Registration Dossier
Registration Dossier
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EC number: 610-200-5 | CAS number: 446292-07-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Hydroxyaminophthalimid was investigated using the Salmonella/microsome plate incorporation test for point-mutagenic effects 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 3200 µg/plate did not cause any bacteriotoxic effects. No inhibition of growth was noted as well. Substance precipitation occurred at the dose of 3200 µg/plate and above. Therefore, the test was no longer interpretable at 5000 µg/plate.
Evidence of mutagenic activity of Hydroxyaminophthalimid was seen. On Salmonella typhimurium TA 1535 and TA 100, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was only found without S9 mix. The lowest reproducible effective dose was 200 µg/plate for S. typhimurium TA 1535 and 1600 µg/plate for TA 100. The Salmonella/microsome test thus showed Hydroxyaminophthalimid to have a mutagenic effect.
Short description of key information:
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 1535 and TA 100 without metabolic activation
[Bayer AG, Report No. PH-34850, 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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