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EC number: 220-474-4 | CAS number: 2778-42-9
A repeated dose reproductive/developmental toxicity study was conducted to screen potential adverse effect of test substance on systemic toxicity and reproduction, including embryo/foetal development in the rat according to OECD Guideline 421, in compliance with GLP. The test substance was administered by gavage at concentrations of 0, 15, 150 and 250 mg/kg bw/day to groups of ten rats of either sex for a period of 19 d in males and 40-41 d in females. Following 14 days of dosing, male and female rats were paired within their dose groups to produce litters. On Day 5 post-partum, all surviving animals were killed and examined macroscopically. Parental animals were observed for clinical signs. Bodyweights and food consumption were recorded during the maturation phase which was continued for males after the mating phase. Mated females were weighed on Days 0, 7, 14 and 20 post-coitum and Days 1 and 4 post-partum and food consumptions recorded between Days 1 to 7, 7 to 14 and 14 to 20 post-coitum and 1 to 4 post-partum. The offspring were observed daily for clinical signs. The litter signs and individual pup bodyweights were recorded on Days 1 and 4 post-partum. During the lactation period the offspring were observed for intra-litter onset and duration of landmarks of physical development. On specific days of lactation, reflexological assessment of offspring was performed. Post mortem macroscopic examinations were performed on all adults and offspring including decedents. Histopathology was carried out on reproductive organs from control and high dose group parental animals at termination. The effects observed in adult animals are detailed in the chapter on repeated dose toxicity (Section 5.6.1). The NOAEL for adults was established at 150 mg/kg bw/day. There were no treatment related effects on fertility, mating performance gestation length at any dose level, and no significant histopathological changes were observed for the reproductive organs of adults at termination. There were no treatment related effects upon litter sizes at birth or on subsequent offspring survival throughout lactation. There were no effects on offspring reflexological responses and no effect on the intra-litter sex ratios. At 250 mg/kg bw/day group mean bodyweight of offspring at Day 1 and 4 of lactation were lower than controls. However, study control weight values were generally higher than historical controls; this was due to one control litter with higher than normal mean offspring weights. Under the test conditions, administration of the test material to adult male and female rats throughout maturation, mating, gestation and early lactation resulted in significant effects on adults at 250 mg/kg bw/day. However, there were no significant effects on reproductive or developmental parameters, so that the NOAEL for these endpoints was considered to be 250 mg/kg bw/day (Knox, 2005).
A reproductive/developmental screening study was conducted in rat to investigate potential adverse effect of m-TMXDI on reproduction, including embryo/foetal development. No adverse effects on reproductive parameters were noted at doses up to 250 mg/kg bw/day. The substance therefore does not qualify for classification for these endpoints.
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