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EC number: 939-516-4
CAS number: -
increased mutation frequency seen at the two highest concentrations (800
and 1000 ug/mL) in absence of a concentration response relationship are
not considered biologically significant and do not fulfil the criteria
for a positive response due to the absence of a dose-response
* Values are at least three times that for the solvent control.
The test material was evaluated in the Chinese hamster ovary assay with
and without metabolic activation. The test material did not meet the
criteria set for a positive response set by the author of the report and
was considered to be negative by the author.
There are no data for polyglycerine. Data are available for glycerol,
the major component of target substance. Glycerol was negative in two
separate Ames tests, a Chinese hamster ovary HGPRT assay, a Chinese
hamster ovary SCE assay and an Unscheduled DNA Synthesis assay using rat
hepatocytes. Given the lack of a mutagenic response in all the in vitro
studies with glycerol, and the lack of a carcinogenic response in a
chronic tox/carcinogenicity study with glycerol and with polyglycerol
(as part of polyglycerol polyricinoleate) (the relevant read-across
analogues), conduct of an in vivo mutagenicity study is not required
since according to Column 2 of Annex VIII and IX, further
genotoxicity testing in vivo is only required if there are positive
findings in the in vitro studies. For
more read-across justification and support, please refer to the attached
Classification for genetic toxicity according to GHS and the Directive
67/584/EEC (DSD) is not warranted. Data on the major component,
glycerol, indicated no genotoxic responses. In addition, data from
rodent cancer bioassays with glycerol and polyglycerol
(as part of polyglycerol polyricinoleate) indicated no evidence
of carcinogenic potential.
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