Registration Dossier
Registration Dossier
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EC number: 205-793-9 | CAS number: 151-56-4
Carcinogenicity
Administrative data
Description of key information
In an inhalation study with Sprague-Dawley rats, histopathological changes in kidney and trachea and an increased incidence of tumours in trachea, lung, skin and breast were observed. Furthermore, the lifespan of the rats was reduced.
Key value for chemical safety assessment
Justification for classification or non-classification
According to Annex I of EU Directive 67/548/EEC the substance is classified as category 2 carcinogen (R45).
According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 the classification is: H350, Cat. 1B.
Additional information
From an inhalation study with Sprague-Dawley rats it can be concluded that ethyleneimine causes histopathological changes in kidney and trachea and an increased incidence of tumours in trachea, lung, skin and breast (BASF, 1978). The animals were exposed to 8.9 µg/L for 27 weeks or until death (approximately 66 weeks).
After exposure to the test substance no symptoms were observed except sporadic sneezing of single animals. The test substance exposed group showed a shortened average survival time compared to the control group. Lethality was increased during exposure to the test substance.
In the kidneys of the male animals of the test groups papillary necroses and oedema were observed. In addition, inflammatory and hyperregenerative changes of the trachea were described in test animals. The incidence of squamous epithelial metaplasia was noticeably increased in test animals compared to control animals (control group/ test group: males 1/35; females 0/2). In one female rat (test group) the formation of polyps was diagnosed. In the lungs of control and test animals squamous epithelial metaplasia accumulated. In one male test animal an adenocarcinoma of the lung was observed. A higher incidence of breast tumours (control group/test group 32/60) in females and skin tumours in males (control group/test group 1/11) indicated a correlation with the exposure to the test substance. 5 male animals from the subchronic dose group showed carcinomas. The incidence of skin tumours in females was lower: in the test group 3 tumours including one carcinoma, in the control group 2 tumours including one carcinoma.
The animals of both test substance exposed groups showed no reduction in body weight compared to the corresponding control groups. No changes of the measured haematology, clinical chemistry and urinalysis parameters were observed compared to the control group.
This study is considered as key study.
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