Registration Dossier
Registration Dossier
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EC number: 237-081-9 | CAS number: 13601-19-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- No data available
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Compared to OECD test guidelines, this study has significant shortcomings, possibly affecting the outcome of the study, and therefore it is not considered reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1992)
- Deviations:
- yes
- Remarks:
- The highest recommended concentration of 5000 µg/plate was not tested; The positive controls in the absence of S9 were not acceptable; Only one plate per concentration was tested and no independent repeat was performed; recommended 5th strain not included
- GLP compliance:
- no
- Remarks:
- performed before GLP came into force.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetrasodium hexacyanoferrate
- EC Number:
- 237-081-9
- EC Name:
- Tetrasodium hexacyanoferrate
- Cas Number:
- 13601-19-9
- Molecular formula:
- C6FeN6.4Na
- IUPAC Name:
- tetrasodium hexamethanuidimidoylironbis(ylium)
- Details on test material:
- - Name of test material (as cited in study report): Manox Sodium Ferrocyanide
- The substance was received from Manox Ltd. in January 1977
- Physical state: Pale yellow crystals soluble in water
- Structural formula: Na4Fe(CN)6
Constituent 1
Method
- Target gene:
- Histidine gene
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:
- Rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- 4, 20, 100, 500 and 2500 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Phosphate buffer, pH 7.0
- Justification for choice of solvent/vehicle: The substance is soluble in water
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS: No replicates, one plate per concentration
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:
- At least a doubling of the mean negative control values was looked for at some concentration of the test substance if a mutagenic effect was to be suspected. Known mutagens normally produce at least a four-fold increase in one of the strains at optimal concentrations.
- Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- other: Yes, except for TA100 and TA1537 at which no doubling compared to the mean negative control values was observed.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- not valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- not valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The substance was completely dissolved on the plates at all concentrations.
Applicant's summary and conclusion
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