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EC number: 271-085-1
CAS number: 68515-43-5
The influence of Diplast L9 -11 on the fertility and reproductive
capacity of two successive generations was assessed in male and female
rats using methods prescribed by OECD test guidelines. The substance was
administered continuously in the diet at concentrations of 1000, 5000 or
10000 ppm to groups of rats throughout the two generations. The highest
dosage group animals were given 20000 ppm for approximately six weeks
(43 days) at the start of the F0 generation but this was reduced to
10000 ppm because of a marked reduction in bodyweight gain of the males.
The substance had no adverse effects upon fertility or reproductive
performance when rats were exposed to diets containing up to 10000 ppm
of the test material through two successive generations. The substance
had no adverse effect on the seminology parameters investigated and no
histopathological effects on the reproductive organs.
A two-generation fertility study has been undertaken. In this study no
adverse effects upon fertility or reproductive performance when rats
were exposed to diets containing up to 10000 ppm, corresponding to a
mean daily intake of at least 650 mg/kg/day, through two successive
generations. D911P fed through two generations had no adverse effect on
the seminology parameters investigated and no histopathological effects
on the reproductive organs.
Developmental toxicity: NOAEL - 1000 mg/kg/day
Increased levels of salivation after
dosing were seen sporadically in all groups, including control. A
greater number of animals were affected at 1000 mg/kg/day than in the
Control and lower dosage groups; however, it was noted that post-dosing
salivation is frequently observed in studies with oral gavage dosing and
its occurrence is generally considered to reflect distaste of the dosing
formulation rather than
indicating toxicological effect. Several
animals in all groups (including control) showed staining of the coat on
the head and body, and some incidences of hairloss: these observations
were considered to be related to the use of oil as the dosing vehicle
and to be of no toxicological significance.
Bodyweights and bodyweight gain during
gestation were unaffected by treatment. Adjustment of overall bodyweight
gain for the contribution of the gravid uterus showed no adverse effect
of treatment on bodyweight gain.
Food consumption during gestation was
unaffected by treatment; group mean values for all treated groups were
similar to the Control throughout
Macroscopic findings at neuropsy of
females on Day 20 of gestation were unremarkable being generally
restricted to confirmation of signs (hairloss staining) observed
in-life. No findings considered to be of toxicological significance were
All females were pregnante , however one
female at 1000 mg/kg/day was found to only have three empty implantation
sites (two in the left and one in the right uterine horn). This litter
was classified as total litter resorption (total litter loss in-utero).
Given the isolated nature of this finding, and the absence of any
adverse effect on the process of implantation (as judged by
pre-implantation loss) or on foetal survival (as judged by
post-implantation loss), an association with treatment was considered
The number of implantations, resorptions
and live foetuses were essentially similar in all groups and were
unaffected by treatment. There was no evidence that the implantation
process or in-utero survival had been adversely affected by
administration of the test substance. Sex ratio, expressed as percentage
males, was comparable in all groups.
Placental, litter and foetal weights
There were no obvious adverse effects of
treatment on placental, litter or foetal weights.
It was noted that mean foetal weight was
higher in both sexes at 1000 mg/kg/day, with differences from Control
attaining statistical significance for females; this was not considered
to be of any toxicological significance.
There were 3, 1, 2 and 3 foetuses (3, 1, 2
and 2 litters affected) in Groups 1 to 4 respectively showing major
abnormalities. Neither the type, incidence nor distribution of major
abnormalities indicated any obvious adverse effect of treatment with the
The incidence and distribution of minor
visceral and skeletal abnormalities or skeletal variants did not
indicate any adverse effect of treatment on foetal development.
At 1000 and 250 mg/kg/day, detailed
visceral examination revealed a higher incidence of foetuses showing
dilated ureter compared to the Control, although this incidence was
within the recent background control data range. Accompanying this
finding was a higher incidence of renal cavitation and hydroureter in
animals allocated to skeletal processing, at these dosages compared to
Collectively these findings were noted to
cluster, with two litters at 250 mg/kg/day and two litters at 1000
mg/kg/day being particularly affected. In view of the litter clustering
and the absence of any clear dosage relationship, these findings were considered
to be coincidental, and emphasised by a low incidence in the Control
At 1000 and 500 mg/kg/day there was also
an increased incidence of foetuses with 13/14 or 14/14 ribs. Again there
was no dose relationship and, as the total number of litters affected
remained similar to that of the Control group, it was considered that
this finding could not, with certainty, be attributed to treatment.
Potential developmental toxicity has been studied in the rat using
methods in accordance with OECD TG414. Daily treatment from before
implantation to just before the expected day of parturition resulted in
no clear adverse effects on pregnancy of the female rat or on
embryofoetal survival and development at dose levels up to 1000 mg/kg
A study of developmental toxicity has been undertaken. In this study no
clear adverse effects on pregnancy of the female rat or on embryofoetal
survival and development were apparent at dose levels up to 1000 mg/kg
Classification is not justified based on the available information from
a 2 -generation reproductive toxicity study and a study of developmental
toxicity. This justification is supported by the ECB decision on the
substance regarding classification and labelling (Meeting of the
Commission Working Group on the Classification and Labelling of
Dangerous Substances, ECB Ispra 16 -18th January 2002, ECBI/15/02 Rev.3).
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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