Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-896-0
CAS number: 7360-38-5
A prenatal developmental toxicity study has been performed with the
registered substance. No adverse effects on any of the reproductive
parameters investigated was observed.
Treatment of pregnant female rats from Day 6 to 19 after mating at dose
levels up to and including 1000 mg/kg bw/day was well tolerated and
there were no unscheduled deaths or test item-related signs of toxicity.
Treatment with the registered substance did not adversely affect the
reproductive parameters investigated: gravid uterine weight, incl.
cervix and ovaries, corpora lutea, implantation sites, resorption sites
(classified as early or late), fetuses (live and dead).
Prenatal developmental toxicity (OECD 414, rat): NOAEL (maternal
systemic toxicity) = 1000 mg/kg bw/day; NOAEL (development) = 1000 mg/kg
Propane-1,2,3-triyl 2-ethylhexanoate was investigated for adverse
effects on prenatal development in a study conducted according to OECD
guideline 414 and under GLP conditions (Envigo, 2019b). The test
substance was administered during the organogenesis and fetal growth
phases of pregnancy (Days 6 to 19 of gestation) in the Han Wistar Rat.
Three groups of 20 females received the test substance at doses of 100,
300 or 1000 mg/kg bw/day by oral gavage. A control group received the
vehicle (corn oil) only. Animals were killed on Day 20 after mating for
reproductive assessment and fetal examination. Clinical observations
(Days 0, 5, 12, 18 and 20 after mating), body weight (Days 0, 3 and 6-20
after mating) and food consumption (Days 0-3, 3-6, 6-10, 10-14, 14-18
and 18-20 after mating) were recorded. Adult females were examined
macroscopically at necropsy on Day 20 after mating and the gravid uterus
weight and thyroid weight were recorded. Microscopic pathology
investigations of the maternal thyroid glands were also performed.
Ano-genital distance was measured in the fetuses. All fetuses were
examined externally at necropsy and subsequently by detailed internal
visceral examination or skeletal examination. Treatment of pregnant
female rats with the test item was well tolerated and there were no
unscheduled deaths or test item-related signs. Group mean body weight
gain, gravid uterine weight, adjusted body weight gain, food consumption
and thyroid/parathyroid weights were unaffected at all dose levels
investigated, and there were no test item-related maternal macroscopic
abnormalities detected at scheduled termination. Histopathological
examination of the thyroids did not reveal any test item-related
lesions. There was no effect of the test substance on T3/T4 or TSH
concentrations at any dose level investigated. There was also no effect
of maternal exposure to the test substance on developmental parameters,
as assessed by the mean numbers of implantations, resorptions, live
young, sex ratio and pre- and post-implantation losses. Placental
weight, litter weight and fetal weights and ano-gential distance were
similar between treatment groups and control. The very low incidence
(i.a. single occurence) of major fetal abnormalities were considered
spontaneous and are not thought to be related to treatment with the test
item. Minor fetal abnormalities, skeletal variants and macroscopic
abnormalities included delayed ossification, which is a transient stage
in fetal development and therefore not considered adverse, and slight
increase in incidence of partially fused jugal to maxilla in the mid
dose group, which did not show a dose-response relationship and is a
transient marker of fetal maturity. Therefore, the slight increase in
incidence of partially fused jugal to maxilla in the intermediate dose
group only was considered to be incidental and unrelated to maternal
treatment with the test substance. Based on the results, it was
concluded that the high dose level of 1000 mg/kg bw/day (the limit dose)
represented the No Observed Adverse Effect Level (NOAEL) for maternal
toxicity and for embryo-fetal survival, growth and development.
The available data on reproductive / developmental toxicity do not
meet the criteria for classification according to Regulation (EC) No.
1272/2008, and are therefore conclusive but not sufficient for
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again