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EC number: 231-955-3
CAS number: 7782-42-5
Table: Summary of pregnancy data
Dosage (mg/kg food)
Pairs started (N)
Females showing evidence of copulation (N)
Females achieving pregnancy (N)
Conceiving days 1-5 (N)
Conceiving days 6-14 (N)
Pregnancy = 21 days (N)
Pregnancy=22 days (N)
Pregnancy => 23 days (N)
Dams with live young born (N)
Dams with live young at day 4 p.p. (N)
Corpora lutea/dam (mean)
Live pups/dam at birth (mean)
Live pups/dam at day 4 (mean)
Sex ratio (m/f) at birth (mean)
Sex ratio (m/f) at day 4 (mean)
Litter weight at birth (mean)
Litter weight at day 4(mean)
Pup weight at birth (mean)
Pup weight at day 4(mean)
Dams with 0
Dams with 1
Dams with 2
Dams with 3
LOSS OF OFFSPRING
Pre-implantation (corpora lutea minus implantations)
Females with 0
Females with 1
Females with 2
Females with 3>
Pre-natal (implantations minus live births)
Post-natal (live births minus alive at post natal day 4)
ANALYSIS OF TEST ITEM CONCENTRATION
results of the analyses of the test item concentration in food of group
2-4 are summarized in Table “Food Analysis”.
mean substance intake calculations are summarized in Table “Substance
analyses showed that preparations contained 108, 103, and 96 % of the
target concentration of the three dose groups, respectively.
on mean body weights and food consumption data, this resulted in the
following actual substance intake: 91, 261, and 813 mg/kg body
weight/day for males; 120, 343, and 1067 mg/kg body weight/day for
females in the premating period; 106, 309, and 930 mg/kg body weight/day
for females during gestation; and 111, 370, and 1159 mg/kg body
weight/day for females during lactation, respectively.
TABLE: FOOD ANALYSIS
Target concentration in food, mg/kg food
Chemically determined concentration, mg/kg food (% of target value)
TABLE: SUBSTANCE INTAKE
Group 2 (Low dose)
Group 3 (mid dose)
Group 4 (high dose)
Mean BW [g]
Mean FC [g/animal/d]
SI [mg/kg BW/day]
Analytical Concentration[mg/kg food]
% target dose
In a combined repeated dose toxicity study
with the reproduction/developmental toxicity screening test (OECD 422),
Expanded Graphite Powder was administered to 10 Wistar rats
(Crl:WU)/sex/dose in diet at dose levels of 1300, 3700 and 11500 ppm
food, corresponding to actual substance intake levels of 91, 261 and 813
mg/kg body weight/day for males, 120, 343 and 1067 mg/kg body weight/day
for females in the premating period, 106, 309 and 930 mg/kg body
weight/day for females during gestation and 111, 370 and 1159 mg/kg body
weight/day for females during lactation, respectively.
The animals were treated for 2 weeks
before mating and during the mating period. Successful mating was
confirmed by detection of sperm in vaginal smears and/or a vaginal plug
(day 0 post conceptionem) and treatment was continued through postnatal
day 4. Males were treated for at least 28 days.
Since the outcome of the first pairing
was insufficient, a second subset of 40 female and 40 male animals was
randomly assigned to the four groups for one more mating trial. For
the four dose groups, mating yielded 19 (control), 19 (LD), 20 (MD), and
18 (HD) sperm positive females, in groups 1-4, respectively. This
resulted in 14, 10, 13, and 10 pregnancies; 11, 9, 13, and 10 females
with liveborn offspring in F0 dams, and 11, 9, 12, and 10 females with
live litters on day 4 p.p., respectively.
There were no compound-related adverse
clinical signs, effects on body weight, weight gain, food consumption or
functional observations in any dose group. In addition, haematological
and clinical chemistry data were within expected ranges for the rat
species, strain and age. Occasionally, statistically significant
differences in organ weights were observed, which were not considered
The main necropsy findings consisted
of reduced size of testes and epidydimides, which were found in all
groups including the control group.
There were no treatment-related
effects observed for reproductive parameters, including precoital time
or fertility (number of mated females, number of pregnant females,
number of implantation sites, number of liveborn pups).
In addition, no effect could be
observed on litter size, pup survival and pup body weight.
Based on the results of this study,
the NOAEL is considered to be >11500 ppm food, corresponding
to actual substance intake levels of 813 mg/kg bw/day (males), 1067
mg/kg bw/day (females in premating period), 930 mg/kg bw/day (females
during gestation) and 1159 mg/kg bw/day (females during lactation), i.e.
the highest dose tested.
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