Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and reliable study carried out by OECD ToolBox 3.2.0. Meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
other: software
Title:
QSAR ToolBox 3.2.0.103
Author:
OECD
Year:
2014
Bibliographic source:
http://www.oecd.org/env/ehs/risk-assessment/theoecdqsartoolbox.htm

Materials and methods

Principles of method if other than guideline:
Read-across from category members
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Prednisolone
EC Number:
200-021-7
EC Name:
Prednisolone
Cas Number:
50-24-8
IUPAC Name:
11,17,21-trihydroxypregna-1,4-diene-3,20-dione

Test animals

Species:
rat

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 300 mg/kg bw

Any other information on results incl. tables

Toxicity of the target chemical (4.30E+03 mg/kg) is predicted from category members using read-across based on 1 values within the range 3.87E+03 - 3.87E+03 mg/kg from 1 nearest neighbours compared by prediction descriptors. Category members are single chemicals or mixtures and are selected based on the profile of the target chemical. Only chemicals having experimental data are listed in the category.

The target chemical FALLS within applicability domain of the prediction.

The descriptor values for the target chemical and the category members in case they are set of tautomers, set of metabolites or mixtures are calculated using the following rule(s):

1. "Similarity" - taking the weighted average value

The endpoint data used in the prediction is selected from the following database(s):

1. ECHA CHEM

The prediction is based on 1 values within the range 1.97 - 1.97, log(1/mol/kg)

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not acute toxicant by oral route.