Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study already evaluated and accepted by national autorities. Information from migrated NONS file as per inquiry # [06-0000021278-68-0000].

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
405-370-0
EC Name:
-
Cas Number:
6334-25-4
Molecular formula:
C14H28N2O6
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 phosphonic 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 observation:
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 discarded 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 concurred controls, reaching statistical significance in male of both dose groups. Decreased ALT in top dose females and decreased phosphorous 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

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
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