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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from Authorized database

Data source

Reference
Reference Type:
other: Authorized database
Title:
Acute oral toxicity of CAS no 57-13-6
Author:
U. S. National Library of Medicine
Year:
2017
Bibliographic source:
HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC, 2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study of Urea in rats
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Urea
EC Number:
200-315-5
EC Name:
Urea
Cas Number:
57-13-6
Molecular formula:
CH4N2O
IUPAC Name:
Urea
Test material form:
solid
Details on test material:
Name of the test chemical: Urea
Molecular Weight: 60.0556 g/mol
Molecular Formula:CH4N2O
InChI: 1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Urea
Molecular Weight: 60.0556 g/mol
Molecular Formula:CH4N2O
InChI: 1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)
Substance Type: Organic
Physical State: Solid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
8471 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
8 471 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % mortality observed
Mortality:
not specified
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be 8471 mg/kg bw when rat were treated with Urea.
Executive summary:

In a acute oral toxicity study,rats were treated with Urea orally. 50 % mortality observed was observed in treated rats at 8471 mg/kg bw. Therefore,LD50 was considered to bemg/kg bw when rats were treated with Urea.