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: 701-218-5
CAS number: -
In a subchronic repeated dose toxicity study (OECD TG 408) on rats with
doses of up to and including the limit dose of 1000 mg/kg bw/day, no
effects were observed on weight or histopathology of reproductive
glands/tissues/organs. The oestrous cycle was also not affected by the
A data waiver for reproductive toxicity
studies according to OECD TG 421/422 and 443 is claimed.
OECD TG 414 study on rats: no effects on fetal development; NOAEL 1000
mg/kg bw/day (highest dose tested)
OECD TG 414 study on rabbits: no effects on fetal development; NOAEL 600
mg/kg bw/day (highest dose tested)
Table 1: general reproduction data
A developmental toxicity study with the substance was performed according to OECD TG 414. Twenty-five inseminated female Wistar rats per dose group were administered (gavage) daily from day 6 to 20 p.c. the test substance at doses of 0, 100, 300, and 1000 mg/kg bw in Lutrol®(PEG 400). The fetuses were delivered by cesarean section on day 21 of gestation. Investigation was performed on general tolerance of the test substance by the females as well as on its effect on intrauterine development.
Appearance, behavior, mortality, absolute and corrected body weight gains, food intake, water intake, and fecal and urinary excretions were unaffected at dose levels up to and including 1000 mg/kg bw.
No treatment related gross pathological findings occurred at dose levels up to and including 1000 mg/kg bw.
The gestation rate, appearance and weights of placentas, postimplantation loss and correspondingly the number of fetuses, fetal sex distribution, and fetal weights were unaffected by the treatment at dose levels up to and including 1000 mg/kg bw.
A treatment related effect on malformations, external, visceral, and skeletal (including cartilage) deviations was not evident at dose levels up to and including 1000 mg/kg bw.
Summarizing and evaluating all data investigated revealed a NOAEL of 1000 mg/kg bw/day for each maternal toxicity and developmental toxicity.
Dose Formulation Analyses
The concentrations analysed in the formulations of Groups 2, 3 and 4
were in agreement with target concentrations (i.e. mean accuracies
between 85% and 115%, actual values 97-99%).
No test item was detected in the Group 1 formulation.
The formulations of Groups 2 and 4 were homogeneous (i.e. coefficient of
variation ≤ 10%, actual values 0.62-2.1%).
Table 1: Summary of results
Dose level (mg/kg bw/day)
Females that aborted or delivered
Females that died
Females that were euthanized
Females examined at scheduled necropsy
Mean number of corpora lutea
Mean number of implantation sites
(total number and % per litter)
Dams with stillbirths, resorptions only and/or dead fetuses
Pre-implantation loss (total number and % per litter)
Post-implantation loss (total number and % per litter)
Mean body weight on day 29 pc (g)
Mean corrected body weight gain day 7-29 pc (%)
Gravid uterine weight (g)
Mean live offspring (number and percent)
Mean fetal body weight (males; g)
Mean fetal body weight (females; g)
Mean fetal body weight (sexes combined; g)
Malformations (including runts) (number and % per litter)
Variations (% per litter)
In a prenatal developmental toxicity study (performed according to OECD
TG 414) 22 pregnant female New Zealand White rabbits per group were
treated by oral gavage with Polyether P 293 in doses of 60, 200 and 600
mg/kg bw from GD 7 to 28. A higher dose level than 600 mg/kg bw/day was
considered unfeasible due to mortality (2/6 pregnant females) observed
at 1000 mg/kg bw/day in the dose range finder.
No mortality occurred during the study period that was considered to be
related to treatment with the test item. No maternal or developmental
toxicity was observed in the 60, 200 and 600 mg/kg bw/day groups.
In conclusion, based on the results in this prenatal developmental
toxicity study the maternal and developmental No Observed Adverse Effect
Level (NOAEL) for Polyether P 293 was established as being at least 600
A developmental toxicity study (performed according to OECD TG 414)
revealed no treatment related effects for appearance, behaviour,
mortality, absolute and corrected body weight gains, food intake, water
intake, and fecal and urinary excretions up to and including 1000 mg/kg
bw. No treatment related gross pathological findings occurred at dose
levels up to and including 1000 mg/kg. The gestation rate, appearance
and weights of placentas, postimplantation loss and correspondingly the
number of fetuses, fetal sex distribution and fetal weights were
unaffected by treatment at dose levels up to and including 1000 mg/kg. A
treatment related effect on malformations, external, visceral and
skeletal (including cartilage) deviations was not evident at dose levels
up to and including 1000 mg/kg.
Summarizing and evaluating all data investigated revealed a NOAEL of
1000 mg/kg bw for each maternal and developmental toxicity.
No classification required for toxicity to reproduction according to
Regulation (EC) No 1272/2008, Annex I.
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.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
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