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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: dermal
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
Version / remarks:
Version not reported
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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

Type of coverage:
occlusive
Vehicle:
corn oil
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Lethargy was noted in 1 male and 1 female during the treatment period.
Gross pathology:
No treatment-related effects on organs were observed.
Other findings:
Signs of toxicity (local): Slight erythema of treated skin was noted in one male on days 5 and 8 and scaliness in 1 male on day 5.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for the acute dermal exposure of rats to the test item was determined to be > 2000 mg/kg b.w., the only concentration tested.
Executive summary:

The acute dermal toxicity of the test item was determined in a limit test conducted at a dose of 2000 mg/kg b.w., with male and female Wistar rats, according to EU Annex V guidelines. The LD50 was determined to be > 2000 mg/kg b.w., the only concentration tested.

No deaths and effects on organs were observed. Lethargy was noted in 1 male and 1 female during the treatment period. Slight erythema of treated skin was noted in one male on days 5 and 8 and scaliness in 1 male on day 5. The test item does not meet the GHS criteria and is not classified.

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