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Diss Factsheets

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published public domain study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Toxicological Studies of Urea. Acute, Subacute and Chronic tests in Rats and Mice.
Author:
Sato, N., Aikawa, K., Sugimoto, T., Kotera, K., Tauchi, K., Tanaka, H., Ikada, K. & Igarashi, N.
Year:
1977
Bibliographic source:
Oyo Yakuri (Pharmacometrics) 13(5): 749-772

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute toxicity in the mouse following a single subcutaneous dose.
GLP compliance:
no
Remarks:
: older, published study
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
Details on test material:
No information available

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No information available

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
not specified
Details on exposure:
Single subcutaneous dose
Doses:
No information available
No. of animals per sex per dose:
5/sex
Control animals:
not specified
Details on study design:
Single subcutaneous dose
Statistics:
No information available

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
9 200 mg/kg bw
95% CL:
>= 8 600 - <= 9 800
Sex:
female
Dose descriptor:
LD50
Effect level:
10 700 mg/kg bw
95% CL:
>= 9 500 - <= 12 100
Mortality:
No information available
Clinical signs:
No information available
Body weight:
No information available
Gross pathology:
No information available
Other findings:
No information available

Any other information on results incl. tables

Signs of toxicity included sedation, loss of righting reflex and staggering gait. The acute subcutaneous LD50 values for urea in the mouse were calculated to be 9.2 (8.6 -9.8) and 10.7 (9.5 -12.1) g/kg bw in male and female mice, respectively.

Applicant's summary and conclusion

Conclusions:
Urea is of very low toxiicty by the subcutaneous route.
Executive summary:

Groups of male and female mice were administered a single dose of urea by subcutaneous injection. Signs of toxicity included sedation, loss of righting reflex and staggering gait. Acute subcutaneous LD50 values for urea in the mouse were calculated to be 9.2 (8.6 -9.8) and 10.7 (9.5 -12.1) g/kg bw in male and female mice, respectively. Urea was therefore found to be of very low toxicity.