1.1 Oral Toxicity (RCC-NOTOX 1989e) Rat/Wistar Species/strain: 5/sex/dose Number/sex of animals: 14 days Observation period: 2000, 2800, 3750, or 5000 mg/kg by oral gavage, administered in Method of administration: dose volumes of 2.21, 3.09, 4.14, 5.13 mL/kg, respectively. OECD TG 401; EC Method B1 Test method: 2 000 mg/kg: 1 male; Mortality: 2 800 mg/kg: 1 male, 2 females;
adjuvant method non-adjuvant method Non sensitising; Mildly sensitising. Repeat Dose Oral, gavage 28 day Rat NOAEL 100 mg/kg/day Oral, drinking water 14 day palatability study Rat NOAEL 500 mg/kg/day Oral, drinking water 28 day Rat 500 mg/kg/day Inhalation, 2 week Rat NOAEL 70 ppm Inhalation, 13 week Rat NOAEL 50 ppm Developmental Probe study, oral, gavage Rat maternal toxicity 100 mg/kg/day; NOAEL, developmental effects,500 mg/kg/day. Oral, gavage Rabbit NOAEL, maternal toxicity, 100 mg/kg/day. NOAEL, developmental effects, 250 mg/kg/day Inhalation Rat NOAEL, maternal toxicity & developmental effects, 225 ppm. Reproduction Oral, drinking water, 2-generation Rat Parental NOAEL, systemic effects, 50 mg/kg/day; NOAEL, reproductive effects, 1000 mg/kg/day; NOAEL, neonatal toxicity 250 mg/kg/day. Genotoxicity Reverse mutation S. typhimurium Non-mutagenic Forward mutation CHO cells Non-mutagenic Chromosomal aberration, in vitro Lymphocytes Non-clastogenic Induction of micronuclei, in vivo Mouse Non-clastogenic 9.1 Acute Toxicity 9.1.1 Oral Toxicity (RCC-NOTOX 1989e) Species/strain: Rat/Wistar Number/sex of animals: 5/sex/dose Observation period: 14 days Method of administration: 2000, 2800, 3750, or 5000 mg/kg by oral gavage, administered in dose volumes of 2.21, 3.09, 4.14, 5.13 mL/kg, respectively. Test method: OECD TG 401; EC Method B1 Mortality: 2 000 mg/kg: 1 male; 2 800 mg/kg: 1 male, 2 females;