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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: no data on strains

Results and discussion

Test results
Species / strain:
other: no data on strains
Genotoxicity:
negative

Any other information on results incl. tables

Toxicity of the target chemical (Negative) is predicted from category members using read-across based on 61 values (Negative x61) from 5 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. "log Kow" - taking the weighted average value

2. "Similarity" - taking the weighted average value

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

1. Bacterial mutagenicity ISS STY

2. Genotoxicity OAS IS

The prediction is based on 61 neighbours' values, 61 of them equal to prediction.

Prediction confidence is measured by the p-value = 7.86E-30 (very strong confidence)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

By this read-across approach with a structural analogues, emerged that the substance 16a,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate has no genetic toxicity.