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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.