Registration Dossier

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
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study was not conducted under GLP conditions. The study was a screening assay and not meant for classification purposes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Internal lab protocol: Huntingdon Research Centre Protocol MCB/101
Principles of method if other than guideline:
The study was a bacterial reverse mutation screening assay utilizing S. thyphimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): C4A
- Substance type: Mono-constituent
- Physical state: Not reported
- Analytical purity: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported

Method

Target gene:
Hisitidine operon.
Species / strain
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 mix
Test concentrations with justification for top dose:
0.1, 1, 10, and 100 ug/plate
Vehicle:
- Vehicle(s)/solvent(s) used: None
Controls
Negative controls:
no
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: TA 1535 and 100: beta-naphthylamine, TA 98 and 1538: 2-acetylaminofluorene, TA 1537: Neutral red
Details on test system and conditions:
METHOD OF APPLICATION: Not reported

DURATION
- Preincubation period: Not reported
- Exposure duration: Not reported
- Expression time (cells in growth medium): Not reported
- Selection time (if incubation with a selection agent): Not reported
- Fixation time (start of exposure up to fixation or harvest of cells): Not reported

SELECTION AGENT (mutation assays): Not reported

NUMBER OF CELLS EVALUATED: Not reported

DETERMINATION OF CYTOTOXICITY
- Method: Not reported
Evaluation criteria:
Not reported

Results and discussion

Test results
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not examined
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

Based on the results of the study, the test article was mutagenic in the Bacterial Reverse Mutation Assay in the presence and absence of metabolic activation.
Executive summary:

The mutagenic potential of the test article (CASRN 74993-03-6, Appearance, purity and batch not reported) was evaluated in the Bacterial Reverse Mutation Assay with S. thyphimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 in the presence and absence of a metabolic activation system (S9 mix).  The study was not GLP compliant. The test method was based on Huntingdon Research Centre Protocol MCB/101.  The test article (solvent not listed) was dosed at 0.1, 1, 10, and 100 ug/plate. Separate experiments were performed in the presence and absence of metabolic activation. Strain specific positive controls and vehicle controls were tested in parallel. The test article produced a 1 0 -270 -fold, dose related increase of control values in the number of revertant colonies in tester strains TA 1535, TA 98, and TA 100 in the presence and absence of metabolic activation. There was no increase in revertant colonies in treated TA 1537 and TA 1538 strains in the presence and absence of metabolic activation.  Based on the results of the study, the test article was mutagenic in the Bacterial Reverse Mutation Assay in the presence and absence of metabolic activation.