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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

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:
3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
EC Number:
406-690-3
EC Name:
3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Cas Number:
43136-14-7
Molecular formula:
C51H88N4O2
IUPAC Name:
3-octadecyl-1-[4-({4-[(octadecylcarbamoyl)amino]phenyl}methyl)phenyl]urea
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
200 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5 male and 5 females per doses
Control animals:
yes
Positive control:
None reported

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No deaths and no other toxicologically significant findings.
Mortality:
no mortality observed
Description (incidence):
No deaths and no other toxicologically significant findings.
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Description (incidence and severity):
No significant treatment-related gross or microscopic findings were observed.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No significant treatment-related gross or microscopic findings were observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
No treatment related findings were observed at any of the nominal concentrations tested. The NOAEL and NOEL were determined to be 1000 mg/kg bw/day.
Executive summary:

The test item was investigated for repeated dose oral toxicity following EU Annex V guidelines. Male and female Wistar rats were exposed to the test item at nominal concentrations of 50, 200 and 1000 mg/kg/b.w./day over 28 days with dosing 7 days/week. No treatment related findings were observed at any of the nominal concentrations tested. The NOAEL and NOEL were determined to be 1000 mg/kg bw/day.

The study is a GLP compliant, guideline study and is suitable for assessment of this endpoint with restrictions.