Remarks - Results All animals survived and showed the expected weight gain during the study. The notified chemical is of low toxicity via the oral route. Safepharm (1997b) Acute toxicity – dermal Notified chemical (approximately 30% concentration) OECD TG 402 Acute Dermal Toxicity – Limit Test. Commission Directive 92/69/EEC B.3 Toxicity (Dermal) – Limit Test. Species/Strain Rat/ Sprague-Dawley Vehicle Test substance administered as supplied Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose Mg bw Mortality 1 5 per sex 2,000 0/10 LDdermal50 > 6,390 mg/kg bw. (equates to > 2,000 mg solids/kg bw) Signs of Toxicity - Local Slight straw-coloured staining was noted at the treatment sites of 8 animals. The staining did not affect evaluation of skin responses. Skin effects at the application site comprised erythema (up to 2), superficial epidermal cracking and desquamation were observed from day 1 up to day 8. All treated skin sites appeared normal on day 9. Signs of Toxicity - Systemic No signs of systemic toxicity were noted during the study. Effects in Organs No abnormalities were noted at necropsy. Remarks - Results All animals survived and showed the expected weight gain during the The notified chemical is of low toxicity via the dermal route. Safepharm Irritation – skin Notified chemical (approximately 93% concentration) OECD TG 404 Acute Dermal Irritation/Corrosion. Commission Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New White Number of Animals 3 Male Vehicle Test substance administered as supplied Observation Period 14 days Type of Dressing Semi-occlusive Remarks - Method No significant protocol deviations. Single 4-hour semi-occlusive application to intact skin. The rabbits were observed for deaths or overt signs of toxicity at 1, 24, 48 and 72 hours post-dosing. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
Nominal Concentration at 0 hour (mg/L) Time-weighted mean measured concentration (mg/L) Number of Fish Mortality (%) 3 h 6 h 24 h 48 h 72 h 96 h Control 0 20 0 0 0 0 0 0 3.2 1.9 20 0 0 0 0 0 0 5.6 3.2 20 0 0 0 0 0 0 10 6.5 20 0 0 0 0 10 25 18 16.0 20 0 5 55 100 100 100 32 32.0 20 0 85 100 100 100 100 LC50 8.8 (7.5 – 10.0) mg/L at 96 hours (time-weighted mean measured concentrations) NOEC 3.2 mg/L at 96 (time-weighted mean measured concentrations) Remarks – Results All validity criteria for the test were satisfied. All the exposure solutions containing the test substance were observed to be homogeneous dispersions without a precipitate. Due to a significant decline in measured test concentrations at 72 and 96 it was appropriate to use the time-weighted mean measured concentrations for the analyses. Analysis of the mortality (LC50) was done by the moving average method (Thompson, 1947) based on the time-weighted mean measured test concentrations. The notified chemical is toxic to fish Safepharm (1998f) Acute toxicity to aquatic invertebrates Notified chemical OECD TG 202 Daphnia sp. Acute Immobilisation Test – Static Test Species Daphnia Exposure Period 48 hours Auxiliary Solvent Not reported Water Hardness Not reported Analytical Monitoring Spectrophotometer (Perkin-Elmer Lambda 20 or equivalent) Remarks - Method The test was conducted according to the guidelines above and good laboratory practice (GLP) principles. No significant deviations from the test guidelines were reported. Nominal Concentration Time-weighted mean measured concentration Number of D. magna Cumulative % Immobilised (mg/L) (mg/L) 24 h 48 h Control 0 20 0 0 1.0 0.5 20 0 0 1.8 1.3 20 0 0 3.2 2.4 20 0 0 5.6 3.4 20 0 0 10.0 7.8 20 0 0 18.0 13.0 20 0 0 32.0 24.0 20 0 20 56.0 33.0 20 0 75 100.0 76.0 20 0 100 EC50 23.0 (20.0 – 27.0) mg/L at 48 hours (time-weighted mean measured concentrations of filtered media)