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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: no histopathologic examination
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: ChR-CD
Sex:
male
Details on test animals or test system and environmental conditions:
no further data
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Amount applied: 3.1 - 5.66 mL
Doses:
6250, 9000, 14624, 17206 or 19789 mg/kg bw
No. of animals per sex per dose:
10 m
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Necropsy of survivors performed: no
Other examinations performed: clinical signs and body weight
Statistics:
Probit
Sex:
male
Dose descriptor:
LD50
Effect level:
16 742 mg/kg bw
Based on:
test mat.
95% CL:
14 422 - 20 325
Mortality:
0/10, 0/10, 4/10, 5/10 and 7/10
Clinical signs:
other: >= 6250 mg/kg: salivation, wet and stained perianal area, congestion, stained mouth, nose and feet, chromodacryorrhea, alopecia, tremors, fasciculations, piloerection, and weight loss >= 9000 mg/kg: diarrhoea, weakness and ruffled fur >= 14624 mg/kg: eyes
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With an oral LD50 value of 16742 mg/kg bw in rats, 1,1,3,3-tetrabutyl-urea is practically nontoxic.
Executive summary:

1,1,3,3-tetrabutyl-urea was tested in an acute oral toxicity study with rats. Five groups of 10 male ChR-CD rats were dosed once via gavage with 6250, 9000, 14624, 17206 or 19789 mg/kg bw. With an oral LD50 value of 16742 mg/kg bw, 1,1,3,3 -tetrabutyl-urea was practically nontoxic.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
16 742 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original reference not available (only very brief summary)
Qualifier:
no guideline followed
Principles of method if other than guideline:
not further specified
GLP compliance:
no
Test type:
other: not further specified
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Sex:
male
Dose descriptor:
LD50
Effect level:
> 7 500 mg/kg bw
Mortality:
no data
Clinical signs:
other: no data
Gross pathology:
no data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
For the test substance a LD50 value of > 7500 mg/kg bw was given.
Executive summary:

For male rabbits a dermal LD50 value of > 7500 mg/kg bw has been reported.

Endpoint conclusion
Dose descriptor:
LD50
Value:
7 500 mg/kg bw

Additional information

1,1,3,3-tetrabutyl-urea was tested in an acute oral toxicity study with rats. Five groups of 10 male ChR-CD rats were dosed once via gavage with 6250, 9000, 14624, 17206 or 19789 mg/kg bw. With an oral LD50 value of 16742 mg/kg bw, 1,1,3,3-tetrabutyl-urea was practically nontoxic.

For male rabbits a dermal LD50 value of > 7500 mg/kg bw has been reported.

Justification for classification or non-classification

From the available data it can be concluded that the acute toxicity of 1,1,3,3-tetrabutylurea is low. Therefore, there is no need for classification and labelling.