Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

100% of escretion in 96h mainly in faeces, but also in urine.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The following remarks on the toxicokinetics of N,N,N',N'-tetrakis-(2 -hydroxyethyl) hexanediamide are based on physiochemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.

The test compound has been investigated for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes as well as for skin sensitisation and reproductive toxicity.

In the test for acute and dermal toxicity, the test compound was applied to rats and rabbits at single doses of 5,000 mg/kg body weight. There were no mortalities or body weight effects in any of the studies. Diarrhea, observed 4 hours after oral administration, was the only treatment related clinical sign. Necropsy revealed no gross changes.

In the irritation tests on skin and eyes, only very slight signs of irritation were seen, which were however clearly below the threshold for classification and labeling. Signs of systemic toxicity were not observed.
In a 28-day toxicity study, the test compund formulated as a solution in distilled water was administered daily to rats by gavage at dose levels of 10, 100, and 1,000 mg/kg bw/day.
Clearly treatment-related effects with respect to clinical pathology were not observed. Higher adjusted liver weight were recorded for rats in the high dose group, being statistically significant for males only. Significantly higher adjusted kidney weights were recorded for male and female rats of the high dose group. In all other respects including clinical findings and histopathology, treatment related effects were not observed.

In a one-generation reproduction toxicity study, rats were administered 1,000, 4,500, and 20,000 ppm (target concentrations of 50 to 1,000 mg/kg bw/day) test compound in the diet, beginning at approx. six weeks of age. Animals
were mated after eleven weeks of exposure and treatment continued throughout gestation, lactation, and until terminal necropsy. There was no treatment related mortality observed in any of the groups. Clinical signs were limited to soft and/or irregular feces observed in male and female animals exposed to 20,000 ppm. Due to the delayed onset of this effect (males: after the mating period; females: after 6-7 weeks of treatment), the significance and relation to
treatment is unclear. Reproductive toxicity was not observed in any of the treatment groups.
No other indications on the toxicokinetix behaviour of the test compound could be derived from the results of the available studies.
Due to the very good water solubility of 625 g/l and a low octanol/water partition coefficient of log Kow = -2.45 it can be assumed that the resorption of the test compound from the gastrointestinal tract and the skin with subsequent systemic availability is poor. Exposure to the test compound by inhalation is highly unlikely due to the low vapour pressure of 0.0000125 hPa (25 °C).