Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- 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
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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 DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test conduct was not GLP conform but was in accordance with the current requirements for the UDS assay as mentioned in the OECD TG 482 (1986).
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 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Version / remarks:
- (1986)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
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-methylbenzenesulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 4-Amino-2-chlortoluol-5-sulfonsäure
- Analytical purity: commercial grade
- Lot/batch No.: BASF
- Stability under test conditions: stability was ensured by the sponsor
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- hepatocytes: isolated from a male Sprague-Dawley obtained from CIBA-GEIGY Tierfarm, Sisseln
- Details on mammalian cell type (if applicable):
- The freshly isolated hepatocytes from the male rat weighing about 194 g were cultivated in WILLIAMS' Medium E containing 10% fetal bovine serum
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 15.625 - 1000 µg/mL
UDS assay: 8, 40, 200 and 1000 µg/mL - Vehicle / solvent:
- The substance was suspended in DMSO; the solvent alone was used for the negative controls.
Controls
- Untreated negative controls:
- yes
- Remarks:
- (medium)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- Migrated to IUCLID6: (100 µM)
- Details on test system and experimental conditions:
- PRELIMINARY TOXICITY TEST
This test was performed to determine the highest concentration to be used in the DNA-repair assay. The suitable concentration
as the highest to be used in the DNA-repair test is determined according to following three criteria:
- a sufficiently large number of cells must adhere to the cover-slips;
- at least 25% of the cells must show viability upon examination by means of the vital-staining technique;
- a corresponding percentage of the cells must be in good condition upon morphological examination.
From the results of the toxicity test, the highest suitable concentration for the DNA repair assay was set at 500 µg/mL.
UDS ASSAY
First Experiment:
A series of compartments in Multiplates containing gelatinized THERMANOX cover-slips was seeded with 4 x 10E+5 cells per compartment (density 10 E+5 cells/mL; 4 mL/compartment).The cells were allowed to attach to the cover-slips during an attachment period of 1.5-2 hours. They were then washed and cultivated overnight in renewed medium (adhesion period). The compartments were filled with 4 mL of culture medium during the attachment period and with 2 mL during the adhesion period.
From the test item and from the positive control substance stock solutions were prepared, from each of which 20 µL were added to four compartments containing 2 mL medium. In the case of negative controls corresponding volumes of the vehicle and of the culture medium were added.
Immediately after addition of the test substance, 3H-thymidine was added (specific activity 20 Curies/mmol, obtained from the Radiochemical Centre, Amersham, England, Batch Nr. 135). 8 µCi in 8 µL was added to the 2 mL medium in each compartment. At the end of the incubation period of 5 hours the cells were washed twice with BSS and fixed with ethanol/acetic acid (3:1 v/v). The cover-slips were mounted on microscope slides and prepared for autoradiography. The exposure time was 6 days. The autoradiographs were stained with hematoxylin-eosine.
EVALUATION OF THE SLIDES
The background in the autoradiographs was determined in cell-free areas microscopically and was found to be negligibly low.
From each of the treatment groups and from the positive and the negative controls 150 nuclei in altogether three slides (50 cells/slide) were scored, the number of silver grains counted, the mean values and the standard deviations calculated. Counting of silver grains over the nuclei of the hepatocytes was carried out by means of an electronic counter (ARTEK Model 982) attached to a ZEISS microscope. Cells which were in the DNA-synthesis phase showed more than 120 silver grains/nucleus (0.1% of cells concerned); these cells were excluded from the determination of the silver grain/nucleus count. - Evaluation criteria:
- The test substance is generally considered to be mutagenic or carcinogenic if the mean number of silver grains per nucleus in relation to the negative controls is more than doubled at any concentration.
Results and discussion
Test results
- Species / strain:
- hepatocytes: isolated from a male rat
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Remarks:
- Comparison of the mean number of silver grains per nucleus in the negative controls and after treatment with the test item in the various concentrations revealed no marked differences.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (up to 1000 µg/mL, no cytotoxicity was evident.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TOXICITY TEST
The toxicity test was performed with concentrations of 15.625 to 1000 µg/mL. None of the tested concentrations proved toxic. Therefore the concentration of 1000 µg/mL was selected as the highest for the DNA-repair assay.
UDS ASSAY
The negative controls (medium and solvent) gave mean values of 1.65 +/- 1.17 and 1.54 +/- 0.97 grains per nucleus, respectively.
In the treated groups, the mean number of silver grains per nucleus were as follows:
8 µg/mL: 1.83 +/- 1.42
40 µg/mL: 1.89 +/- 1.36
200 µg/mL: 1.98 +/- 1.32
1000 µg/mL: 2.09 +/-1.47
Thus, the evaluation criteria for a positive result, that the mean number of silver grains per nucleus in relation to the negative controls has to be more than doubled at any concentration, was not fulfilled.
The positive control substance DMN showed a mean value of 22.2 +/- 9.75 silver grains per nucleus, thus having produced a marked increase when compared to negative control. - Remarks on result:
- other: strain/cell type: see above
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.