Urea

Acute Toxicity: oral

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

Test material information

Constituent 1

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.