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EC number: 607-759-2
CAS number: 25618-55-7
Carcinogenicity results are based on the read across substances glycerol or Polyglycerol esters (PGPR). See "Read across report" attached to the dossier.Key study: 2-year repeated dose study with Polyglycerol Polyricinoleate (PGPR) in rats and mice. Identified NOEL value was ca. 2.5 g/kg b.w. per day based on the overall effects.
Based on the read-across substance
(Polyglycerol Polyricinoleate PGPR) and supporting information (glycerol),
Polyglycerol-3 does not possess any carcinogenic properties. No
classification as carcinogen is required.
Carcinogenicity studies with Polyglycerol-3 are not
available.However information on the read across substances Polyglycerol
Polyricinoleate (PGPR) and glycerol is available.
2-year repeated dose study with
Polyglycerol Polyricinoleate (PGPR) in Rats and Mice (key-study):
The carcinogenic potential and chronic
toxicity of the food emulsifier ADMUL WOL brand of polyglycerol
polyricinoleate (PGPR) was evaluated in rats and mice. Groups of 60 male
and 60 female rats were given purified diets containing 5% of either
PGPR or groundnut oil for 2 years. Groups of 25 male and 25 female mice
were given purified diets containing 5% of either PGPR or groundnut oil
for 80 weeks.
The authors state that no carcinogenic effect
of PGPR was observed. In addition, dietary PGPR had no adverse effect on
growth, food consumption, longevity and hematology. Organ weight
analysis revealed an increase in liver and kidney weight in both male
and female rats and female mice. Histological analysis of tissues
revealed no treatment related adverse effects.As
the slightly increased liver and kidney weights were not accompanied by
correlating findings, these effects were not considered adverse.
The NOAEL value for carcinogenicity and
chronic toxicity for both test species rats and mice was calculated as
approx. 2500 mg/kg bw/day based on the overall effects.
Available information on glycerol:
hereafter the text on thecarcinogenicityof
glycerol (text copied from OECD SIDS dossier of glycerol, page 20):
In a limited and non OECD Guideline 12-24
month dietary study in rats, evidence of malignant neoplasms were
reported in 5/26, 1/22, 5/22, 0/22, 0/21, 5/22 and 0/22 animals in
controls and at 5%, 10%, 20% (natural glycerol) and at 5%, 10%, 20%
(synthetic glycerol). At the top dose, the treatment period was one
year. Benign neoplasms were encountered including pheochromacytomas and
granulosa cell tumours in 0/26, 2/22, 1/22, 0/22, 4/21, 4/22 and 1/22
animals in controls and at 5%, 10%, 20% (natural glycerol) and at 5%,
10%, 20% (synthetic glycerol), respectively.The
authors concluded that glycerol does not initiate tumor development in
the rat (Hine 1953).
In male ddY mice administration of glycerol
(5% in drinking water during 1-20 weeks) after a single s. c. injection
with 4-nitroquinoline 1-oxide (4-NQO) was reported to enhance lung tumor
development. Histopathologically most lung tumors were identified as
adenomas (Nagahara 1987, Inayama 1986). The mechanism of tumor induction
was independent from pulmonary cell kinetics (Nagahara 1987).
Conclusion: No studies conducted to modern
regulatory guidelines are available. The studies that are available are
therefore of lower quality. No increase in tumor formation was observed
in a limited dietary carcinogenicity study in the rat. Data from
non-guideline studies designed to investigate tumor promotion activity
in male mice suggest that oral administration of glycerol up to 20 weeks
had a weak promotion effect on the incidence of lung tumor formation. In
the same studies, treatment with glycerol alone (administered in the
drinking water) did not result in an increase in the number of tumor
bearing mice relative to controls. Overall, these data do not raise
concern for carcinogenic potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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