N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

20 mg/kg bw/day

Additional information

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.

Short description of key information:
N,N,N',N'-tetrakis-(2-hydroxyethyl) hexanediamide, when administered in the diet, has no observed effect level (NOEL) for gerneral toxicity in parental animals at 4500 ppm. At 20,000 ppm, indications of toxicity were limited to soft and/or irregular feces in both sexes. Due to their delayed onset, the toxicological significance and relationship to treatment of these signs were considered equivocal. Reproductive toxicity was not observed at doses up to and including 20,000 ppm.

Effects on developmental toxicity

Description of key information

No developmental toxicity/teratogenicity studies are available for N,N,N',N'-tetrakis-(2-hydroxyethyl) hexanediamide.  A data waiver is claimed.

Justification for classification or non-classification

Regarding toxicity to reproduction (embryotoxicity and fertility) N,N,N',N'-tetrakis-(2-hydroxyethyl) hexanediamide is not classified according to the criteria of EC Regulation 1272/2008.