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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 250-465-0 | CAS number: 31098-20-1
- 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
- Study period:
- 06 May - 01 Jun 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods for Determination of Toxicity, Annex to Directive 92/69/EEC, Part B, Method B.14. Other effects - Mutagenicity: Salmonella typhimurium - Reverse Mutation Assay. 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods for Determination of Toxicity, Annex to Directive 92/69/EEC, Part B, Method B.13. Other effects - Mutagenicity: Escherichia coli - Reverse Mutation Assay. 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese, Ministry of Health and Welfare, Guidelines for Toxicity studies of Drugs, 4 I, Bacterial Reverse Mutation Test, 1987.
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium 3-sulphonatopropyl acrylate
- EC Number:
- 250-465-0
- EC Name:
- Potassium 3-sulphonatopropyl acrylate
- Cas Number:
- 31098-20-1
- Molecular formula:
- C6H10O5S.K
- IUPAC Name:
- potassium 3-(prop-2-enoyloxy)propane-1-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): Sulphopropyl acrylate, potassium salt (SPA); acrylic acid; sulfopropyl ester; potassium salt 2-propenoic acid, sulfopropyl ester, potassium salt; potassium sulfopropyl acrylate
- Substance type: white powder
- Analytical purity: min. 99.4%
- Lot/batch No.: BA 9008
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- his operon (Salmonella strains)
trp operon (Escherichia coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system: cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- source of S9: Harlan Olac Ltd.
- method of preparation of S9 mix: male Sprague-Dawley rats were administered a single intra-peritoneal dose of Aroclor 1254 (500 mg/kg bw) in Arachis oil. On the fifth day after administration, the livers of the rats were removed and S9 fraction prepared through centrifugation at 9000 g. The S9 mix used in the experiment contained: S9 fraction (10% v/v), MgCl2 (8 mM), KCL (33 mM), sodium phosphate buffer pH 7.4 (100 mM), glucose-6-phosphate (5 mM), NADPH (4 mM), NADH (4 mM).
- quality controls of S9: The efficacy of each batch of S9 fraction was confirmed using 7,12-dimethylbenzanthracene and 2-aminoanthracene - Test concentrations with justification for top dose:
- First and second experiment: 312.5, 625, 1250, 2500 and 5000 μg/plate with and without metabolic activation
Additional dose levels for TA 98 in experiment 1: 39.06, 78.13 and 156.25 μg/plate with metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: the test substance is soluble in water up to 50 mg/mL
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N-nitro-N-nitrosoguanidine, 9-aminoacridine, 2-nitrofluorene, 2-aminoanthracene (see 'Any other information on results incl. tables' for details).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72 h
NUMBER OF REPLICATIONS: 3 plates per dose level, in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn
OTHER:
In a range-finding study, the effect of 5, 50, 500 and 5000 μg/plate of the test substance was assessed. Plates were also prepared without the addition of bacteria to assess the sterility of the test substance, S9-mix and phosphate buffer. Plates were incubated at 37°C for 72 h. - Evaluation criteria:
- The mutagenic activity of the test substance was evaluated according to:
1) If treatment produces an increase in revertant colony numbers of at least twice the concurrent solvent controls, with some evidence of a positive dose-response relationship, in two separate events, with any bacterial strain either in the presence or absence of S9-mix, it is considered to show evidence od mutagenic activity in this system.
2) If treatment with a test material does not produce reproducible increases of at least 1.5 times the concurrent solvent controls, at any dose level with any bacterial strain, it is considered to show no evidence of mutagenic activity in this test system.
3) If the results obtained fail to satisfy the criteria for a clear 'positive' or 'negative' response given in (1) and (2), the following approach is taken in order to resolve the issue of the material's mutagenic activity in this test system. (i) Repeat tests may be performed using modifications of the experimental method. (ii) The test data may be subject to analysis to determine the statistical significance of any observed increases in revertant colony numbers. - Statistics:
- Mean values of the three plates per dose level were calculated.
Statistical analysis was only used in cases where no clear positive or negative result was available, using procedures described by Mahon et al. (1989).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Other confounding effects: due to contamination of the plates, the results of 39.06, 78.13 and 156.25 μg/platewith metabolic activation for TA98 were disregarded in the first experiment
RANGE-FINDING/SCREENING STUDIES: The results were negative for all strains and dose levels tested (data not shown). The 5, 50 and 5000 μg/plate results for TA 98 and the 5 μg/plate results for TA 1538 were invalid due to contamination of the plates.
Any other information on results incl. tables
Table 1. Test results of Experiment 1 (plate incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||||
Base-pair substitution type |
Frameshift type |
||||||
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
TA 1538 |
||
- |
Solvent control |
124 |
13 |
61 |
21 |
12 |
13 |
– |
0 |
94 |
9 |
55 |
23 |
12 |
12 |
– |
312.5 |
101 |
11 |
57 |
25 |
11 |
18 |
– |
625 |
108 |
10 |
61 |
26 |
10 |
18 |
– |
1250 |
106 |
9 |
70 |
21 |
17 |
17 |
– |
2500 |
115 |
10 |
66 |
23 |
15 |
20 |
– |
5000 |
112 |
13 |
57 |
25 |
10 |
18 |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
NF |
9AC |
NF |
Concentrations (μg/plate) |
3 |
5 |
2 |
1 |
80 |
2 |
|
Mean No. of colonies/plate (average of 3) |
310 |
198 |
570 |
194 |
X |
377 |
|
+ |
Solvent control |
116 |
19 |
82 |
29 |
10 |
19 |
+ |
0 |
116 |
17 |
83 |
22 |
11 |
13 |
+ |
39.06 |
NT |
NT |
NT |
C |
NT |
NT |
+ |
78.13 |
NT |
NT |
NT |
C |
NT |
NT |
+ |
156.25 |
NT |
NT |
NT |
C |
NT |
NT |
+ |
312.5 |
103 |
19 |
57 |
31 |
16 |
14 |
+ |
625 |
105 |
14 |
69 |
32 |
16 |
17 |
+ |
1250 |
119 |
13 |
72 |
30 |
13 |
20 |
+ |
2500 |
117 |
11 |
66 |
31 |
13 |
12 |
+ |
5000 |
121 |
15 |
66 |
24 |
11 |
15 |
Positive controls, +S9 |
Name |
AA |
AA |
AA |
AA |
AA |
AA |
Concentrations (μg/plate) |
1 |
2 |
20 |
0.5 |
2 |
0.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
612 |
231 |
621 |
257 |
72 |
297 |
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
9AC = 9-aminoacridine
NF = nitrofluorene
AA = 2-Aminoanthracene
NT = not tested
C = contaminated
X = too many colonies to count accurately
Table 2. Test results of experiment 2 (plate incorporation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||||
Base-pair substitution type |
Frameshift type |
||||||
TA 100 |
TA1535 |
WP2 uvrA |
TA98# |
TA1537# |
TA 1538# |
||
- |
Solvent control |
104 |
9 |
71 |
25 |
11 |
10 |
– |
0 |
103 |
10 |
73 |
21 |
14 |
9 |
– |
312.5 |
96 |
15 |
64 |
26 |
15 |
13 |
– |
625 |
110 |
8 |
78 |
22 |
12 |
10 |
– |
1250 |
90 |
10 |
50 |
30 |
14 |
10 |
– |
2500 |
108 |
7 |
53 |
20 |
14 |
12 |
– |
5000 |
99 |
9 |
48 |
21 |
14 |
11 |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
NF |
9AC |
NF |
Concentrations (μg/plate) |
3 |
5 |
2 |
1 |
80 |
2 |
|
Mean No. of colonies/plate (average of 3) |
294 |
230 |
602 |
146 |
X |
300 |
|
+ |
Solvent control |
100 |
13 |
52 |
28 |
13 |
15 |
+ |
0 |
107 |
21 |
76 |
34 |
14 |
10 |
+ |
312.5 |
110 |
17 |
59 |
27 |
13 |
13 |
+ |
625 |
115 |
20 |
65 |
24 |
15 |
11 |
+ |
1250 |
97 |
14 |
61 |
28 |
15 |
18 |
+ |
2500 |
100 |
15 |
49 |
28 |
17 |
17 |
+ |
5000 |
98 |
14 |
54 |
26 |
18 |
19 |
Positive controls, +S9 |
Name |
AA |
AA |
AA |
AA |
AA |
AA |
Concentrations (μg/plate) |
1 |
2 |
20 |
0.5 |
2 |
0.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
551 |
229 |
494 |
216 |
70 |
242 |
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
9AC = 9-aminoacridine
NF = nitrofluorene
AA = 2-Aminoanthracene
NT = not tested
X = too many colonies to count accurately
# = data obtained form a separate experiment at a later date due to contamination
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test substance was negative with and without metabolic activation.
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.