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EC number: 285-550-1
CAS number: 85116-97-8
Oral (read-across, OECD 414), rat:
NOAEL developmental toxicity: ≥ 900 mg/kg bw/day
NOAEL maternal toxicity: ≥ 900 mg/kg bw/day
The hazard assessment is based on the data currently available. New
studies with the registered substance and/or other member substances of
the glycol esters category will be conducted in the future. The
finalised studies will be included in the technical dossier as soon as
they become available and the hazard assessment will be re-evaluated
For further details, please refer to the category concept document
attached to the category object (linked under IUCLID section 0.2)
showing an overview of the strategy for all substances within the glycol
Fatty acids, C16-18, esters with ethylene glycol was tested in an
oral prenatal developmental toxicity studies according to OECD 414 in
compliance with GLP (Henkel, 1997).
Groups of 24 or 25 female rats per dose were dosed with the
respective test compound via gavage from Day 6-15 post mating.
Concurrent negative control groups receiving the vehicle alone were
Animals were dosed via gavage with 100, 300 and 900 mg/kg bw/day
of Fatty acids, C16-18, esters with ethylene glycol. No mortalities in
maternal animals and no compound-related symptoms were observed in the
treatment groups. In addition, body weight and body weight gains were
within the expected ranges. No compound-related differences were noted
between the mean reproduction data of the test groups in comparison to
the control group. At scheduled necropsy no macroscopic changes were
noted in the dams of the treatment groups. Furthermore, pre-implantation
loss, post-implantation loss, mean number of resorptions, embryonic
deaths and total fetuses were not affected by treatment with the test
substance. In addition, mean fetal placental and uterus weights were not
affected. The fetal sex ratio was comparable in all groups and no
treatment-related fetal abnormalities were found at necropsy. The
examined fetuses showed no treatment-related malformations and the
figures of visceral variations in the test groups were considered to be
similar to the control group. The mean weight of live male and female
fetuses in the mid-dose group was significantly increased, whereas the
weights of live fetuses of the other treatment groups exhibited no
significant differences. The figures of skeletal ossifications and
variations showed no treatment-related deviations; thus various
findings, all without dose-relationship, were considered to be
Based on the lack of adverse effects in this study, the NOAEL for
maternal toxicity and developmental toxicity for rats was considered to
be above 900 mg/kg bw/day.
Conclusion on developmental toxicity
The available data do not provide evidence that the source
substance Fatty acids, C16-18, esters with ethylene glycol exhibits
hazardous properties for in utero development. Therefore, based on
common functional groups, structural similarities and common breakdown
products, no properties for developmental toxicity are expected for
Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8).
Based on the analogue read-across approach, the available data on
developmental toxicity do not meet the classification criteria according
to Regulation (EC) No. 1272/2008, and is therefore conclusive but not
sufficient for classification.
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.
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