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EC number: 224-506-8
CAS number: 4390-04-9
data is being read across from the source study that tested
Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, ≤2% aromatics
based on analogue read across.
The test material was administered by oral
gavage to three groups of Crl:CDBR female rats at doses of 400, 800, and
1000 mg/kg/day. A fourth group (Group 1) served as a control and
received the carrier (corn oil) only. Mated females were dosed once
daily from Gestation Day (GD) 6 through GD 15. Dosing volumes were 5
mL/kg for all groups and based on the animals' most recent body weights.
There was no evidence of overt systemic
maternal toxicity at any dose level tested. overt signs of maternal
toxicity were not apparent at any dose tested, as indicated by the
absence of adverse clinical or postmortem findings or effects on body
weight, food consumption, and/or uterine implantation data.
Similarly, there were no treatment-related
adverse effects on fetal development or growth observed at any dose
level tested. There was a statistically significant increase in the
incidence of rudimentary ribs in the low dose (400 mg/kg/day) group, but
not at the higher doses, compared with controls, which resulted in an
increased incidence of total fetuses with skeletal variations in the 400
mg/kg/day group. However, all these incidences were within the
historical control range of this laboratory. Therefore, this common
finding in fetal rats was not considered biologically important.
Accordingly, the maternal and developmental
NOAELs (No Observable Adverse Effect Level) were established at 1000
mg/kg/day under the conditions of this study.
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