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EC number: 618-690-2 | CAS number: 90982-32-4
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Mutagenicity Test in Industrial Safety and Health Law (1991), Ministry of labor of Japan, Japan Industrial Safety and Health Association, Tokyo.
- Deviations:
- no
- Principles of method if other than guideline:
- The reverse mutation test was done by preincubation method.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
- EC Number:
- 618-690-2
- Cas Number:
- 90982-32-4
- Molecular formula:
- C15H15ClN4O6S
- IUPAC Name:
- ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
- Test material form:
- solid
- Details on test material:
- - Purity: 98.5%
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate
- Test concentrations with justification for top dose:
- Dose finding test: 0, 156, 313, 625, 1250, 2500 & 5000 µg/plate
Main study: 0.02 to 313 µg/plate for Salmonella strains; 313 to 5000 µg/plate for Escherichia strain - Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene and 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Details on test system and experimental conditions:
- The reverse mutation test was done by preincubation method.
Stock cultures of tester strains were inoculated against the liquid growth medium and grown with shaking at 37°C for 8 hours. Densities of the fresh bacterial cultures were measured with turbidometer. 0.1 ml of a test solution, a 0.1 ml aliquot of one of the bacterial suspensions and 0.5 ml of either S9 mix for assay with metabolic activation or 0.1 M sodium-phosphate buffer (pH 7.4) for assay without metabolic activation were mixed in a sterilized test tube and incubated with gentle shaking at 37°C for 20 min. After preincubation, 2 ml of molten top agar was added to this mixture and then poured onto a minimal glucose agar plate. When the agar overlay solidified, these plates were incubated at 37°C for 48 hours. Two plates per one dose level were used for each assay. Revertant colonies were counted with the eye or a colony counter. The presence of the background lawn was observed using a stereoscopic microscope and microbial growth was checked. - Evaluation criteria:
- The test substance is positive in this assay when the mean number of revertants is more than double of the negative control value and when it increases significantly dose-dependent.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium strains TA1535, TA1537, TA98, TA100 and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDIES:
Preliminary tests with the highest dose level of 5000 µg per plate showed that microbial toxicity was observed against the S. typhimurium strains, but not against the E. coli strain. Based on these results, seven dose levels including the dose level to cause the microbial growth inhibition were selected for the S. typhimurium strains. For the Escherichia coli strain five dose level of 313 to 5000 µg per plate were selected.
Any other information on results incl. tables
Results of the main test (1st test) without S9 mix
Test substance concentration (µg/plate) |
Number of revertants (number of colonies/plate) |
||||
Base-pair change type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2 uvrA- |
TA98 |
TA1537 |
|
Solvent control |
88 |
9 |
15 |
11 |
8 |
0.02 |
|
5 |
|
|
|
0.04 |
|
10 |
|
|
|
0.08 |
|
8 |
|
|
6 |
0.15 |
|
12 |
|
11 |
2 |
0.3 |
|
5 |
|
8 |
4 |
0.6 |
|
4 |
|
13 |
2 |
1.2 |
|
0 |
|
8 |
3 |
2.4 |
|
|
|
7 |
1 |
4.9 |
44 |
|
|
6 |
1 |
9.8 |
43 |
|
|
0 |
|
20 |
35 |
|
|
|
|
39 |
26 |
|
|
|
|
78 |
0 |
|
|
|
|
156 |
0 |
|
|
|
|
313 |
0 |
|
15 |
|
|
625 |
|
|
14 |
|
|
1250 |
|
|
17 |
|
|
2500 |
|
|
18 |
|
|
5000 |
|
|
15 |
|
|
Positive control |
AF-2 |
NaN3 |
ENNG |
AF-2 |
9-AA |
Concentration (µg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
Number of revertants |
591 |
308 |
513 |
216 |
683 |
Results of the main test (1st test) with S9 mix
Test substance concentration (µg/plate) |
Number of revertants (number of colonies/plate) |
||||
Base-pair change type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2 uvrA- |
TA98 |
TA1537 |
|
Solvent control |
59 |
7 |
22 |
22 |
7 |
0.02 |
|
|
|
|
|
0.04 |
|
11 |
|
|
|
0.08 |
|
9 |
|
|
9 |
0.15 |
|
12 |
|
25 |
5 |
0.3 |
|
10 |
|
19 |
2 |
0.6 |
58 |
3 |
|
13 |
2 |
1.2 |
58 |
0 |
|
15 |
0 |
2.4 |
25 |
0 |
|
7 |
0 |
4.9 |
10 |
|
|
5 |
0 |
9.8 |
8 |
|
|
0 |
|
20 |
0 |
|
|
|
|
39 |
0 |
|
|
|
|
78 |
|
|
|
|
|
156 |
|
|
|
|
|
313 |
|
|
20 |
|
|
625 |
|
|
22 |
|
|
1250 |
|
|
19 |
|
|
2500 |
|
|
17 |
|
|
5000 |
|
|
21 |
|
|
Positive control |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
Number of revertants |
1420 |
322 |
914 |
319 |
270 |
Results of the main test (2nd test) without S9 mix
Test substance concentration (µg/plate) |
Number of revertants (number of colonies/plate) |
|||
Base-pair change type |
Frameshift type |
|||
TA100 |
TA1535 |
TA98 |
TA1537 |
|
Solvent control |
67 |
5 |
12 |
8 |
0.02 |
|
5 |
|
|
0.04 |
|
5 |
|
|
0.08 |
|
4 |
|
5 |
0.15 |
|
5 |
9 |
5 |
0.3 |
|
5 |
12 |
3 |
0.6 |
|
2 |
9 |
3 |
1.2 |
65 |
0 |
8 |
0 |
2.4 |
52 |
|
3 |
0 |
4.9 |
49 |
|
0 |
|
9.8 |
27 |
|
0 |
|
20 |
40 |
|
|
|
39 |
41 |
|
|
|
78 |
0 |
|
|
|
Positive control |
AF-2 |
NaN2 |
AF-2 |
9-AA |
Concentration (µg/plate) |
0.01 |
0.5 |
0.1 |
80 |
Number of revertants |
298 |
259 |
319 |
571 |
Results of the main test (2nd test) with S9 mix
Test substance concentration (µg/plate) |
Number of revertants (number of colonies/plate) |
|||
Base-pair change type |
Frameshift type |
|||
TA100 |
TA1535 |
TA98 |
TA1537 |
|
Solvent control |
73 |
12 |
24 |
10 |
0.02 |
|
|
|
|
0.04 |
|
8 |
|
|
0.08 |
|
6 |
|
7 |
0.15 |
|
6 |
20 |
6 |
0.3 |
78 |
4 |
18 |
5 |
0.6 |
58 |
4 |
15 |
3 |
1.2 |
42 |
2 |
13 |
0 |
2.4 |
36 |
0 |
15 |
0 |
4.9 |
38 |
|
8 |
0 |
9.8 |
21 |
|
0 |
|
20 |
0 |
|
|
|
Positive control |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration (µg/plate) |
1 |
2 |
0.5 |
2 |
Number of revertants |
1135 |
355 |
609 |
217 |
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic when tested in S. typhimurium and E. coli strains, with and without metabolic activation system.
- Executive summary:
The test substance was examined for the mutagenicity in bacterial assays using five different bacterial strains of Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA. The test was performed at five to seven dose levels of 0.02 to 5000 µg per plate. The number of revertants induced by the test substance in each strain was less than double of the solvent control value.
These findings led the conclusion that the test substance is not mutagenic under the test conditions employed.
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