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EC number: 285-547-5
CAS number: 85116-93-4
No data for the toxicity to reproduction was available (See
Waiver: Toxicity to Reproduction).
RA-S, CAS No. 11138-60-6, Key, Azuka and Daston, 2004, Dev. Tox., dermal, RL2 - NOAEL for prenatal development: 2000 mg/kg/d
No study was available testing the
teratogenicity and prenatal development of the Fatty acids, C16-18,
esters with pentaerythritol (CAS No. 85116-93-4). Data of a structural
analogue was used in a read-across approach. Decanoic acid, ester with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No.11138-60-6)
was tested in a prenatal developmental toxicity study according to OECD
Guideline 414. The test substance was percutaneously applied to
Sprague-Dawley rats for 6 h/day under occlusive conditions. 25 animals
per dose were dosed with 0, 200, 600 or 2000 mg/kg/d in corn oil on days
6-15 after gestation.
The two highest dose levels caused some
local irritation at the site of application, but no decreases in
maternal weight gain or food consumption. There were no differences from
control in any of the developmental parameters measured, including
embryo/fetal viability, fetal weight, malformations, or variations.
Therefore, a NOAEL of 2000 mg/kg/d was derived for prenatal development
(RA-S, CAS 11138-60-6, Key, Azuka and Daston, 2004, Dev. Tox., dermal,
Considering the industrial,
professional or general uses of the test compound, the dermal exposure
is a relevant way of exposure. No route specific metabolism is expected.
According to the DSD and CLP criteria
for classification and labelling of dangerous substances the CAS No.
85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol) is not
classified as toxic to reproduction.
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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