Hexanediamide, N1,N1,N6,N6-tetrakis(2-hydroxyethyl)-

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Inquiry result from ECHA

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-370-0

EC Name:

-

Cas Number:

6334-25-4

Molecular formula:

Hill formula: C14 H28 N2 O6

IUPAC Name:

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

Test animals

Species:

rat

Strain:

other: CD-derived

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: Distilled water. Solutions adjusted to pH 5.2 with phosphoric acid

Details on oral exposure:

Method of administration: Gavage

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 10 mg/kg bw/day
Male: 5 animals at 100 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 10 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
There were no deaths and no clinical signs of toxicity were
observed.
Laboratory findings:
The following haematological and biochemical changes were
generally within the historical control range and thus of
doubtful toxicological significance (the test laboratory
discounted the findings).
In the top dose males, statistically significant decreases
were seen in neutrophils and platelets, with a
dose-dependent trend at other doses. Cholesterol levels,
were lower in top dose males and females, and in
intermediate dose males, compared to concurrent controls,
reaching statistical significance in male of both dose
groups. Decreased ALT in top dose females and decreased
phosphorus in top dose males was also noted.
Effects in organs:
At the top dose, slight increases in relative organ weights
(<20%) were noted for the liver and kidney in both sexes.
Minimal centrilobular hepatocyte vacuolation was noted in
two top dose males, but this was not considered to be of
toxicological significance.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Classified as: Not classified