Registration Dossier
Registration Dossier
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EC number: 204-482-5 | CAS number: 121-57-3
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Sufficiently detailed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of Some Commonly Used Dyes
- Author:
- KING-THOM CHUNG, GEORGE E. FULK, AND A. W. ANDREWS
- Year:
- 1 981
- Bibliographic source:
- APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Oct. 1981, p. 641-648
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sulfanilic acid
- IUPAC Name:
- sulfanilic acid
- Details on test material:
- Test substance from Fisher Scientific Co., Fair Lawn, N.J.
Constituent 1
Method
- Target gene:
- uvrB
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:
- S9
- Test concentrations with justification for top dose:
- 1 - 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-aminoacridine, 2- nitrofluorene, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 30 min
NUMBER OF REPLICATIONS: 2 - Evaluation criteria:
- A compound was considered mutagenic when the number of revertants above background was at least twice the value of the historical control mean or twice the value of the current control mean, whichever was greater, and a dose-response curve could be demonstrated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Positive controls validity:
- valid
- 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
In a study similar to OECD test guideline 471, the test substance was not mutagenic. - Executive summary:
In a study similar to OECD test guideline 471, the test substance was not mutagenic.
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