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EC number: 270-302-7
CAS number: 68424-43-1
Developmental toxicity test according to OECD 414 in rats: NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/d (highest dose tested)
Group 1 (control)
Group 2 (100 mg/kg bw/d)
Group 3 (300 mg/kg bw/d)
Group 4 (1000 mg/kg bw/d)
Number of dams
Mean ± St. dev.
% of Corp. Lutea
Number of dams affected
% of Impl. Sites
Implantation sites scars
Embryonic/Fetal Deaths total
% of Fetuses
Weight of Fetuses (Litter Basis)
*/**: Dunnett-Test based on pooled variance significant at level
5% (*) or 1% (**)
Lanolin Fatty Acids (CAS 68424-43-1) was tested in a prenatal
developmental toxicity study according to OECD Guideline 414 (Whitlow,
2013). The test substance was applied by gavage to Han-Wistar rats. 22
female animals per dose were treated with 100, 300 or 1000 mg/kg bw/day
test substance dissolved in corn oil on Days 6-15 of gestation. Control
animals (22 females per dose) received the vehicle. Observations and
examinations of the animals included clinical signs, body weight, food
consumption and post-mortem examinations, with emphasis on the uterus
and its content.
All females survived until the scheduled necropsy on day 21 post
coitum. No clinical symptoms or signs were observed at any dose level
during the study that were considered to be related to the test item. No
test item-related changes were observed in the amount of food consumed
during the study. Absolute body weight and body weight gain were not
affected by treatment with the test item. The relevant reproduction data
(post-implantation loss and number of fetuses per dam) were not affected
by treatment with the test item. No findings were observed at any dose
level during macroscopical examination.
No findings were observed during external examination of the
fetuses in any group. No test item-related effects on the sex ratio and
body weights of the fetuses were noted in any group. There were no
findings seen during visceral examination that were considered to be
related to maternal administration of the test item. Severe kidney
pelvic dilatation was seen in one fetus in the group given 1000 mg/kg
bw/day, and severely malpositioned testis was recorded for one fetus in
the group given 100 mg/kg bw/day. However, as both instances were
isolated findings, these were not considered to be test item-related.
Examination of bone and cartilage abnormalities and variations revealed
no test substance related effects. Furthermore no test substance related
effects were observed after examination of ossification and
supernumerary ribs. Examination of additional cartilage variations
revealed that costal cartilage not reaching sternum was statistically
significantly increased at 1000 mg/kg bw/day on a litter and on a fetus
basis. This incidence has been observed in this strain and is therefore
not considered to be test item-related. All further findings were within
the range of the historical control data or did not increase in a
dose-dependent manner. There were no findings observed that were
considered to be related to maternal administration of the test item.
In conclusion, a NOAEL of 1000 mg/kg bw was derived for prenatal
development and for maternal toxicity.
The available data on toxicity to reproduction of the test
substance do not meet the criteria for classification according to
Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore
conclusive but not sufficient for classification.
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