The test material did not induce significant increases in the numbers of polyploid cells in both experiments at any dose level, in the presence or absence of S9. the notified chemical was non clastogenic the Result: conditions of the test 9.3.4 Micronucleus Assay in the Bone Marrow Cells of the Mouse No report of micronucleus assay was provided. in vivo 9.4 Overall Assessment of Toxicological Data The notified chemical was of very low acute oral (LD50 >5000 mg/kg) and low acute dermal toxicity (LD50 >2000 mg/kg) in rats. No report on inhalation toxicity was provided. It was a slight eye irritant and slight to moderate skin irritant to rabbits. Evidence of skin sensitisation potential was not observed in guinea pigs in an adjuvant study. In a repeat dose oral toxicity study in rats, a NOAEL was established as >1000 mg/kg/day based on no adverse effects at the highest dose tested. The notified chemical was not mutagenic in the bacterial stains tested. In an chromosome aberration study using in vitro human lymphocytes, a non-dose response slight increase in aberrant cells were observed in the absence of metabolic activation (S9). No report of an micronucleus assay was in vivo provided. Based on the toxicological data provided, the notified chemical, Lexmark Red Dye 93A is not classified as a hazardous substance according to the NOHSC Approved Criteria for (NOHSC, 1999). Classifying Hazardous Substances 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier and are summarised in the following table. The tests were performed in compliance with OECD/EEC Test Methods and according to OECD Principles of Good Laboratory Practices. Test Species Results (Nominal concentrations) Acute Toxicity Rainbow Trout 96 h LC50 > 100 mg/L – Semi-Static NOEC > 100 mg/L Oncorhynchus mykiss (OECD TG 203) Acute Toxicity Water Flea 48 h EC50 > 100 mg/L – Immobilisation NOEC > 100 mg/L Daphnia (OECD TG 204)
The test material did not induce significant increases in the numbers of polyploid cells in both experiments at any dose level, in the presence or absence of S9. Result: the notified chemical was non clastogenic the conditions of the test 9.3.4 Micronucleus Assay in the Bone Marrow Cells of the Mouse No report of in vivo micronucleus assay was provided. 9.4 Overall Assessment of Toxicological Data The notified chemical was of very low acute oral (LD50 >5000 mg/kg) and low acute dermal toxicity (LD50 >2000 mg/kg) in rats. No report on inhalation toxicity was provided. It was a slight eye irritant and slight to moderate skin irritant to rabbits. Evidence of skin sensitisation potential was not observed in guinea pigs in an adjuvant study. In a repeat dose oral toxicity study in rats, a NOAEL was established as >1000 mg/kg/day based on no adverse effects at the highest dose tested. The notified chemical was not mutagenic in the bacterial stains tested. In an in vitro chromosome aberration study using human lymphocytes, a non-dose response slight increase in aberrant cells were observed in the absence of metabolic activation (S9). No report of an in vivo micronucleus assay was provided. Based on the toxicological data provided, the notified chemical, Lexmark Red Dye 93A is not classified as a hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999). 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier and are summarised in the following table. The tests were performed in compliance with OECD/EEC Test Methods and according to OECD Principles of Good Laboratory Practices. Test Species Results (Nominal concentrations) Acute Toxicity – Semi-Static (OECD TG 203) Rainbow Trout Oncorhynchus mykiss 96 h LC50 > 100 mg/L NOEC > 100 mg/L Acute Toxicity – Immobilisation (OECD TG 204) Water Flea Daphnia 48 h EC50 > 100 mg/L NOEC > 100 mg/L
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