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EC number: -
CAS number: -
The acute oral toxicity of the registration substance, 2,2'-(C12-14 evennumbered alkyl imino) diethanol, is derived based on the read-across approach. The LD50 for oral routes is estimated to be 1500 mg/kg bw, which corresponds to the EU CLP (GHS) classification as category 4 for acute oral toxicity.
Assessment of the acute oral toxicity
The acute oral toxicity of the registration
substance is derived based on the read-acrosss approach.
There are four studies on read-across
supporting substance CAS 71786 -60 -2. The obtained results are
consistently indicative that the LD50 for the registration substance is
likely to be in the range of 1500 mg/kg bw.
- Male and female rats were administered a
single dose of the undiluted test compound ranging from 1.0 to 2.5 g/kg
bw. Clinical signs in all rats after dosing included piloerection,
hunched posture and abnormal gait (waddling). These signs were
accompanied by lethargy, decreased respiratory rate, ptosis and pallor
of the extremities amongst rats at all the dose levels, increased
salivation amongst rats dosed at 1.0, 1.26, 1.6 and 2.5 g/kg, and
diarrhoea in one female rat treated at 1.26 g/kg and one male at 1.6
g/kg. Recovery of survivors as judged by external appearance and
behaviour was apparently complete 5 to 7 days after dosing. Body weight
of the survivors was not affected, animals that died had decreased
bodyweights. Necropsy findings were normal in survivors; in
non-survivors these consisted of congestion of the lungs, and pllaor of
the liver, kidneys and spleen. The acute median lethal oral doses (LD50)
and their 95% confidence limits were estimated to be 1.7 (1.3 to 2.1)
g/kg bw for males, and 1.3 (1.0 to 1.6) g/kq bw for females.
- Male and female rats (2 -6 per group) were
administered a single dose of the test substance by gavage ranging from
0 to 10 ml/kg bw. The test compound was prepared as a graded series of
concentrations in corn oil, so that a constant dosage volume of 10 ml/kg
was administered. The animals were observed for two weeks and
bodyweights were determined weekly. Gross necropsy was performed on all
animals. At doses of 2.0 ml/kg and higher animals died. Non-specific
signs of reaction consisted of varying degrees of lethargy accompanied
by pilo-erection and perspiration. Later especially at the higher dosage
levels, increased salivation, lachrymation and nasal discharge,
diuresis, diarrhoea and dyspnoea were observed. Death was preceded by
hypothermia, tremors, ataxy and coma, and generally occurred within 1 -
2 days after dosing. Survivors recovered within 4 days; body weight gain
was low in the first week and normal during the second week of
observation. There was no apparent difference in susceptibility between
the sexes. Autopsy of survivors revealed no treatment related effects;
autopsy of rats that died revealed inflammation, with occasional
haemorrhage, of the lungs and alimentary tract and areas of
discolouration in the liver.
The LD50 is beween 1.0 and 5.0 ml/kg. As no
mortality was observed at 1.0 ml/kg bw, 50% of the animals died at 2.0
ml/kg bw, and 100% at 3.2 ml/kg bw, the LD50 value is most probably
(slightly) lower than 2000 mg/kg bw.
- 3 groups of ten fasted rats each (five
males and five females per group) were given a single, oral dose of the
test material at dose levels of 1.6, 2.5 or 4.0 g/kg bw. The animals
were observed for 14 days after the day of dosing and were then killed
for gross pathological examination. Deaths occurred at 1.6 g/kg bw and
above. Clinical signs of toxicity noted were pilo-erection, hunched
posture, increased salivation, abnormal gait, lethargy, pallor of the
extremities, decreased respiratory rate, ptosis, and diarrhoea. Recovery
was apparently complete bay day 4 (1.6 g/kg bw) or day 11 (2.5 g/kg bw).
Low bodweight gains were recorded on Day 8 amongst female rats at 1.6
and 2.5 g/kg; normal bodyweight gains were recorded for these rats on
Day 15. Bodyweight gains were recorded for all other surviving rats on
Days 8 and 15. No abnormalities were noted at necropsy in survivors;
deceased animals showed congestion of the lungs and pallor of the spleen
and kidneys. The acute median lethal dose (LD50) was found to be 2.1
(1.7 -2.5) g/kg bw for males and females combined. For males only: 2.0
(1.6 -2.5) g/kg bw, for females only: 2.2 (1.7 -2.8) g/kg bw.
-Ten female rats per dose group were treated
at doses of 1000, 3000 and 5000 mg/kg bw. All rats treated at 5000 mg/kg
bw, nine rats at 3000 mg/kg bw and one rat at 1000 mg/kg bw did not
survive the treatment. The LD50 of 1720 mg/kg bw was obtained.
The acute oral toxicity of the registration substance, 2,2'-(C12-14
evennumbered alkyl imino) diethanol, is derived based on the read-across
approach. The LD50 for oral routes is estimated to be 1500 mg/kg bw,
which corresponds to the EU CLP (GHS) classification as category 4 for
acute oral toxicity.
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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