Registration Dossier
Registration Dossier
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EC number: 610-147-8 | CAS number: 438056-69-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Anilinomorpholinon was investigated in two non GLP Screening Ames-Tests on the Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. Evidence of mutagenic activity of Anilinomorpholinon was seen in both screening tests with metabolic activation only (on Salmonella typhimurium TA 100 and TA 98 or TA 100, TA 98 and TA 102, respectively).
In the GLP Salmonella/microsome plate incorporation test for point-mutagenic effects Anilinomorpholinon was investigated in doses up to and including 5000 µg/plate on the Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and TA 102.
Doses up to and including 5000 µg/plate did not cause any bacteriotoxic effects. No inhibition of growth was noted as well.
Evidence of mutagenic activity of Anilinomorpholinon was seen. On Salmonella typhimurium TA 98, 100 and TA 102, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found with and without S9 mix for TA 98 and TA 100 (effect was stronger with S9 mix) and only with S9 mix for TA 102. The lowest effective dose was 158 µg/plate for S. typhimurium TA 100 and 500 µg/plate for TA 98 and TA 102.
The Salmonella/microsome tests thus showed Anilinomorpholinon to have a mutagenic effect.
Short description of key information:
Gene mutation in vitro Screening test (bacterial reverse mutation assay, non GLP, OECD TG 471, EU Method B. 13/14, EPA OPPTS 870.5100): positive in the Salmonella typhimurium strains TA 100 and TA 98 with metabolic activation
[Bayer AG, Report No. PH-32612, 2003-02-20]
Gene mutation in vitro Screening test (bacterial reverse mutation assay, non GLP, OECD TG 471, EU Method B. 13/14, EPA OPPTS 870.5100): positive in the Salmonella typhimurium strains TA 100, TA 98 and TA 102 with metabolic activation
[Bayer AG, Report No. PH-34344, 2006-03-08]
Gene mutation in vitro (bacterial reverse mutation assay, GLP, OECD TG 471, EU Method B. 13/14, EPA OPPTS 870.5100): positive in the Salmonella typhimurium strains TA 100 and TA 98 with and without metabolic activation and TA 102 with metabolic activation
[Bayer AG, Report No. PH-34849, 2007-04-03]
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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