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EC number: 939-516-4
CAS number: -
No additional information available.
were found on the reproductive efficiency of the parents, nor on the
growth, fertility and reproductive performance
of the untreated F1 generation, and no histological
changes occurred in the tissues of both the F1 and
Onset of oestrus cycle and weight and microscopy of the endocrine organs
were comparable to control values for both F1 and F2 animals.
In the parent generation all 10 females became pregnant (litter size
9.0, controls 8.1) and in the F1 9/10 females became pregnant (litter
size 8.7, controls 8.1).
Glycerin was administered by oral gavage to groups of male and female
rats through two generations. There was no effect noted on growth,
fertility and reproductive performance through two generations at a dose
level of ~2000 mg/kg/day.
data do not exist for polyglycerine, data do exist for the major
component, glycerine and also for polyglycerine polyricinoleate (PGPR)
which breaks down in the gastrointestinal tract releasing polyglycerine
(called Polyglycerine-Heavy in Justification document). There was no
evidence of an effect on fertility based on a two-generation
reproduction study with either glycerin (~2000 mg/kg/day) or
polyglycerine ricinoleate (1.5% in the diet). The PGPR study did not
convert percent PGPR in the diet to mg/kg/day consumed. Using the
following assumptionsa, Males-26 grams food consumed/day, at
549 grams and Females-20 grams food consumed/day at 358 grams, a 9% PGPR
in the diet corresponds to 4255 mg/kg/day for males and 5005 mg/kg/day
for females. This
corresponds to 383 mg Polyglycerine-heavy/kg/day for the males and 450
mg Polyglycerine-heavy/kg/day for the females).
weights and feed consumption came from F0 generation values in report on 2
generation rat reproduction study DR-0189
There are no data for polyglycerine, however data exist for the major component, glycerine and also for polyglycerine polyricinolate (PGPR) which breaks down in the body releasing polyglycerine. Justification for the use of these data is in the document attached at section 13 of the IUCLID.
Table 1 Partial listing of skeletal findings in rabbits
number of fetuses affected/number of litters affected
6 -AN = 6 -aminonicotinamide
A developmental toxicity study was conducted in rabbits. There was no
effect on developmental toxicity of offspring of female rabbits dosed
with glycerin at doses as high as 1180 mg/kg/day.
Although no data exist for polyglycerine,
data do exist for the major component, glycerine. There was no evidence
of a developmental toxicity effect in rats (1310 mg/kg/day), mice (1280
mg/kg/day) or rabbits (1180 mg/kg/day) administered glycerine orally.
Although no developmental toxicity study has been conducted on the
higher MW glycerine present in polyglycerine, there were no
developmental toxicity effects noted in a rat 3-generation reproduction
study of polyglycerine polyricinoleate (PGPR). PGPR has been shown to be
metabolized in the GI tract releasing polyglycerine which is excreted
unchanged in the urine (diglycerine and triglycerine) and feces (higher
MW glycerines) (Detailed in Sections 7.1.1 and 13).
No additional information available.
There is no justification for classification based on data from
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