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EC number: 217-461-0
CAS number: 1860-26-0
Assessment of the
There are no studies
available in which the toxicokinetic properties of
2-ethyl-N,N-bis(2-ethylhexyl)hexylamine were investigated.
(molecular weight of 353.7 g/mol) is a colourless to yellow liquid with
low water solubility (calculated
water solubility for the uncharged molecule: 0.00013 mg/L at 25 °C ; and
for the charged molecule: 0.1031 mg/L at 25 °C (EPISUITE, see chapter
“water solubility”). The
log Pow for the uncharged molecule was calculated to be 10.13 at 25 °C
(EPISUITE, see chapter “partition coefficient”), indicating that
accumulation of the substance is possible.
In an acute oral
toxicity study, rats were administered the substance by gavage at a
limit dose of 8170 mg/kg bw. No mortality, clinical signs and pathologic
abnormalities were reported; therefore no conclusions concerning
bioavailability of the substance after oral administration can be drawn
from this study (BASF AG 1975, see chapter “acute oral toxicity”).
No acute dermal
toxicity study is available. Based on a water solubility below
1 mg/L, dermal uptake is likely to be low. In addition, for
highly lipophilic substances (log Pow greater than 6) that come into
contact with the skin, the rate of transfer between the stratum corneum
and the epidermis will be slow and will limit absorption across the
skin. Uptake into the stratum corneum itself may be slow. Dermal uptake
for such substances is expected to be low (ECHA GD 7c, 2008).
has a very low measured vapour pressure of 0.00078 Pa at 20 °C (BASF AG
1986, see chapter “vapour pressure”); accordingly, in an inhalation
hazard test of the dissolved substance with saturated vapour atmosphere,
none of the 12 tested rats showed clinical signs indicative for systemic
availability after inhalative exposure.
In addition, a
Combined Repeated Dose Toxicity Study with the
Reproduction/Developmental Toxicity Screening Test according to OECD TG
422 (GLP conform, 2010) and a subchronic repeated dose toxicity study
according to OECD TG 408 (GLP conform, 2014) was performed with the
substance in Wistar rats (see chapter “repeated dose toxicity”). In
these studies the substance was administered in the diet and no NOAEL
for general, systemic toxicity of the test substance could be determined
for the F0 parental animals based on clinical-pathological and
histopathological findings in all treated groups, predominantly
dose-related histiocytic/mixed cell infiltrates in multiple organs which
lead to secondary multiple local inflammatory reactions. Thus,
bioavailability of the substance after oral administration is indicated.
Using the OECD toolbox
vs.2.0, the (improved) liver metabolism simulator provided 50, and the
skin simulator 19 potential metabolites (OECD toolbox vs.2.0, 2011).
Most of the predicted
metabolites were hydroxylated aliphatic tertiary amines. Two of the
liver metabolites and five of the skin metabolites were predicted by
OASIS to be direct acting mutagens. These metabolites were aldehydes
which may possibly act as direct acting Schiff Base formers. This
prediction is not supported by various experimental studies on genetic
toxicity. Studies on genotoxicity, i.e. ames assay, gene mutation in
mammalian cells in-vitro, chromosome aberration assay in-vitro, gave no
indications of a reactivity of the substance or its metabolites under
the test conditions (i.e. no increased mutagenicity or cytotoxicity in
treatments with or without metabolic activation).
hydroxylated metabolites as well as the parent chemical have a molecular
weight lower than 500 g/mol. The potential metabolites are expected to
be soluble in water and therefore are likely to be excreted
predominantly via the urine (ECHA GD 7c, 2008).
ECHA (2008). GD 7c.
Endpoint specific Guidance.
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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