Registration Dossier
Registration Dossier
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EC number: 201-831-3 | CAS number: 88-44-8
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-and OECD testing guideline compliant study with well characterised test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Principles of method if other than guideline:
- Method: other: OECD Test Guidelines 471 and 472 "Genetic Toxicology (Salmonella typhimurium and Escherichia coli)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-aminotoluene-3-sulphonic acid
- EC Number:
- 201-831-3
- EC Name:
- 4-aminotoluene-3-sulphonic acid
- Cas Number:
- 88-44-8
- Molecular formula:
- C7H9NO3S
- IUPAC Name:
- 2-amino-5-methylbenzene-1-sulfonic acid
- Details on test material:
- Mitsuboshi Chemical Co., Ltd.: purity >99%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium (TA100, TA1535, TA98, TA1537); Escherichia coli (WP2uvrA)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from male rat liver, induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9mix and +S9mix: 0, 313, 625, 1250, 2500, 5000 ug/plate
- Vehicle / solvent:
- S9 from male rat liver, induced with phenobarbital and 5,6-benzoflavone
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: See details in test conditions below
- Details on test system and experimental conditions:
- number of replicate: 2
plates per test: 3
application: pre-incubation
positive control groups and the solvent:
without S9 mix; 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (TA98, TA100, WP2; DMSO), sodium azide (TA1535; pure water), 9-aminoacridine
(TA1537; DMSO)
with S9 mix; 2-aminoanthracene (all five strains; DMSO)
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium (TA100, TA1535, TA98, TA1537); Escherichia coli (WP2uvrA)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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'.
Any other information on results incl. tables
Salmonella typhimurium
Escherichia coli
TA100, TA1535, TA98, TA1537 WP2 uvrA
+ ? -
+ ? -
-S9 mix: [ ] [ ] [ * ]
[ ] [ ] [ * ]
+S9 mix: [ ] [ ] [ * ]
[ ] [ ] [ * ]
In each experiment, the positive control chemicals induced
the expected responses, indicating that the assay was
working satisfactorily.
Applicant's summary and conclusion
- Conclusions:
- This substance was not mutagenic to Salmonella typhimurium
and Escherichia coli.
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