2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

2001

Report date:

2001

Reference 2

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

Test material information

Constituent 1

Reference substance name:

Prednisolone

EC Number:

200-021-7

EC Name:

Prednisolone

Cas Number:

50-24-8

Molecular formula:

C21H28O5

IUPAC Name:

11,17,21-trihydroxypregna-1,4-diene-3,20-dione

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 levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 857 mg/kg bw

Based on:

test mat.

Effect levels 2

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:

other: In a clinical presentation of acute intoxication signs of adrenal insufficiency were observed: lethargy, slovenliness of animals` coat, bloody issues from a nasopharynx.

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.