Registration Dossier

Administrative data

Description of key information

In a 28-day rat study with N,N,N',N'-tetrakis-(2-hydroxyethyl) hexanediamide, 1000 mg/kg/day can be regarded as the no-toxic effect level. In the absence of corresponding histopathological changes, the increases  in adjusted liver and kidney weights were not regarded as being  toxicologically important. The differences from controls among some  biochemical and hematological parameters were generally within the  expected background range. Thus the "no observedadverse effect level" (NOAEL) derived from this study is 1000 mg/kg bw  for male and female rats (Edwards et al., 1990).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

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.

Justification for classification or non-classification

According to the criteria of EC Regulation 1272/2008 N,N,N',N'-tetrakis-(2-hydroxyethyl) hexanediamide is not classified because of a low oral repeated dose toxicity.