Oxidising Properties Non-oxidising Expert Statement. Remarks The oxidising properties were screened based on the UN Recommendations of the Transport of Dangerous Goods (Manual of Test and Criteria, Annex 6, Orange Book, 3rd Edition, 1999). The oxygen balance was calculated as which –265, indicates that the test substance is considered to be non-oxidising and therefore does not need to be tested experimentally. RCC Ltd (2003l) 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 > 2000 mg/kg bw Low toxicity Rat, dermal LD50 > 2000 mg/kg bw Low toxicity Rat, acute inhalation No data available Rabbit, skin irritation Non-irritating Rabbit, eye irritation Non-irritating Mice, Local Lymph Node Assay (notified chemical Evidence of sensitisation at 10%, 25%, 50%) Mice, Lymph Node Assay (product containing No evidence of sensitisation notified chemical at 5%) Mice, Local Lymph Node Assay (product containing No evidence of sensitisation notified chemical at 10%) Rat, Oral repeat dose toxicity - 28 days. NOEL could not be established. Genotoxicity - bacterial reverse mutation Non mutagenic Genotoxicity in vitro Chinese Hamster V79 cells Non clastogenic – 7.1. Acute toxicity oral – Notified chemical. OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – EC Directive 92/69/EEC B.1tris Acute Oral Toxicity Acute Toxic – Class Method. Species/Strain Rat/Han BrI: Wist (SPF) Vehicle PEG 300 Remarks Method No significant protocol deviations. – RESULTS Group Number and Sex Dose Mortality of Animals mg/kg bw 1 6 females 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity All animals survived until the end of the study period. No clinical signs were observed during the course of the study. One female showed a loss of body weight (0.5%) between test day 8 and the end of the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. Effects in Organs No macroscopic findings were recorded at necropsy. Remarks Results None. – The notified chemical is of low toxicity via the oral route.
Oxidising Properties Non-oxidising Expert Statement. Remarks The oxidising properties were screened based on the UN Recommendations of the Transport of Dangerous Goods (Manual of Test and Criteria, Annex 6, Orange Book, 3rd Edition, 1999). The oxygen balance was calculated as –265, which indicates that the test substance is considered to be non-oxidising and therefore does not need to be tested experimentally. RCC Ltd (2003l) 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 > 2000 mg/kg bw Low toxicity Rat, dermal LD50 > 2000 mg/kg bw Low toxicity Rat, acute inhalation No data available Rabbit, skin irritation Non-irritating Rabbit, eye irritation Non-irritating Mice, Local Lymph Node Assay (notified chemical at 10%, 25%, 50%) Evidence of sensitisation Mice, Lymph Node Assay (product containing notified chemical at 5%) No evidence of sensitisation Mice, Local Lymph Node Assay (product containing notified chemical at 10%) No evidence of sensitisation Rat, Oral repeat dose toxicity - 28 days. NOEL could not be established. Genotoxicity - bacterial reverse mutation Non mutagenic Genotoxicity – in vitro Chinese Hamster V79 cells Non clastogenic 7.1. Acute toxicity – oral Notified chemical. OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC B.1tris Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Han BrI: Wist (SPF) Vehicle PEG 300 Remarks – Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 6 females 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity All animals survived until the end of the study period. No clinical signs were observed during the course of the study. One female showed a loss of body weight (0.5%) between test day 8 and the end of the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. Effects in Organs No macroscopic findings were recorded at necropsy. Remarks – Results None. The notified chemical is of low toxicity via the oral route. RESULTS
STD1137FR.docx