0, 100, 333 or 1 000 culture medium; g/mL Doses: in the absence of microsomal enzymes (from Aroclor1254-induced Wistar rat liver S9 fraction) either a 24 hour treatment time and a 24 hour fixation time or a 48 hour treatment time and a 48 hour fixation time (1 000 dose) was used; g/mL in the presence of S9 fraction treatment time was 3 hours and fixation time 24 or 48 hours (1 000 dose) g/mL OECD TG473 Test method: in the dose range finding test, the notified chemical Comment: precipitated in the culture medium at a concentration of 1 000 and this was, g/mL therefore, used as the highest concentration in the main studies; no clear affect of the notified chemical on mitotic index was observed under the various treatment conditions; the number of cells with chromosomal aberrations found in the solvent control cultures were within the laboratory historical control range (min = 0, max = 5; mean = 0.9 aberrant per 100 metaphases in the absence of S9 and min = 0, max = 5; mean = 0.7 aberrant cells per 100 metaphases in the presence of S9) the notified chemical was not clastogenic Result: in as judged by similar frequencies of chromosomal aberrations in treated and control cultures; the positive control substances demonstrated the sensitivity of the assay Overall Assessment of Toxicological Data The notified chemical was of very low oral toxicity and low acute dermal toxicity in rats (LD50 > 2 000 mg/kg in both studies). It was a slight to moderate skin irritant and a slight eye irritant in rabbits, was not a skin sensitiser in guinea pigs and was not genotoxic or in vitro in No organ toxicity was observed in a 28-day oral gavage rat study in which the NOEL vivo. was established as the top dose, 1 000 mg/kg/day. The notified chemical is not classified as a hazardous substance according to NOHSC (National Occupational Health and Approved Criteria for Classifying Hazardous Substances Safety Commission, 1994a) on the basis of the toxicological data supplied.
Doses: 0, 100, 333 or 1 000 g/mL culture medium; in the absence of microsomal enzymes (from Aroclor1254-induced Wistar rat liver S9 fraction) either a 24 hour treatment time and a 24 hour fixation time or a 48 hour treatment time and a 48 hour fixation time (1 000 g/mL dose) was used; in the presence of S9 fraction treatment time was 3 hours and fixation time 24 or 48 hours (1 000 g/mL dose) Test method: OECD TG473 Comment: in the dose range finding test, the notified chemical precipitated in the culture medium at a concentration of 1 000 g/mL and this was, therefore, used as the highest concentration in the main studies; no clear affect of the notified chemical on mitotic index was observed under the various treatment conditions; the number of cells with chromosomal aberrations found in the solvent control cultures were within the laboratory historical control range (min = 0, max = 5; mean = 0.9 aberrant per 100 metaphases in the absence of S9 and min = 0, max = 5; mean = 0.7 aberrant cells per 100 metaphases in the presence of S9) Result: the notified chemical was not clastogenic in as judged by similar frequencies of chromosomal aberrations in treated and control cultures; the positive control substances demonstrated the sensitivity of the assay Overall Assessment of Toxicological Data The notified chemical was of very low oral toxicity and low acute dermal toxicity in rats (LD50 > 2 000 mg/kg in both studies). It was a slight to moderate skin irritant and a slight eye irritant in rabbits, was not a skin sensitiser in guinea pigs and was not genotoxic in vitro or in vivo. No organ toxicity was observed in a 28-day oral gavage rat study in which the NOEL was established as the top dose, 1 000 mg/kg/day. The notified chemical is not classified as a hazardous substance according to NOHSC Approved Criteria for Classifying Hazardous Substances (National Occupational Health and Safety Commission, 1994a) on the basis of the toxicological data supplied.
NA655FR.docx