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EC number: 229-194-7
CAS number: 6425-39-4
For this substance, no study is available for the determination of toxicokinetics (absorption, distribution, metabolism and excretion). Therefore, a qualitative assessment is performed on the basis of the physico-chemical properties of the substance.
The test substance is a liquid with a high water solubility
(miscible), a moderate log Kow (0.5) and a low vapour pressure (66 Pa).
Its pKa is 6.8. The substance is found not to be a skin irritant but a
mild eye irritant. The substance is not a skin sensitiser.
No toxicokinetic data (animal or human studies) are available on
this substance. The information present in this document is mostly based
on physico-chemical parameters which allow a qualitative assessment of
the toxicokinetic behaviour of the test substance rather than a
Following its high water solubility, the substance will readily
dissolve into the gastrointestinal fluids and subsequently pass through
aqueous pores or be carried through the epithelial barrier by the bulk
passage of water.
Based on the moderate log Kow, absorption by passive diffusion
will be favoured. Although its molecular weight which is >200 (244
g/mol), passive diffusion is not considered to be significantly
It is generally thought that ionised substances do not readily
diffuse across biological membranes. The intestine is where absorption
after oral administration normally takes place. The pKa of the test
substance suggests that this substance will be partly in its ionised
form and hence diffusion can be hampered in some extent.
In an acute oral toxicity
study (Industrial Bio-Test Laboratories, 1978 owned by huntsman), the
substance was tested in rats (OECD 401) at following doses: 118.5, 400,
1350, 2025, 3088 and 4556 mg/kg. No deaths were observed up to and
including 1350 mg/kg. The LD50 was derived to be 2025 mg/kg. At 3038
mg/kg bw slightly pale spleen was observed in one male and at 4556 mg/kg
bw moderate postmortem autolysis was observed in two females and
advanced postmortem autolysis was observed in two males. These
observations may indicate some absorption of the test substance.
In a 28-day oral rat study (Imatanaka, 1994, owned by Huntsman),
animals were exposed to vehicle (olive oil), or 8, 40, 150 and 600 mg/kg
bw/day of the substance. At 600 mg/kg bw/day, animals died or were
killed in extremis before the end of the exposure period. This dose was
clearly toxic. The main cause of death seems to be vacuolization in many
organs and tissues,indicating significant absorption of the test
In a combined repeated dose/reprotox/developmental screening study
performed with the test substance according to OECD Guideline 422
(Martell, 2013, owned by Huntsman), the NOAEL was 300 mg/kg bw/day for
F0 males and females. The NOAEL for embryo-fetal toxicity was 300 mg/kg
bw/day. These results do not deviate from the oral absorption assumption
as the substance, in this study, was tested up to 300 mg/kg bw/day, a
lower dose than the one for which effects (and therefore absorption)
were observed in the 28 -day study.
In the gastro-intestinal tract hardly any degradation of the
substance is to be expected.
The oral absorption factor is set to 50%, based on
the anticipated hampered diffusion of the test substance as an ionized
substance. The results of the toxicity studies do not provide reasons to
deviate from this proposed value.
Given the vapour pressure of 66 Pa, the test substance is a low
volatile substance and the availability for inhalation as a vapour is
Once in the respiratory tract, the very hydrophilic substance may
be retained within the mucus, and subsequently absorption may occur.
Absorption directly across the respiratory tract epithelium by passive
diffusion is favoured in view of the moderate log Kow value.
Based on the above considerations, the inhalatory absorption
factor for the substance is set to 100%, as a worst case
In view of its high water solubility and moderate log Kow,
penetration into the lipid-rich stratum corneum and hence dermal
absorption might be limited although its physical form (liquid) favours
In an acute dermal toxicity study (Hunstman, 1978), New Zealand
White male/female rabbits were acutely exposed to 1350, 2025, 3038 and
4556 mg/kg bw of DMDEE. No mortality was observed at 1350 or 2025 mg/kg
bw/d. In the 3038 mg/kg bw 2 animals out of 4 died. All animals (4/4)
died in the 4556 mg/kg bw dosing group. Therefore, after 14 days of
observation, an LD50 value of 3038 mg/kg bw was reported. These
observations may indicate some absorption of the test substance although
the amounts dosed were higher than the upper dose used in acute dermal
The substance is found not to be a skin irritant nor a skin
Generally default values of 10% and 100% are used for dermal
absorption, based on molecular weight and log Kow value (ECHA guidance
on IR&CSA, R.7c). The dermal absorption factor is therefore set to 100%
(default), based on a molecular weight < 500 and a log Kow in the range
of -1 to 4. However, it is also generally acknowledged that dermal
absorption will not be higher compared to oral absorption; as a result,
the dermal absorption factor for the substance is set to 50%.
The results of the available toxicity studies using the dermal route do
not provide reasons to deviate from this proposed value.
The high water solubility, moderate log Kow and low molecular
weight predict that the substance will distribute widely through the
body. This is confirmed by the observations in a subacute oral toxicity
study, in which vacuolization has been observed in many organs and
tissues, indicating that the substance has distributed all through the
In view of the moderate log Kow and the high water solubility, the
substance will not easily accumulate in the body (lung, adipose tissue,
Once absorbed, the substance might undergo phase I
biotransformation (including aliphatic and aromatic hydroxylation and
cleavage of the ether group (O-dealkylation)) followed by
conjugation reactions (phase II) including glucuronidation and sulfation.
Given the high water solubility and low molecular weight
(amplified by the expected cleavage of the ether bond), the substance
and its metabolites will be mainly excreted via the urine.
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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