Hydrogen peroxide-urea

Acute Toxicity: other routes

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

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

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 levels

Effect levels 1

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

Effect levels 2

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).