Registration Dossier
Registration Dossier
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EC number: 242-355-6 | CAS number: 18472-87-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer-reviewed scientific journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the toxicity of coal tar dyes II. Examination of the biological reaction of coal tar dyes to vital body.
- Author:
- Yasuhide Tonogai, Yashio Ito, Masatomo Tati, youki ose and Takahiko Sato
- Year:
- 1 979
- Bibliographic source:
- The journal of toxicological sciences,Vol 4, 211-220,1979
Materials and methods
- Principles of method if other than guideline:
- Genetic toxicity were performed for erythrosine in Bacillus subtilis/: H17(rec+)and M45(Rec-) using Bacillus subtilis recombination assay.
- GLP compliance:
- not specified
- Type of assay:
- Bacillus subtilis recombination assay
Test material
- Reference substance name:
- Erythrosine
- IUPAC Name:
- Erythrosine
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): erythrosine (FD and C Red No. 3)
- Molecular formula (if other than submission substance): C20-H6-I4-Na2-O5
- Molecular weight (if other than submission substance): 879.86
- InChl Key (if other than submission substance): RAGZEDHHTPQLAI-UHFFFAOYSA-L
-Substance type- Organic
- Physical state: Solid (powder)
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: Bacillus subtilis/: H17(rec+)and M45(Rec-)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 10µM
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: as impregnation on paper disk
DURATION
- Exposure duration: 24 hrs
- Expression time (cells in growth medium): 24 hrs - Evaluation criteria:
- The length of growth inhibition of the bacterial streak was measured
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- other: Bacillus subtilis/: H17(rec+)and M45(Rec-)
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Erythrosine failed to induce gene mutation in Bacillus subtilis H17 (Rec+) and M45 (Rec-) in the rec assay. - Executive summary:
Erythrosine was tested for gene mutation in vitro in the bacterium Basillus subtilis H17 (Rec+) and M45 (Rec-) in the rec assay performed.
Agar plates were streaked with inocula of two strains and paper disk 8 mm of diameter, immersed with 10 µM of dye in DMSO solution, was placed on the surface so as to cover the beginning of the bacterial streaks. After incubation for 24 hrs at 37◦C, the length of growth inhibition of the bacterial streak was measured.
The length of growth inhibition was found to be 2mm in Rec+and 3mm in Rec-strains.
Erythrosine failed to induce gene mutation in Bacillus subtilis H17 (Rec+) and M45 (Rec-) in the rec assay.
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