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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

AEEA is rapidly and quantitatively absorbed following oral administration. A comparable inhalation absorption is assumed. Nonetheless, a default factor of 2 (ECHA REACH TG ) was applied for oral to inhalation extrapolation as a conservative approach. Dermal absorption is approx. 10%. Excretion is rapid and occurs predominantly via urine, as unchanged AEEA (55-65%) and to a lesser extent as metabolites (N-acetyl-AEEA (5-11%), two unidentified metaboites accounting for 16-30%).   

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

2-(2-aminoethylamino)ethanol (AEEA) is rapidly and quantitatively (> 85 % within 48 hours) absorbed following oral administration to female Wistar rats (t½ values 0.1 -0.2 hours). Maximum blood levels were reached within 0.5 hours. The organ distribution was low and comparable in all experiments. No significant difference occurred with respect to dose level.

Excretion was also rapid with most of the dose (85 - 98 %) recovered in the 0 - 48 hour urine, less in feces and only very low quantities in expired volatiles and as 14CO2. The plasma elimination of orally administered 14C-AEEA was biphasic, with alpha and beta elimination t½ -values of 1.6 - 1.8 hours and 16.7 - 17.3 hours, respectively. Radioactivity at termination in tissues was low (2.3 -3.3 %). Only the parent compound AEEA was found in plasma. Most of AEEA was excreted unchanged in the urine. Four radiolabeled metabolites were observed in urine from all three oral dose groups. These metabolites comprised approximately 5 - 10 % (Metabolite A), 11 -20 % (Metabolite B), 5 - 11 % (N-acetyl-AEEA) and 55-65 % (AEEA) of the administered dose. The pregnancy status did not cause significant differences in absorption, elimination, excretion, and metabolic profile following the oral administration of AEEA.

After 8 hour dermal application of a 10 -fold higher dose, no quantifiable plasma levels were reached at most readings. Urinary excretion was quantifiable, and bioavailability was approx. 10 % compared to the oral route. The amount of absorbed test material here was 8.44 +/- 6.1 %.

Absorption after inhaltion exposure is assumed to be comparable to oral absorption.

In a toxicokinetics study AEEA (14C-labeled) was administered to pregnant Wistar rats to examine the distribution of 14C-AEEA in conceptus tissues following repeated dose application. Three animals from 2 groups were orally administered 14C-AEEA (300 mg/kg, 470 uCi/kg) daily during GD 17 to 19, the fourth rat in each group was not treated, but was used to determine background radioactivity. All animals were anesthetized by isoflurane inhalation either 6 or 48 h after the third and final dose of 14C-AEEA. Dam blood was collected from the vena cava after caesarean section while under deep anesthesia. Following collection of the amniotic fluid and chorioallentoic placenta, the fetuses from each litter were divided into four subgroups of at least two fetuses each, for further evaluation: a) determination of the total radioactivity in fetal blood, aorta, and the remaining carcass, b) autoradiography of isolated vessels and c) autoradiography of vessels in situ.

AEEA-derived radioactivity (as 14C-AEEA equivalents) was fairly evenly partitioned between the fetal and maternal compartments 6 hr after the final dose was given on GD 19, such that the blood level in the fetus was about 80 % of that in the dam (36.2 and 47.0 ug-eq AEEA/g blood, respectively, p > 0.05). The level of 14C-AEEA equivalents fell in both compartments over the following 42 h (p < 0.05, compared to 6 h), but was still markedly present and more so in the fetus. At 48 h after the final dose, fetal and maternal blood levels were reduced to 67 and 25 % of the 6 -h values, that is 24.4 and 11.9 ug-eq AEEA/g blood, respectively (p < 0.05).

Within the fetus, radioactivity was distributed evenly between the aortic arch, descending aorta, and the remainder of the carcass at 6 h (p > 0.05), but appeared to be marginally retained in the aortic vessels compared to the carcass at 48 h (p < 0.05). Autoradiography of whole fetus and great vessels collected from fetuses at GD 19 (group 1, subgroups 2 and 3) showed radioactivity to be evenly distributed throughout the fetus, with a slightly higher concentration in the liver, consistent with absorption of radioactive material through the hepatic portal vein. There was no apparent preferential localization of radioactivity associated with the great vessels, either in situ or in isolated vessels. Upon macroscopic investigation of fetuses from subgroup 2, five of the six fetuses from group 2 that were examined on GD 21 exhibited high aortic arch. None of those from group 1 that were examined on GD 19 exhibited the lesion.

In a toxicokinetics study AEEA (14C-labeled) was administered to pregnant Wistar rats to examine the potential transfer of AEEA to the suckling pup at a known peri-postnatal developmentally toxic dose level following repeated dose application. Three animals from 2 groups were orally administered 14C-AEEA (250 -300 mg/kg bw) daily during PND 1 -12.

Approximately 6 hr after the administration of 14C-AEEA, milk (approximately 300 uL) was collected from group 1 animals on LD 4 and LD 12 and from group 2 animals on LD 8. Pups were separated from the dams 4 h before milking, and returned within 5 min after the collection of milk.

Approximately 5 min before milking, the dams were anesthetized with isoflurane and injected intraperitoneally with oxytocin (1–2 IU) in two split doses, 5 to 10 min apart. After the collection of milk, blood was collected from the pedal vein, jugular vein, or sinus orbital. Milk and blood samples were analyzed for radioactivity by liquid scintillation spectrometry.

Although the level of radioactivity in the blood of the dams was consistent over the 12-day exposure period, the concentration of AEEA fell after LD 5, reflecting a decrease in the delivered dose of AEEA as the specific activity of the dosing solution increased on LD 6. Animals that were milked on LD 4 had received 300 mg AEEA/kg bw before sample collection, whereas those milked at later time points received 240 mg AEEA/kg bw from LD 6. As a consequence, the level of 14C-AEEA equivalents in the blood fell and was 10 % lower on LD 8 compared to LD 4, but was essentially unchanged between LD 8 and LD 12. Orally administered 14C-AEEA equivalents partitioned preferentially into milk by 1.6- to 2.5-fold. The concentration of 14C-AEEA equivalents in the milk decreased by 10 % between LD 4 and LD 8, in line with the reduction in blood level, but fell by over 30 % during LD 8 to 12 (p = 0.0538). The potential exposure of the suckling offspring was calculated from the concentration of 14C-AEEA equivalents in the milk, along with assumptions for milk consumption and bodyweight of suckling Wistar rat pups. The derived values for pup bodyweights on LD 4, LD 8, and LD 12 were 10, 16, and 24 g, respectively, while for milk consumption they were 4.0, 5.3, and 6.0 g, respectively. Pup exposure to 14C-AEEA equivalents (AEEA and metabolic derivatives) was estimated to be 28.6, 21.1, and 10.8 mg/g on LD 4, LD 8, and LD 12, respectively, equivalent to 9.6, 8.8, and 4.5 % of the dose administered to the dams on the same day.