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
Test Item Concentration % (w/v) Stimulation (S.I.) Group 2 10 2.5 Group 3 25* 2.9* Group 4 50* 6.2* EC3 = 25.8% (w/w) * The value was used in calculation of EC3 Remarks – Results On the second application day, a slight ear swelling was observed at both dosing sites in all mice of Group 4 (50%), persisting for the remainder of the in-life phase of the study. No test item-related clinical signs were observed in any animals of the other groups. There was evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (RCC Ltd, 2003q) Skin sensitisation – mouse local lymph node assay (LLNA) - product containing notified chemical at 5% 5% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Local Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v) Remarks – Method No significant protocol deviations. Test Item Concentration % (w/v) S.I. 2 2.5 1.0 Group 3 5 1.0 Group 4 10 1.0 Remarks – Results None. There was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to polypropylene containing 5% notified chemical. (RCC Ltd, 2003r) Skin sensitisation – mouse local lymph node assay (LLNA) - product containing notified chemical at 10% 10% notified chemical in polypropylene, incorporated by extrusion at 175°C, and then ground and used in the test. OECD TG 429: Skin Sensitisation: Lymph Node Assay (adopted 24 April 2002). Species/Strain Mouse/CBA/CaOlaHsd Vehicle Acetone : Olive oil, 4:1 (v/v)