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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro DNA damage and/or repair study
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer-reviewed scientific journal

Data source

Reference Type:
Studies on the toxicity of coal tar dyes II. Examination of the biological reaction of coal tar dyes to vital body.
Yasuhide Tonogai, Yashio Ito, Masatomo Tati, youki ose and Takahiko Sato
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

Constituent 1
Reference substance name:
Constituent 2
Chemical structure
Reference substance name:
Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
EC Number:
EC Name:
Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
Cas Number:
Molecular formula:
disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
Test material form:
solid: particulate/powder
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)


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:
Vehicle / solvent:
- Vehicle(s)/solvent(s) used:DMSO
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
- 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
No data available

Results and discussion

Test results
Species / strain:
other: Bacillus subtilis/: H17(rec+)and M45(Rec-)
Metabolic activation:
not specified
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
Migrated from field 'Test system'.

Applicant's summary and conclusion

Interpretation of results (migrated information):

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 37C, 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.