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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:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is reported on RTECS database. The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2001
Report Date:
2001
Reference Type:
other: RTECS database
Title:
TU4152000
Author:
Canadian Center for Occupational Health and Safety
Year:
2010
Bibliographic source:
RTECS - Registry of Toxic Effects of Chemical Substances

Materials and methods

Principles of method if other than guideline:
No data.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 857 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 879 mg/kg bw
Based on:
test mat.
Mortality:
The animals died on the 3rd and 7th day.
Clinical signs:
In a clinical presentation of acute intoxication signs of adrenal insufficiency were observed: lethargy, slovenliness of animals` coat, bloody issues from a nasopharynx.
Body weight:
Weight loss was observed.

Any other information on results incl. tables

TOXIC EFFECT:

- Behavioral: somnolence (general depressed activity).

- Blood: hemorrhage.

- Nutritional and Gross Metabolic: weight loss or decreased weight gain.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 reported in male and female rats is higher than 2000 mg/kg bw. Thus, prednisolone was not considered an acute toxicant.