Group Number and Sex of Animals Dose (mg/kg bw) Mortality 1 5 M 2,000 0/5 2 5 F 2,000 0/5 LD50 > 2,000 mg/kg bw Signs of Toxicity - Local Irritation signs including erythema, oedema, desquamation and crust were observed in test animals. All signs were reversible within the observation period. Signs of Toxicity - Systemic No treatment-related effects were observed. Effects in Organs No treatment-related effects were observed. Remarks - Results Under the conditions of the test, the notified chemical was not associated with mortality and signs of systemic toxicity, although local irritation effects were recorded. The notified chemical is of low toxicity via the dermal route. BSL (2015b) Irritation skin (in vitro) – Notified chemical OECD TG 439 Skin Irritation: Reconstructed Human Epidermis In Vitro Test Method EC Commission Regulation No 640/2012 B.46. Skin Irritation: - In Reconstructed Human Epidermis Test Method Vehicle Distilled Remarks - Method No significant deviation of the protocol was noted. The Model™ (EPISKIN-SM™), a reconstituted three-dimensional human epidermis model, was used in the test. The purity of the test substance was reported as 81%. Test material Mean of triplicate Relative mean SD of relative mean tissues Viability (%) viability 0.814 100 5.0 Negative control 0.660 81.1 8.5 Test substance 0.062 7.6 5.8 Positive control OD = optical density; SD = standard deviation Remarks - Results The relative mean tissue viability after 15 minutes of exposure and 42 hours post incubation was > 50%. The notified chemical was a non-irritant under the conditions of the test. BSL Irritation eye (in – Notified chemical OECD TG 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants Vehicle Physiological saline (0.9% sodium chloride in water) Remarks - Method No significant deviation of the protocol was noted. The purity of the test substance was reported as 81%.
Group Number and Sex of Animals Dose (mg/kg bw) Mortality 1 5 M 2,000 0/5 2 5 F 2,000 0/5 LD50 > 2,000 mg/kg bw Signs of Toxicity - Local Irritation signs including erythema, oedema, desquamation and crust were observed in test animals. All signs were reversible within the observation period. Signs of Toxicity - Systemic No treatment-related effects were observed. Effects in Organs No treatment-related effects were observed. Remarks - Results Under the conditions of the test, the notified chemical was not associated with mortality and signs of systemic toxicity, although local irritation effects were recorded. The notified chemical is of low toxicity via the dermal route. BSL (2015b) Irritation – skin (in vitro) Notified chemical OECD TG 439 In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method EC Commission Regulation No 640/2012 B.46. In Skin Irritation: - Reconstructed Human Epidermis Test Method Vehicle Distilled Remarks - Method No significant deviation of the protocol was noted. The Model™ (EPISKIN-SM™), a reconstituted three-dimensional human epidermis model, was used in the test. The purity of the test substance was reported as 81%. Test material Mean of triplicate tissues Relative mean Viability (%) SD of relative mean viability Negative control 0.814 100 5.0 Test substance 0.660 81.1 8.5 Positive control 0.062 7.6 5.8 OD = optical density; SD = standard deviation Remarks - Results The relative mean tissue viability after 15 minutes of exposure and 42 hours post incubation was > 50%. The notified chemical was a non-irritant under the conditions of the test. BSL Irritation – eye (in Notified chemical OECD TG 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants Vehicle Physiological saline (0.9% sodium chloride in water) Remarks - Method No significant deviation of the protocol was noted. The purity of the test substance was reported as 81%.
STD1566-FR-final.DOCX