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EC number: 931-295-2
CAS number: -
The oral LD50 of Etherdiamine C13i/acetate
is around 500 mg/kg body weight.
A study was performed, according to OECD 401
and under GLP, to determine the acute oral median lethal dose (LD50) of
the test material, administered as a solution in arachis oil B.P. in the
Sprague-Dawley strain rat . In a range-finding study (2000, 200 and 25
mg/kg bw, 2 animals sex dose) all animals were found dead the next day
at 2000 mg/kg bw and one animal died at 200 mg/kg bw at day 4. Following
these results a group of ten fasted animals (five males and five
females) was given a single oral dose of test material preparation at a
dose level of 200 mg/kg bodyweight. There were no deaths. Signs of
toxicity were confined to hunched posture and pilo-erection observed 4
hrs after dosing in all animals and on day one in one male. All animals
showed expected gain in bodyweight during the study period. No
abnormalities were noted at necropsy of animals killed at the end of the
study . The acute oral median lethal dose (LD50) o f the test material,
LILAFLOT D817, to the Sprague-Dawley strain rat was found to be greater
than 200 mg/kg but less than 2000 mg/kg bodyweight. Formal
classification under GHS is not possible, but LD50 is expected >= 300
mg/kg, using a LD50 cut-off level of 500 mg/kgbw seems appropriate.
Acute oral toxicity:
There are two studies available on the
etherdiamine product without acetic acid:
The first study involves the
evaluation of the acute oral toxicity of etherdiamine C13i in a OECD
401-like study, under GLP. The test material was administered as a
solution in arachis oil. In a range-finding study (2000, 200 and 25
mg/kg bw, 2 animals per sex per dose) all animals were found dead the
next day at 2000 mg/kg bw and one animal died at 200 mg/kg bw at day 4.
In the final study, 10 animals were dosed with 200 mg/kg bw which
resulted to no mortality.
The study therefore concluded to a
LD50 between 200 and 2000 mg/kg bw. Formal classification under GHS is
not possible, but LD50 is expected >= 300 mg/kg, and using a LD50
cut-off level of 500 mg/kgbw seems appropriate.
These results are supported by a
second available study where acute oral toxicity was evaluated following
a OECD 401 study outline. This study resulted to a LD50 of 518 mg/kg bw
(c.i.: 442-606 mg/kg) for Etherdiamine C13i. Gross pathology of deceased
animals showed blood stained stomach and intestinal contents, probably
caused by the corrosive nature of the test material.
Both studies indicate a similar level
of toxicity for the etherdiamine. Although both studies have been
performed on etherdiamine C13i without acetate, they are considered to
be relevant for the evaluation of etherdiamine C13i with acetate as
well. Dermal corrosion studies have shown that the presence of acetate
does not impact the corrosive properties of the compound. Additionally,
the conversion of about half of the etherdiamine to etherdiamine-acetate
salt, as is the case for theEtherdiamine /acetate product mixture,is not
considered to have a large impact as it will probably be dissociated
again in stomach and intestinal fluids.
Acute dermal toxicity:
Etherdiamine C13i/acetate is corrosive
to the skin. Testing for acute dermal toxicity is therefore not
justified. Toxicity following dermal exposure is characterised by local
tissue damage, rather than the result of percutaneously absorbed
material. For corrosive substances, the use of protective gloves and
other equipment, such as face shields, aprons and good work practices
are mandatory. Consequently, the occurrence of substantial dermal
exposure of amounts comparable to the levels for acute oral toxicity is
Acute inhalation toxicity:
is no study on inhalation toxicity available on Etherdiamine C13i.
stipulates that testing by the inhalation route is appropriate if
exposure of humans via inhalation is likely taking into account the
vapour pressure of the substance and/or the possibility of exposure to
aerosols, particles or droplets of an inhalable size. REACH guidance
R.7.a, chapter. 7.4 Acute toxicity, indicates that in principle no
inhalation studies are needed when vp < 0.1 Pa at 20°C or particle size
> 100 µm. Etherdiamine C13i is a liquid with a vapour pressure of 0.005
Pa at 25°C. Also the use of this substance will not result in aerosols,
particles or droplets of an inhalable size, so exposure to humans via
the inhalation route will be unlikely to occur, and no acute inhalation
test was performed.
is expected >= 300 mg/kg, and using a LD50 cut-off level of 500 mg/kgbw
substance therefore needs to be classified for acute toxicity according
to GHS as Cat.4 with hazard statement H302 “harmful if swallowed”.
dermal testing with corrosive materials is not justified. Consequently,
no classification can be made for acute dermal toxicity. Effects will be
characterised by local tissue damage. Systemic uptake via skin is likely
to be very limited.
classification for acute dermal toxicity is therefore indicated.
acute inhalation toxicity the information for classification is lacking,
and testing is not justified.
Etherdiamine C13i/acetate is not a
pure aliphatic, alicyclic and aromatic hydrocarbon and has a relatively
high viscosity (Kinematic viscosity 377 mm2/s at 20 °C) and so does
not indicate an immediate concern for aspiration hazard.
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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