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EC number: 240-969-9 | CAS number: 16919-27-0
Table 1 Summarised data of the mutagenicity study
Potassium hexafluoro titanate [mg/kg bw, p.o.]
Sampling time (h)
No. of polychromatic erythrocytes scored per group*
Micronucleated polychromatic erythrocytes
Mean frequency per 1000 PCE
27 mg/kg bw, i.p.
* = males and females combined
** = per 1000 counted cells
s. = significant at p ≤ 0.05 for increases compared to the control
n.s. = not significant at p≤ 0.05 for increases compared to the control
p.o. = per oral
i.p. = intraperitoneal
PCE = ploychromatic erythrocytes
NCE = normochromatic erythrocytes
The following GLP and guideline conform GLP studies are considered as key studies and will be used for classification:
The in vitro mammalian cell gene mutation test by Lloyd (2012) according to OECD 476 has shown that dipotassium hexafluorotitanate did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells up to the highest test concentration, limited by cytotoxic effects.
Testing in bacteria reverse mutation assays, although of limited relevance for metals (HERAG, 2007), also yielded negative results (Thompson, 1997) up to the limit concentration of 5000 µg/plate.
Negative as well as positive results were obtained in clastogenicity assays: Dipotassium hexafluorotitanate appears to induce micronuclei in vitro in cultured human peripheral blood lymphocytes, but only at high concentrations and via mechanisms that appear to lack physiological relevance (Watters, 2012), and is not mirrored in corresponding in vivo (RL=1) GLP-conform micronucleus test in the bone marrow of rats exposure via the oral route (Flügge, 2012). Availability of the substance was demonstrated by signs of general toxicity, thus exposure of the target organ was ensured.
In conclusion, based upon the evaluation of all available studies, genotoxicity is not an endpoint appropriate to be carried forward to risk characterisation.
HERAG (2007) Fact sheet 05 - Mutagenicity. EBRC Consulting GmbH / Hannover /Germany.August 2007. [www.herag.net]
Based upon the evaluation of all available studies, the classification of dipotassium hexafluorotitanate with respect to mutagenic potential is not appropriate. Thus, accordingto Directive EEC 67/548 and to EC Regulation No. 1272/2008, dipotassium hexafluorotitanate is not considered to have a mutagenic potential, hence, no classification or labelling is required.
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