Registration Dossier
Registration Dossier
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EC number: 277-918-5 | CAS number: 74543-22-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- A Compilation Of Genotoxicity And Carcinogenicity Data On Aromatic Aminosulphonic Acids
- Author:
- R. Jung, D. Steinle And R. Anliker
- Year:
- 1 992
- Bibliographic source:
- Food and chemical toxicology Vol 30, No. 7, pp 635-660, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Gene mutation for 6-aminonaphthalene-2-sulfonic acid was evaluated by bacterial gene mutation assay.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 6-aminonaphthalene-2-sulphonic acid
- EC Number:
- 202-208-9
- EC Name:
- 6-aminonaphthalene-2-sulphonic acid
- Cas Number:
- 93-00-5
- Molecular formula:
- C10H9NO3S
- IUPAC Name:
- 6-aminonaphthalene-2-sulfonic acid
- Test material form:
- other: Liquid
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): 2-aminonaphthalene-6-sulphonic acid
- Molecular formula (if other than submission substance): C10H9NO3S
- Molecular weight (if other than submission substance): 223.251 g/mol
- Substance type:Organic
- Physical state:Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-aminonaphthalene-6-sulphonic acid
- Molecular formula (if other than submission substance): C10H9NO3S
- Molecular weight (if other than submission substance): 223.251 g/mol
- Substance type:Organic
- Physical state:Liquid
Method
- Target gene:
- Ames Salmonella –Microsome test
Species / strain
- Species / strain / cell type:
- S. typhimurium, other:
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with
- Metabolic activation system:
- hepatic S-9 derived from the rat, hamster, monkey and humans.
- Test concentrations with justification for top dose:
- not specified
- Vehicle / solvent:
- No data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- not specified
- Rationale for test conditions:
- not specified
- Evaluation criteria:
- not specified
- Statistics:
- not specified
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other:
- Metabolic activation:
- with
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH:No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES:
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: other: bacterial gene mutation assay
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic effects were observed in Ames Salmonella –Microsome test genetic toxicity with metabolic activation study when 2-aminonaphthalene-6-sulphonic acid. exposed to Salmonella typhimurium.
- Executive summary:
In Ames assay of genetic toxicity study to Salmonella typhimurium which is treated with2-aminonaphthalene-6-sulphonic acid.The test performed in the presence of Aroclor-induced rat liver microsomalS-9cell fraction to observe the mutagenic effect of 2-aminonaphthalene-6-sulphonic acid. Non-mutagenic effects were observed with S 9 metabollic activation to Salmonella typhimurium when treated with 2-aminonaphthalene-6-sulphonic acid. Therefore 2-aminonaphthalene-6-sulphonic acid was considered to be non mutagenic . Hence the test substance cannot be classified as gene mutant in vitro.
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