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EC number: 614-523-2
CAS number: 68475-37-6
Test substance radioactivity and stability:
The results of the HPLC analysis of the bulk
formulation of [C^14]ester gum prior to the initiation of the study
indicated that the compound was 99.97% radiochemically pure and
reanalysis of the radiolabelled compound at study termination yielded
similar results. In turn the radiolabelled compound was considered
stable. The chemical and radiochemical stability of ester gum in the
dosing emulsions of [C^14]ester gum was determined by SEC analyses of an
emulsion on the day of preparation and 3 days later and the results
indicated that no chemical or radiochemical degradation of the ester gum
in the emulsion occurred during the 3-day storage period.
Formulation analysis of [C^14]ester gum
Chemical concentration analyses and
radioanalyses conducted on the top, middle and bottom samples indicated
that each emulsion was homogeneous.
Formulation analysis of feed containing
unlabelled ester gum:
The mean concentration of ester gum in the
feed was comparable on Day 1 (16.7 mg/g) and Day 14 (16.4 mg/g)
indicating that the ester gum had remained stable during this period.
Dietary consumption of ester gum (Phase I):
Each male rat consumed an average 207.6 mg
of ester gum during the approximate 20-hour feeding period.
Dietary consumption of ester gum (Phase II):
Rats consumed a daily average of 124.6-252.9
mg of ester gum during the 10-day feeding period.
Dietary consumption of ester gum (Phase IV):
Each female rat consumed an average of 139.7
mg of ester gum during the approximate 18-hour feeding period.
data is being read across from the source study that tested Resin acids
and Rosin acids, esters with glycerol based on category read across that
is explained in the category justification document attached in Section
13 of the dossier.
In a study to investigate the absorption of
orally administered ester gum, groups of 8 males and 8 females were
provided ad libitum access to diets containing14000 ppm unlabelled Ester
Gum 8BG for approximately 1 day, 8 males were provided the same diet for
10 days, and a separate group of 9 males received no dietary Ester Gum
8BG but were implanted with bile and jugular cannulas. After dietary
administration of Ester Gum 8BG or after cannula insertion, each animal
received a single oral gavage dose of 200 mg/kg/bw [C^14]ester gum. All
animals were placed in glass metabolism cages. Those
receiving dietary ester gum prior to administration of the labeled
material had urine, feces, and expired CO2 collected every 12 hours
during the first 24 hours and then every 24 hours for the entire
120-hour post-dose observation period. Animals with cannulas had bile
and blood samples collected every 4 hours for 24 hours after
administration of radiolabelled ester gum.
In males and females exposed to unlabelled
Ester Gum 8BG in the diet for one to 10 days prior to oral gavage
administration of [C^14]ester gum, the levels of radioactivity recovered
in either expired CO2, urine or the cage rinses each accounted for only
1% or less of the dose. Between 94.7-105.9% (males) and 97.6-98.5%
(females) of the dose was eliminated in the feces during the 120-hour
sample collection interval and the radioactivity present in the cage
rinses was assumed to be derived from fecal material. Traces of
radioactivity in the carcasses collected at study termination were
believed to have been due to the gastrointestinal tract not being
removed prior to analysis of the carcasses and it was assumed that the
low levels of radioactivity present did not represent absorbed
radioactivity but rather residual [C^14]ester gum in the
intestines. HPLC analysis indicated that a small amount (2.2% or less)
of the radiolabelled components were hydrolyzed by-products of
[C^14]ester gum. Radioactivity analyses of two bile samples collected
from 0-4 hours after administration of [C^14]ester gum indicated that no
intact [C^14]ester gum was present in the samples. Most of the
radioactivity (1.6-2.9%) eluted as a single peak suggesting that the
radioactivity represented a hydrolysis product(s). Low levels of
radioactivity detected in the blood during the first 24 hours after
[C^14]ester gum administration accounted for 0.1% or less of the dose
and radioactivity in livers from these same rats accounted for 0.1-0.2%
of the administered dose indicating that hepatic retention of
radioactivity was essentially negligible.
Based on the findings of the present study,
ingestion of Ester Gum 8BG has a low potential to bioaccumulate. Only
a small percentage of the administered [C^14]ester gum was hydrolyzed
and absorbed from the gastrointestinal tract with most of the dose
(>95%) recovered in the feces within the first 48 hours.
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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