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EC number: 214-288-2
CAS number: 1119-86-4
The oral administration
of decan-1,2 -diol to male and female Wistar rats at the dose levels of
100, 300 and 1000 mg/kg bw/day produced no clinical signs or mortality.
There were no toxicologically significant effects on body weights and
food consumption in males and females during the entire dosing period.
The mean number and
weight of male, female and total pups per litter were unaffected by the
treatment. The test item had no effects on the mean litter size and mean
viable litter size. There were no external abnormalities in live or dead
pups in any of the groups. The Day 4 survival index was significantly
lower at all the doses tested, when compared to vehicle control group.
This finding was mainly contributed by the loss of an entire litter in
each group during lactation period. As this isolated finding can be
spontaneously observed (it was observed in a previous OECD 421 study
performed in-house), the lower Day 4 survival index observed at all the
doses was considered incidental and thus not treatment-related.
significant changes were observed in pre-coital time, gestation length,
mating and fertility parameters. No treatment-related effects were
observed on the number of implantations, percentage of pre and post
implantation losses. There were no test item-related changes in terminal
body weights in both the sexes. The organ weights of testes and
epididymides remained unaffected by test item administration. There were
no test item related gross and microscopic changes in the reproductive
organs of males and females at all the doses tested. No gross
pathological changes were observed in dead pups and pups sacrificed on
lactation Day 4 at all the doses tested. In females at ≥ 300 mg/kg
bw/day dose groups and in males at 1000 mg/kg bw/day dose group, test
item-related thickening of non-glandular stomach was observed.
The No Observed
Adverse Effect Level (NOAEL) for reproductive/developmental toxicity in
Wistar rats is 1000 mg/kg bw/day.
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