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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable scientific journal, sufficient description of performed studies

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of substituted carbazoles in Salmonella typhimurium
Author:
LaVoie E., Briggs G., Bedenko V., Hoffmann D.
Year:
1982
Bibliographic source:
Mutation Research, 101 (1982), p. 141-150

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
9-ethylcarbazole
EC Number:
201-660-4
EC Name:
9-ethylcarbazole
Cas Number:
86-28-2
Molecular formula:
C14H13N
IUPAC Name:
9-ethyl-9H-carbazole

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254(R) induced rat liver S9-mix
Test concentrations with justification for top dose:
0, 5, 10, 25, 50, 100, 250 µg/plate with and without metabolic activation
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, N-Methyl-N-nitro-N-nitrosoguanidine, quinoline, chrysene, 2-aminoanthracene, picrolonic acid
Details on test system and experimental conditions:
METHOD OF APPLICATION:
in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls

Evaluation criteria:
Compound was considered mutagenic when the average number of revertants obtained at any dose level was at least twice that of the solvent control.
Statistics:
The average number of revertant colonies is calculated for each dose.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
positive
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation

The test item is mutagenic in S. typhimurium strain TA 100 in the presence of exogenous metabolic activation.
Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 5, 10, 25, 50, 100, 250 µg/plate. Under the conditions tested the test compound caused an increase in the number of revertant colonies in S. typhimurium TA 100 in the presence of metabolic activation.

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