Registration Dossier
Registration Dossier
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EC number: 700-834-1 | CAS number: 9041-08-1
Endpoint summary
Administrative data
Description of key information
There were several reports are available investigating effects of the test substance in exposure related ovservations in humans, weight of evidence.
Additional information
To conclude, inhalation of ≤32,000 International Units, as a lower respiratory tract dose, of unfractionated test substance did not affect pulmonary function. A dose-dependant anticoagulant effect could be demonstrated on the circulating blood (antifactor-Xa, activated partial thromboplastin time) and the endothelial cells as release of tissue factor pathway inhibitor. However, these changes were small and of no clinical relevance. The authors therefore consider inhalation of test substance in these or smaller doses to be safe with respect to pulmonary function and systemic anticoagulation. (Bendstrup, 2000)
These studies indicate that the test substance administration can be associated with complement-mediated platelet injury. The dose-dependent nature of this process may account for the occurrence of thrombocytopenia in some of these patients. (Cines, 1980)
The findings suggest that hyperkalemia can develop with the use of low-dose test substance, within seven days of initiating test substance therapy, and that patients with diabetes mellitus or chronic renal insufficiency are especially predisposed to this complication. (Edes, 1984)
The test substance-induced hyperkalemia is a potentially life threatening problem. (Busch, 1987)
Skin reaction to test substance is a recognised complication of subcutaneous test substance. The reaction is due to the test substance component and thought to be a localised arthus reaction or test substance induced, immune mediated platelet aggregation. (Nair, 1997)
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