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EC number: -
CAS number: -
Table 1: Clinical Observations (P)
Moving the bedding
Table 2: Macroscopic Findings (P)
kidney (right): red spots
kidneys: discoloured dark
kidneys: discoloured blue
epididymis (left): yellow spot
epididymis (right): yellow spot
epididymis: discoloured blue
testes: discoloured blue
pancreas, stomach, duodenum, jejunum, ileum, caecum, colon: discoloured blue
hardening on the fat besides right ovary
ovaries: discoloured dark
uterus, oviduct, cervix: discoloured dark
lung: left side blue spot
lung: both sides blue spots
vagina: discoloured dark
Table 3: Body weight changes
Day of treatment
100 mg/kg bw
300 mg/kg bw
1000 mg/kg bw
TS - Terminal sacrifice
*Significant (p<0.05); as determined
with the individual data
Table 4: Reproductive Indices
A reproduction/developmental toxicity screening test of FAT
40849/C TE was conducted in Wistar rats to assess possible effects on
the fertility and embryofetal development.
Four groups comprising of 10 male and 10 non-pregnant nulliparous
female rats each were dosed daily by gavage with 100, 300 and 1000 mg/kg
bw/day of FAT 40849/C TE. The control group received sterile water in
similar volume as the treated groups. Administration was carried out
during 14 days pre-mating and 14 days mating period in both males and in
females, during gestation period and up to Post natal day (PND) 3 in
females. Males were dosed for 28 days. Males and females were sacrificed
on Day 29 and PND 4, respectively and subjected to necropsy.
Animals were examined daily for the clinical signs and mortality.
Body weight and food consumption was measured weekly except during the
mating period. Each litter was examined as soon as possible after
delivery of the dam to establish the number and sex of pups,
stillbirths, live births, runts and the presence of gross abnormalities.
Live pups were counted, sexed and litters weighed on PND 1 and 4.
No mortalities or predominant clinical signs considered to be
treatment-related were observed during the study period. Body weight and
food consumption were as well not affected by the treatment, as were
precoital interval, duration of gestation and reproductive indices.
Discolouration of organs and the digestive tract noted in almost all
treated animals is considered to be attributable to the colour of the
test item and as such not a systemic effect due to the test item
administration. No treatment-related or dose-dependent effect regarding
organ weight was seen in either sex or dose group. Histological findings
were considered to be related to test item deposition with no
accompanying findings that would indicate organ damage.
No treatment-related effect was observed regarding any litter
Based on the data generated from this reproduction/developmental
toxicity screening test with FAT 40849/C TE, the NOAEL is considered to
be 1000 mg/kg bw/day in males and females.
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