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EC number: 201-064-4 | CAS number: 77-86-1
The test item 2-aminopropane-1,3-diol (APD) was administered daily by oral gavage to pregnant Hannover Wistar rats from gestation day 6 (GD6) to gestation day 19 (GD19). There was no test item effect on maternal body weight / body weight gain, corrected body weight /body weight gain and on food intake in any test item groups up to and including 1000 mg/kg bw/day. There were no toxicologically significant differences, or test item related-changes in the evaluated intrauterine parameters (including number of corpora lutea and implantation site, pre- and post-implantation loss, number of foetal death and total intrauterine mortality) up to and including 1000 mg/kg bw/day. No remarkable test item-related internal or external observations were recorded for any pregnant animals during necropsy. No remarkable abnormalities were observed on the placentas in any examined groups. No toxicologically relevant adverse effect of the test item was observed on the foetal parameters (number of viable foetuses, sex distribution of foetuses, mean foetal weight per litter, number of foetuses with retarded body weight) up to and including 1000 mg/kg bw/day. There was no biologically relevant and/or statistically significant increase in external, visceral and/or skeletal malformations in any test item treated groups when compared to control. Some skeletal variations ascribed to slightly retarded ossification (unossified hyoid body on the skull, ossified sternebra (3 or less); unossified vertebra and carpal, ossified ≤ 2.5) showed higher incidence (mostly with statistical significance) in the high dose and mid group. These variations are all associated with delayed ossification at skeletal development, commonly related to retarded foetal development. No signs of maternal toxicity were detected during the study based on clinical signs and bodyweight; however, in the 90-day rat repeated dose toxicity study with this test item, systemic toxicity was observed, in the absence of body weight or clinical signs. The foetal skeletal findings were considered to reflect a non-adverse, slight retardation of ossification.
In this study, from the observations made in the dams and their foetuses, there were no changes on embryos or foetuses other than skeletal variations related to delayed ossification during skeletal development. The No-Observed-Adverse-Effect Levels (NOAEL) for maternal toxoicity, embryotoxicity, foetotoxicity, foetal malformations and skeletal development were determined to be 1000 mg/kg bw/day. The No-Observed-Effect Level (NOEL for skeletal development was 100 mg/kg bw/day
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