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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
Reference substance name:
Salicylamide
EC Number:
200-609-3
EC Name:
Salicylamide
Cas Number:
65-45-2
Molecular formula:
C7H7NO2
IUPAC Name:
salicylamide
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.