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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 peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Gene mutation toxicity study of the test chemical
Author:
Dillon et al
Year:
1994
Bibliographic source:
Mutagenesis

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:
The test chemical was studied for its ability to induce mutations in strains of Salmonella typhimurium
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: D&C red 9
- IUPAC name: Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- Molecular formula: C17H13ClN2O4S.1/2Ba
- Molecular weight : 888.952 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, other: TA98 and TA100
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 was prepared from Aroclor-induced male Fischer F344 rats
Test concentrations with justification for top dose:
0, 222, 444, 888, 1776 or 3552 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical is soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: Liquid preincubation

DURATION
- Preincubation period: 30 mins in gyratory water bath
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for increase in the number of revertants/plate
Statistics:
Mean ± SD

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
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 is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

The test chemical was studied for its ability to induce mutations in strains of Salmonella typhimurium TA98 and TA100.

 

The test compound was dissolved in DMSO and was tested at concentration of 0, 222, 444, 888, 1776 or 3552µg/plate using Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system. Preincubation assay was performed with a preicubation for 30 mins. The plates were observed for histidine independence. Concurrent solvent and positive controls were included in the study.

 

The test chemical is not mutagenic to the Salmonella typhimurium TA100 and TA98 in the presence and absence of liver S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.