Remarks - Results Very slight erythema was noted for 2 of the test animals immediately after patch removal, with symptoms persisting in 1 of these animals at the 1 hour observations. All treated skin sites appeared normal at the 24 hour observation. The notified chemical is slightly irritating to the skin. Harlan (2013j) Irritation eye (in vitro) – Notified chemical (20% w/v dilution). OECD TG 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants. Controls Negative/Vehicle: 0.9% sodium chloride. Positive: 20% w/v Imidazole. Remarks - Method No significant protocol deviations. GLP Compliance. Negative and positive control items were tested concurrently. Test material Mean opacities of triplicate Mean permeabilities of IVIS (SD) tissues (SD) triplicate tissues (SD) 2.7 0.037 3.2 Vehicle control 1.6 0.009 1.7 Test substance* 52.0 1.44 73.6 Positive control* SD = Standard deviation; IVIS = in vitro irritancy score *Corrected for background values Remarks - Results The corneas treated with the test item and negative control were clear whereas the corneas treated with the positive control were cloudy. The controls gave satisfactory responses confirming the validity of the test system. The notified chemical was not corrosive or a severe eye irritant under the conditions of the test. Harlan (2013k) Irritation eye – Notified chemical. OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White. Number of Animals 3 Males. Observation Period 3 days. Remarks - Method No significant protocol deviations. GLP Compliance. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect
Remarks - Results Very slight erythema was noted for 2 of the test animals immediately after patch removal, with symptoms persisting in 1 of these animals at the 1 hour observations. All treated skin sites appeared normal at the 24 hour observation. The notified chemical is slightly irritating to the skin. Harlan (2013j) Irritation – eye (in vitro) Notified chemical (20% w/v dilution). OECD TG 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants. Controls Negative/Vehicle: 0.9% sodium chloride. Positive: 20% w/v Imidazole. Remarks - Method No significant protocol deviations. GLP Compliance. Negative and positive control items were tested concurrently. Test material Mean opacities of triplicate tissues (SD) Mean permeabilities of triplicate tissues (SD) IVIS (SD) Vehicle control 2.7 0.037 3.2 Test substance* 1.6 0.009 1.7 Positive control* 52.0 1.44 73.6 SD = Standard deviation; IVIS = in vitro irritancy score *Corrected for background values Remarks - Results The corneas treated with the test item and negative control were clear whereas the corneas treated with the positive control were cloudy. The controls gave satisfactory responses confirming the validity of the test system. The notified chemical was not corrosive or a severe eye irritant under the conditions of the test. Harlan (2013k) Irritation – eye Notified chemical. OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White. Number of Animals 3 Males. Observation Period 3 days. Remarks - Method No significant protocol deviations. GLP Compliance. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period