Registration Dossier
Registration Dossier
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EC number: 456-830-2 | CAS number: 745070-61-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Experimentally, there is no evidence that the test substance is systemically available. Even though the molecular weight and the log POW are within the range for absorption, the sterically hindered aromatic amide is poorly soluble in both water, buffered solutions of pH 4, 7 and 9 as well as in fat. Transport within the aqueous and lipophilic compartments is expected to be too slow for uptake. Second, the substance hydrolyses neither in gastric juice at pH 1.1 nor in saliva at pH 8.7. Finally, there are no indications that the test substance is subject to metabolic degradation either by the intestinal microbiota or by mammalian cells. The theoretical degradation products are monocyclic aromatic amines which are known for their ability to cause methaemoglobinaemia, cyanosis and genotoxicity. The test substance however caused no test item related effects in the acute oral and dermal toxicity studies (LD50 > 2000 mg/kg bw), the 28-day subacute toxicity study and in the 90-day oral (in-feed) toxicity study in rats. The transient paleness of the faeces reflects the elimination of the compound. No genotoxicity occurred in the chromosome aberration test in Chinese Hamster lung fibroblasts, in mouse lymphoma L5178Y cells, in the Ames test as well as in vivo in the micronucleus test.
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