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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

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, IIkada K, and Igarashi N
Year:
1977
Bibliographic source:
Oyo Yakuri (Pharmacometrics) 13(5): 749-772
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
route. intravenous injection
GLP compliance:
no
Remarks:
pre-GLP study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
intravenous
Vehicle:
not specified
Doses:
not specified
No. of animals per sex per dose:
not specified

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 was 5.4 (4.9 – 5.9) g/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
5 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 was 5.3 (4.8 - 5.7) g/kg bw

Applicant's summary and conclusion

Conclusions:
The intravenous LD50 was > 5,000 mg/kg bw in male and female rats.
Executive summary:

Reportedly, the intravenous LD50was > 5,000 mg/kg bw in male and female rats (Sato et al., 1977).