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兔口服二甘醇的产前毒性研究。

Investigation of the prenatal toxicity of orally administered diethylene glycol in rabbits.

作者信息

Hellwig J, Klimisch H J, Jäckh R

机构信息

Department of Toxicology, BASF Aktiengesellschaft, Ludwigshafen, Germany.

出版信息

Fundam Appl Toxicol. 1995 Nov;28(1):27-33. doi: 10.1006/faat.1995.1142.

DOI:10.1006/faat.1995.1142
PMID:8566480
Abstract

Diethylene glycol was tested for prenatal toxicity after oral administration (gavage) to pregnant Himalayan rabbits. The substance was administered to 15 female rabbits per group by stomach tube in daily doses of 100, 400, or 1000 mg/kg body wt from Day 7 postinsemination (p.i.) through Day 19 p.i. The control group received the vehicle only (twice distilled water). There were no compound-related effects on the dams concerning food consumption, body weight, body weight gain, or clinical or necropsy observations even at the highest dose of 1000 mg/kg body wt/day. All data obtained on gestational parameters also revealed no biologically relevant differences between the control and treated groups. The fetal external, soft tissue, and skeletal findings, which were classified as malformations, variations, and/or retardations, were seen in the treated fetuses at a frequency similar to the corresponding and/or historical controls. Thus, under the conditions of this study, no signs of maternal toxicity or embryo-/fetotoxicity were induced by diethylene glycol. Therefore, a no-observable-adverse-effect level for diethylene glycol of > 1000 mg/kg body wt/day was established for both the maternal and the developing Himalayan rabbit.

摘要

对妊娠的喜马拉雅兔经口灌胃给予二甘醇,以测试其对产前的毒性。从受精后第7天(p.i.)至第19天,以每日100、400或1000毫克/千克体重的剂量通过胃管给每组15只雌兔给药该物质。对照组仅接受赋形剂(双蒸水)。即使在最高剂量1000毫克/千克体重/天的情况下,对于母兔,在食物消耗、体重、体重增加或临床或尸检观察方面也没有与化合物相关的影响。关于妊娠参数获得的所有数据也表明,对照组和处理组之间没有生物学上相关的差异。在处理组胎儿中观察到的胎儿外部、软组织和骨骼方面的发现,分类为畸形、变异和/或发育迟缓,其出现频率与相应的和/或历史对照相似。因此,在本研究条件下,二甘醇未诱发母体毒性或胚胎/胎儿毒性迹象。因此,确定二甘醇对母兔和发育中的喜马拉雅兔的无可见不良作用水平均>1000毫克/千克体重/天。

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