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EC number: 807-130-4 | CAS number: 53716-82-8
In the key (OECD 422) study, Cyrene™ was administered oral by gavage daily at 0, 30, 300, or 1000 mg/kg bw/day to male rats for 42 consecutive days and to female rats for up to 55 days (pre pairing, throughout gestation, and during the first 2 weeks of lactation), no toxicologically significant differences were evident in mean number of implantation sites or pups born.
Post-implantation survival index for dams administered 1000 mg/kg bw/day was 7% lower than controls; however, statistical significance was not achieved. This decrease in the post-implantation survival index was attribtable to the total in utero litter loss; this impacted the mean percentile post-implantation. Other live birth or survival indices were not affected. As such, the marginally lower implantation survival index was considered to have arisen incidentally.
Sex ratio (% males) was slightly higher for litters of dams administered 1000 mg/kg bw/day, compared with controls. No statistical significance was achieved, as such, this slight increase in male sex ratio is not considered to be related to the test article.
Lower body weights were evident for pups from litters of dams administered 1000 mg/kg bw/day, compared with controls. No adverse effect on litter weight was noted for litters of dams administered 30 or 300 mg/kg bw/day. Therefore, the NOAEL for developmental toxicity was established at the dose level of 300 mg/kg bw/day due to the reduced body weights in pups at the dose level of 1000 mg/kg bw/day.
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