Proliferative response Stimulation Index Concentration (% w/w) in (DPM/lymph node) (Test/Control Ratio) dimethyl sulphoxide Test Substance 5 1166.97 1.77 10 1153.09 1.75 25 943.13 1.43 Vehicle control: 659.94 Not applicable Dimethyl sulphoxide Proliferative response Stimulation Index Concentration (% v/v) in (DPM/lymph node) (Test/Control acetone/olive oil 4:1 Positive control: -hexylcinnamaldehyde 5 - 2.8 10 - 2.3 25 - 5.5 - proliferative response not provided Remarks - Results No deaths occurred. Blue staining of the fur was noted in all test animals during the study. No signs of systemic toxicity were noted during the study. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. Safepharm Laboratories (2003i) 7.7. Repeat dose toxicity Notified chemical Similar to OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. Species/Strain Rat/Wistar Route of Administration Oral gavage – Exposure Information Total exposure days: 28 days; Post-exposure observation period: 14 days (high dose and control groups) Vehicle Water Remarks - Method Additional 14-day recovery groups were also included for high dose and control groups. Group Number and Sex Dose Mortality of Animals mg/kg bw/day I (control) 5/sex 0 0 II (low dose) 5/sex 100 0 III (mid dose) 5/sex 300 0 IV (high dose) 5/sex 1000 0 V (control recovery) 5/sex 0 0 VI (high dose recovery) 5/sex 1000 0 Mortality and Time to Death No mortalities were observed.
Concentration (% w/w) in dimethyl sulphoxide Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 5 1166.97 1.77 10 1153.09 1.75 25 943.13 1.43 Vehicle control: Dimethyl sulphoxide 659.94 Not applicable Concentration (% v/v) in acetone/olive oil 4:1 Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Positive control: -hexylcinnamaldehyde 5 - 2.8 10 - 2.3 25 - 5.5 - proliferative response not provided Remarks - Results No deaths occurred. Blue staining of the fur was noted in all test animals during the study. No signs of systemic toxicity were noted during the study. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. Safepharm Laboratories (2003i) 7.7. Repeat dose toxicity Notified chemical Similar to OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. Species/Strain Rat/Wistar Route of Administration Oral – gavage Exposure Information Total exposure days: 28 days; Post-exposure observation period: 14 days (high dose and control groups) Vehicle Water Remarks - Method Additional 14-day recovery groups were also included for high dose and control groups. Group Number and Sex of Animals Dose mg/kg bw/day Mortality I (control) 5/sex 0 0 II (low dose) 5/sex 100 0 III (mid dose) 5/sex 300 0 IV (high dose) 5/sex 1000 0 V (control recovery) 5/sex 0 0 VI (high dose recovery) 5/sex 1000 0 Mortality and Time to Death No mortalities were observed.
STD1093FR.docx