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EC number: 500-097-4 | CAS number: 37353-75-6 1 - 4.5 moles propoxylated
In vitro gene mutation studies in bacteria and mammalian cells, and in vitro chromosome aberration studies were performed using BPA 2PO and BPA 5PO. Studies were performed according to OECD Guidelines or following methods similar to OECD Guidelines. All studies gave negative results in the presence and absence of metabolic activation.
In the absence of S9 -mix, a significant increase in the highest dose tested (50 µg/mL) was observed only when gaps were included in the analysis; this effect was apparent only at a markedly toxic concentration; individual values were within or at the upper limit values of the historical control range.
In the presence of S9-mix, a statistical significant increase in aberrant cells was observed only in the presence of marked cytotoxicity (85% reduction in mitotic activity) at t=24h only (not at t=48h). The observed increases in aberrant cells under the described conditions are considered no evidence for clastogenic activity.
A marked increase in the incidence of polyploid cells was observed in Dianol 320 treated cells in the presence of S9 mix at and above 100 µg/mL (7-23-65 polyploid cells at 100 -150 -175 µg/mL, respectively) at a sampling time of 24h; at a sampling time of 48h, in the presence of S9 -mix, an increase in polyploid cells was observed at and above 150 µg/mL (8 -24 polyploid cells at 150 -175 µg/mL, respectively). This observation may be indicative of an effect of Dianol 320 on spindle formation/function.
No increase in chromosomal aberration was observed either with short-term treatment (without S9 and with S9) or continuous treatment.
To investigate the genetic toxicity of Bisphenol A propoxylated , gene mutation tests in bacteria were conducted with S. typhimurium TA 100, TA 1535, TA 98, TA 1537 and E. coli WP2uvrA strains.
No mutagenic activity was found in all strains of S. typhimurium and E. coli, with and without metabolic activation. Toxicity was not observed in any strain, with and without metabolic activation, up to the limit concentration.
Bisphenol A propoxylate is not mutagenic under the conditions of the test.
In the first mutation assay no cytotoxicity was apparent at concentrations up to and including 100 µg/mL; total cell death was observed at 150 µg/mL (-S9). In the second test, no cytotoxicity was observed up to and including 150 µg/mL. In the supplementary assay, reduced plating efficiency was observed at and above 130 µg/mL (-S9); in the presense of S9 toxicity was observed at and above 160 µg/mL.
No increases in mutation frequencies (or mutant colony numbers) were observed in Dianol 320 treated culteres, both in the absence and presence of S9.
The in vitro genotoxicity of the registered substance was evaluated in accordance with REACH. It is concluded that it is not mutagenic and no in vivo testing is required.
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