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EC number: 695-748-3
CAS number: 65286-55-7
No toxicokinetic data (animal or human studies) are available on
this substance. A qualitative assessment of the toxicokinetic behaviour
is based on physico-chemical parameters.
Bis-(N,N-dimethylaminoethoxyethyl)-methylamine (CAS 65286 -55-7;
EC 695 -748 -3) is a colourless liquid with an amine-like odour. The
test item was determined to be completely miscible with water with an
estimated solubility of >1000 g/L at 20°C. Other characteristics
include, low partition coefficient (Pow = 0.916 at 22.0 +/- 0.5°C and pH
12, log Pow = -0.0386) and a low vapour pressure of 4.97 Pa (at 20°C).
It has a low molecular weight of 261 g/mole. The substance is
demonstrated to be corrosive and sensitizing to the skin.
No toxicokinetic data (animal or human studies) are available on
this substance. The data present in this dossier are based on
physico-chemical parameters and will allow a qualitative assessment of
the toxicokinetic behaviour of the test substance.
Generally, substances with a molecular weight below 500 are
favourable for absorption; also the test substance was found to be
miscible in water (>1000 g/l). Water-soluble substances will readily
dissolve into the gastrointestinal fluids. However, the absorption of
hydrophilic substances by passive diffusion may be limited by the rate
at which the substance partitions out of the gastrointestinal fluid. The
low partition coefficient (-1 <log Kow <4) will favour absorption (log
Kow = -0.0386). It is generally assumed that the absorption along the
gastrointestinal tract predominantly takes place in the small intestine
since it has a very large surface area and the longest transit time.
An acute oral toxicity study was not performed considering that
the substance is demonstrated to be corrosive to the skin.
The combined repeated dose toxicity test with
reproductive/developmental screening performed on male and female Wistar
rats was conducted according to OECD guideline 422 (Edwards, 2018).
Following doses were included: 0 (control), 20, 60, 100 mg/kg bw/day.
The primary observation in the study was vacuolation/vacuolated
macrophages in numerous tissues from males treated with 20 mg/kg bw/day
and above and degeneration of hepatocytes in the liver for males of all
dose levels and females treated with 60 or 100 mg/kg bw/day. With
regards to vacuolation/vacuolated macrophages in numerous tissues, the
vacuoles observed are considered transient and non-adverse based on
scientific peer-reviewed literature regarding weakly basic aliphatic
amines (which can be primary, secondary or tertiary amines) and
supporting evidence from similar compounds within the same chemical
family of aliphatic amines (Smith et al., 2019, internal document).
The physicochemical properties and the extensive findings in
tissues/organs suggest the substance is readily absorbed via oral/GI
As a result, the oral
absorption factor is set to 100%.
Given the low vapour pressure of 4.97 Pa, the test substance is
not a highly volatile substance and the availability for inhalation as a
vapour is rather limited.
Generally, liquids readily diffuse/dissolve into the mucus lining
of the respiratory tract. In the case of the test substance, the high
water solubility will favor the rate at which the particles dissolve
into the mucus. Hydrophilic substances such as this one might be
absorbed through aqueous pores. The test substance can also be retained
in the mucus and transported out of the respiratory tract. However, the
low to moderate log Kow would indicate a favourable absorption directly
across the respiratory tract epithelium by passive diffusion.
Based on the physicochemical properties, the respiratory absorption
factor is set to 100%.
The test substance is a liquid substance and therefore it is more
easily taken up by the skin in comparison to solid products. In order to
cross the skin, a compound must first penetrate into the stratum corneum
(non-viable layer of corneocytes forming a complex lipid membrane) and
may subsequently reach the viable epidermis, the dermis and the vascular
network. It is expected that the penetration of the test substance into
the lipid rich environment of the stratum corneum will be possible to a
limited extent due to the limited lipophilic character (log Kow of
-0.0386) of the substance resulting in a low dermal absorption. However,
water solubility is sufficiently high to partition from the stratum
corneum into the epidermis.
In addition, the test substance was observed to be corrosive
(category 1B) in an in vitro skin corrosion test (OECD 431; Warren,
2017). The substance is demonstrated to be a skin sensitizer category 1
in a key, reliable local lymph node assay (OECD 429; Klatt, 2015). These
characteristics will also influence the dermal absorption.
As a result, the
default dermal absorption factor is set to 50%.
The high-water solubility and low molecular weight predict that
the substance will distribute widely through the body. The potentially
affected organs would be the liver and uterus, as observed in the OECD
Based on the liquid
form of the test substance no accumulation is expected within the lungs.
The substance is poorly lipophilic, it is not expected to accumulate
within the adipose tissue or the stratum corneum.
Once absorbed, extensive hydroxylation may occur to increase the
solubility of the substance and oxidative deamination, followed by rapid
sulfation or glucuronidation is expected.
The water soluble conjugated metabolites from Phase II
biotransformation will be excreted from the systemic circulation through
the urine. Most of them will have been filtered out from the blood by
the kidneys, though a small amount can enter the urine directly by
passive diffusion. There is also the potential for re-absorption into
the systemic circulation across the tubular epithelium.
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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