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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from HSDB database

Data source

Reference
Reference Type:
other: Authoritative database
Title:
In vitro genetic toxicity for CAS 17796-82-6
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Ames Bacterial Reverse Mutation Assay was carried out for the substance
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(cyclohexylthio)phthalimide
EC Number:
241-774-1
EC Name:
N-(cyclohexylthio)phthalimide
Cas Number:
17796-82-6
Molecular formula:
C14H15NO2S
IUPAC Name:
N-(cyclohexylthio) phthalimide

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA-1535, TA-1537, TA-1538, TA-98, TA-100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0.1, 1.0, 10, 100 and 500 ug/plate
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:
Not specified
Rationale for test conditions:
Not specified
Evaluation criteria:
Not specified
Statistics:
Not specified

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA-1535, TA-1537, TA-1538, TA-98, TA-100
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: no mutagenic potential

Applicant's summary and conclusion

Conclusions:
2-(cyclohexylsulfanyl)-1H-isoindole-1,3(2H)-dione is determined to be negative in Ames Bacterial Reverse Mutation Assay.
Executive summary:

Ames Bacterial Reverse Mutation Assay was carried out to determine the genetic toxic effects of the substance2-(cyclohexylsulfanyl)-1H-isoindole-1,3(2H)-dione. The test used the Salmonella typhimurium TA-1535, TA-1537, TA-1538, TA-98, TA-100 strains at concentrations of 0.1, 1.0, 10, 100 and 500 ug/plate with and

without S9 metabolic activation. The substance 2-(cyclohexylsulfanyl)-1H-isoindole-1,3(2H)-dione was determined to be negative in Ames Bacterial Reverse Mutation Assay. Hence the substance is considered as Non mutant.