Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
All the studies on in-vitro gene mutation in bacteria with the test substance show negative results. A comet assay and a chromosomal aberration test with mamalian cells are also available, but these assays give a negative and positive result, respectively. However, the publication of the comet assay refers to earlier publications, which indicate the test substance as mutagenic and carcinogenic. In addition, aniline and N,N-dimethylaniline, present as impurities above 1%, are both classified as carcinogenic (Carc. 2). Hence, the test substance as described in this dossier is considered to be potentially genetic toxic.
Short description of key information:
Various Ames tests on multiple strains show that the test substance does not induce genetic toxicity in bacterial in-vitro tests. Two different mamalian in-vitro tests show contradictionary results. The key value is based on a chromosomal aberration test most recently performed.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
According to the CLP regulation 1272/2008, classification of the test substance (pure) does not include carcinogenecity. However, according to the same regulation, the test substance presented in this dossier should be classified as potential carcinogenic based on its impurities. In addition, this classification is further justified by the high similarity between the test substance and these two impurities, aniline and N,N-dimethylaniline, together with the reported positive result in a chromosomal aberration test with mamalian cells.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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