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EC number: 700-208-8
CAS number: -
Group / Dose level
Fertility index in %
Non-pregnant rats/ rats used
2 / 12
4 / 12
3 / 12
Gestation index in %
Pregnant rats without live pups (NVP) / Number of pregnant rats
0 / 10
1 / 8
2 / 10
Reproductive parameters and indices:
Number of corpora lutea
Number of implantation sites per dam
Number of pups (born aliveand dead) per dam
Number of pups (born alive) per dam
Fertility index %
Gestation index %
Birth index %
Live birth index %
Pre-implantation loss %
Post-implantation loss %
**: p≤0.01, Fisher or Chi2 t-test
#1: The listed indices are calculated
from the total number of corpora lutea, implantation sites and fetuses
#2: The number of corpora lutea per dam
was below the background data (13.8 – 16.5 corpora lutea per dam) in all
test item treated groups and no dose response relationship was noted.
Hence, the observed low numbers were considered as not test
item-related in all dose groups.
#3: The reduced birth index was still in
range of background data (87 – 97%) and not considered as
#4: The increased post-implantation loss
was still in the range of background data (3.6 – 12.7%) and not considered
as test item-related.
Test item-related changes aremarked
The aim of the study was to obtain information on possible effects
of the test item on general toxicity, reproduction and/or development
according to OECD guideline 421. The test item was administered orally
to rats at dose levels of 100, 300 or 1000 mg MPA/kg b.w./day.
The application started two weeks before mating on test day one and
ended on the day or one day before sacrifice. Day of sacrifice was on
test day 36 for the male rats and on lactation day 4 or shortly
thereafter for the female rats.
No test item-related premature deaths were noted in the test item
Pale faeces were noted for 3 of 12 animals of the high dose group (1000 mg
MPA/kg b.w./day) (one pregnant and 2 non-pregnant) during the
gestation or the lactation period.
A small reduction in body weight was noted for the male and female
rats of the high dose group (1000 mg MPA/kg b.w./day), which
was more pronounced for the female rats.
Body weight at autopsy was accordingly reduced for the male and
female rats of the high dose group (1000 mg MPA/kg b.w./day).
A reduction in food consumption was noted for the female rats of
the high dose group (1000 mg MPA/kg b.w./day) during the
A test item-related thickened cardia part, squamous cell
hyperplasia and hyperkeratosis were noted in 3 or rather 4 stomachs from
the female rats of the high dose group (1000 mg MPA/kg b.w./day)
during macroscopic and microscopic examination.
No influence was noted on the reproductive organs and the stages
A prolonged gestation length, reduced numbers of implantation
sites per dam, of pups (born alive and dead) per dam, of pups
(born alive) per dam and an increased pre-implantation loss were
noted in the intermediate and the high dose group (300 and 1000 mg
Additionally, an increased post-implantation loss and an
increased number of stillbirth were noted in the high dose group (1000 mg
MPA/kg b.w./day), leading to a a reduced birth and live
Effects on the development of the F1generation
A reduced survival index and a reduced body weight were
noted for the pups of the high dose group (1000 mg MPA/kg b.w./day).
The following no-observed-adverse-effectlevels were established:
NOAEL (no-observed-adverse-effect level): 300
mg/kg b.w./day, p.o.
a) adverse effects on sexual function and fertility
NOAEL (no-observed-adverse-effect level): 100
mg/kg b.w./day, p.o.
b) adverse effects on development of the offspring
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