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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:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Quotation of National Toxicity Program database for experimental results. No experimental data; strains etc. given. Reporting of various QSAR predictions. No validation of QSARs.

Data source

Reference
Reference Type:
publication
Title:
Prediction of Salmonella mutagenicity
Author:
Zeiger E, Ashby J, Bakale G, Enslein K, Klopman G & Rosenkranz HS
Year:
1996
Bibliographic source:
Mutagenesis, 1996, 11(5), 471-484

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No details in publication
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99%

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98, TA100, TA1535
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat and hamster liver S9
Test concentrations with justification for top dose:
no data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA98, TA100, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Several SAR and QSAR methods were applied:

SA (structural alert; Ashby, J., Environ. Mutagen., 1985, 7, 919 -921)

SA+ (structural alert with intervention of expert judgement; Ashby)

CASE (Computer Automated Structure Evaluator, with learning sets from NTP and US-EPA)

TOPKAT

All gave consistent negative (non-mutagenic) predictions for 2 -hydroxybenzamide.

The ke procedure (Bakale G., et al, Carcinogenesis, 1987, 8, 253 -264) gave a questionable result, ke = 3.1

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The study is considered to be suitable for use as supporting information.