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EC number: 248-258-5
CAS number: 27138-31-4
A two generation study in rats was conducted to assess the effects on
reproductive performance of the test material DPGDB. The study was
conducted according to OECD and EPA test guidelines, and in compliance
Dietary administration of DPGDB at concentrations of 1000, 3300 or 10000
ppm was generally well tolerated by the P (F0) and subsequent F1
parental animals and their respective progeny. Exposure to the test
material was in line with expectation throughout both generations
fluctuations reflected the different physiological status of the animals
and were predictably highest for females during peak lactation and in
young animals. Bodyweight change of F1 females before paring and F1
males were slightly but significantly lower than in Controls.No adverse
effects were seen on overall parental food consumption; food conversion
efficiency calculated during the 10 week pre-mating phase was considered
similar to controls for both generations.Oestrous cycle, mating
performance, fertility and fecundity were similar in all groups.
Gestation lengths and the parturition process were unaffected by
treatment. Assessment of the terminal vaginal smears taken from F0
females revealed a higher incidence of females in oestrus in groups
treated with DPGDB compared with controls. This finding was not apparent
among F1 females and is considered to be of doubtful biological
Litter parameters at birth of the F1 and F2 progeny and their survival
to weaning showed no apparent detrimental effects of treatment with
DPGDB. However, in both F1 and F2 offspring at 10000 ppm there was a
slight reduction on weight gain during days 14-21 of age and this
finding may be linked to the transition to direct exposure to the test
material as the offspring weaned on to solid diet at the same dietary
inclusion levels as their parents.
No treatment related findings were seen at microscopic examination of
the F1 offspring not selected to form the next generation or the F2
offspring killed after weaning.Macropathology, histopathology assessment
and sperm analysis for the F0 and F1 adults showed no adverse effects of
The only possible effect of treatment detected at assessment of organ
weights from F1 and F2 offspring was significantly lower absolute and
relative spleen weight among F2 males and females compared to controls.
The toxicological significance if this finding is uncertain since it was
not detected among F1 offspring or among F0/F1 adult animals.The
evidence from this study suggested that a dietary concentration of DPGDB
at 10000 ppm should be considered as the No Observed Adverse Effect
Level (NOAEL) for P (F0) and F1 parent animals. The NOAEL for developing
offspring is considered to be 3300 ppm. The No Observed Effect Level
(NOEL) for reproductive parameters is considered to be 10000 ppm.
The evidence from this study suggested that a dietary concentration of
DPGDB at 10000 ppm should be considered as the No-Observed-Effect-Level
(NOEL) for F0 and F1 parent animals. The
No-Observed-Adverse-Effect-Level (NOAEL) for survival and growth of the
offspring is considered to be 10000 ppm.
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