N,N-Dimethylformamide. MAK Value Documentation, supplement – Translation of the German version from 2019

A. Hartwig, M. Arand
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Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re-evaluated N,N -dimethylformamide [68-12‐2] taking into account the increased respiratory volume at the workplace (see List of MAK and BAT Values, Sections I b and I c). N,N -Dimethylformamide is a liver toxin and the maximum concentration at the workplace (MAK value) of 5 ml/m3 was set using data from a two-year study in mice showing liver cell hypertrophy and single cell necrosis at the lowest concentration tested of 25 ml/m3. In this study, rats were less susceptible as regards the liver toxicity of N,N -dimethylformamide. Species differences in toxicokinetics are a plausible explanation for the higher toxicity in mice. As human metabolism of N,N -dimethylformamide is quantitatively similar to that of rats, their susceptibility is expected to be similar to that of rats. On the basis of the NOAEC (no observed adverse effect concentration) of 25 ml/m3 for rats, the MAK value of 5 ml/m3 is retained even taking into account the increased respiratory volume at the workplace. Peak Limitation Category II and the excursion factor of 2 are confirmed. The assignment of N,N -dimethylformamide to Pregnancy Risk Group B is retained. In an earlier assessment, it was concluded that exposure to a concentration of up to 1 ml/m3 is not expected to lead to developmental toxicity. This prerequisite for an assignment of N,N -dimethylformamide to Pregnancy Risk Group C is confirmed, also taking into account the increased respiratory volume at the workplace. The MAK Collection for Occupational Health and Safety 2020, Vol 5, No 1 1 MAK Value Documentations — N,N-Dimethylformamide MAK value (2005) 5 ml/m3 (ppm) ≙ 15 mg/m3 Peak limitation (2011) Category II, excursion factor 2 Absorption through the skin (1969) H
N, N-Dimethylformamide。MAK价值文档,补充- 2019年起德语版本的翻译
德国工作区域化学品健康危害调查委员会考虑到工作场所呼吸量增加,重新评估了N,N -二甲基甲酰胺[68-12‐2](见MAK和BAT值清单)。第I b和I c节)。N,N -二甲基甲酰胺是一种肝毒素,工作场所的最大浓度(MAK值)为5 ml/m3,使用的数据来自一项为期两年的小鼠研究,结果显示最低浓度为25 ml/m3时肝细胞肥大和单细胞坏死。在本研究中,大鼠对N,N -二甲基甲酰胺的肝毒性较不敏感。毒性动力学的物种差异是对小鼠较高毒性的合理解释。由于人体对N,N -二甲基甲酰胺的代谢在数量上与大鼠相似,预计其易感性也与大鼠相似。在大鼠的NOAEC(未观察到不良反应浓度)为25 ml/m3的基础上,即使考虑到工作场所呼吸量的增加,MAK值仍保持在5 ml/m3。确定了峰值限制类别II和偏移因子2。N,N -二甲基甲酰胺的妊娠危险组B的分配被保留。在较早的评估中,得出的结论是,暴露于高达1毫升/立方米的浓度预计不会导致发育毒性。这是将N,N -二甲基甲酰胺分配到妊娠风险组C的先决条件,也考虑到工作场所呼吸量的增加。职业健康与安全MAK收集2020,Vol 5, No 11 MAK值文件- N,N-二甲基甲酰胺MAK值(2005)5ml /m3 (ppm) 15mg /m3峰值限制(2011)II类,漂移因子2通过皮肤吸收(1969)H
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