Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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 peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Gene mutation toxicity study of the test chemical
Author:
Muzall and Cook
Year:
1979
Bibliographic source:
Mutation Research

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical by performing the spot test.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: FD&C Red No. 2- Molecular formula: C20H11N2O10S3.3Na- Molecular weight: 604.4789 g/mol- Substance type: Organic- Physical state: No data- Purity: No data- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
other: frame-shift histidine mutants are TA1537 and TA98 and two base-pair substituted histidine mutants are TA1535 and TA100
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
The microsomal fraction (S9) was prepared from male Sprague-Dawley rats
Test concentrations with justification for top dose:
10-250 mg
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Captan
Details on test system and experimental conditions:
METHOD OF APPLICATION: In agar (Spot test)DURATION- Preincubation period: No data- Exposure duration: No data- Expression time (cells in growth medium): No data- Selection time (if incubation with a selection agent): No data- Fixation time (start of exposure up to fixation or harvest of cells): No dataSELECTION AGENT (mutation assays): No dataSPINDLE INHIBITOR (cytogenetic assays): No dataSTAIN (for cytogenetic assays): No dataNUMBER OF REPLICATIONS: No dataNUMBER OF CELLS EVALUATED: No dataDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No dataOTHER EXAMINATIONS:- Determination of polyploidy: No data- Determination of endoreplication: No data- Other: No dataOTHER: No data
Rationale for test conditions:
No data
Evaluation criteria:
Mutagenicity was indicated by a clustering of revertant colonies directly around the test material or at the edge of the inhibitory zone.
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TA1537, TA100, TA1535
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
The test chemical did not induce mutation is Salmonella typhimurium strain TA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. Spot test was performed at dose levels from 10-250 mg using Salmonella typhimurium strain TA98, TA1537, TA100, TA1535 with and without S9 metabolic activation system. Captan was used as positive control chemical and the solvent control used was DMSO. Mutagenicity was indicated by a clustering of revertant colonies directly around the test material or at the edge of the inhibitory zone. The test chemical did not induce clustering of revertant colonies directly around the test material or at the edge of the inhibitory zone using Salmonella typhimurium strain TA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.