Registration Dossier
Registration Dossier
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EC number: 473-450-2 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-Mar-2006 to 14-Apr-2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- No. 338 Red
- IUPAC Name:
- No. 338 Red
- Details on test material:
- - Substance type: Red powder
- Lot/batch No.: 50670
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium : TA1535, TA1537, TA98 et TA100. Escherichia coli : WP2uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Concentration range in the range finding test (without and with metabolic activation): 15, 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without and with metabolic activation): 15, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test compound was soluble in DMSO and DMSO has been accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9
Migrated to IUCLID6: for WP2uvrA, TA100 and TA1535
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
Migrated to IUCLID6: for TA1537
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9
Migrated to IUCLID6: for TA98
- Positive control substance:
- other: 2-aminoanthracene for WP2uvrA, TA100, TA1535 and TA1537
- Remarks:
- with S9
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9
Migrated to IUCLID6: for TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in the revertant frequency over the dose range tested and/or a reproduceble increase at one or more concentrations in at least one bacterial strain with or without S9.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/plate)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/plate)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/plate)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed at the dose level of 5000 µg/plate.
- A pink colour, becoming darker with increasing concentrations, was noted from 150 µg/plate and above
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was observed at the dose level of 5000 µg/plate in the absence and presence of S9-mix in all tester strains.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
MUTAGENICITY
- In the absence of S9, no increases in the number of revertant colonies were observed
- In the presence of S9 the following dose related increases in the number of revertant colonies were observed
Range finding test
TA1535: 6.6-fold
TA1537: 4.7-fold
TA98: 78-fold
TA100: 9.6-fold
WP2uvrA: 9.5-fold
Main test
TA1535: 4.0-fold
TA1537: 15-fold
TA98: 126-fold
TA100: 11-fold
WP2uvrA: 8.8-fold
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
The test material was considered to be mutagenic.
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