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Toxicological information

Acute Toxicity: other routes

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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 literature study
Cross-reference
Reason / purpose:
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:
Investigation of toxicity following a single subcutaneous dose
GLP compliance:
no
Remarks:
: older published study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional information available

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
No information available

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
water
Details on exposure:
Single exposure
Doses:
No information is reported
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:
9 400 mg/kg bw
95% CL:
>= 8 200 - <= 10 800
Sex:
female
Dose descriptor:
LD50
Effect level:
8 200 mg/kg bw
95% CL:
>= 7 100 - <= 9 500
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

The acute subcutaneous LD50 of urea in male and female rats was found to be 9.4 (8.2 -10.8) g/kg bw and 8.2 (7.1 -9.5) g/kg bw, respectively.

Applicant's summary and conclusion

Conclusions:
Urea was found to be of very low acute toxicity by the subcutaneous route.
Executive summary:

Groups of Wistar rats (male and female) were administered single subcutaneous doses of urea. Signs of toxicity included sedation, loss of righting reflex and staggering gait LD50 values were found to be 9.4 (8.2 -10.8) g/kg bw and 8.2 (7.1 -9.5) g/kg bw in males and females respectively, indicating very low toxicity by this route. It is noted that the subcutaneous LD50 values are higher than the limit dose for acute dermal toxicity.