RESULTS Group Number and Sex Dose Mortality of Animals mg/kg bw 5 2000 None 5 females 2000 None LD50 2000 mg/kg bw of Toxicity - Local Necrosis was observed in 7 out of 10 animals. Erythema and oedema were observed in all the test sites and persisted for the first 7 days Signs of Toxicity - Systemic None Effects in Organs None Remarks - Results The notified chemical was corrosive as necrosis was observed in 7 out of 10 application sites CONCLUSION The notified chemical is of low toxicity via the dermal route. TEST FACILITY Toxickon Corporation (2001b) toxicity inhalation – Remarks Not provided Irritation skin – TEST SUBSTANCE Notified chemical METHOD OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation) USEPA 40/798. Species/Strain Rabbit/New Zealand White Number of Animals 3 (2 males and 1 female) Vehicle None Observation Period Not known Type of Dressing Semi-occlusive. Remarks - Method Four topical application to intact skin RESULTS Maximum Maximum at Lesion Mean Value End of Animal No. Maximum Observation Duration of Any Period 1 2 3 Effect 0.67 0.67 0.67 1 48 hours 0 Erythema/Eschar 0 0 0 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well defined erythema was observed in all rabbits (3) after 1 hour of application. All rabbits exhibited very slight erythema at both 24 and 48 hour observation periods. The irritation was reversed with no signs of erythema present at the 72 hour observation. CONCLUSION The notified chemical is slightly irritating to skin. TEST FACILITY Toxikon Corporation (2001c) Irritation eye –
RESULTS Group Number and Sex of Animals Dose mg/kg bw Mortality 5 2000 None 5 females 2000 None LD50 2000 mg/kg bw of Toxicity - Local Necrosis was observed in 7 out of 10 animals. Erythema and oedema were observed in all the test sites and persisted for the first 7 days Signs of Toxicity - Systemic None Effects in Organs None Remarks - Results The notified chemical was corrosive as necrosis was observed in 7 out of 10 application sites CONCLUSION The notified chemical is of low toxicity via the dermal route. TEST FACILITY Toxickon Corporation (2001b) toxicity – inhalation Remarks Not provided Irritation – skin TEST SUBSTANCE Notified chemical METHOD OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation) USEPA 40/798. Species/Strain Rabbit/New Zealand White Number of Animals 3 (2 males and 1 female) Vehicle None Observation Period Not known Type of Dressing Semi-occlusive. Remarks - Method Four topical application to intact skin RESULTS Lesion Mean Animal No. 1 2 3 Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period Erythema/Eschar 0.67 0.67 0.67 1 48 hours 0 Oedema 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well defined erythema was observed in all rabbits (3) after 1 hour of application. All rabbits exhibited very slight erythema at both 24 and 48 hour observation periods. The irritation was reversed with no signs of erythema present at the 72 hour observation. CONCLUSION The notified chemical is slightly irritating to skin. TEST FACILITY Toxikon Corporation (2001c) Irritation – eye
STD1023FR.docx