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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. The added
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 unlikely.
Acute inhalation toxicity:
There is no study on inhalation toxicity available on Etherdiamine C13i.
REACH 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.
LD50 is expected >= 300 mg/kg, and using a LD50 cut-off level of 500 mg/kgbw seems appropriate.
The substance therefore needs to be classified for acute toxicity according to GHS as Cat.4 with hazard statement H302 “harmful if swallowed”.
Acute 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.
No classification for acute dermal toxicity is therefore indicated.
For 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.
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