Registration Dossier
Registration Dossier
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EC number: 402-230-0 | CAS number: 399-95-1 FAP
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenic potential of 4-Amino-3-fluoro-phenol was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Herbold, 2005). Doses up to and including 1200 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strain-specific bacteriotoxic effect. Due to this effect this range could only be used up to and including 3200 µg per plate for assessment purposes. Substance precipitation did not occur. Evidence of mutagenic activity of 4-Amino-3-fluoro-phenolwas seen. On Salmonella typhimurium TA 102, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found only with S9 mix. The lowest reproducible effective dose was 1600 µg per plate. The Salmonella/microsome test thus showed 4-Amino-3-fluoro-phenol to have amutagenic effect. However, since this effect was found only with S9 mix and only for high doses, it may be assumed, that this effect is due to an impurity and not to 4-Amino-3-fluoro-phenol itself.
The clastogenic potential of 4-Amino-3-fluoro-phenol was evaluated in a chromosome aberration test on Chinese hamster V79 cells in the presence and absence of S9 mix according to OECD TG 473 (Nern, 2005). Without S9 mix cytotoxic effects were observed at 10 µg/ml and above. With S9 mix cytotoxic effects were observed at 50 µg/ml and above. Precipitation in the medium was not observed. Cultures treated with the test substance in the absence and in the presence of S9 mix showed biologically relevantly and statistically significantly increased numbers of aberrant metaphases. Based on this test, 4-Amino-3-fluoro-phenol is considered to be clastogenic for mammalian cells in vitro.
Justification for selection of genetic toxicity endpoint
No study was selected, since both genotoxicity in vitro tests with 4-Amino-3-fluoro-phenol were positiv.
Short description of key information:
Salmonella/microsome test (Ames test): positive with strain TA 102 (+ S9 mix) and negative with strains TA 98, TA 100, TA 1535 and TA 1537 (+/- S9 mix)
Chromosome aberration test (V79 cells): positive (+/- S9 mix)
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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