The notified chemical is slightly irritating to the eye. CIT 7.6. Skin sensitisation mouse local lymph node assay (LLNA) – Notified chemical. OECD TG 406 Skin Sensitisation. OECD Draft New Guideline 429 Skin Sensitisation: Local Lymph Node Assay. EC Directive 96/54/EC B.6 Skin Sensitization. Species/Strain Mouse/CBA/J Vehicle Ethanol:Water::1:1 Proliferative response Stimulation Index Concentration (DPM/lymph node) (Test/Control Ratio) Test Substance 0 125.14 0.5% 92.35 0.74 1% 127.13 1.02 2.5% 136.71 1.09 5% 134.42 1.07 10% 103.70 0.83 Positive Control HCA at 25% 799.09 6.39 There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. CIT (2002e). 7.7. Repeat dose toxicity Notified chemical. OECD TG 407 Repeated Dose 28-day Oral Toxicity in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Sprague-Dawley. Route of Administration Oral gavage. – Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week. Vehicle Purified water. Group Number and Sex Dose Mortality of Animals mg/kg bw/day I (control) 5/sex 0 None II (low dose) 150 “ “ III (mid dose) 450 1/10 “ IV (high dose) 1000 None “ V (control recovery) 0 “ “
The notified chemical is slightly irritating to the eye. CIT 7.6. Skin sensitisation – mouse local lymph node assay (LLNA) Notified chemical. OECD TG 406 Skin Sensitisation. OECD Draft New Guideline 429 Skin Sensitisation: Local Lymph Node Assay. EC Directive 96/54/EC B.6 Skin Sensitization. Species/Strain Mouse/CBA/J Vehicle Ethanol:Water::1:1 Concentration Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 0 125.14 0.5% 92.35 0.74 1% 127.13 1.02 2.5% 136.71 1.09 5% 134.42 1.07 10% 103.70 0.83 Positive Control HCA at 25% 799.09 6.39 There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. CIT (2002e). 7.7. Repeat dose toxicity Notified chemical. OECD TG 407 Repeated Dose 28-day Oral Toxicity in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Sprague-Dawley. Route of Administration Oral – gavage. Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week. Vehicle Purified water. Group Number and Sex of Animals Dose mg/kg bw/day Mortality I (control) 5/sex 0 None II (low dose) “ 150 “ III (mid dose) “ 450 1/10 IV (high dose) “ 1000 None V (control recovery) “ 0 “