Remarks - Results All male animals and two surviving female animals exhibited body weight losses on the first day post-exposure. Two male animals and two surviving female animals showed further body weight losses or no body weight gains from day 1 to 3 post-exposure. Reasonable body weight gains were observed in all surviving animals during the remainder of the recovery period except one female animal exhibited no body weight gain during the final week of recovery. The test substance is of low toxicity via inhalation. Harlan (2013) Irritation skin – Mixture of notified chemicals OECD TG 404 Acute Dermal Irritation/Corrosion (2002). EC Council Regulation No 440/2008 B.4 Acute Toxicity (Skin Irritation). EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New White Number of Animals 3 M Vehicle None Observation Period 14 days Type of Dressing Semi-occlusive. Remarks - Method GLP Certificate. No protocol deviations. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 1.67 2 1.33 2 < 14 d 0 Erythema/Eschar 0.33 0.33 0.33 2 < 48 h 0 Oedema * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No deaths occurred during the study. No clinical signs or stating of the treated skin was noted. The body weight was within the usual range. No necropsy was performed. Well-defined erythema was observed in all animals at the 1- and 24-hour reading. The erythema persisted as very slight to slight in all three animals up to the 72 hours before disappearing from 7 to 14 days after the treatment. Slight oedema at the 1-hour reading to very slight oedema at the 48-hour reading were observed in all animals. Scaling appeared in all animals 10 and 14 days after treatment. The scaling was moderate for one animal and severe for two animals 10 days after treatment and decreased on the last day of observation to be slight for one animal and moderate for two animals. The test substance is irritating to the skin. Harlan (2011e) Irritation eye – Mixture of notified chemicals OECD TG 405 Acute Eye Irritation/Corrosion (2002). EC Council Regulation No 440/2008 B.5 Acute Toxicity (Eye Irritation).
Remarks - Results All male animals and two surviving female animals exhibited body weight losses on the first day post-exposure. Two male animals and two surviving female animals showed further body weight losses or no body weight gains from day 1 to 3 post-exposure. Reasonable body weight gains were observed in all surviving animals during the remainder of the recovery period except one female animal exhibited no body weight gain during the final week of recovery. The test substance is of low toxicity via inhalation. Harlan (2013) Irritation – skin Mixture of notified chemicals OECD TG 404 Acute Dermal Irritation/Corrosion (2002). EC Council Regulation No 440/2008 B.4 Acute Toxicity (Skin Irritation). EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New White Number of Animals 3 M Vehicle None Observation Period 14 days Type of Dressing Semi-occlusive. Remarks - Method GLP Certificate. No protocol deviations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 1.67 2 1.33 2 < 14 d 0 Oedema 0.33 0.33 0.33 2 < 48 h 0 * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No deaths occurred during the study. No clinical signs or stating of the treated skin was noted. The body weight was within the usual range. No necropsy was performed. Well-defined erythema was observed in all animals at the 1- and 24-hour reading. The erythema persisted as very slight to slight in all three animals up to the 72 hours before disappearing from 7 to 14 days after the treatment. Slight oedema at the 1-hour reading to very slight oedema at the 48-hour reading were observed in all animals. Scaling appeared in all animals 10 and 14 days after treatment. The scaling was moderate for one animal and severe for two animals 10 days after treatment and decreased on the last day of observation to be slight for one animal and moderate for two animals. The test substance is irritating to the skin. Harlan (2011e) Irritation – eye Mixture of notified chemicals OECD TG 405 Acute Eye Irritation/Corrosion (2002). EC Council Regulation No 440/2008 B.5 Acute Toxicity (Eye Irritation).