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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study, non-standard method

Data source

Reference
Reference Type:
publication
Title:
Absence of urea toxicity in young pigs
Author:
Button, C. Joubert, J.P. Maartens, B.P.
Year:
1982
Bibliographic source:
Journal of the South African Veterinary Association 53(1): 67-68

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute oral dose, presented in feed
GLP compliance:
no
Remarks:
: older, published study
Test type:
other: investigative study: non-standard method
Limit test:
yes

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
Details on test material:
Laboratory grade urea.

Test animals

Species:
pig
Strain:
other: cross-Landrace
Sex:
male
Details on test animals or test system and environmental conditions:
Young male cross-Landrace piglets; 10 weeks old (litter mates). The piglets weighed 14, 16 and 13 kg. The piglets were housed in individual stalls, bedded with straw and had water freely available.

Administration / exposure

Route of administration:
other: oral dosing gun, and oral in feed
Vehicle:
other: water or feed
Details on oral exposure:
Testing commenced with acute oral doses of urea dissolved in water and administered by dosing gun. Following this piglets were fed a dry pig meal containing urea for 10 days. One piglet was given two further oral doses in water, and two piglets were fed the urea diet for a further 5 days (Table 1).
Each pig was offered 1 kg food per day.
Doses:
Various - see Table 1
No. of animals per sex per dose:
3 male piglets
Control animals:
no
Details on study design:
Three litter mates were exposed to urea via acute oral doses and in the feed.
Statistics:
No information available

Results and discussion

Preliminary study:
No information available
Effect levels
Sex:
male
Dose descriptor:
LDLo
Effect level:
> 16 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
other: No symptoms suggestive of urea toxicity were seen.
Gross pathology:
Pathology was not performed.
Other findings:
No other findings reported.

Any other information on results incl. tables

Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information : non-standard species Criteria used for interpretation of results: EU
Conclusions:
Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.
Executive summary:

Urea was non-toxic to a 10 week old pig in an acute dose as high as 16 g/kg bw. 10% mass/mass urea in pig food over a period of 5 days did not result in any signs of toxicity.