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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Remarks:
MHLW, Japan

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-ethylenedi(stearamide)
EC Number:
203-755-6
EC Name:
N,N'-ethylenedi(stearamide)
Cas Number:
110-30-5
Molecular formula:
C38H76N2O2
IUPAC Name:
N,N'-ethylenedi(stearamide)

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration of treatment / exposure:
28d
Frequency of treatment:
once daily (7 days/week)
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 300 and 1000 mg/kg/day
Basis:
nominal in diet
No. of animals per sex per dose:
Group size: 5 animals per sex per dose

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: 28d test

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No effects were seen, in any of the treament groups and in either sex

Applicant's summary and conclusion