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EC number: 201-837-6 | CAS number: 88-51-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
- Flammability
- Explosiveness
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the procedure prescribed by Ames et al. (Mut. Res. 21: 347-364, 1975) and was in principle similar to the OECD TG 471, however with following main deviations: neither TA102 nor a DNA repair-proficient E.coli WP2 strain was included as tester strain for detection of cross-linking mutagens. Furthermore, the evaluation of revertants was based on extinction measurement by means of an automatic analyser for microbiological purposes COBAS Bact designed by ROCHE, in conjunction with a Computer Hewlett-Packard 9816. Test considered sufficiently validated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (No strain for detection of cross-linking mutagens such as TA102 or the DNA repair-proficient E.coli WP2 strain as recommended by the OECD TG was tested.)
- Principles of method if other than guideline:
- The test was conducted according to the Ames procedure as described by Ames et al. (Mut. Res. 21: 347-364, 1975).
For analysis, the automatic analyser for microbiological purposes COBAS Bact designed by ROCHE was used, in conjunction with a Computer Hewlett-Packard 9816. - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-amino-6-chlorotoluene-3-sulphonic acid
- EC Number:
- 201-837-6
- EC Name:
- 4-amino-6-chlorotoluene-3-sulphonic acid
- Cas Number:
- 88-51-7
- Molecular formula:
- C7H8ClNO3S
- IUPAC Name:
- 2-amino-4-chloro-5-methylbenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 4-Amino-2-chlortoluol-5-sulfonsäure
- Analytical purity: No details on purity given in the study report
- Lot/batch No.: BASF
Constituent 1
Method
- Target gene:
- All strains are mutants from histidine auxotrophy (his) to histidine prototrophy (his+).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: defect in the excision repair system (uvrB)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fraction from the liver of Sprague-dawley rats treated with Aroclor 1254 mixed with a series of appropriate cofactors (MgCl2, KCl, glucose-6-phosphate, NADP, phosphate buffer)
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 3.4 to 2500 µg/mL
Main test, with and without S9 mix: 2.44, 9.77, 39.1, 156, 625, 2500 µg/mL - Vehicle / solvent:
- The substance was suspended in DMSO; the solvent alone was used for the negative controls.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (see solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- other: Daunorubicin-HCl 0.5 µg/mL PBS
- Remarks:
- TA 98
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 and TA 100
Migrated to IUCLID6: 0.083 µg/mL PBS
- Positive controls:
- yes
- Remarks:
- without S9 mix
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537
Migrated to IUCLID6: 5µg/mL DMSO
- Positive controls:
- yes
- Remarks:
- with S9 mix
- Positive control substance:
- other: 2-Aminoanthracene 0.17 µg/mL DMSO
- Remarks:
- TA 98 and TA 100
- Positive controls:
- yes
- Remarks:
- with S9 mix
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100 (because of inconsistent findings obtained for this strain when tested with 2-Aminoanthracene, testing with TA 1535 was repeated using Cyclophosphamide for positive control)
Migrated to IUCLID6: 50 µg/mL PBS
- Positive controls:
- yes
- Remarks:
- with S9 mix
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 1535
Migrated to IUCLID6: 133.3 µg/mL PBS
- Positive controls:
- yes
- Remarks:
- with S9 mix
- Positive control substance:
- other: Acridine orange 3.33 µg/mL DMSO
- Remarks:
- TA 1537
- Details on test system and experimental conditions:
- The histidine-auxotrophic bacteria were incubated in minimum medium in measurement chambers with a volume of 0.3 mL together with the test material at 37 °C. In the experiments in which the substance was metabolically activated, 20% of S9 mix was added to the minimum medium. At test initiation the medium contained 1 to 5x10E+6 bacteria/mL.
The minimum medium was Vogel-Bonner medium E, supplemented with 20 g/l glucose, 0.5 mg/l biotin and 0.4% nutrient broth (Difco Laboratories, Detroit, Michigan, U.S.A). The test material in the vehicle was added to the chambers in a volume of 10 µL.
For analysis, the automatic analyser for microbiological purposes COBAS Bact designed by ROCHE was used, in conjunction with a Computer Hewlett-Packard 9816.
Turbidity of the content of the chambers was measured automatically at the wave length of 546 nm at intervals of 20 min over a period of about 46 hours. The cultures were shaken prior to each measurement. Four measurement chambers were incubated per strain and per group (test and control group). In the first experiment for technical reasons the values for the first 6 hours were not registered.
For evaluation, the revertant growth in each of the chamber was determined by measuring the extinction at different time points during incubation (10, 20, 30 and 40 hours). - Evaluation criteria:
- A test substance is considered to be mutagenic in this test system if a dose-dependent increase in the number of chambers with revertant growth occurs. The time of the beginning of revertant growth gives an indication of the number of back-mutant bacteria induced. Growth-inhibiting effects can be observed simultaneously. Revertant growth appearing later than after 40 hours was considered to be spontaneous in origin and thus were interpreted as negative result.
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
- Remarks:
- (comparison of the number of back-mutant colonies in controls and treated cultures with the various concentrations of test item revealed no marked deviations)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (tested up to 2500 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of main test results expressed in revertant growth (+) or none (-):
Mutagenicity Test with COBAS BACT: Summary of Results in absence of S9 mix |
|||||
Strain |
Test group |
Chamber |
|||
1 |
2 |
3 |
4 |
||
TA 98 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
- |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
+ |
- |
|
156 µg/mL |
- |
- |
- |
- |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
|
TA 100 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
+ |
+ |
|
9.77 µg/mL |
+ |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
- |
|
156 µg/mL |
+ |
- |
- |
- |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
|
TA 1535 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
- |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
- |
|
156 µg/mL |
- |
- |
- |
- |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
|
TA 1537 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
- |
|
9.77 µg/mL |
- |
- |
- |
+ |
|
39.1 µg/mL |
- |
- |
- |
+ |
|
156 µg/mL |
- |
+ |
- |
+ |
|
625 µg/mL |
+ |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
Mutagenicity Test with COBAS BACT: Summary of Results in presence of S9 mix |
|||||
Strain |
Test group |
Chamber |
|||
1 |
2 |
3 |
4 |
||
TA 98 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
+ |
|
9.77 µg/mL |
+ |
- |
- |
- |
|
39.1 µg/mL |
+ |
- |
- |
- |
|
156 µg/mL |
- |
- |
- |
+ |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
|
TA 100 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
+ |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
- |
|
156 µg/mL |
- |
- |
- |
- |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control (2-Aminoanthracene!) |
- |
+ |
- |
- |
|
TA 1535 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
+ |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
- |
|
156 µg/mL |
- |
- |
- |
- |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
|
TA 1537 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
- |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
- |
|
156 µg/mL |
- |
- |
- |
+ |
|
625 µg/mL |
- |
- |
- |
- |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control |
+ |
+ |
+ |
+ |
Additional testing with TA 100, this time using Cyclophosphamide as positive control substance:
Mutagenicity Test with COBAS BACT: Summary of Results in presence of S9 mix |
|||||
TA 100 |
Neg. Control |
- |
- |
- |
- |
2.44 µg/mL |
- |
- |
- |
- |
|
9.77 µg/mL |
- |
- |
- |
- |
|
39.1 µg/mL |
- |
- |
- |
+ |
|
156 µg/mL |
+ |
+ |
- |
- |
|
625 µg/mL |
- |
- |
- |
+ |
|
2500 µg/mL |
- |
- |
- |
- |
|
Pos. Control (Cyclophosphamide) |
+ |
+ |
+ |
+ |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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